Search Results for "Topical Skincare"
Elizabeth T. Makino BS CCRA MBA,a Lily I. Jiang PhD,b Priscilla Tan BA,a Tsing Cheng PhD,a and Rahul C. Mehta PhDa
The growing male skincare market reflects the increased interest of men in addressing facial aging concerns and maintaining a healthy youthful appearance. Because of differences in skin structure and aging as well as in lifestyle and behavior, male facial skin presents unique challenges that may result in different priorities or treatment strategies compared to female skin. A clinical study was conducted to assess clinical efficacy and tolerability of a topical skincare treatment product that was developed to address several male facial skin concerns related to skin quality, skin aging, and shaving. The treatment product provided significant improvements in all clinical efficacy parameters including overall photodamage, tactile roughness, fine line/wrinkles, and coarse lines/wrinkles. Furthermore, significant improvements in erythema as well as dryness/scaling were observed. Subject self-assessment questionnaires showed that the treatment product was highly rated in both self-perceived efficacy as well as product attributes. Use of skincare treatment products that tackle specific male facial skin concerns could further optimize skin quality and support healthy and youthful looking skin in men.
J Drugs Dermatol. 2018;17(3):301-306.
Flor A. Mayoral MD,a Julie R. Kenner MD PhD,b and Zoe Diana Draelos MDc
The use of cosmeceuticals by patients is now commonplace. Without consultation and direction from an informed clinician, marketing pressures can lead consumers to make poor product choices that can result in wasted money and unsatisfactory outcomes. Skin professionals need a scientifically based, succinct tool to guide their patients toward best topical skincare practices. The Skin Health and Beauty PyramidTM is an educational framework and product guide created from extensive scientific literature and study review on ingredients, formulations and technologies affecting skin biology. This clinical tool can simplify product choices for physicians and clinicians in the process of professionally guiding patients toward the optimal use of topical products to achieve best outcomes for skin health and beauty.
J Drugs Dermatol. 2014;13(4):414-421.
Elizabeth T. Makino BS MBA,a Annie Jain MD,b Priscilla Tan BA,a Audrey Nguyen BS,a Alain Moga MSc,c Cécile Charmel,d Kuniko Kadoya PhD,a Tsing Cheng PhD,a and Rahul C. Mehta PhDa
Introduction: Air pollution continues to be a global health concern and recent studies have shown that air pollutants can cause skin damage and skin aging through several pathways that induce oxidative stress, inflammation, apoptosis, and skin barrier dysfunction. Preventive measures need to be considered to retain optimal skin health, and topical skincare products may be able to alleviate the negative effects of air pollution on skin. A randomized, double-blind, placebo-controlled clinical usage study was conducted to assess the efficacy and tolerability of a novel two-part skincare system (LVS) that was developed to provide protection against environmental skin aggressors including air pollution. After 8 weeks of use in subjects exposed to extremely high levels of pollution, LVS provided significant improvements compared to placebo in all clinical efficacy parameters including crow’s feet wrinkles, overall skin damage, skin tone evenness, tactile roughness, and visible redness. Subject self-assessment questionnaires showed that the treatment product was highly rated in self-perceived efficacy. Decreased SQOOH and MDA content in skin swab samples suggest that LVS helped to reduce oxidative stress in patients’ skin. Histological analyses of biopsy samples using biomarkers related to skin structure, damage and function (collagen IV, MMP1, CPD, and CD1a) further support the clinical benefits of LVS. Altogether, the presented study is among the first to show that topical skincare products can help to reduce pollution-induced skin damage and improve skin quality, especially when specifically formulated with active ingredients that combat the harmful effects of air pollutants.
J Drugs Dermatol. 2018;17(9):975-981.
No abstract details for the moment.
Heather Woolery-Lloyd, MD
This supplement to the Journal of Drugs in Dermatology
was supported by a medical education grant from Johnson & Johnson
Zoe Diana Draelos MD,a Tatiana Kononov BS MBA,b and Theresa Fox BSb
A 14-week single-center clinical usage study was conducted to test the efficacy of a peptide treatment serum and supporting skincare regimen in 29 women with mild to moderately photodamaged facial skin. The peptide treatment serum contained gamma-aminobutyric acid (GABA) and various peptides with neurotransmitter inhibiting and cell signaling properties. It was hypothesized that the peptide treatment serum would ameliorate eye and facial expression lines including crow’s feet and forehead lines. The efficacy of the supporting skincare regimen was also evaluated. An expert investigator examined the subjects at rest and at maximum smile. Additionally, the subjects completed self-assessment questionnaires. At week 14, the expert investigator found a statistically significant improvement in facial lines, facial wrinkles, eye lines, and eye wrinkles at rest when compared to baseline results. The expert investigator also found statistically significant improvement at week 14 in facial lines, eye lines, and eye wrinkles when compared to baseline results at maximum smile. In addition, there was continued highly statistically significant improvement in smoothness, softness, firmness, radiance, luminosity, and overall appearance at rest when compared to baseline results at the 14-week time point. The test regimen was well perceived by the subjects for efficacy and product attributes. The products were well tolerated with no adverse events.
J Drugs Dermatol. 2016;15(9):1100-1106.
Staci Brandt PA-C MBA MSa and Peter Lio MDb
Sensitive skin is a common skin complaint frequently associated with skin diseases or adverse reactions to cosmetic products. Manufacturers have produced numerous products targeted for patients with sensitive skin and frequently label these products as being hypoallergenic. This term implies that the product may be less likely to cause an allergic reaction and be better suited for those with sensitive skin. However, there is no federal regulatory definition of this term and products may not have clinical support of their claim. Patch testing ingredients is frequently done to identify potential irritants; however, patch-testing product formulations may provide more realistic expectations about potential skin sensitivity and help support claims of hypoallergenicity. Ten skincare products were assessed for their sensitizing potential and hypoallergenicity in 14 repeat insult patch test clinical studies, involving over 2,000 subjects. In these studies, the products were deemed to be hypoallergenic if there was no evidence of sensitization or allergic reactions. The results from these trials demonstrated that all ten products were well tolerated, showed no sensitization or allergic reactions, and support claims of hypoallergenicity.
J Drugs Dermatol. 2014;13(3):264-266.
The purpose of this supplement is to provide both the biological basis and clinical impact of several targeted products aimed at specific physiologic and pathologic states including aging skin, diaper dermatitis, occupational irritant dermatitis, and atopic dermatitis.
Skin aging is a combination of multifactorial mechanisms that are not fully understood. Intrinsic and extrinsic factors modulate skin aging, activating distinctive processes that share similar molecular pathways. One of the main characteristics of youthful skin is its large capacity to retain water, and this decreases significantly as we age. A key molecule involved in maintaining skin hydration is hyaluronic acid (HA). Concentration of HA in the skin is determined by the complex balance between its synthesis, deposition, association with cellular structures, and degradation. HA bio-equivalency and bio-compatibility have been fundamental in keeping this macromolecule as the favorite of the skincare industry for decades. Scientific evidence now shows that topically applied HA is unable to penetrate the skin and is rapidly degraded on the skin surface.
Topical "anti-aging" products, with their seemingly limitless list of ingredients, make extensive claims to reduce wrinkles, fine lines, and sun damage, among others. Sales in the United States alone for cosmeceutical products are expected to increase by 7.4% per year to $8.2 billion by 2012. However, in this enormous industry, there has been a significant lack of rigorous controlled trials of efficacy. It is difficult for both dermatologists and consumers to make informed decisions in a market that is yet to be clearly defined and regulated. We elucidate the scientific basis for, as well as the literature behind, common active ingredients found in products intended to reverse photoaging, discuss some interesting new activities, and provide a review of several comprehensive studies on over-the-counter (OTC) products.
J Drugs Dermatol. 2012;11(2):220-224.
Sophie Seité PhD,a Florence Benech PharmD,b Sandrine Berdah PhD,b Muriel Bayer PharmD,b Sophie Veyrat PharmD,b Evelyne Segot PharmD PhD,b Marcela Sakalikova Mgr,c Lucia Gibejova Mgr,c Hana Zelenkova MD PhDc
OBJECTIVE: The objective of these studies was to investigate whether a skincare product containing Ambophenol, Neurosensine, and La Roche-Posay thermal spring water formulated in a highly protective packaging can have an impact in the management of rosacea-prone skin subjects.
METHODS: Several studies were performed to evaluate the efficacy of this product in the management of rosacea prone skin, as either monotherapy or adjunctive therapy or to maintain the efficacy of a Metronidazole treatment. The first study was performed on 37 women aged 18-45 with added stage 2 erythro-couperosis, who applied test formula as monotherapy twice a day for 4 weeks. During a second study, a dermatological evaluation was performed on patients with stage I or II rosacea, a questionnaire containing information about patient characteristics, tolerance, clinical signs, symptoms and skin reactivity to “trigger factors” was completed by dermatologists at baseline and 2 months after treatment with the test formula as either monotherapy or adjunctive therapy. Finally, in a third study, 65 patients finishing a Metronidazole treatment applied once daily and the tested formula twice daily were divided into 2 groups using the test formula or vehicle control, twice a day for 8 weeks for the evaluation of efficacy as adjunctive therapy.
RESULTS: We noted that the test formula, as an adjunctive therapy, helped prolong the efficacy of a Metronidazole treatment. In monotherapy, there was a significant efficacy of the test formula associated with an excellent tolerance. A significant improvement of all the clinical signs and symptoms of rosacea and a reduction of the skin reactivity to "trigger factors" were shown.
CONCLUSIONS: These studies highlight the interest value and impact of a skincare product containing Ambophenol, Neurosensine, and La Roche-Posay thermal spring water formulated in a highly protective packaging in monotherapy or in combination with or after a therapeutic treatment in the management of patients suffering from rosacea.
J Drugs Dermatol. 2013;12(8):920-924.
C. Stanley Chan MDa and Jeffrey S. Dover MDa-c aSkinCare Physicians, Chestnut Hill, MA bDepartment of Dermatology, Yale University School of Medicine, New Haven, CT cDepartment of Surgery, Dartmouth Medical School, Hanover, NH
Safe and effective laser treatments are crucial, especially in darker-skinned individuals. Herein, we report our experience treating Fitzpatrick skin types IV to VI with a long-pulsed, 1,064-nm neodymium-doped yttrium aluminum garnet laser. With the right treatment settings, darkly pigmented individuals can undergo laser hair removal effectively.
J Drugs Dermatol. 2013;12(3):366-367.
Hilary Reich MD,a,b Irmina Wallander BA,a Lacie Schulte MS BA,a Molly Goodier BS,a and Brian Zelickson MDa
SUMMARY BACKGROUND: Many over the counter topical products claim to reverse the signs of cutaneous photo-damage. To date, the two most studied ingredients for improving the texture, tone, and pigmentation of the skin are topical retinoids and hydroquinone.1
OBJECTIVE: This split face study compares a mass market skincare regimen with a prescription skin care regimen for improvement in photo damaged skin.
METHODS: Twenty-seven subjects with moderate photo damaged facial skin were enrolled. Each subject was consented and assigned with the mass market anti-aging system (Treatment A) to one side of the face and the prescription anti-aging system (Treatment B or Treatment C) to the other side of the face. Treatment B contained 13 subjects whom did not use 0.025% Retinol cream. Treatment C contained 14 subjects who used a 0.025% Retinol Cream. Subjects had 4 visits over 12 weeks for digital photography and surveys. Photographs were evaluated by blinded physicians.
RESULTS: Physician objective analysis showed all three systems to have a statistically significant clinical improvement in photoaged skin seen in as little as 4 weeks of use. Participant’s surveys rated the mass market system higher than both of the professional systems for visible skin changes, ease of use, and likelihood to recommend to a friend. Twelve of twenty-seven subjects preferred the mass market system for overall improvement while twelve thought each system gave the same improvement.
CONCLUSION: This study demonstrates that a mass marketed skin care system can give similar clinical improvements in photo-aged skin as a professionally dispensed prescription system and the majority of participants preferred the mass-marketed system.
J Drugs Dermatol. 2016;15(1):37-44.
Nikhil Chakravarty,a,b Caitlyn Kellogg,b Jason Alvarez,b,c Ozlem Equils MD FAAP,b,d,e Margie Morgan PhDe
Exposure to various types of ultraviolet (UV) radiation from the sun has been linked to skin cancer. Use of sunscreen can reduce the damaging and carcinogenic effects of UV radiation. However, multiple chemicals in sunscreen can trigger allergic responses, making people less inclined to use sunscreen. Thus, finding natural, plant-based alternatives to sunscreen with similar efficacy has become an important area of research. Myrrh oil, extracted from the shrub Commiphora myrrha, has been used in the treatment of topical wounds and studies have shown that it may provide protection against solar radiation. This study sought to further investigate if C. myrrha oil can confer protection against UV radiation. A UV-sensitive strain of Saccharomyces cerevisiae was grown in petri dishes with one half covered by aluminum foil and the other half covered by clear polyethylene food wrap. The polyethylene half was treated with either SPF 15 or SPF 30 sunscreen, C. myrrha oil or a combination of C. myrrha oil and either sunscreen. The plates were exposed to sunlight. Colony death was quantified using visual estimation. While UV blocking by C. myrrha oil alone was not as effective as that by the synthetic sunscreen, the 1:1 combination of C. myrrha oil and SPF 15 sunblock was significantly more effective than SPF 15 sunblock alone to prevent S. cerevisiae death. These data suggest that naturally-based sunscreens supplemented with synthetic UV deterrents may provide a more holistic approach to prevent UV-induced skin damage.
J Drugs Dermatol. 2018;17(8):905-907.
Monique J. Vanaman Wilson MD,a Isabela T. Jones MD,b Joanna Bolton MD,c Lisa Larsen DO,d Douglas C. Wu MD PhD,e and Mitchel P. Goldman MDe,f
Purpose: Though hydroquinone (HQ) remains the gold standard for treatment of hyperpigmentation, concerns about its safety have prompted the development of HQ-free topical skin lightening systems.
Objective: To compare the efficacy and tolerability of a new HQ-free system and a popular HQ-based system for the improvement of facial hyperpigmentation and photoaging in darker skin types.
Methods: This investigator-blinded trial randomized 30 subjects of Fitzpatrick skin types III to VI with moderate to severe hyperpigmentation to a new 7-product HQ-free system or a 7-product HQ-based system for 12 weeks. At 4, 8, and 12 week follow-up visits, a blinded investigator assessed efficacy and tolerability using standardized scales. Subjects also performed a self-assessment at each visit.
Summary: Both the HQ-free and HQ-based systems produced significant improvements in Overall Hyperpigmentation that were sustained through week 12 (P=0.008, 0.0003). The HQ-based system demonstrated better improvement in overall hyperpigmentation at weeks 4, 8, 12 (P=0.01, 0.001, 0.003, respectively). Mottled Pigmentation Area Severity Index (MoPASI) scores improved with both systems (P=0.02, 0.01), with no statistically significant differences between the two treatment groups.
Subject-rated hyperpigmentation was not different between groups. Subjects reported significantly more discomfort with the HQ-free system at week 8 (P=0.02); otherwise, measures of irritation were the same between groups. All irritation was described as mild to moderate. At week 12, 100% of subjects in the HQ-free group and 92.3% of subjects in the HQ-based group were satisfied with their outcome.
Conclusion: Both a new HQ-free skincare system and a widely-available HQ-based system improved hyperpigmentation in Fitzpatrick skin types III to VI. Though the HQ-based system produced greater improvement in hyperpigmentation when compared to the HQ-free system, there was no difference in MoPASI scores between the treatment groups. Subjects were satisfied with both treatments and reported only mild to moderate irritation using either system.
J Drugs Dermatol. 2017;16(11):1127-1132.
Staci Brandt PA-C MBA MS,a Matthew H. Meckfessel PhD,a and Peter A. Lio MDb
Atopic dermatitis is a common skin disease characterized by eczematous eruptions and impaired skin barrier function. Patients,
as well as their families, frequently report reductions in quality of life. Pruritus, lack of sleep, and impaired social functioning
all contribute to this reduction. A skincare regimen of gentle cleansing and daily moisturization is integral to managing atopic
dermatitis. While there are a multitude of reports supporting the use of moisturizers, there is a paucity regarding the use of
cleansers, especially cleansers formulated with ingredients known to improve skin hydration. A clinical study was conducted to
assess the tolerability and cosmetic acceptability of a body wash formulated with the filaggrin break-down products arginine and
pyrrolidone carboxylic acid in subjects with atopic dermatitis-prone skin (Cetaphil® RestoraDerm® Body Wash). The results of this
study indicate that Cetaphil RestoraDerm Body Wash was well tolerated, reduced itch, improved quality of life, and was well-liked
by subjects with atopic dermatitis-prone skin.
J Drugs Dermatol. 2014;13(9):1108-1111.
Debbie M. Palmer DO and Jennifer Silverman Kitchin MD
It is believed that oxidative stress is caused by an imbalance between the production of reactive oxygen and a biological system’s
ability to neutralize the reactive intermediates. Oxidative damage occurs because of both intrinsic and extrinsic mechanisms. Together,
intrinsic and extrinsic damage are the primary causes of skin aging. The skin uses a series of intrinsic antioxidants to protect
itself from free radical damage. Naturally occurring extrinsic antioxidants have also been widely shown to offset and alleviate these
changes. Unlike sunscreens, which have an SPF rating system to guide consumers in their purchases, there is no widely accepted
method to choose antioxidant anti-aging products. ORAC (Oxygen Radical Absorbance Capacity) and ABEL-RAC (Analysis By Emitted
Light-Relative Antioxidant Capacity), are both accepted worldwide as a standard measure of the antioxidant capacity of foods, and are
rating systems that could be applied to all antioxidant skincare products. The standardization of antioxidant creams could revolutionize
the cosmeceutical market and give physicians and consumers the ability to compare and choose effectively
Quality-switched (QS) lasers and their applications have evolved greatly since the ruby laser's effect on tattoo ink was first reported in the
1960s. The 1983 description of selective photothermolysis explained the efficacy of QS lasers for the treatment of cutaneous pigmented
lesions and tattoos and cemented their status as the gold standard for these targets. Within the past decade, the uses for QS lasers have
expanded dramatically, including nonablative rejuvenation and the treatment of onychomycosis. Additional applications and refined techniques
and technologies promise to maintain the stature of QS lasers as an integral part of the laser surgeon's arsenal.
J Drugs Dermatol. 2012;11(11):1296-1299.
Jose Raúl Montes MD FACS FACCS and Elizabeth Santos DrPH
Men’s interest and participation in cosmetic procedures has increased in recent years; however, the factors that motivate or discourage men from undergoing these procedures is not well understood. To evaluate which factors impact men’s decisions towards cosmetic procedures, an observational, single-site, cross-sectional study utilizing a voluntary questionnaire was executed in a target population size of 209 men ≥21 years old who visited the study site from 2015 to 2017. A majority of the male respondents incorporate a basic skincare regimen into their daily routine (90%), have had experience with neurotoxin treatments (54%), and expressed interest in either neurotoxin or dermal filler treatments (77% and 83%, respectively). The main motivating reason to undergo a cosmetic procedure was pursuit of a youthful appearance and the main discouraging reasons were cost and time for appointments or recovery. This study suggests that a majority of our male patients have either embraced or are interested in cosmetic treatments, but the cost and time play a big role in their decision. As cosmetic providers, we should reflect a commitment to the male population through marketing efforts and offerings to increase participation in minimally invasive aesthetic procedures.
J Drugs Dermatol. 2018;17(9):941-946.
Hilary C. Reich MD,a Irmina Wallander BA,b Lacie Schulte BA,b Hilary Frickman BA,b
and Suzanne Flickenger BA,b Brian Zelickson MDb
The home beauty device market is rapidly growing, having more than tripled in the last four years. This study evaluates several
specific attachment heads using a novel home skincare platform (HSP). By incorporating multiple treatment heads for cleansing,
skin smoothing, and skin infusion, this device has the potential to address many potential treatment goals. The first subset of this
study is a blinded, randomized split-face study evaluating the efficacy of the HSP device with a standard brush head for make-up
removal and compares the HSP device to a currently marketed home cleansing device. The results show that the HSP cleansing
head was comparable to the leading home skin cleansing device on the market. The HSP’s skin smoothing head showed statistically
significant improvement in erythema and dryness over baseline levels with significant histologic changes including normalization
of epidermal thickness in only 10 days of use. This is comparable to and exceeds many well-studied antiaging treatments
after weeks and months of therapy. Finally, the infusion head demonstrated improvement in skin hydration over baseline levels.
J Drugs Dermatol. 2015;14(4):391-399.
James Q. Del Rosso DO FAOCD, Joseph Bikowski MD
Metronidazole was the first topical agent approved by the US Food and Drug Administration for the treatment of
rosacea. Several controlled studies have confirmed the efficacy and safety of topical metronidazole 0.75% gel, lotion
and cream and 1% cream for rosacea. At present, little data exists regarding the use of combination topical therapy in
rosacea management, although anecdotal evidence and preliminary studies suggest at least some additive benefit when
topical metronidazole is used in combination with sulfacetamide 10%/sulfur 5%. In this paper, the results of observational
experience evaluating topical metronidazole 0.75% gel used in combination with other topical rosacea therapies
and/or subantimicrobial dose doxycycline are reported.
Background: Although reliable prevalence data are not available, adult acne is thought to be somewhat common, and it is not unusual for patients
to have acne as well as early signs of skin aging. A novel anti-acne/anti-aging formulation (Treatment A) has been developed for daily use by
patients to address both signs of skin aging and facial acne vulgaris. The novel, non-prescription formulation includes several ingredients shown
to target factors underlying the pathogenesis of acne vulgaris while also addressing multiple components in the pathophysiology of skin aging.
Methods: A blinded, randomized, split-face study was conducted to evaluate and compare the tolerability and efficacy of the novel anti-acne/
anti-aging product in subjects with photodamaged skin and acne vulgaris relative to tretinoin cream 0.025% (Treatment B). All subjects also
were given supportive skincare, consisting of a cleanser, moisturizer, and sunscreen. Each treatment was assessed for its effects on subjects'
appearance, lesion count reductions, and tolerability.
Results: Treatment A produced statistically significantly greater improvements in skin tone evenness, skin tone clarity, and blemishes
and blotchiness. There were also statistically greater reductions in total lesion count for acne patients on the side of the face treated with
Treatment A compared to Treatment B; Treatment A was also associated with early (day 2) improvement in skin tone evenness and clarity,
tactile skin smoothness, and blemishes and blotchiness. Both treatments demonstrated favorable tolerability.
Conclusion: The novel topical anti-aging/anti-acne therapy (Treatment A) within a comprehensive skin care regimen of cleanser, moisturizer, and
sunscreen may maximize efficacy and tolerability and contribute to our armamentarium for treating both photodamage and acne at the same time.
J Drugs Dermatol. 2012;11(6):737-740
Snehal P. Amin MD, David J. Goldberg MD
Many effective and simple topical anesthetic products are available today and commonly used in medical and non-medical
settings. The increased use of topical anesthetics, especially by non-physicians in the medical and non-medical settings,
has resulted in increased rates of complications including ineffective anesthesia, allergy, and even potential fatalities.
This review focuses on various techniques and formulations for topical anesthesia and their appropriate applications
in cosmetic and laser dermatology. In addition, the history, pharmacology, and clinical complications of topical
anesthetics are discussed.
Brad A. Yentzer MD, Richard W. McClain BS, Steven R. Feldman MD PhD
Background: Guidelines support this use of topical retinoids as a fundamental part of acne treatment regimens. However, existing
dogma holds that topical retinoids may initially worsen acne.
Purpose: To review the available data from clinical trials for evidence of initial worsening of acne with topical retinoids.
Methods: A PubMed and Google Internet search was performed for sources indicating or refuting worsening of acne with topical
Results: No primary data from clinical trials were identified to support the dogma of acne worsening secondary to topical retinoids.
Available data point to topical retinoids improving acne, even during the first couple weeks of treatment.
Conclusion: It is unlikely that acne worsens or "flares" due to the initiation of topical retinoids. Some acne patients may have worsening
of acne during the first week or two as part of the natural disease process.
Marta I. Rendon MD FAADa and Sylvia Barkovic BAb
The bene ts of monotherapy with hydroquinone for melasma and retinoids for photodamaged skin is well established. Here we report results of a hydroquinone skincare regimen designed for melasma treatment combined with a cosmetic retinol cream on subjects presenting with both melasma and facial photodamage in a 24-week study. Improvement in melasma and photodamage ef cacy pa- rameters of melasma pigmentation intensity and melasma area and severity index (MASI), as well as overall photodamage and mottled hyperpigmentation were found by week 4, the rst post-baseline time point. By week 8 signi cant improvements were also found in melasma disease severity assessment, tactile roughness, ne wrinkles, crepiness, actinic lentigines, and laxity. By week 18 signi cant reduction in coarse wrinkles was evident. Bene ts persisted through the study end on the panel of 31 subjects, with over 3⁄4 of par- ticipants demonstrating improvements in 10 of the 11 graded attributes. For the remaining attribute, coarse wrinkling, approximately 50% of the panel showed improvement. The regimen produced an average of “marked improvement” in melasma severity (51-75% improvement). Results of tolerance evaluations documented overall treatment mildness for a majority of the study participants. Subject questionnaires concur with high ratings of the study regimen for tolerability, ef cacy perception, product aesthetics and overall treat- ment satisfaction in subjects of Fitzpatrick Skin Type III-VI classi cation with melasma and photodamage in mild-to-moderate severity.
J Drugs Dermatol. 2016;15(11):1435-1441.
Jennie B. Nally MD, Diane S. Berson MD
Therapeutic options for rosacea include topical agents, oral therapies, laser and light treatments, and surgical procedures.
Topical therapies play a critical role in the treatment of patients with papulopustular rosacea and erythematotelangiectatic
rosacea, and have the ability to effectively minimize certain manifestations of the disease, including papules, pustules, and
erythema. The 3 primary agents for the topical treatment of rosacea are metronidazole, azelaic acid, and sodium sulfacetamide-
sulfur. Each of these therapies is approved for the treatment of rosacea and has been validated by multiple studies.
Additional topical therapies including benzoyl peroxide, clindamycin, retinoids, topical steroids, calcineurin inhibitors, and
permethrin are not approved for the treatment of rosacea and play variable roles in the management of this condition.
The primary treatment for superficial fungal infections is antifungal topical formulations, and allylamines and azoles represent the two major classes of topical formulations that are used to treat these infections. The stratum corneum (SC) is composed of keratinocytes that are surrounded by a matrix of lipids. The efficacy of topically applied formulations depends on their ability to penetrate this lipid matrix, and the vehicle plays an integral role in the penetration of active molecule into skin. There are several challenges to formulating topical drugs, which include the biotransformation of the active molecules as they pass through the SC and the physical changes that occur to the vehicle itself when it is applied to the skin. This article will review current and emerging topical antifungal vehicles.
J Drugs Dermatol. 2016;15(Suppl 2):s44-48.
Suzanne Bruce MD,a Jwala Karnik MD,b Laurence Dryer PhD,c and David Burkholder PhDd
BACKGROUND AND OBJECTIVES: The etiology of aging human skin includes intrinsic physiologic changes greatly accelerated by photoaging,
predominantly through exposure to UV light. Consumer interest and demand for anti-aging skin care products is extremely high especially
in light of aging populations. Prenatal (fetal) tissue has been shown to possess healing characteristics and regenerative effects.
A proprietary tissue engineering technology has been developed to produce a soluble human extracellular matrix material with growth
factors and proteins. Neonatal cells are cultured on microbeads under conditions of low oxygen tension. This human cell-conditioned
media (hCCM) contains a variety of growth factors and cytokines similar to those found in fetal cells and has been incorporated into a
topical preparation for use in facial wound healing (after laser resurfacing procedures) and improving the appearance of aging skin. The
objective of this study was to observe the effects of an MRCxTM-containing topical skincare regimen on subjects with demonstrated
aging skin damage (photodamage) when used consistently over a 3 month time period.
METHODS: Female subjects age 35-65 with Fitzpatrick Skin Type I-IV and mild to moderate amounts of photodamage, fine lines, and
wrinkles used Regenica® Replenishing Crème and Regenica® Renew SPF 15 for 3 months. At each visit, photos were taken of subjects
while investigators completed skin grading assessments and subjects completed self-assessments. Investigator assessments
included evaluation of tactile roughness, visual texture, wrinkles, blotchiness, skin tone evenness, radiance, and translucence on a
5-point scale. Subjects’ self-assessments included assessment of fine lines and wrinkles, firmness, evenness of skin tone, brightness,
resilience, clarity, and radiance. Changes from baseline were evaluated for each parameter and P values for changes from baseline to
each study visit for investigator’s assessments and to end-of-study for self-assessments were calculated.
RESULTS: Eighteen of 21 enrolled female subjects completed the study. Three subjects chose to drop from the study. Statistically significant
improvements in investigator assessments of tactile roughness, visual texture, wrinkles, blotchiness, skin tone evenness, radiance
and translucency compared to baseline were observed at weeks 4, 8, and 12 after initiating treatments. Progressive improvement
was seen through the last study visit (visit 5, week 12). Similar statistically significant improvements in subjects’ self-assessments
were seen comparing the first post-baseline visit (visit 2, week 2) to subsequent visits. 93.5 % subjects agreed (somewhat or strongly)
with all of the positive subject assessment statements at week 12. Importantly, 100 % of subjects indicated at the end of the study
that they would recommend the product to a friend and would want to purchase the product. No treatment-related adverse events
were recorded during the study.
CONCLUSIONS: Regenica was safe and clinically effective in reducing anti-aging effects in this group of female subjects aged 35-65 years
as measured by both investigator assessments and subjects’ self-assessments.
J Drugs Dermatol. 2014;13(9):1074-1081.
Jeff Freed MD, Michael Wells MD, Cloyce Stetson MD, Dongwoo Lee MS
We describe a patient with mycosis fungoides who developed a bulla shortly after the start of topical methchlorethamine.
Dermal-epidermal separation has been reported to occur with topical methchlorethamine on histological examination.
It is plausible that the compromised dermal-epidermal junction may manifest as a clinical bulla after a secondary insult. To
our knowledge, clinical bulla formation due to topical methchlorethamine has not been reported.
Steven B. Deliduka MD, Pearl C. Kwong MD PhD
Nevus comedonicus is a rare developmental defect of the pilosebaceous unit. It is also thought to be a variant of epidermal nevus.
Previously reported treatments include surgical excision, CO2 laser, dermabrasion, extraction, topical retinoic acid, and numerous topical
We present a case of a 7-year-old boy with bilateral nevus comedonicus who experienced cosmetic improvement with topical
tazarotene and calcipotriene cream. This combination represents a novel therapeutic approach to the treatment of this cutaneous
Data continue to establish the role of inflammation, not only in the pathogenesis of acne but also in the development of its most devastating
sequelum, scarring. Although topical therapy is preferred by most acne patients and the physicians who treat them, historically
no topical intervention has provided primarily anti-inflammatory effects. Topical dapsone 5% gel offers documented efficacy for
the reduction of both inflammatory and non-inflammatory acne lesions. It has been proven safe, presenting none of the hematologic
risks associated with oral dapsone. Data suggest the vehicle formulation enhances healing and contributes to tolerability, making
topical dapsone 5% gel a worthwhile anti-inflammatory treatment for many patients with mild-to-moderate acne vulgaris.
Divya Railan MD, Tina S. Alster MD
Topical anesthetic agents are frequently used by dermatologists to decrease the pain associated with a variety of cutaneous
procedures, including laser surgery, soft tissue augmentation, and other cosmetic surgical treatments. These lidocaine-containing
creams play an integral role in the cosmetic dermatology office by providing patient comfort with minimal side
effects. This review of topical lidocaine preparations should aid practitioners in the selection of an appropriate topical
anesthetic, taking into consideration its onset and duration of action and potential side effects.
Nikhil G. Rao, BA and Robert J. Pariser, MD
Annular erythema is an unusual, often idiopathic disorder that tends to respond poorly to topical therapy.
Two patients with idiopathic, topical corticosteroid-resistant annular erythema showed prompt clearing of
lesions treated with 0.1% tacrolimus ointment and persistence of untreated ones which themselves responded
to subsequent treatment.
These two cases demonstrate a clear-cut therapeutic response of chronic, topical corticosteroid-resistant annular
erythema to topical tacrolimus ointment 0.1% BID. Additional experience with tacrolimus ointment, hopefully
in controlled circumstances, should clarify its potential value in treating annular erythema.
Sung Won Lee MD, Margit Juhasz MD, Pezhman Mobasher MD, Chloe Ekelem MD, and Natasha Atanaskova Mesinkovska MD PhD
Introduction: Currently, only topical minoxidil (MNX) and oral finasteride (FNS) are approved by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of androgenetic alopecia. Although FNS is efficacious for hair regrowth, its systemic use is associated with side effects limiting long-term utilization. Exploring topical FNS as an alternative treatment regimen may prove promising.
Methods: A search was conducted to identify studies regarding human in vivo topical FNS treatment efficacy including clinically relevant case reports, randomized controlled trials (RCTs), and prospective studies.
Results: Seven articles were included in this systematic review. In all studies, there was significant decrease in the rate of hair loss, increase in total and terminal hair counts, and positive hair growth assessment with topical FNS. Both scalp and plasma DHT significantly decreased with application of topical FNS; no changes in serum testosterone were noted.
Conclusion: Preliminary results on the use of topical FNS are limited, but safe and promising. Continued research into drug-delivery, ideal topical concentration and application frequency, side effects, and use for other alopecias will help to elucidate the full extent of topical FNS’ use.
J Drugs Dermatol. 2018;17(4):457-463.
Erika C. von Grote PhD, Kiruthi Palaniswamy PharmD, and Matthew H. Meckfessel PhD
Occupational irritant contact dermatitis (ICD) affecting the hands is a common and difficult-to-manage condition. Occupations that necessitate contact with harsh chemicals, use of alcohol-based disinfectants, and frequent hand washing elevate the risk of ICD. Management strategies that do not adequately prevent accumulated damage and repair skin, can develop into chronic dermatoses which negatively impact work productivity and quality of life. A 2-step skin-care regimen (Excipial Daily Protection Hand Cream (EP) and Excipial Rapid Repair Hand Cream (ER), Galderma Laboratories, L.P.) has been developed as a daily-use management strategy to protect and repair vulnerable hands. The protective barrier cream is formulated with aluminum chlorohydrate and designed for pre-exposure application to enhance the skin’s natural protective barrier and minimize excessive moisture while wearing protective gloves. The repair cream, a lipid-rich formulation, is intended for post-exposure application to rehydrate and facilitate the skin’s natural healing process. The results of 3 clinical studies highlighted in this review demonstrate how the use of a 2-step skin-care regimen offers a greater protective effect against ICD than the use of barrier cream alone, and also how the formulation of the barrier cream used in these studies helps minimize the occlusion effect caused by gloves and does not interfere with the antibacterial efficacy of an alcohol-based hand sanitizer. This 2-step skin-care regimen is effectively designed to manage and minimize the risk of ICD development in a variety of patients and provides clinicians an additional tool for helping patients manage ICD.
J Drugs Dermatol. 2016;15(12):1504-1510.
James Q. Del Rosso DO FAOCD
Combination therapy is the standard of care in the management of acne vulgaris. It is essential to treat as many aspects
of acne pathogenesis as possible. Due to increasing insensitivity of Propionibacterium acnes to antibiotics, the concomitant
use of other topical agents that exhibit other modes of antibacterial and anti-inflammatory activity is integral to the
successful treatment of acne. The combination of topical benzoyl peroxide and clindamycin gel has been shown to be
more effective than either agent alone. The addition of a topical retinoid may further enhance therapeutic results. This
12-week study evaluated the safety and efficacy of initial topical benzoyl peroxide 5%/clindamycin 1% gel as monotherapy
and in combination with adapalene gel versus adapalene gel monotherapy in the management of acne.
Leon H. Kircik MDa and Panagiotis Zografos MScb
Psoriasis is a chronic inflammatory skin disease where the use of topical corticosteroids is a mainstream treatment. However, the continuous use of high potency topical corticosteroids is limited by a variety of well known adverse events which include, atrophy, and telangiectasia. Also, inhibition of lipid synthesis by steroids can cause impairment of the epidermal barrier, which is already disrupted in most of the inflammatory cutaneous disorders such as psoriasis. This will further lead to increase transepidermal water loss (TEWL), decreased hydration, dry skin, and irritation. On the other hand, topical vitamin D analogs directly affect keratinocyte proliferation and differentiation as well as modulation of epidermal lipids and antimicrobial peptides. Although the exact mechanism of action of topical vitamin D analogs is not well understood in the treatment of psoriasis, their efficacy and safety has been shown in several clinical trials over the years and they are widely used for psoriasis. Therefore, combination of topical steroids and vitamin D analogs may be a logical option for the treatment of psoriasis.
J Drugs Dermatol. 2015;14(10):1113-1116.
Steven R. Feldman MD PhD
Topical treatment is a pillar of dermatologic practice. The delivery of drug by a topical vehicle is dependent on complex physical chemistry and on how well patients apply the product. The potency of topical agents is not solely dependent on the concentration of active drug in the vehicle. A corticosteroid molecule may have vastly different potency depending on what vehicle is used to deliver it. Similarly, a new gel vehicle is able to deliver considerably more active antifungal than an older vehicle technology and may represent a promising vehicle for other novel formulations. The use of new vehicles can provide more effective means for treating patients with skin disease.
J Drugs Dermatol. 2014;13(4):423-427.
Alan D. Widgerow MBBCh MMed FCS FACS,a Sabrina G. Fabi MD FAAD FAACS,b
Roberta F. Palestine MD,c Alexander Rivkin MD,d Arisa Ortiz MD FAAD,b Vivian W. Bucay MD FAAD,e
Annie Chiu, MD,f Lina Naga MD,g Jason Emer MD,h and Paul E. Chasan MD FACSi
Normal aging and photoaging of the skin are chronic processes that progress gradually. The extracellular matrix (ECM), constituting over 70% of the skin, is the central hub for repair and regeneration of the skin. As such, the ECM is the area where changes related to photodamage are most evident. Degradation of the ECM with fragmentation of proteins significantly affects cross talk and signaling between
cells, the matrix, and its constituents. The accumulation of collagen fragments, amorphous elastin agglutinations, and abnormal cross-linkages between the collagen fragments impedes the ECM from its normal repair and regenerative capacity, which manifests as wrinkled, non-elastic skin. Similar to how the chronic wound healing process requires wound bed preparation before therapeutic intervention, treatment of chronic aging of the skin would likely benefit from a “skin bed preparation” to optimize the outcome of rejuvenation procedures and skin maintenance programs. This involves introducing agents that can combat stress-induced oxidation, proteasome dysfunction, and non-enzymatic cross linkages involved in glycation end products, to collectively modulate this damaged ECM, and upregulate neocollagenesis and elastin production. Agents of particular interest are matrikines, peptides originating from the fragmentation of matrix proteins that exhibit a wide range of biological activities. Peptides of this type (tripeptide and hexapeptide) are incorporated in ALASTIN™ Skin Nectar with TriHex™ technology (ALASTIN Skincare, Inc., Carlsbad, CA), which is designed to target ECM modulation with a goal of optimizing results following invasive and non-invasive dermal rejuvenating procedures.
J Drugs Dermatol. 2016;15(Suppl 4):s63-s71.
Guy F. Webster MD PhD
Topical dapsone gel 5% is indicated for the treatment of acne vulgaris and has been marketed since late 2008. The topical formulation
retains the anti-inflammatory benefits of dapsone while minimizing the risk of toxicity associated with systemic exposure. This
review summarizes the pharmacokinetic and safety data of topical dapsone gel 5% in acne patients, including those with glucose-
6-phosphate dehydrogenase (G6PD) deficiency, and provides support for dapsone usage in sulfonamide-allergic patients. Overall,
topical dapsone gel has a favorable short- and long-term safety profile and has been shown to have no risk of hemolytic anemia,
including in G6PD deficient patients. Although there are some structural similarities between dapsone and sulfonamides, dapsone is
not a sulfonamide and cross-reaction with sulfonamides has not been demonstrated.
Savita Chaudhary MD Fellow ISDa and Surabhi Dayal MDb
BACKGROUND: Various treatment modalities are available for management of melasma, ranging from topical and oral to chemical peeling, but none is promising alone. Very few studies are available regarding efficacy of combination of topical treatment with chemical peeling. Combination of chemical peeling and topical regimen can be a good treatment modality in the management of this recalcitrant disorder.
OBJECTIVE: To assess the efficacy of combination of topical regimen (2% hydroquinone, 1% hydrocortisone and 0.05% tretinoin) with serial glycolic acid peeling in the treatment of melasma in Indian patients.
METHODS: Forty Indian patients of moderate to severe epidermal variety melasma were divided into two groups of 20 each. One Group i.e. peel group received topical regimen (2% hydroquinone, 1% hydrocortisone and 0.05% tretinoin) with serial glycolic acid peeling and other group i.e. control group received topical regimen (2% hydroquinone, 1% hydrocortisone, 0.05% tretinoin).
RESULTS: There was an overall decrease in MASI from baseline in 24 weeks of therapy in both the groups (P value < 0.05). The group receiving the glycolic acid peel with topical regimen showed early and greater improvement than the group which was receiving topical regimen only.
CONCLUSION: This study concluded that combining topical regimen (2% hydroquinone, 1% hydrocortisone and 0.05% tretinoin) with serial glycolic acid peeling significantly enhances the therapeutic efficacy of glycolic acid peeling. The combination of glycolic acid peeling with the topical regimen is a highly effective, safe and promising therapeutic option in treatment of melasma.
J Drugs Dermatol. 2013;12(10):1149-1153.
Ajith P. Kannangara MD, Denise Levitan MD, Alan B. Fleischer Jr. MD
Topical 5-fluorouracil (5-FU) has been used in the treatment of various benign and malignant tumors of the skin, but only few address its
therapeutic value on cutaneoues T-cell lymphoma. (CTCL). The authors report six cases of early stage CTCL responded to topical 5-FU.
All of these patients (four females and two males) with early stage CTCL (1A=4; 1B=1; 2B=1) had good response to topical 5-FU following
three to 18 months’ treatment. Four patients achieved complete response (CR) and two patients responded partially (PR). Tolerance
to the treatment was good, with the exception of mild irritation, with no patients reporting serious side effects. The overall efficacy,
relatively modest price and low incidence of side effects indicate that topical 5-FU has a place for treatment of early stage CTCL.
Laura F. Sandoval DO,a Scott A. Davis MA,a and Steven R. Feldman MD PhDa,b,c
BACKGROUND: Topical corticosteroids are the standard-of-care treatment for dermatitis, mild psoriasis, and other inflammatory skin diseases. Prescribing practices rely on knowledge of topical corticosteroid potency, as well as potential side effects including steroid allergies.
PURPOSE: The primary aim of this study is to determine how dermatologists classify particular topical corticosteroids according to potency, and which products they prefer in cases when allergenicity is a concern.
METHODS: The data were collected and analyzed from 105 US-based dermatologists surveyed at the 2011 Summer American Academy of Dermatology meeting.
RESULTS: The majority of dermatologists were in agreement on the potency ranking of many commonly prescribed topical corticosteroids. Two thirds of the surveyed dermatologists expressed concern about allergy to topical corticosteroids. In cases of a suspected allergy, desoximetasone was the leading product dermatologists would choose to prescribe.
LIMITATIONS: The survey was limited to attendees of an educational conference, possibly leading to an overestimation of dermatologist knowledge of topical steroids.
CONCLUSIONS: This study shows that dermatologists are generally knowledgeable about group classifications of corticosteroids in terms of potency and that they can appropriately select a topical product with low potential for allergy.
J Drugs Dermatol. 2013;12(7):786-789.
Zülal Erbagci MD, A. Almıla Tuncel MD, Ibrahim Erbagci MD
Porokeratosis is a group of cutaneous disorders of keratinization characterized by a predisposition to malignant transformation.
The condition, which may be associated with immune suppression, is usually resistant to therapy and has a high frequency
of recurrence. Imiquimod, a potent topical immune response modifier with antiviral, antitumor, and immunoregulatory
properties, is currently approved for the treatment of external anogenital warts and actinic keratosis. However, there
have been also several reports demonstrating its efficacy in a variety of premalignant and malignant conditions. We report
on 2 cases with immunosuppression-associated porokeratosis successfully treated with 5% topical imiquimod application.
Christopher I. Zoumalan MD FACS
Scar formation is the body’s natural healing response to reestablish dermal integrity following an injury. Excessive scarring, however, can cause significant cosmetic, functional, and psychological problems. A wide variety of topical creams, lotions, and oils are available for scar treatment or wound healing. Sieving through the options and selecting the best option for their patients can be challenging for clinicians, especially given that clinical evidence for many of the active agents in commonly used topical treatments is lacking. The goal of this review is to provide an overview of topical treatments utilized for scar management, including their mechanism of action and evidence of efficacy. As knowledge of the wound healing process is critical to understanding the effects of topical treatments, the pathophysiology of wound healing is also reviewed.
J Drugs Dermatol. 2018;17(4):421-425.
Laura K. Ganger MD, Iltefat H. Hamzavi MD
A common problem among aging women, salt and pepper facial hair poses a significant psychosocial impact as well as a challenge
for treatment. Various laser therapies or topical eflornithine HCl 13.9% cream are commonly used to reduce the rate
of hair growth. We report a case of a woman with salt and pepper hair in the beard distribution. A combination of laser hair
removal with concurrent use of topical eflornithine was used in the treatment.
Steven L. Harlan MD FAAD
Background: There have been many reports of topical steroids treatment for the face causing perioral dermatitis, steroid
acne, and steroid rebound phenomenon.
Objective: To assess patient reported outcomes in patients receiving compounded topical (hydrocortisone 0.75% and precipitated
sulfur 0.5%) lotion for up to 15 years for common dermatological conditions of the face.
Methods: In a retrospective study, 300 patients were randomly sampled from the dermatology clinic who had used, or were
continuing to use, a lotion based, pharmacy-compounded topical preparation for the face. The topical compound was used
in therapies for seborrheic dermatitis and combination with prescription topical therapy for patients with acne and rosacea
with tolerability problems.
Results: None of the 300 patients experienced steroid acne, rebound phenomenon, or perioral dermatitis associated with
use of hydrocortisone 0.75% and precipitated sulfur 0.5% on the face.
Conclusion: There was no evidence found that perioral dermatitis, steroid acne, or rebound phenomenon occurs when
sulfur is compounded with topical hydrocortisone 0.75%.
Allergan's Tazorac is at the Vanguard of the Next Generation of Topical Retinoids
Over the last 4 decades, topical retinoids have become standard therapy for the treatment of acne vulgaris. Although the market currently encompasses multiple formulations of next-generation topical retinoids, Tazorac is unique among them due to its dual role as a treatment option for both acne vulgaris and psoriasis vulgaris. Tazorac has also demonstrated that it is highly effective for the treatment of acne vulgaris as a monotherapy or in combination with other agents. Recent studies show that Tazorac can be combined effectively with dapsone 5% gel or with a benzoyl-peroxide - containing formulation to augment efficacy. Additionally, Tazorac does not have a generic substitution, so physicians can be assured that their patients will receive exactly what they have been prescribed.
Kelley Pagliai Redbord MD, C. William Hanke MD
Background: Topical photodynamic therapy (PDT) involves the use of a photosensitizing topical medication that is activated
by a light source in the presence of oxygen leading to cellular destruction and subsequent photorejuvenation. In
1999, the US FDA approved PDT for the treatment of nonhyperkeratotic actinic keratoses (AKs) on the face and scalp.
Observations: The study population comprised 85 patients treated with short-contact, topical aminolevulinic acid (ALA)-
PDT for a total of 247 treatments. Ninety percent of patients with a variety of dermatologic disorders had significant improvement
or total clearance. Ninety-eight percent of patients had no complications. Only 2 patients in our series had
a significant complication.
Conclusions: Short-contact, topical ALA-PDT is a safe and effective treatment for a variety of dermatologic disorders
including photoaging and AKs.
Jonathan S. Weiss, MD and Joel S. Savin, MD
The agents most commonly used in combination for the management of acne include topical retinoids and antibiotics. Topical
retinoids normalize desquamation of the follicular epithelium, whereas antibiotics inhibit the growth of P. acnes and the production
of free fatty acids. This therapeutic combination decreases comedogenesis, bacterial growth, and inflammation, thus targeting three
of the four pathogenic factors associated with acne. Efficacy and tolerance are maximized with combination therapy, and the degree
of skin irritation is minimized. Furthermore, adjunctive therapy with topical retinoids and antibiotics tends to produce results more
quickly than single-agent therapy.
This article will examine the individual agents used in combination for acne management, and discuss the mechanisms by which they
achieve efficacy. The rationale of utilizing topical retinoids with antibiotics will be highlighted, particularly in relation to improved tolerance
and reduced irritation.
Christian Diehl MDa and Alicia Ferrari MDb
BACKGROUND: Seborrheic dermatitis (SD) is a chronic mild skin disorder with high prevalence. Various treatment options are available, including topical antifungals and anti-inflammatories. Antifungal and anti-inflammatory properties of Quassia amara have been reported.
AIM: To check the efficacy and safety of a topical gel with 4% Quassia amara extract and compare it with topical 2% ketoconazole and 1% topical ciclopiroxolamine in the treatment of facial SD.
METHODS: A group of 60 patients displaying facial SD were randomly distributed in 3 groups and given either a topical gel with 4% Quassia amara extract, a topical gel with 2% ketoconazole, or a topical gel with 1% ciclopirox olamine for 4 weeks.
Disease severity was assessed at the start and weekly along treatment, as well as 4 weeks after the end of treatment. In each selected area, severity of erythema, scaling, pruritus, and papules were scored from 0 to 3, the sum of these values representing the score of SD on the face. This evaluation was conducted at each visit. The decrease in SD score with all 3 products was compared at each visit. At each stage, overall improvement, safety, and tolerability were also assessed.
RESULTS: Of the 60 patients, 54 (90%) completed the study. The 3 therapeutic options resulted to be very effective, with a significant advantage in efficacy for 4% Quassia extract. For the other 2 drugs, the results were in line with those previously published in the literature.
CONCLUSION: Topical gel with 4% Quassia extract represents a new, safe, and effective treatment for facial SD.
J Drugs Dermatol. 2013;12(3):312-315.
Viral M. Patel BS, Robert A. Schwartz MD MPH DSc (Hon), and W. Clark Lambert MD PhD
Dermatologic drugs should be employed with caution in women of childbearing age who are pregnant or considering pregnancy. Topical drugs have little systemic absorption. Therefore, they are deemed safer than oral or parenteral agents and less likely to harm the fetus. However, their safety profile must be assessed cautiously, as there is limited available data. In this article, we aggregate human and animal studies and provide recommendations on using topical dermatologic medications in pregnancy.
J Drugs Dermatol. 2016;15(7):830-834.
Hilary E. Baldwin MD,a Marge Nighland BS,b Clare Kendall MA,c David A. Mays PharmD MBA,c Rachel Grossman MD,b,c and Joan Newburger PhDc
Topical tretinoin has been approved for use in dermatology for 40 years and is currently approved for the treatment of acne vulgaris
and photodamage. During this time, topical tretinoin has accumulated significant efficacy and safety data in the treatment of acne and
photodamaged skin and demonstrated clinical potential for treating a range of other dermatologic conditions. The diverse effects may
be due to complex underlying mechanisms of action associated with tretinoin, including keratolytic activity, collagenesis, and other
mechanisms associated with the activation of nuclear retinoic acid receptors (RARα, RARβ, and RARγ). In this article, we review the
history of topical tretinoin use to date and outline emerging research suggesting that topical tretinoin may have potential clinical use
for treating a multitude of other dermatological conditions when used either as monotherapy or in combination with other agents. We
also describe newer formulations of topical tretinoin that have been designed to reduce irritation potential. In light of the substantial history
of safety and efficacy of topical tretinoin in acne and photodamage, we speculate that it holds promise in treating many additional
dermatological conditions, which may be explored in future research.
J Drugs Dermatol. 2013;12(6):638-642, e94-e105.
Treatment options for acne vulgaris have expanded considerably in the past decade. The main goals of treatment continue to be
reducing acne lesions while maintaining patient satisfaction and adherence to treatment. As dermatologists, the art of treatment
is to develop, fine-tune, and utilize combinations of agents to increase compliance, thereby optimizing patient outcomes. In acne
management, one strategy involves concomitant use of topical retinoids with benzoyl peroxide or a fixed combination of topical
antibiotic/benzoyl peroxide. This strategy requires application of one product in the morning and one in the evening due to concerns
of benzoyl peroxide–induced degradation of retinoid activity. Presented are two cases in which a topical retinoid and a topical fixed
combination of clindamycin/benzoyl peroxide were used concomitantly in patients with mild-to-moderate acne. Research-based and
practical rationale on the simultaneous use of newer-generation retinoids and benzoyl peroxide–based products, without concern of
retinoid degradation, is discussed.
Lauren K. Hoffman BA,a Neal Bhatia MD,b Joshua Zeichner MD,b Leon H. Kircik MDc
Topical treatment is the mainstay of acne therapy. The most commonly prescribed topical medications for acne include benzoyl peroxide, clindamycin, and retinoids. Despite their effectiveness in treating mild to moderate acne vulgaris, these topical medications are found to be irritating, and are historically associated with poor tolerability and diminished patient adherence. Thus, choosing the right formulation that will be effective and well tolerated is essential. Novel formulations that optimize drug concentration and utilize improved delivery vehicles have helped to enhance the tolerability and efficacy, and allow for less frequent application or co-application of drugs that were previously considered incompatible. This article will review the goals of topical therapy for the treatment of acne, in addition to common therapies and their challenges. Advanced formulations and combination formulations of benzoyl peroxide, clindamycin, and tretinoin will also be discussed.
J Drugs Dermatol. 2018;17(6 Suppl):s6-10.
Kristin Totoraitis BS,a Joel L. Cohen MD,b and Adam Friedman MDc
Surgical procedures are an important piece of a dermatologist’s daily practice. Therefore, the optimization of post-surgical wound healing
is an area of utmost importance and interest. Although low risk, one notable barrier to proper wound healing is surgical site infection.
In an attempt to mitigate this risk and improve surgical outcomes, multiple topical products continue to be used both pre- and postprocedure.
Traditionally, this includes both topical antibiotics and antiseptics. However, these products are not without consequence.
The overuse of topical antibiotics as prophylaxis for infection has contributed to increased bacterial resistance, and in fact is no longer
recommended by the American Academy of Dermatology in clean post surgical wounds. Topical antiseptics, including chlorhexidine and
povidone-iodine, can have a cytotoxic effect on keratinocytes and may actually impede wound healing as a result. In addition, chlorhexidine
in particular can produce both otologic and ocular toxic effects when used on the face. Emerging products, such as hypochlorous
acid, may be a potential alternative to the more commonly used agents, as it has effective antimicrobial actions and minimal adverse
effects. Therefore, the purpose of this review is to highlight several topical products used to optimize post-surgical wound healing and
discuss both their efficacy and safety.
J Drugs Dermatol. 2017;16(3):209-212.
Kenneth Beer MD, Jeanine Downie MD
We report a case of a 53-year-old African American woman with an unusual example of striae caused by topical steroid
usage and discuss the widespread usage of these products.
Esra Adışen MD, Yeşim Kaymak MD, Mehmet Ali Gurer MD, Elif Durukan PhD
Background: Topical tetracycline was the first topical antibiotic approved for the treatment of acne, its use has been limited because of the skin penetration problems of the active ingredient.
Objectives: The objective of this study was to evaluate the effectiveness of a new formulation of topical tetracycline [Imex®, tetra-cycline hydrochloride 3%, 20g] monotherapy in the treatment of mild to moderate acne vulgaris.
Methods: The sample group consisted of 87 volunteer students of both sexes with grade 1 to grade 2 acne as assessed by Investiga-
tor’s Global Assessment (IGA) severity grading system. Subjects were instructed to apply topical tetracycline twice daily for 8 weeks.
Subject were evaluated at baseline and at weeks 2, 4, and 8.
Results: Of 87 subjects, 68 completed the 8-week treatment period. The mean reduction rates of opened comedones were 55.4%,
closed comedones were 27.1%, papules were 24.8 %, pustules were 27.3 %. After 8 weeks of treatment, a statistically significant
reduction was only observed in the mean counts of the papules and pustules (P < 0.001).
Conclusion: Tetracycline is a well-tolerated topical agent and is particularly effective in the treatment of inflammatory lesions in acne.
Aditya K. Gupta MD PhD FAAD FRCP(C), Michael Uro DPM, Elizabeth A. Cooper BESc HBSc
Methods to treat onychomycosis are varied, using therapies that can be categorized as topical, oral or device-related. Since their
development, oral therapies have represented the gold standard for treatment over other methods. However, efficacy with oral therapies
remains limited, and safety may be an issue, leaving many patients requiring alternative treatments. With research advances,
topical therapies as alternatives for onychomycosis are being investigated with greater interest as new technologies are overcoming
previous limitations of topical treatments, such as lack of nail penetration. New device-related topical therapy methods are particularly
noteworthy, as they may allow for shorter, more convenient treatments for patients, reducing issues with topical compliance, and, in
cases of non-drug light-based therapies, they will avoid potential for drug reactions. Research in these fields is preliminary, and the
impact these methods may have on the future of onychomycosis remains to be seen.
Mototsugu Fukaya MDa and Hajime Kimata MD PHDb
BACKGROUND: Though topical corticosteroids (TC) are used for treating atopic dermatitis (AD) as a standard, there exist several problems including topical steroid addiction (TSA) or Red skin syndrome. Moreover, the number of patients, who refrain from using TC because of steroid-phobia, is increasing. Recently, topical PPAR alpha ligand application has been reported to improve experimental allergic dermatitis. The purpose of this study was to investigate the short-term efficacy and safety of topical clofibrate, one of PPAR alpha ligand, in such steroid-phobic patients with AD.
METHODS: This study was conducted as a double-blind design to investigate the effects of random administration of topical clofibrate and base (placebo) on skin manifestation and blood parameters of patients for 2 weeks. Severity was digitized using severity scoring systems for atopic dermatitis by the Japanese Dermatological Association (SSS-JDA) before and after two weeks. Subjective severity of patients was evaluated using visual analog scale (Pt-VAS). Serum thymus and activation-regulated chemokine (TARC) and immunoglobulin E (IgE) were also investigated.
RESULTS: Twenty patients were enrolled, and 19 of 20 patients completed the study. In 19 patients, the value of severity score using SSS-JDA was decreased significantly after administration of topical clofibrate (P=0.001). Subjective evaluation using Pt-VAS (P=0.008) and serum TARC levels (P=0.03) were also significantly decreased after two weeks of topical clofibrate. There was not a significant difference in serum IgE levels. No adverse effect was observed.
CONCLUSIONS: Topical clofibrate is useful for patients with AD especially who are reluctant to use topical steroids.
J Drugs Dermatol. 2014;13(3):259-263.
Joshua A. Zeichner MD
Acne vulgaris (AV) is an inflammatory skin disease characterized by the presence of comedones, papules, pustules, and nodules. Consensus guidelines recommend the use of combination therapy using different drugs with complementary mechanisms of action to best address as many acne pathogenic factors as possible at the same time. Topical acne medications exist as individual agents that may be combined in physician-recommended regimens or as pre-formulated fixed-dose combination products. In addition, there are several new and promising topical therapies currently being developed that work by different mechanisms of action from traditionally used acne therapies. The following review will cover commonly used drugs, newcomers to the market, and what the future holds for the topical treatment of AV.
J Drugs Dermatol. 2016;15(1 Suppl 1):s11-s16.
This supplement explores the microbiology of topical antifungal drugs, the science behind vehicle formulations and delivery systems, and the data on topical treatment efficacy. Armed with this knowledge, clinicians can more effectively target superficial cutaneous fungal infections and ultimately increasing their patients’ quality of life.
Julia S. Lehman MD, Gabriel F. Sciallis MD
Idiopathic proctodynia, an enigmatic pain syndrome affecting the perianal region, can be persistent, relatively refractory to treatment,
and associated with considerable psychological distress. The authors present the case of a patient with a long history of severe proc-
todynia that had been resistant to a range of topical and systemic treatments. With the use of topical amitriptyline hydrochloride 2.5%
and ketamine hydrochloride 0.5% cream, the patient’s pain resolved rapidly, leading to a substantially improved quality of life.
Cindy Berthelot MD, Allison Rivera MD, Madeleine Duvic MD
Mycosis fungoides (MF) is a rare neoplasm of epidermotropic CD4+ lymphocytes and represents a majority of all cutaneous
T cell lymphomas. Early stage MF is limited to cutaneous patches and plaques that can be treated with topical modalities
with high response rates. More aggressive systemic treatment of early disease does not alter survival or cure the disease
and could accelerate progression by causing immunosuppression. Topical corticosteroids, mechlorethamine, and carmustine
have been the mainstays of early treatment of MF for more than 30 years. More recently, topical formulations of
retinoids, novel rexinoids, methotrexate, immunomodulators, and photodynamic compounds have been investigated for
their potential roles in treating early MF. The future of topical treatments for MF is promising both as primary and adjunctive
Lidocaine Gel in a Unique Drug Delivery SystemLeslie S. Baumann MD, Lisa Grunebaum MD, Mohamed L. Elsaie MD, Jennifer Murdock BS, Eric Jablonka BS, Kristian Figueras MS, Michaela Bell BS
Background: Ideally, topical anesthetics should provide rapid analgesic action without causing toxic blood levels of lidocaine or other side effects. Various formulations of lidocaine as a topical anesthetic have been tested and are currently on the market. Here, the authors report on a topical lidocaine with a novel delivery system that provides a rapid onset of action without toxic plasma levels of lidocaine.
Objective: Study 1 assessed the time needed for a topical 4% lidocaine gel with a unique drug delivery system to produce optimal anesthetic effects. Study 2 assessed lidocaine plasma concentrations and assessed the time to maximal anesthetic effect.
Methods: In both studies, subjects received six botulinum toxin type A injections for crow’s feet wrinkles in six separate zones in
the lateral periocular regions bilaterally. The first injection was administered in the absence of topical 4% lidocaine gel. Gel was then applied to the remaining five zones and injections were given at set time points out to 45 minutes. In study 2, blood samples were taken from baseline to 60 minutes.
Results: Significant anesthetic effect with topical 4% lidocaine gel was attained without occlusion in approximately 25–30 minutes.
However, optimum effects were observed between 35–40 minutes after application. Additionally, topical 4% lidocaine, when used
appropriately, did not produce lidocaine plasma levels associated with toxicity.
Conclusion: Topical 4% lidocaine gel with a unique drug delivery system produces significant anesthesia without occlusion in approximately 25–30 minutes with optimal effects observed between 35–40 minutes after application. Topical 4% lidocaine gel can be used effectively and safely as a topical anesthetic in the physician’s office.
Anna H. Zivkovich and Steven R. Feldman MD, PhD
Topical corticosteroids are the most common treatment agent for psoriasis in the United States (U.S.). Conventional dermatologic
wisdom holds that ointment preparations provide the highest potency (due to their occlusive nature and moisturizing ability) and are
best suited for psoriasis. This article presents evidence challenging the conventional belief that ointment vehicles are necessarily best
for psoriasis. A previous systematic review of the efficacy of clinical trials of potent topical corticosteroids did not support greater efficacy
or greater delivery of potent topical corticosteroids with ointment vehicles compared to other topical preparations. Moreover,
preference studies demonstrate that psoriasis patients often find application of ointment to be messy, raising concerns about both
short-term and long-term adherence to treatment. Recent compliance studies demonstrate that poor compliance to topical treatment
is common among psoriasis patients and contributes to poor psoriasis treatment outcomes. Non-ointment topical corticosteroid
products exhibit excellent efficacy in clinical practice. Much of the poor outcomes in psoriasis, even tachyphylaxis, likely relate less to
actual medication failure and more to failure to apply the medication. Topical psoriasis treatment is likely to be more successful when
physicians and patients discuss what type of vehicle the patient will use and plan treatment accordingly.
Hyok Bu Kwon MD,a Yunseok Choi MD,a Hwa Jung Kim MD,b and Ai-Young Lee MDa
BACKGROUND: Topical all-trans-retinoic acid (tretinoin) prevents skin atrophy induced by long-term use of topical corticosteroids, without abrogating their anti-inflammatory effects.
OBJECTIVE: The goal of this study was to determine the efficacy of tretinoin plus topical corticosteroids (tretinoin plus) for repigmentation in patients with vitiligo.
METHODS: A placebo-controlled, paired-comparison, left-right study was conducted for a period of 6 months on tretinoin plus and the vehicle plus the same topical corticosteroid (vehicle plus) treatment in 50 patients diagnosed with generalized vitiligo. Clinical responses were assessed using the computerized analysis, and the results were compared with the visual analysis.
RESULTS: The percentage agreement between the 2 analyses was 91.8%. Among 49 participants who successfully completed this study, 27 (55%) showed a better response to tretinoin plus than to vehicle plus. The improved response was noted at an early stage of treatment, during the first 3 months in 60% of patients.
CONCLUSION: Combined therapy with tretinoin plus topical corticosteroids is safe and effective and provides another option for treatment of patients with vitiligo.
J Drugs Dermatol. 2013;12(4):e63-e67.
James Q. Del Rosso DO FAOCDa and Emil Tanghetti MDb
Tazarotene is a synthetic retinoid that, depending on the concentration and vehicle, is approved by the US Food and Drug Administration for the topical treatment of acne vulgaris (AV) and plaque psoriasis. Tazarotene is also used as adjunctive treatment for specified clinical manifestations of chronically photodamaged skin (facial fine wrinkling, mottled facial hypopigmentation and hyperpigmentation, and benign facial lentigines), along with comprehensive skin care and photoprotection from sunlight. The gel formulation was released in the United States in 1997, with the cream formulation made available in 2000. Multiple studies are available supporting the effective and safe use of topical tazarotene for each of its indications. This article provides an overview of the pharmacology of topically applied tazarotene, discussing in particular up-to-date information on the efficacy, tolerability, and safety of topical tazarotene for AV, including monotherapy and combination therapy studies. Topical tazarotene 0.1% in both formulations is highly effective in reducing both inflammatory and noninflammatory acne lesions, and can be used in combination with other topical agents, including formulations containing benzoyl peroxide or dapsone 5% gel. Although many patients tolerate the use of topical tazarotene without significant issues or concerns, some patients experience application-site tolerability reactions, which can usually be managed with proper skin care and are less frequent with the cream formulation.
J Drugs Dermatol.2013;12(3 suppl 2):s53-s58.
Corticosteroids have been combined with other agents in the treatment of melasma for years. In early studies by Kligman and Willis,
topical dexamethasone as monotherapy produced little depigmentation even after 3 months of therapy. A significant concern is that
topical corticosteroids used alone in this setting, especially on the face, may result in epidermal atrophy, telangiectasia, rosacea-like
erythemas, acne, and perioral dermatitis.
Topical corticosteroids, however, including low-potency fluocinolone acetonide, also exert an anti-metabolic effect, resulting in
decreased epidermal turnover, and, thus, may produce a mild depigmenting effect. When used in combination with tretinoin and
hydroquinone in the treatment of melasma, fluocinolone acetonide 0.01% suppresses biosynthetic and secretory functions of
melanocytes, and thus melanin production, leading to early response in melasma, synergy among the three agents, and no significant
side effects over an 8-week period.
Vic A. Narurkar MD,a Sabrina G. Fabi MD FAAD FAACS,b Vivian W. Bucay MD FAAD,c Ruth Tedaldi MD,d Jeanine B. Downie MD,e Joshua A. Zeichner MD,f Kimberly Butterwick MD,g Amy Taub MD,h Kuniko Kadoya PhD,i Elizabeth T. Makino BS MBA CCRA,i Rahul C. Mehta PhD,i and Virginia L. Vega PhDi
Skin aging is a combination of multifactorial mechanisms that are not fully understood. Intrinsic and extrinsic factors modulate skin aging, activating distinctive processes that share similar molecular pathways. One of the main characteristics of youthful skin is its large capacity to retain water, and this decreases significantly as we age. A key molecule involved in maintaining skin hydration is hyaluronic acid (HA). Concentration
of HA in the skin is determined by the complex balance between its synthesis, deposition, association with cellular structures, and degradation. HA bio-equivalency and bio-compatibility have been fundamental in keeping this macromolecule as the favorite of the skincare industry for decades. Scientific evidence now shows that topically applied HA is unable to penetrate the skin and is rapidly degraded on the skin surface.
SkinMedica’s HA5 Rejuvenating Hydrator (SkinMedica Inc., an Allergan company, Irvine, CA) promotes restoration of endogenous epidermal HA homeostasis and provides instant smoothing and hydration of the skin. These dual benefits are accomplished through the combination of 2 breakthrough technologies: 1) a unique blend of actives powered by SkinMedica proprietary flower-derived stem cell extract that restores the endogenous production of HA; and 2) a proprietary mix of 5 HA forms that plump the skin, decreasing the appearance of fine lines/wrinkles.
Pre-clinical studies demonstrated that HA5 induces expression of key epidermal differentiation and barrier markers as well as epidermal HA synthases. A decrease expression of hyaluronidases was also observed upon HA5 application. Initial clinical studies showed that within 15 minutes of application, HA5 instantly improves the appearance of fine lines/wrinkles and skin hydration. Subjects that continue using HA5 (for 8 weeks) demonstrated significant improvements in fine lines/wrinkles, tactile roughness, and skin hydration. In summary, the blend of these 2 key technologies present in HA5 promotes restoration of endogenous epidermal HA while delivering instant smoothing effects.
J Drugs Dermatol. 2016;15(1 Suppl 2):s24-s37.
Marko Lens MD PhD,a Marie-Helen Podesta Marty PharmDb
While there is at least one standardized test available for evaluating the antioxidant capacity of cosmetic formulations, the authors proposed a new in vivo method to determine kinetics of squalene (SQ) photo-oxidation products (squalene monohydroperoxide, SQ mOOH) as a reliable method with which to evaluate antioxidant capacity of a cosmetic formulation. Topical antioxidant formulation was applied on the foreheads of 30 volunteers. Sebum samples were collected before application of topical antioxidant and after one hour, three hours and five hours from the application of topical antioxidant. One half of the sebutape was irradiated and SQmOOH/SQ ratios in the skin lipid were analyzed using HPLC method. These results showed protective action of the topical antioxidant formulation against skin lipid peroxidation with a significant reduction of the quantity of SQmOOH (P<0.0001). Determination of the kinetics of squalene peroxidation is a reliable in vivo method in the evaluation of antioxidant capacity of cosmetic formulations.
J Drugs Dermatol. 2011;10(3):262-267.
Pain is a common patient complaint with dermatologic laser procedures and effective pain management is important for the comfort and satisfaction of patients undergoing these procedures. Many topical anaesthetics are available as options to decrease the pain associated with these procedures, although not all have the same degree of safety. An FDA-approved lidocaine and tetracaine topical anesthetic cream [Pliaglis®, liodocaine and tetracaine 7%/7% cream (LT cream), Galderma Laboratories LP, Fort Worth, TX] is safe and effective when used with common laser therapies such as ablative and nonablative laser resurfacing, laser hair removal, laser treatment of vascular lesions, and laser tattoo removal. LT cream should be considered by dermatologists when choosing a topical anesthetic for laser dermatologic procedures.
J Drugs Dermatol. 2013;12(9):986-989.
Deirdre Cocks Eschler MD and Peter A. Klein MD
Objective: To critically review the body of clinical trials refuting or supporting the efficacy of topical antihistamines in the relief of pruritus.
Design: Review of PubMed from January 1950 through September 2009 and the Cochrane Database of Systematic Reviews to
identify therapeutic trials of topical antihistamines in the relief of pruritus.
Main Outcome Measures: All randomized controlled trials or clinical trials of topical antihistaminic compounds used in the treatment
of pruritus. The authors found 19 trials throughout the literature. The quality of each trial was ranked by applying a modified
version of Sackett’s criteria for clinical evidence. Grade A trials are large, randomized, double-blind, placebo-controlled studies with
low false-positive (α) and low false-negative (β) errors. Grade B studies are also randomized, double-blind, placebo-controlled studies,
but include a small number of patients. Grade C trials lack one or more of the following criteria: randomization, placebo control
Results: Only four large, randomized, double-blind, placebo-controlled clinical trials with definitive conclusions (grade A) support the
use of topical antihistaminic agents, specifically topical doxepin, for relief of pruritus. Of seven grade B trials, four supported the efficacy
of topical antihistamines while three refute their use in relieving pruritus. One grade B trial was inconclusive. All remaining trials
(grade C) lacked placebo controls or randomization, or contained fewer than 20 patients in each treatment group.
Conclusion: While topical antihistamines are widely prescribed for the treatment of pruritus, the evidence to support their use is
mixed. Topical doxepin has been demonstrated to reduce pruritus. Evidence is lacking, however, for other topical antihistamines,
including diphenhydramine (Benadryl®), that are widely used and available without a prescription.
Actinic keratoses (AKs) are common dysplastic epidermal lesions that share clinical, histologic, and molecular features with squamous
cell carcinoma. Therapeutic options include destructive modalities (i.e., cryosurgery, curettage) or topical fluorouracil treatment.
The efficacy of topical fluorouracil for the treatment of widespread AK lesions has been demonstrated in multiple studies, but
treatment is often associated with significant skin irritation. Various approaches to decrease irritation while maintaining efficacy have
been attempted, including altered treatment regimens, combination therapies, and variations in vehicle formulations. Recently, a
novel topical fluorouracil cream that contains 0.5% 5-fluorouracil in a microsphere vehicle has been approved for the treatment of AK.
Data demonstrate that this low-dose formulation is effective in reducing AK lesions while maintaining a tolerable irritation profile.
Acne vulgaris (AV) is one of the most common diseases that we encounter in our clinics every day. Yet, despite the dermatology community’s perceived familiarity with acne vulgaris, it is worthwhile to note that we continue to learn more and more about the epidemiology and the pathogenesis of AV as well as novel therapeutic options. Patients with acne desire clearance. Dermatology providers today have more options than ever to tailor treatment to each patient’s needs, in light of current best evidence regarding the pathogenesis and treatment of the disease. While no new chemical entities for topical delivery have revolutionized our approach to acne management, ongoing evolution in topical vehicle formulation is optimizing therapeutic benefit and the patient experience, leading to better clinical outcomes.
Rajesh Balkrishnan PhD, Fabian T. Camacho MS, Daniel J. Pearce MD, Amit S. Kulkarni MS, Lori Spencer PhD, Alan B. Fleischer Jr. MD, Steven R. Feldman MD PhD
Of the topical preparations available, the ultra-high potency corticosteroids have an important role in treating psoriasis.
However, the use of these agents in many other conditions and patient populations may not be appropriate. This
study examines the prescribing patterns of Class I topical corticosteroids in patients with skin disease by analyzing data
from the National Ambulatory Medical Care Survey (1990-2000). Of the nearly 718 million visits for skin disease,
Class I topical corticosteroids were prescribed in nearly 3% of all skin disease-related visits, with prescription rates being
highest in psoriasis (22%). The study found greater prescription rates of Class I topical steroids by dermatologists compared
to non-dermatologists [Odds Ratio (OR) = 4.39 (95% CI: 2.15, 8.99)]. However, there were also a large number
of questionable prescriptions for other conditions, which could be construed as misuse of these medications. Despite
limitations and the potential dubious use seen here, Class I topical corticosteroid use is relatively commonplace.
Education efforts and novel preparations of Class I agents will help to ensure the best possible care for patients suffering from significant skin diseases like psoriasis.
Summer D. Moon BS a and James M. Spencer MD MS b
A 93-year-old woman presented with biopsy-proven invasive melanoma of 2.75 mm depth, arising from a melanoma in situ. Standard treatment of this depth would be an extensive and mutilating excision, which presented a therapeutic dilemma. Imiquimod has the ability to clear melanoma in situ, but its effect on invasive melanoma is unknown. After a thorough discussion with the patient, we decided to attempt to treat the melanoma in situ with topical imiquimod and then excise the smaller invasive component. Following 5 weeks of topical imiquimod therapy, the area where the nodular melanoma had previously been was excised. Histological examination of the excisional specimen revealed no residual melanoma detected. In this case, it appears that 5 weeks of topical imiquimod therapy completely cleared an invasive melanoma of 2.75 mm depth, as well as clearing the component of melanoma in situ. The patient was followed for 14 months with no evidence of recurrence.
J Drugs Dermatol. 2013;12(1):107-108.
Leon H. Kircik MD, James Q. Del Rosso DO, FAOCD, Matthew Zirwas MD
Taro Pharmaceuticals Solves a Puzzling Enigma for Dermatologists
FDA regulations require that generic topical steroids match the active ingredients, concentration, and dosage of brand topical steroids, but the generic formulations do not have to match the bioequivalence of branded formulations. Vasoconstrictor assays have found large differences in bioequivalence between generic and trade name topical steroid formulations containing the same steroid in the same concentration in both cream and ointment vehicles. However, Taro Pharmaceuticals desoximetasone 0.05% and desoximetasone 0.25% ointments are a notable exception. Both branded and generic desoximetasone 0.05% and desoximetasone 0.25% ointments are produced by Taro Pharmaceuticals and contain the same excipients in the vehicle. Consequently, physicians do not have to be concerned about differences in therapeutic effectiveness between Taro's generic and brand desoximetasone ointments.
Vicky Kwan Wong, BA; Christine Della Croce, MA; Sara Schonfeld; Anthony M. Mastrangelo, PhD and Mark Lebwohl, MD
Topical corticosteroids have improved the management of many inflammatory skin diseases, such as psoriasis
and atopic dermatitis. However, these medications are associated with certain adverse effects that are potentially
serious. The potent anti-inflammatory actions of these drugs increase susceptibility to bacterial and fungal
infections, and therefore may preclude them from use when infection is the known cause of the disease. In
addition, children may be more vulnerable than adults to systemic effects of topical corticosteroids because percutaneous
absorption is proportionately greater. These are important considerations, and physicians need to
weigh and compare the risks and benefits associated with these medications before initiating treatment. This
involves an appreciation of which patient populations are at high risk, which skin conditions are incompatible
with topical corticosteroid therapy, and which alternative nonsteroidal medications are effective in treating
inflammatory skin diseases.
Richard W. McClain BS, Brad A. Yentzer MD, Steven R. Feldman MD PhD
Background: Topical corticosteroids are often considered to have greater safety and poorer efficacy than oral corticosteroids in
treating psoriasis and atopic dermatitis. There are limited data for assessing relative efficacy of topical and systemic corticosteroids,
however. The concentration of corticosteroid in skin, adjusted for the relative potency of the active compound, may be a predictor of
clinical efficacy and can be estimated for both topical and oral administration.
Purpose: To analyze the assumption that oral corticosteroid therapy should be more potent than topical therapy by comparing relative
corticosteroid concentrations in the skin expected with topical versus systemic administration.
Methods: The estimated skin concentration of prednisone following oral dosing was calculated based on data showing 70–100%
bioavailability and an even tissue distribution. Data on the concentration of corticosteroids found in skin after topical application were
obtained from the literature. The relative potencies of corticosteroid molecules were then used to compare skin concentrations of
corticosteroid following topical versus oral treatment.
Results: Data derived from the existing literature demonstrated that hydrocortisone 2.5% ointment, triamcinolone 0.1% ointment,
and clobetasol 0.05% foam achieved effective skin concentrations greater than the effective concentration achieved by oral prednisone.
Betamethasone 0.1% cream achieved effective concentrations in skin within the range created by oral prednisone.
Limitations: This analysis was limited by the paucity of data regarding cutaneous concentrations of corticosteroids after topical application,
and by the differing experimental designs utilized in the available studies.
Conclusion: Most topical corticosteroids have the potential to achieve greater effective drug levels in the superficial layers of skin
than those achieved with standard doses of oral prednisone. The apparently greater efficacy of oral corticosteroid therapy may be
attributable, in part, to poor patient compliance with topical therapy. Systemic alterations in immune function following oral, but not
topical, corticosteroid use may also play a role.
Topical fluorouracil is widely used for the treatment of precancerous and cancerous lesions of the skin. The most common side effect of this medication is localized irritant dermatitis. The authors report a case of dysgeusia with metallic taste as a side effect of this medication. While not previously seen with topical use, this is not an uncommon side effect seen with systemic administration of 5-fluorouracil. The etiology of dysgeusia from chemotherapeutic agents and systemic absorption of fluorouracil is discussed.
J Drugs Dermatol. 2011;10(10:1201-1203
Robert S. Salk DPM, Kirk A. Grogan DPM, Thomas J. Chang DPM
Topical 5-fluorouracil (5-FU) is an antineoplastic antimetabolite that inhibits DNA and RNA synthesis, thereby preventing
cell replication and proliferation. This mechanism of action may allow topical 5-FU to be utilized in the treatment
of human papilloma virus (HPV). We conducted a study comparing 5% 5-FU cream under tape occlusion versus
tape occlusion alone in 40 patients presenting with plantar warts. Nineteen out of 20 patients (95%) randomized to 5%
5-FU with tape occlusion had complete eradication of all plantar warts within 12 weeks of treatment. The average time
to cure occurred at 9 weeks of treatment. Three patients (15%) had a recurrence at the 6-month follow-up visit; accordingly,
an 85% sustained cure rate was observed. It is concluded that use of topical 5% 5-fluorouracil cream for plantar
warts is safe, efficacious, and accepted by the patient.
Kyle B. Bartlett MD,a Scott A. Davis MA,a and Steven R. Feldman MD PhDa,b,c
BACKGROUND: Thirty to 40% of patients using topical treatments do not comply with their treatment regimen.
OBJECTIVE: To examine how tolerability is assessed, tolerability ratings, and clinical significance of tolerability ratings of topical antimicrobials for acne.
METHODS: A literature search was performed using the terms “tolerability AND acne AND (benzoyl peroxide OR antimicrobial OR clindamycin OR erythromycin OR dapsone OR sulfur OR sulfacetamide).” Inclusion criteria were: 1) evaluation of tolerability, 2) use of an identified topical antimicrobial for acne treatment without combination retinoid use, 3) an original study, in English.
RESULTS: Thirty-four of 132 articles met the inclusion criteria. Tolerability was measured through subject and investigator assessment of specific tolerability parameters and by reporting of adverse events. Nearly all of the acne treatments were well tolerated. Treatment related study discontinuation rates were low and had little to no relation to the degree of tolerability measures.
LIMITATIONS: Patients may be more adherent in clinical trials than in clinical practice. Differences in the measure used to assess tolerability make comparisons difficult.
CONCLUSIONS: Topical antimicrobial acne therapy is generally well tolerated. Discontinuation rates are low under study conditions. Tolerability of topical antimicrobial therapy for acne may not have great clinical significance.
J Drugs Dermatol. 2014;13(6):658-662.
Wendy Cantrell DNP, Theresa Canavan MD, and Boni Elewski MD
Onychomycosis is a common fungal infection of the nail unit that results in discoloration, subungual debris, thickening, onycholysis,
and often pain and impairment of mobility. Dermatophytomas are characterized by a thick fungal mass within and under the nail plate
and are especially resistant to treatment. Here we report a case of a patient with a dermatophytoma who had failed oral terbinafine but
was successfully treated with efinaconazole 10% topical solution.
J Drugs Dermatol. 2015;14(5):524-526.
Tejaswi Mudigonda BS, William Kaufman MD, and Steven R. Feldman MD PhD
Severe atopic dermatitis can have an enormous impact on a child and the child’s caregivers. Topical corticosteroids can be highly effective,
but not all patients respond. If atopic dermatitis does not improve with a topical corticosteroid, poor adherence should be strongly considered as the cause of treatment failure. We report a child with horrendous atopic dermatitis whose disease resolved rapidly in the hospital when therapy was changed to a product that was easier to apply.
J Drugs Dermatol. 2016;15(1):114-115.
James Q. Del Rosso DO FAOCD, Emil Tanghetti MD
A major challenge encountered in clinical practice in patients with acne vulgaris is irritation related to topical medications
used for treatment. Advances in vehicle technology have improved formulations containing active ingredients known to
produce irritation in some patients, such as benzoyl peroxide (BP) and topical retinoids. Clinical studies, including combination
therapy studies have demonstrated that certain additives, such as silicates and specific humectants, reduce irritation
by maintaining barrier integrity. A patented gel formulation of BP 5%/clindamycin phosphate 1% (clindamycin) containing
dimethicone and glycerin has been studied both as a monotherapy and in combination with topical retinoid use. This
article evaluates specific vehicle additives included in this gel formulation and explains their role in reducing irritation.
Data from clinical trials utilizing this technology in acne management are also reviewed.
Scott A. Davis MAa and Steven R. Feldman MD PhDa-c
BACKGROUND: Psoriasis is treated with several classes of treatments that may be used in combination, but the ways combination therapies are used are not well characterized.
PURPOSE: To determine the frequency of prescribing calcipotriene and other psoriasis drugs in combination.
METHODS: Visits with a sole diagnosis of psoriasis were selected from 1990-2010 data from the National Ambulatory Medical Care Survey. The number of combination therapies used, the leading therapies in each class of medications, and the leading types used in combination were analyzed.
RESULTS: About 10.2 million of 20.3 million psoriasis visits used multiple treatments. The mean number of prescribed medications increased over time (P=.0003). The top 10 treatments included 6 topical steroids, calcipotriene, 2 other topicals, and methotrexate. The most common combinations were topical steroid plus other topical (15.0%), multiple topical steroids (11.5%), topical steroid plus vitamin D analogue (9.7%), and topical steroid plus systemic treatment (6.9%). Vitamin D analogues and systemic treatments were prescribed with increasing frequency over time, while fewer topical steroids were used, and use of other topicals did not change significantly.
LIMITATIONS: Visits with multiple diagnoses had to be excluded to ensure that the medications listed were for psoriasis.
CONCLUSIONS: Combination therapy is the most common way to treat psoriasis in the United States. The wide range of combination therapies prescribed may reflect increased attention to individualization of treatment to match patients’ diverse preferences.
J Drugs Dermatol. 2013;12(5):546-550.
Navid Ezra MD,a Mehran Taban MD,b Daniel Behroozan MDa,c,d
Background: Central serous chorioretinopathy (CSC), also known as central serous retinopathy (CSR), is a visual impairment, often temporary, usually in a single eye, which mostly affects males in the age group of 20 to 50 but may also affect women. CSC occurring after prolonged use of topical steroids in a patient with psoriasis is a novel complication in the English literature.
Observations: We describe a case of a 25-year-old male, with a 15-year history of corticoid ointment use for psoriasis, who presented with loss of vision secondary to CSR.
Conclusions: All topical steroid treatments were discontinued and the patient recovered his vision completely. Although topical corticosteroids are frequently utilized for psoriasis management with a low rate of complication, clinicians should be familiar with this rare yet distressing condition. Furthermore, patients with increased production of endogenous corticosteroids (e.g., those with Cushing's syndrome, hypertension, or obstructive sleep apnea) should be warned of the potential of chorioretinopathy following prolonged use of topical corticosteroids
J Drugs Dermatol. 2011;10(8):930-933.
Alexis Lyons MD,a Joseph Stoll BS,a and Ronald Moy MD FAADa
Introduction: Melasma is a condition in which patients develop symmetric, reticulated, hyperpigmented macules and patches on the face which is thought to be the result of ultraviolet (UV) exposure and hormonal influences, although the pathogenesis is not completely understood. The topical application of epidermal growth factor has been used as a whitening agent, moisturizer, and an aid for wound healing. In this study, we explore the efficacy of topical EGF in the treatment of melasma.
Materials and Methods: This was a randomized, double-blind, placebo-controlled, split-face study to determine the efficacy of a topical EGF serum in the treatment of melasma. Fifteen women with a mean age of 44 were randomized to treatment side of the face and applied a topical EGF serum and a placebo twice daily to each designated side of the face for eight weeks. Patient satisfaction was assessed by use of the MelasQoL Questionnaire as well as a patient outcome survey. Subjects were evaluated using the Physician Global Aesthetic Improvement Scale (GAIS) by two board-certified dermatologists.
Results: GAIS scores showed an improvement in the melasma in 73.4% of subjects vs 13% improvement for the placebo side. The average MelasQoL questionnaire score decreased from 42 to 33 with 73% of subjects having an improvement in their score. In addition, 73% of subjects reported an improvement in their melasma. No adverse events or side effects were reported with use of the topical serum or placebo.
Conclusions: This study suggests that topical EGF is a safe, noninvasive, and effective treatment for melasma.
J Drugs Dermatol. 2018;17(6):970-973.
Suzanne Bruce MD,a Wendy Roberts MD,b Craig Teller MD,c and Lora Colvan BSd
BACKGROUND: Chemical peels are versatile treatments that involve chemical exfoliation of the skin for cosmetic improvement. Deeper peels produce more significant results, but can be associated with longer healing time and potential complications. Novel chemical resurfacing treatments (AGE and MELA) were developed in Europe to produce skin resurfacing via controlled inflammation to promote cell regeneration with minimum negative effects associated with conventional peelings. The AGE Resurfacing regimen is indicated for the treatment of photoaging, and consists of multi-ingredient peeling solution with trichloroacetic acid, pyruvic acid, salicylic acid, mandelic acid, and lactobionic acid. The MELA Resurfacing regimen addresses hyperpigmentation concerns and contains mandelic acid, potassium azeloyl diglycinate, retinol, salicylic acid, phytic acid, lactobionic acid, and lactic acid. Results of previously conducted US clinical experience trial of AGE and MELA resurfacing protocols rated 81% of subjects with some level of improvement according to physician assessment.
OBJECTIVES: To evaluate whether a daily skin care regimen used for 12 weeks could maintain the benefits achieved with AGE and MELA chemical resurfacing treatments.
METHODS: Subjects who completed participation in the AGE and MELA skin resurfacing clinical trial were recruited to participate in a continuation trial and used a daily regimen of MDRejuvena facial products for 12 weeks. No other facial products were permitted. Physicians assessed the severity of individual skin parameters at baseline and week 12 and provided global assessment. Subjects assessed improvement of individual skin parameters at week 12 and provided an overall assessment.
RESULTS: Thirteen subjects participated in the 12-week continuation trial. According to the physician’s global assessment, all subjects demonstrated some level of improvement at week 12 compared to baseline. Physician assessment showed a decrease in severity of all skin parameters assessed at week 12 compared to baseline. According to the subject overall assessment at week 12, 11 of 12 subjects noted some level of improvement, 1 subject saw no improvement, and 1 subject did not provide an overall assessment. Mild to moderate improvement was observed by subjects in all individual skin parameters assessed except for skin discoloration.
CONCLUSIONS: The results of the continuation study demonstrate that use of a daily skin care regimen, which include combination of 2 various strengths of MDRejuvena Rejuvaphyl® Rejuvenating Complex: low strength (LS) and high strength (HS), not only maintains but can enhance the beneficial effects of skin resurfacing treatments for at least 12 weeks.
J Drugs Dermatol. 2016;15(9):1145-1150.
Mio Nakamura MD,a Michael Abrouk MD,b Henry Zhu MD,c Benjamin Farahnik MD,d John Koo MD,a and Tina Bhutani MDa
INTRODUCTION: The potential for systemic effects due to percutaneous absorption of superpotent topical steroids has been a longstanding concern. The Food and Drug Administration currently recommends limiting the use of superpotent topical steroids to 50g per week for 2 or 4 consecutive weeks depending on the formulation, which is mostly based on the exact duration with which phase 3 clinical trials were allowed to be conducted per the FDA. This article reviews all published clinical incidence of adrenal adverse effects in the medical literature, specifically Cushing’s syndrome (CS) and pathologic adrenal suppression (PAAS), to try to ascertain a more realistic limit for the safe use of superpotent topical steroids as it pertains to its potential systemic effects.
METHODS: Literature search was conducted using PubMed. Only cases of CS and PAAS secondary to the use of Class I superpotent topical steroids were included. Pediatric cases and full articles unavailable in English were excluded.
RESULTS: There were a total of 14 cases of CS and 5 cases of subsequent PAAS found in the current literature.
DISCUSSION: From our review of these cases, if the amount used per week is within FDA guidelines, it appears that patients needed to use superpotent topical steroids for far greater than 2 or 4 weeks to develop CS or PAAS. CS did not necessarily predict occurrence of PAAS, but in all cases CS appeared to be a prerequisite for developing PAAS. All cases of CS and all but one case of PAAS were reversible. If excessive amount of greater than 50g per week is avoided, it appears that superpotent topical steroids may be safe to use consecutively for months, perhaps even years, without causing systemic effects.
J Drugs Dermatol. 2017;16(7):643-648.
Joseph B. Bikowski MD
This article will examine various clinical experiences with acne patients successfully treated with topical clindamycin 1% benzoyl
peroxide 5% gel (Duac®) alone and in combination with other acne treatments. Clindamycin 1% benzoyl peroxide 5%,
the only once-daily prescription topical aqueous gel combining a benzoyl peroxide and an antibiotic, has demonstrated excellent
tolerability and efficacy and is stable when used concomitantly with other therapies. A regimen of topical clindamycin 1%
benzoyl peroxide 5% gel, oral doxycycline hyclate (Doryx®), and adapalene gel (Differin®) seems especially advantageous from
a theoretical and practical perspective. Improvement is noted by means of photographic, physician, and/or patient assessments
at baseline and follow-up visits.
Elias Oussedik BS,a Mohammed D. Saleem MD,a Steven R. Feldman MD PhDa,b,c
BACKGROUND: Topical corticosteroids offer great efficacy in controlling a wide variety of dermatoses. Traditional ointment vehicles are messy and difficult to apply, which might limit adherence. Alternative vehicle formulations such as topical sprays might improve adherence due to their ease of application. The potency of desoximetasone spray is not fully characterized.
OBJECTIVE: To evaluate the relative vasoconstrictive potency of desoximetasone 0.25% topical spray formulation.
METHODS: This is a randomized, blinded, single-center study comparing the vasoconstrictive properties of desoximetasone 0.25% topical spray to placebo and seven other known potency topical corticosteroid formulations. The primary endpoint was the degree of vasoconstriction measured using a colorimeter device.
RESULTS: Thirty-two healthy subjects met eligibility criteria. Desoximetasone 0.25% topical spray (REGWQ Grouping = A) showed a trend toward greater vasoconstrictive potency compared to clobetasol propionate 0.05% spray (REGWQ Grouping = A). No adverse or serious events were reported.
Limitations: The trial enrolled 90% females, which may affect the external validity of the study. Different populations may respond differently to desoximetasone spray.
CONCLUSIONS: Desoximetasone 0.25% topical spray is a high to super high range of potency (Class I to Class II) steroid formulation. Given the cosmetic acceptability of spray products, we anticipate that this type of product would be highly effective for the treatment of inflammatory diseases in clinical practice.
J Drugs Dermatol. 2017;16(10):972-975.
Christine S. Ahn BA,a Farah Awadalla MD,e Karen E. Huang MS,a Brad Yentzer MD,a
Tushar S. Dabade MD,a,d and Steven R. Feldman MD PhDa,b,c
BACKGROUND: Psoriasis is a chronic disease that significantly impacts patients’ quality of life. It most commonly manifests as localized disease, for which there are various treatment options.
OBJECTIVE: To determine the prescription patterns of topical corticosteroids and vitamin D analogs for the treatment of psoriasis in the United States and how their use has changed over time.
METHODS: Data from the National Ambulatory Medical Care Survey (NAMCS) from 1994 to 2010 were queried for visits linked with a psoriasis diagnosis. Prescriptions for topical corticosteroids and vitamin D analogs were described. Vitamin D analogs usage was compared across physician specialties. For each sampled visit reported in the NAMCS, visits meeting our inclusion criteria that also mentioned the following medications were identified: topical calcipotriene, topical calcipotriene/betamethasone or any topical corticosteroid indicated for the treatment of psoriasis.
RESULTS: There were an estimated 2.05 million psoriasis visits per year over the 1994-2010 interval. Dermatologists were responsible for 67% of these encounters followed by family practice (14%) and internal medicine (11%). Dermatologists prescribed a vitamin D product at 15% of psoriasis visits, followed by family physicians at 12%, and internists at 5%. Dermatologists prescribed calcipotriene, calcipotriene/betamethasone, and topical corticosteroids in 15%, 4% and 59% of psoriasis visits, respectively. Over time, there was no significant change in the use of topical steroids or vitamin D products by physicians.This study is limited by the inability to determine the severity of psoriasis from the data collected, and the lack of data on the length of treatment with different medications.
CONCLUSIONS: Despite their demonstrated efficacy and safer side effect profile, vitamin D analogs are used less often than topical corticosteroids for the treatment of psoriasis. These findings suggest that vitamin D products may not be utilized to their fullest potential as effective topical therapy or adjuncts to therapy for localized plaque psoriasis.
J Drugs Dermatol. 2013;12(8):906-910.
Aubrey Wagenseller MD, Cecilia Larocca MD, and Neelam A. Vashi MD
Annular elastolytic giant cell granuloma, also known as actinic granuloma, is a rare skin condition with a chronic course that is often resistant to treatment. Literature is sparse, and only a handful of case reports are available to guide treatment decisions. Typical first line treatment options include topical and intralesional steroids, topical pimecrolimus, and cryotherapy. Resistant cases have been treated with cyclosporine, systemic steroids, antimalarials, and oral retinoids. In particular, acitretin and isotretinoin have shown success in three cases. However, these medications can have side effects and require frequent lab monitoring. We present a case of a 47-year-old woman with bilateral forearm lesions consistent with annular elastolytic giant cell granuloma who was successfully treated with topical tretinoin.
J Drugs Dermatol. 2017;16(7):699-700.
Jerry Bagel MD,a and Linda Stein Gold MDb
Psoriasis is a chronic inflammatory skin disease that affects millions of people in the United States as well as worldwide. While there is currently no cure for psoriasis, many treatment options are available. Topical therapies are the mainstay for the majority of patients who have limited or mild psoriasis. Among these medications, topical vitamin D analogs (eg, calcipotriene) and corticosteroids (eg, betamethasone), and these drugs in combination, are the most widely prescribed psoriasis drugs and are the cornerstone of topical therapies. For patients with more severe disease, phototherapy, conventional systemic agents, and biologics are often indicated. Currently, the goal of treatment is to control the clinical symptoms of the skin, reduce systemic disease potential, and improve the patient’s quality of life. Despite the availability of various therapeutic options for psoriasis, many patients go untreated, and even among those who are treated, many do not achieve complete resolution of the disease. The new consensus is to treat to a target of 1% or less of body surface area involvement. Innovative treatment strategies are needed to meet this goal and patients’ desire to achieve clear skin. Combination therapies are widely used by physicians, and adjunctive topical therapies used with other antipsoriatic regimens have been demonstrated to provide many clinical benefts. This article reviews the most recently published clinical evidence of adjunctive use of topical agents with biologics, conventional systemic agents, and phototherapy, to better establish the role of topical agents in combination therapy for the treatment of psoriasis.
J Drugs Dermatol. 2017;16(12):1209-1222.
Staci Brandt PA-C MSMR MBA
This article reviews the published literature about the efficacy of oral and topical zinc as treatments for acne vulgaris. The medical literature was systematically reviewed to identify relevant articles. Each published study was assessed for pathophysiologic results and the quality of the clinical evidence the study provided based on Strength of Recommendation Taxonomy (SORT) criteria. Finally, the body of evidence for using oral or topical zinc in the treatment of acne was assessed, again using SORT criteria. A SORT strength of recommendation of B (inconsistent or limited-quality patient-oriented evidence) appears to be appropriate for both oral and topical zinc. The preponderance of evidence suggests zinc has antibacterial and anti-inflammatory effects and that it may decrease sebum production.
J Drugs Dermatol. 2013;12(5):542-545.
Audrey S. Wang MD,a Larissa Larsen MD,a Shurong Chang MD PhD,a Tiffany Phan BA,a Jared Jagdeo MD MSa,b,c
Dermatofibromas are benign skin lesions that may be treated if symptomatic or for cosmetic concerns. We present a case of an African
American woman with an enlarging, pruritic dermatofibroma on the thigh that was treated with fractionated carbon dioxide (CO2) laser
three times approximately 5 weeks apart. Between laser treatments, topical corticosteroids were applied to the lesion for a total of 13
weeks. The dermatofibroma completely flattened and became asymptomatic within 1 month after the final laser treatment. We hypothesize
that the fractionated CO2 laser ablated a portion of the stromal component of the lesion and introduced microscopic channels
that facilitated deeper penetration of the topical corticosteroids into the lesion. This is the first reported case demonstrating the successful
treatment of a symptomatic dermatofibroma using combination therapy with fractionated CO2 laser and topical corticosteroids.
J Drugs Dermatol. 2013;12(12):1483-1484.
Terry M Jones MD,a Herman Ellman MD,b Tina deVries PhDb
OBJECTIVE: To characterize minocycline pharmacokinetics and relative bioavailability following multiple-dose topical administration of minocycline hydrochloride (HCl) foam 4% (FMX101 4%) as compared with single-dose oral administration of minocycline HCl extended-release tablets (Solodyn®) in subjects with moderate-to-severe acne.
METHODS: A Phase 1, single-center, nonrandomized, open-label, active-controlled, 2-period, 2-treatment crossover clinical study. The study included 30 healthy adults (mean age, 22.6 years; 90% white, and 60% females) who had moderate-to-severe acne. Subjects were assigned to first receive a single oral dose of a minocycline HCl extended-release tablet (approximately 1 mg/kg). At 10 days after the oral minocycline dose, topical minocycline foam 4% was applied, once daily for 21 days. Serial blood samples were obtained before and after administration of oral minocycline and each topical application of minocycline foam 4% on days 1, 12, and 21.
RESULTS: Following oral administration of minocycline (approximately 1 mg/kg), plasma minocycline concentration increased until 3 hours, followed by a log-linear decrease over the remainder of the 96-hour sampling period. Following topical application of a 4-g maximal-use dose of minocycline foam 4% for 21 days, plasma minocycline concentration was very low, with geometric mean Cmax values ranging from 1.1 ng/mL to 1.5 ng/mL. Steady state was achieved by day 6. Overall, minocycline exposure with topical minocycline foam 4% was 730 to 765 times lower than that with oral minocycline. There was no evidence of minocycline accumulation over the 21 days of topical application of minocycline foam 4%. Topical minocycline foam 4% appeared to be safe and well tolerated, with no serious treatment-emergent adverse events (TEAEs), treatment-related TEAEs, or TEAEs that led to treatment discontinuation.
CONCLUSION: Once-daily topical application of minocycline foam 4% did not lead to significant systemic exposure to minocycline. It appears to be a well-tolerated treatment option for individuals with moderate-to-severe acne.
J Drugs Dermatol. 2017;16(10):1022-1028.
Linda F. Stein Gold MD,a Lynda Spelman MBBS FACD,b Mary C. Spellman MD,c Matilda H. Hughes CCRA,d and Lee T. Zane MDd
BACKGROUND: Crisaborole is a novel, boron-based, small-molecule, topical phosphodiesterase-4 inhibitor in development for the treatment
of patients with mild to moderate atopic dermatitis (AD).
METHODS: In this multicenter, randomized, double-blind, dose-ranging, phase 2 study, adolescent patients 12 to 17 years of age with mild to moderate AD and 2 distinct target AD lesions were randomized to once-daily (QD) or twice-daily (BID) treatment with crisaborole
topical ointment. For each patient, 2 target lesions were randomized to receive 29 days of treatment with 0.5% or 2% crisaborole topical ointment. The primary endpoint was change from baseline in AD severity index (ADSI) score for each lesion. Exploratory efficacy endpoints and safety were also assessed.
RESULTS: A total of 86 patients were enrolled and received crisaborole topical ointment 0.5% or 2% QD (n=44) or BID (n=42). All dosing regimens produced dose-related improvements in ADSI as well as in all 5 component signs and symptoms of AD (erythema, excoriation,
exudation, lichenification, and pruritus). The greatest improvements were consistently observed with crisaborole topical ointment, 2% applied BID. With this regimen, ADSI improved from baseline by 71%, and total or partial clearance of target lesions (ADSI ≤2) was achieved by 62% of patients after 29 days of treatment. Both doses of crisaborole topical ointment were well tolerated; mild application site reactions were the only treatment-related adverse events (QD, n=3; BID, n=1).
CONCLUSION: These results provide preliminary evidence of the efficacy and safety of crisaborole topical ointment, 2% applied topically BID in adolescents with mild to moderate AD.
J Drugs Dermatol. 2015;14(12):1394-1399.
Erin Lessner MD,a Samantha Fisher MD,b Katherina Kobraei MD,b Michael Osleber MD,b Rebecca Lessner BS,c Lauren Elliott MD,d and Stanton Wesson MDb
PURPOSE: To access the efficacy of spironolactone and topical retinoids in the treatment of female cyclical acne.
METHODS: A retrospective chart review on 41 female patients age 19-57 years old with cyclical acne was performed. Patients were examined
over the course of 2 to 102 months while taking 50 to 200mg of spironolactone and topical tretinoin 0.025% or adapalene 0.1%
cream. All were diagnosed with acne rated mild to severe, prior to treatment, and were started on an initial dose of 50mg po daily. If
significant improvement was not seen within the first 3-6 months, the dose was either held or increased in 25mg increments every 3
months. Patients on oral and topical antibiotics, as well as patients on photodynamic therapy were excluded from the study. The response
to treatment was rated on a 0-4 scale with 0 being no response and 4 corresponding to clear skin.
RESULTS: One patient (2.4%) had no response to treatment. This patient was only on 50mg po daily for only 2 months. Only 5 (12.2%)
patients had minimal response to treatment and 9 (22.0%), 12 (29.3%), and 14 (34.1%) had a good, excellent, or clear response respectively.
The study showed 26 (63.4%) women on treatment with spironolactone and topical retinoids had an excellent or clear outcome,
and 35 (85.4%) were considered to have a good, excellent, or clear response.
CONCLUSION: The addition of spironolactone to topical retinoid treatment suggests a superior response to retinoids alone in clearance
of female adult cyclical acne.
J Drugs Dermatol. 2014;13(2):126-129.
Hilary Baldwin MD,a Diane Berson MD,b Maria Vitale MS,c Margarita Yatskayer MS,c
Nannan Chen PhD,c and Christian Oresajo MD PhDc,d
Rosacea is a condition most commonly characterized by central facial erythema and pupulopustules. There are highly effective drugs, both oral and topical, for papulopustular disease. At the present time, consistently effective pharmacologic therapy for erythematotelangiectatic rosacea is lacking. Patients whose papulopustular disease has been adequately treated are often still bothered by central facial erythema for which there is no adequate treatment short of laser and light. We present a study utilizing a novel topical composition evaluated for its ability to reduce background erythema remaining after adequate care of papulopustular disease. Patient, investigator and photographic evidence of erythema reduction was seen in 24/25 patients in this 8-week study.
J Drugs Dermatol. 2014;13(3):326-331.
Charles W. Lynde MD FRCPC and Anneke Andriessen PhD
INTRODUCTION: Multiple topical therapies are available for mild to moderate acne vulgaris. The role of antibiotics and their resistance in the treatment of acne was reviewed by an expert panel of dermatologists who practice in Canada.
METHODS: Prior to the consensus meeting, the panel members filled out a survey on their current practice using topical treatment for acne. A literature review was carried out using information obtained from PubMed, Cochrane Library, Medline, and EMBASE. During a consensus meeting organized at the Spring Dermatology Update on April 27, 2014 in Toronto, ON, the panel had a blind vote on the issues at hand.
RESULTS: The panel reached consensus on: 1) Antibiotics are an integral part of acne treatment not only due to their antibiotic effect but also by their anti-inflammatory action. 2) Oral antibiotics should be used for a short period of time if possible. 3) Topical antibiotics should not be used in monotherapy. 4) Retinoids are effective in reducing antibiotic resistance. 5) A benzoyl peroxide wash is as effective as topical benzoyl peroxide in reducing antibiotic resistance. 6) Therapy needs to be re-evaluated in 6-8 weeks versus 12 weeks. The recommendations given by the panel are to be disseminated to both general practitioners and dermatologists.
CONCLUSION: For mild to moderate acne treatment, topical antibiotics in monotherapy are not to be used but may be combined with a retinoid or BPO to safely achieve more successful outcomes.
J Drugs Dermatol. 2014;13(11):1358-1364.
Kavita Darji BA and Nicole M. Burkemper MD
Pityriasis folliculorum has been described as a dry type of rosacea with extensive proliferation of Demodex folliculorum in pilosebaceous follicles of the skin. This skin condition is frequently difficult to manage, with various treatment options showing mixed efficacy. Oral ivermectin, a macrocyclic lactone parasiticide with anti-inflammatory and anti-parasitic effects, is one of the leading treatment modalities for demodicosis. Topical ivermectin has recently been FDA approved as therapy for rosacea. We present the case of a woman with pityriasis folliculorum who showed significant improvement from using topical ivermectin with no adverse events related to treatment.
J Drugs Dermatol. 2017;16(12):1290-1292.
Joseph Bikowski MD FAAD
Clinicians must evaluate a voluminous amount of information from clinical trials when choosing among the growing number
of topical acne treatments. This article describes a simple way to evaluate and broadly compare the efficacy results of
well-controlled phase III clinical trials of topical acne treatments by taking into account the placebo effect (or active control
effect). Key efficacy results are drawn from the package inserts of 7 primary topical acne treatments. To account for
placebo effect, the mean percent reduction with placebo was subtracted from that of the active treatment for each type of
lesion and also calculated as an average of these differences for all lesions. Based upon the principles of research, this method
accounts for within study variances and offers a quick assessment of product efficacy. Clinicians should be cautioned that
this method only allows for broad comparisons and does not establish definitive differences between treatments.
Aton M. Holzer MD, Leonard L. Kaplan PhD, William R. Levis MD
For the past 40 years, dermatologists have safely used contact sensitizers such as dinitrochlorobenzene (DNCB), diphenylcyclopropenone
(DPCP), and squaric acid dibutylester (SADBE) for the treatment of warts, alopecia areata, and even skin cancers.
Most of these studies have utilized these powerful topical immunomodulators in acetone, a volatile solvent that precludes
development of contact sensitizers as products. We have overcome these problems and stabilized these topical
immunomodulators in a non-volatile, nonirritating GRAS (generally regarded as safe) vehicle. The current review article
covers the traditional use of contact sensitizers for a variety of benign and malignant conditions and discusses possible mechanisms
in relation to developments in modern molecular immunodermatology.
Linda Stein Gold MD,a Hilary E Baldwin MD,b Tina Lin PharmDc
Acne vulgaris (acne) is the most common skin disease we see in dermatology practice. Although rare in childhood, severe acne can affect up to 12% of the adolescent population. A chronic disease, it requires both aggressive management and effective maintenance strategies. Oral antibiotics, in combination with topical agents are recommended for treatment, with topical agents being continued as maintenance therapy to minimize resistance and recurrence. However, concerns with systemic side effects have recently resulted in a greater focus on the potential of fixed combination topical therapies to treat severe acne. Here we review the available clinical evidence. There are no studies investigating the use of fixed combination topical therapy exclusively in severe acne. However, studies assessing the treatment of moderate-to-severe acne include subpopulation data in severe patients. Adapalene 0.3%-benzoyl peroxide (BP) 2.5% was found to be effective in patients with severe acne, whereas the fixed combination with a lower concentration of adapalene (0.1%) was no more effective than vehicle. Clindamycin-BP 1.2%/3.75% gel and clindamycin-BP 1.2%/2.5% gel were both found to be effective in severe acne with an apparent BP-dose response. Clindamycin phosphate 1.2%-tretinoin 0.025% demonstrated similar efficacy in severe acne, but with little benefit over individual monads. Realistic topical treatment options now exist for the management of severe acne where patient and physician preference can impact positive outcomes.
J Drugs Dermatol. 2017;16(11):1134-1138.
Anthony A. Gaspari MD, Stephen K. Tyring MD PhD, andTheodore Rosen MD
The therapeutic potential of imiquimod, a toll-like receptor (TLR)-7 agonist, was recognized in the clinical setting more than a decade
ago. Beginning with an approved indication for the treatment of external genital warts in 1997, imiquimod 5% topical cream (Aldara®)
has received further approval for treating actinic keratosis and superficial basal cell carcinoma. Currently, imiquimod 5% topical cream
is the most widely studied and characterized TLR agonist available in the clinical milieu. With new formulations and adjunctive regimens
being studied, this paper briefly reviews the mechanisms of action, approved indications, exploratory indications and the role
of combination therapy, add-on molecules, and new formulations to overcome treatment limitations.
Anish Nadkarni BS, Mohammed D. Saleem MD, and Steven R. Feldman MD PhD
BACKGROUND: Topical corticosteroids are the most common dermatologic medications and are available in numerous different vehicles. Adherence is limited by traditional vehicles because they are messy and time consuming to apply. The preferred spray formulations have the advantage of being applied with ease, resulting in improved adherence and subsequently improved psoriasis. One limitation of topical treatments, especially spray vehicles, is the potential for irritation and sensitization.
OBJECTIVE: To evaluate the irritation and sensitization potential of topical desoximetasone spray formulation.
METHODS: A multicenter, double-blinded, randomized, controlled study assessed the irritancy and sensitization of 0.25% and 0.05% topical desoximetasone spray. Controls included vehicle, a positive control (0.1% sodium lauryl sulfate), negative control (0.9% saline), and an active comparator control (clobetasol spray). The primary outcome of the study was to evaluate the difference in mean cumulative irritation and potential sensitization response of desoximetasone 0.25% and 0.05% topical sprays.
RESULTS: Of the 297 enrolled, 269 completed the study per protocol for the irritation phase and 250 completed the protocol for the sensitization phase. At 22 days, desoximetasone 0.25 and 0.5% spray were less irritating than clobetasol 0.05% spray; mean irritation score difference of -0.46 and -0.57, respectively. Median total irritation score over the 22 days was 0 for all products. No subjects demonstrated any sensitization reaction to any of the six products. No serious adverse reactions were reported.
LIMITATIONS: Selection bias, use of a healthy population, limits the external validity. In addition, the duration of the study was short lived, unlike numerous inflammatory skin diseases.
Conclusions: Desoximetasone spray has little potential for irritation or sensitization. The availability of another spray option for patients desiring less messy treatment may facilitate better adherence and treatment outcomes.
J Drugs Dermatol. 2017;16(8):755-758.
Mario A. Trelles MD PhD, Mariano Velez MD, Michael H. Gold MD
Background: Melasma is a difficult entity to treat. Topical creams or chemical peels offer some success, and the newer fractional
lasers have also been proposed to be useful. This three-armed study compares topical creams, CO2 ablative fractional resurfacing
and the combination of both modalities.
Patients and Methods: Thirty females with melasma, mean age of 38 years, skin types II–IV, were allocated to three groups: group
A received treatment with Kligman’s formula maintenance topical cream program; group B, CO2 fractional resurfacing using high
power, fixed pulse width and low frequency; and group C, both laser and maintenance topical cream treatment. Subjective patient
and clinician assessments based on melasma area severity index (MASI) scores were made at baseline, one, two, six and 12
months, and the satisfaction index (SI) and overall efficacy calculated.
Results: All patients completed the study. The SI and overall efficacy in groups A, B and C were 100% at one month in all groups but
progressively decreased in further assessments except for group C in which better scores were maintained throughout. MASI scores
for group C were statistically significantly improved compared to A and B at six and 12 months (P<0.001 for both).
Conclusion: The fractional CO2 laser and topical cream regimen produced good, well-maintained results in melasma treatment compared
with the monotherapy groups.
Michael A. Lee MDa and Philip R. Cohen MDb
INTRODUCTION: Zoon balanitis is an idiopathic benign inflammatory condition of the glans penis and prepuce. A patient with biopsy confirmed diagnosis of Zoon balanitis who was successfully treated with topical mupirocin ointment monotherapy is described.
METHOD: A search using PubMed database was performed using the following terms: Zoon balanitis (cases, diagnosis, treatment of), balanitis circumscripta plasmacellularis, and mupirocin. Relevant papers and their reference citations were reviewed and evaluated.
RESULTS: The gold standard of treatment for Zoon balanitis has previously been circumcision. More recently, topical calcineurin inhibitors have been shown to be effective. Our patient had successful resolution of his Zoon balanitis after 3 months of mupirocin ointment monotherapy.
DISCUSSION: Zoon balanitis is a benign inflammatory dermatosis. Previous successful treatment modalities include circumcision, phototherapy, laser therapy, and topical calcineurin inhibitors. Topical mupirocin ointment twice daily resulted in resolution of Zoon balanitis in our patient. Additional evaluation of mupirocin ointment as a therapeutic agent should be considered as a potential first-line therapy in patients with Zoon balanitis.
J Drugs Dermatol. 2017;16(3):285-287.
Lichen striatus (LS) is an uncommon linear dermatosis that is primarily seen in children from 4 months to 15 years of age. While
some of these eruptions are asymptomatic, others can be quite pruritic. In darker-skinned individuals, post-inflammatory hypopigmentation
can be significant and may provide a cause for concern for the patients and/or their parents. In our case series of 4
patients, we observed rapid resolution of LS by combining a topical retinoid with a topical steroid. To our knowledge, this is the
first report of successful treatment with this kind of combination therapy in the English literature. The patients not only achieved
satisfying cosmesis, but also complete resolution of their pruritus. The most common side effect of topical tazarotene is localized
irritation at treatment sites, but the patients in this particular series tolerated the treatment well.
J Drugs Dermatol. 2012;11(7):872-875.
Tracey C. Vlahovic DPMa and Warren S. Joseph DPM FIDSAb
OBJECTIVE: To evaluate efficacy, safety, and tolerability efinaconazole topical solution, 10% in diabetic patients with onychomycosis
METHODS: A post-hoc analysis of 112 patients, aged 29-70 years, randomized to receive efinaconazole topical solution, 10% or vehicle from two identical multicenter, double-blind, vehicle-controlled 48-week studies evaluating safety and efficacy. The primary end point was complete cure rate (0% clinical involvement of target toenail, and both negative potassium hydroxide examination and fungal culture) at week 52.
RESULTS: Mycologic cure rates (OC) were significantly greater with efinaconazole (56.5% and 56.3% in diabetic and non-diabetic patients respectively) compared to vehicle (P=0.016 and P<0.001, respectively). The primary end point, complete cure, was also greater for efinaconazole (13.0% and 18.8%, respectively vs 3.7% and 4.7%). Treatment success (percent affected target toenail ≤10%) for efinaconazole was 40.8% and 47.7%, respectively vs 18.5% and 18.2% with vehicle. There was no statistically significant difference between the diabetic and non-diabetic populations for any efficacy endpoint. Adverse events associated with efinaconazole were local site reactions and clinically similar to vehicle.
CONCLUSIONS: Once daily efinaconazole topical solution, 10% may provide a useful topical option in the treatment of diabetic patients with onychomycosis.
J Drugs Dermatol. 2014;13(10):1186-1190.
Edwardo Tschen, MD and Terry Jones, MD
Topical acne therapies are widely used for the treatment of mild to moderately severe acne vulgaris. However, many available treatments have limitations associated with their use, including lengthy time to response, cosmetic acceptability, and photosensitivity. Combinations of topical antibiotics and comedolytics are especially useful, but some formulations have stability challenges. A new combination formulation that contains 1% clindamycin and 5% benzoyl peroxide(BenzaClin® Topical Gel) is currently available. In clinical trials, clinical improvement occurred at the first two follow-up visits and continued throughout treatment. In addition, combination therapy with clindamycin/benzoyl peroxide gel rapidly reduces Propionibacteria acnes counts and suppresses the emergence of clindamycin-resistant P. acnes. This formulation is stable at room temperature for up to 2 months after compounding. The aqueous gel vehicle is less drying, and there is no photosensitivity associated with its use. This study compares the combination treatment of 1% clindamycin and 5% benzoyl peroxide topical gel with other therapeutic options for mild to moderately severe acne vulgaris.
Aanand N. Geria MD, Christina N. Lawson MD, Rebat M. Halder MD
Topical retinoids are an important class of drugs for treating several dermatoses occurring more frequently in patients with pigmented skin, such as melasma, post-inflammatory hyperpigmentation, pseudofolliculits barbae and keloids. They also play a role in managing acne, psoriasis, photoaging, cutaneous T-cell lymphoma, Kaposi sarcoma and disorder of hyperkeratosis in this demographic as well. In general, topical retinoids are well tolerated in pigmented skins. There is little evidence to suggest that patients with darker skin are at increased risk of irritation. However, retinoid dermatitis can induce post-inflammatory hyperpigmentation and attempts should be made to reduce its occurrence by modifying treatment regimens in patients with pigmented skins.
J Drugs Dermatol. 2011;10(5):483-489.
Alice He BS,a Steven R. Feldman MD PhD,a,b,c and Alan B. Fleischer Jr. MDd
BACKGROUND: Atopic dermatitis (AD) is primarily treated with topical therapies, systemic immunosuppressants, or adjunctive therapies.
OBJECTIVE: As novel treatment approaches for AD emerge, we characterize AD treatment and examine trends in treatment over time.
METHODS: Visits for AD were identified in the 2003-2012 National Ambulatory Medical Care Survey (NAMCS). We identified topical
corticosteroids (TCS), antibiotics (Abx), antihistamines (AH), topical calcineurin inhibitors (TCI), and systemic immunosuppressants (SI)
prescribed at AD visits.
RESULTS: There were 990,000 annual visits for AD from 2003-2012 (3.2 visits/1000 people/year). TCS were the most frequently used medication (59% of visits). Topical calcineurin inhibitors (TCI) were the second most prescribed medication for AD among dermatologists
(23% of visits), while antihistamines were second among all other physicians (16-44% of visits). Unlike other medications, use of TCIs decreased over time.
LIMITATIONS: The NAMCS does not follow individual patients over time.
CONCLUSIONS: TCI use has been decreasing. New topical AD treatments may provide an alternative to TCS, better treatment outcomes for moderate-to-severe atopic dermatitis, and an alternative to systemic antihistamines whose efficacy in AD is unproven and whose general use in AD management is discouraged by the American Academy of Dermatology.
J Drugs Dermatol. 2018;17(2):135-140.
James Q. Del Rosso DO FAOCDa and Leon H. Kircik MDb
Superficial cutaneous fungal infections (SCFIs) are commonly encountered in clinical practice in the United States, and comprise infections of the skin by dermatophytes and yeasts. The most common organisms causing SCFI are dermatophytes, especially Trichophyton spp. With the exception of onchomycosis and tinea capitis, most cases of SCFIs are amenable to properly selected topical antifungal therapy used over an adequate period of time.
A variety of topical antifungal agents are available for the treatment of SCFIs, and they encompass a few major chemical classes: the polyenes (ie, nystatin), imidazoles (ie, ketoconazole, econazole, oxiconazole, etc), allylamines (ie, naftifine, terbinafine), benzylamines (ie, butenafine), and hydroxypyridones (ie, ciclopirox). The 2 major classes that represent the majority of available topical antifungal agents are the azoles and the allylamines. Overall, the allylamines are superior to the azoles in activity against dermatophytes, although both are clinically effective. The reverse is true against yeasts such as Candida spp and Malassezia spp, although topical allylamines have proven to be efficacious in some cases of tinea versicolor and cutaneous candidiasis.
Naftifine, a topical allylamine, is fungicidal in vitro against a wide spectrum of dermatophyte fungi and has been shown to be highly effective against a variety of cutaneous dermatophyte infections. Rapid onset of clinical activity and favorable data on sustained clearance of infection have been documented with naftifine. The more recent addition of naftifine 2% cream has expanded the armamentarium, with data supporting a clinically relevant therapeutic reservoir effect after completion of therapy.
J Drugs Dermatol. 2013;12(suppl 11):s165-s171.
Brooke Bair DO and David Fivenson MD
Background: Calcinosis cutis is a term used to describe a group of disorders which result in calcium deposits in the skin. These disorders can be separated based on etiology.
Objective and Methods: Sodium thiosulfate has been used to systemically treat calciphylaxis with little to no adverse effects. We report two cases of ulcerative calcinosis cutis which were refractory to multiple topical treatments and did not improve with correction of underlying electrolyte abnormalities.
Results: Both cases showed an excellent response to topical 25% sodium thiosulfate compounded in zinc oxide.
Limitations: We are limited by a small sample size (n=2) in this case series.
Conclusions:We recommend topical sodium thiosulfate 25% as an alternative treatment for dystrophic calcinosis cutis.
J Drugs Dermatol. 2011;10(9):1042-1044.
Nathaniel J. Jellinek MD FAAD FACMSa and Andrew Korotzer PhDb
OBJECTIVE: To identify those patients who are more likely to achieve treatment success with efinaconazole topical solution 10% based on clinical improvement and mycological status during treatment.
METHODS: A subgroup analysis of patients, aged 18 to 70 years, randomized to receive efinaconazole topical solution 10% or vehicle from 2 identical multicenter, double-blind, vehicle-controlled 48-week studies evaluating safety and efficacy. The primary end point, complete cure rate (0% clinical involvement of target toenail, and both negative potassium hydroxide examination and fungal culture) at week 52 was evaluated based on mycologic cure at week 24, and the degree of clinical improvement in nail involvement at week 12.
RESULTS: Over a quarter (25.1%) of patients treated with efinaconazole topical solution 10% who could demonstrate at least 10% improvement in affected nail involvement by week 12 progressed to complete cures at week 52. Similarly, 21.7% of patients who demonstrated mycologic cure at week 24 achieved complete cures at week 52.
CONCLUSIONS: Early clinical improvement and mycologic clearance may help to predict treatment success with efinaconazole topical solution 10%.
J Drugs Dermatol. 2015;14(8):871-875.
Acne is a very common skin disease; frequently seen in adolescents and often persisting or occurring into adulthood. Topical therapy is very effective in mild to moderate disease, and is used as maintenance therapy. Fixed combination products have been studied in moderately severe disease. Combinations of benzoyl peroxide and either clindamycin or adapalene appear very effective. When utilizing a topical retinoid alone or in combination, it is essential to incorporate an appropriate skin care regimen to minimize local irritation. In the absence of direct comparative clinical trials, this review provides timely guidance for clinicians on the use of these agents, and their benefits in special populations.
J Drugs Dermatol. 2015;14(6):567-572.
Tina S. Alster, MD and Elizabeth L. Tanzi, MD
Successful and long-standing eradication of sebaceous hyperplasia has remained difficult due to the propensity
of these lesions to be extensive. Current treatments include excision, electrodesiccation, laser vaporization,
and oral isotretinoin, each often associated with unacceptable side effects or lesional recurrence. The purpose
of this study was to evaluate the safety and effectiveness of laser-assisted photodynamic therapy using topical
5-aminolevulinic acid (5-ALA) and 595 nm pulsed dye laser (PDL) irradiation for the treatment of sebaceous
Ten patients with sebaceous hyperplasia received 1 or 2 treatments at 6 week intervals with topical 20% 5-ALA
followed 1 hour later by 595 nm PDL irradiation. Matched lesions served as controls and were either treated
with PDL alone or were left untreated. Patients were evaluated at regular intervals for 3 months.
Results demonstrated that combination topical 5-ALA and PDL treatment effected better clinical results than
PDL treatment alone. No changes were observed in untreated control lesions. Side effects were mild and limited
to transient erythema, edema, and focal crusting.
It is the conclusion of the authors that laser-assisted photodynamic therapy with topical 5-ALA and PDL irradiation
can achieve safe and effective improvement of sebaceous hyperplasia. Further study is warranted to
determine the longevity of the clinical results observed.
Sumayah J. Taliaferro MD, George F. Cohen MD
Bowen’s disease of the penis is relatively uncommon, but the prevalence has increased in recent years. Risk factors for penile
squamous cell cancer include smoking, infection with human papilloma virus (HPV), immunosuppression, and a history
of conditions such as balanitis, phimosis, and lichen sclerosis et atrophicus. Bowen’s disease of the penis is often
managed by local excision of the lesion. Less invasive methods are now employed more frequently and include laser ablation,
electrodessication and curettage, cryosurgery, application of 5-fluorouracil, and topical imiquimod 5% cream. This
case report describes the successful treatment of Bowen’s disease of the penis with topical imiquimod 5% cream in a 42-
year-old African American male with human immunodeficiency virus (HIV) disease.
Elena Maydan MD, Pavan K. Nootheti MD, Mitchel P. Goldman MD
Since its FDA approval in 1999, photodynamic therapy (PDT) with topical 5-aminolevulinic acid has become an increasingly
popular modality for the treatment of actinic keratosis (AKs). It is hoped that in addition to improving clinical signs
and symptoms of AKs, PDT might prevent the development of skin cancer. We present a case of a patient developing a keratoacanthoma
immediately following PDT for AKs.
Tina S. Alster MD, Elizabeth L. Tanzi MD, Esperanza C. Welsh, MD
Background: Photorejuvenation of facial skin has been reported after intense pulsed light (IPL) therapy alone and in conjunction
with topical 5-aminolevulinic acid (5-ALA), but no comparative studies between these regimens have been performed.
Objective: To evaluate the safety and effectiveness of combination topical 5-ALA and IPL compared to IPL treatment alone.
Methods: Ten patients with mild to moderate photodamage were randomly assigned treatment with 5-ALA + IPL on one facial
half and IPL alone on the contralateral side. Two treatments were delivered at 4-week intervals. Clinical improvement scores
were determined by masked evaluations of digital photographs obtained at baseline, prior to each treatment session, and at 1, 3,
and 6 months after the final treatment.
Results: Higher clinical improvement scores were noted on the combination 5-ALA + IPL treated areas. Mild edema, erythema,
and desquamation were observed on the facial halves where 5-ALA was applied. No scarring or unwanted pigmentary alteration
Conclusions: Photodynamic therapy with combination topical 5-ALA + IPL is safe and more effective for facial rejuvenation
than IPL treatment alone.
Karen E. Burke,a Xueyan Zhou,a Yongyin Wang,f Joel Commisso,b Carl L. Keenb
Robert M. Nakamura,a Gerald F. Combs Jr.,d and Huachen Weia,e
Previous studies in mice have shown that topical L-selenomethionine (SeMet) can prevent UVB-induced skin cancer when applied continuously before, during, and after the radiation exposure. With topical application of SeMet, selenium levels were shown to increase in the skin and liver, as well as in tumor tissue. Thus, possibly, the timing of SeMet application could affect the degree of inhibition of UVB-tumorigenesis (or maybe even enhance tumorigenesis at some stage). The goal of this research was to determine whether topical SeMet best inhibits UV-induced skin cancer if (a) begun before and continued during and after UVB exposure, (b) if begun before UVB-exposure and discontinued when tumors are first clinically detected, or (c) if begun only after tumors are first detected and continued thereafter. Groups of ten Skh: 1 hairless, non-pigmented mice were treated topically with vehicle lotion, or with SeMet (0.05%) in that vehicle lotion applied either (a) before, during, and after UV exposure, (b) before UV radiation and continued only until the first tumor was detected, or (c) only after the first tumor was detected. In all cases, UV irradiation was discontinued at the time of detection of the first tumor. Optimal inhibition of skin cancer was achieved by application of topical SeMet before, during, and after exposure; significant protection was also attained with application only after the onset of tumors. Notably, statistically significant protection was not seen with SeMet application only prior to tumor detection. These results suggest that even beginning SeMet supplementation late in the process of tumorigenesis can help protect from UV-induced photodamage and skin cancer.
J Drugs Dermatol. 2014;13(10):1214-1223.
Kurt Jarnagin PhD,a Sanjay Chanda PhD,b Dina Coronado BS,a Vic Ciaravino PhD,a Lee T. Zane MD,a Emma Guttman-Yassky MD PhD,b and Mark G. Lebwohl MDb
Crisaborole topical ointment, 2% (formerly known as AN2728) is a benzoxaborole, nonsteroidal, topical, anti-inflammatory phosphodiesterase 4 (PDE4) inhibitor investigational compound that recently completed phase 3 studies for the treatment of mild to moderate atopic dermatitis (AD). The unique configuration of boron within the crisaborole molecule enables selective targeting and inhibition of PDE4, an enzyme that converts the intracellular second messenger 3’5’-cyclic adenosine monophosphate (cAMP) into the active metabolite adenosine monophosphate (AMP). By inhibiting PDE4 and thus increasing levels of cAMP, crisaborole controls inflammation. The use of boron chemistry enabled synthesis of a low–molecular-weight compound (251 daltons), thereby facilitating effective penetration of crisaborole through human skin. In vitro experiments showed that crisaborole inhibits cytokine production from peripheral blood mononuclear cells in a pattern similar to other PDE4 inhibitors and distinct from corticosteroids. Crisaborole also displayed topical anti-inflammatory activity in a skin inflammation model. Once crisaborole reaches systemic circulation
after topical application, it is metabolized to inactive metabolites. This limits systemic exposure to crisaborole and systemic PDE4 inhibition. In phase 1 and 2 clinical studies, crisaborole ointment, 2% was generally well tolerated and improved AD disease severity scores, pruritus, and all other AD signs and symptoms. Two large, randomized, controlled, phase 3, pivotal clinical trials assessing
the efficacy and safety of crisaborole topical ointment, 2% in children, adolescents, and adults with mild to moderate AD were recently completed with positive results.
J Drugs Dermatol. 2016;15(4):390-396.
Benzoyl peroxide (BPO) is a commonly used and highly effective topical treatment for acne that is available in concentrations from
2.5–10%. The compound is not associated with bacterial resistance, and published acne treatment guidelines recommend BPO in conjunction
with the long-term use of both topical and systemic antibiotics. A number of combination products containing antibiotics, BPO
and/or retinoids are available and useful for tailoring treatment to the needs of each patient over the course of what is often a chronic
condition. Fixed combinations of BPO and antibiotics or retinoids address multiple pathogenetic factors by using agents with complementary,
but different modes of action. These agents are convenient to use and may improve adherence to therapy by simplifying the
regimen for the patient. However, BPO is associated with dose-dependent irritation and dryness. Therefore, formulations containing
lower concentrations of BPO (2.5%) minimize irritation, which may improve tolerability and maximize treatment outcomes.
Norashikin Shamsudin MRC P and Alan B. Fleischer Jr. MD
Background: A topical comparison in a randomized controlled trial (RCT) should correctly be termed a vehicle rather than a placebo
as the vehicle in a dermatologic drug product enhances delivery and efficacy of the active compound.
Objectives: To conduct a systematic review of RCTs involving topical drugs published in the Archives of Dermatology, Journal of
the American Academy of Dermatology and British Journal of Dermatology for correct classification of studies as vehicle versus
Methods: RCTs involving topical drugs published in the Archives of Dermatology, Journal of the American Academy of Dermatology
and British Journal of Dermatology from January 1999 to November 2008 were identified through PubMed, supplemented by citation
lists from the individual journals’ web pages. Only original studies that involved using a topical control or used the term topical “vehicle”
or “placebo” were selected. The studies were examined for correct classification as vehicle-controlled, the year of publication,
country of origin, sample size, funding source and nature of study center.
Results: Out of 132, 64 (49%) correctly classified their studies as vehicle-controlled. Pharmaceutical-funded studies (55%, P=0.01)
were significantly associated with the use of correct classification.
Limitations: As only three peer-reviewed dermatology journals were studied, findings may not be generalized to other dermatology
journals and other types of publications.
Conclusion: This systematic review highlights a common pitfall in the reporting of studies of topical dermatology drugs.
Joshua A. Zeichner MD
Dermatophyte infections of the skin and nails are common in the United States. These infections warrant treatment because they are symptomatic and progressive, and can predispose patients to superinfections. Topical drugs such as luliconazole, naftifine, efinaconazole, and tavaborole are newer options for treating these dermatophyte infections with proven safety, efficacy, and ease of use.
J Drugs Dermatol. 2015;14(suppl 10):s35-s41.
Gretchen W. Frieling MD,a Noelle L. Williams BS,b Scott J. M. Lim DO,c and Seth I. Rosenthal MDd
We present a case of an otherwise healthy 81-year-old gentleman with multiple asymptomatic, erythematous, indurated papules and plaques, ranging in size from 0.5 to 1.5 cm, involving the dorsal, lateral, and palmar surfaces of the fingers bilaterally. A clinical suspicion of erythema elevatum diutinum (EED) led to initial treatment with topical dapsone 5% gel (ACZONE; Allergan Inc, Irvine, CA). Lesional biopsy demonstrated a dense perivascular infiltration of polymorphonuclear leukocytes and chronic inflammatory cells with perivascular fibrin deposition. Focal neutrophilic infiltration of superficial dermal blood vessel walls was present, suggesting a leukocytoclastic vasculitis. Stains for bacteria and fungi were negative. Clinicopathologic findings were consistent with EED, and in the interim, improvement with topical dapsone 5% gel was noted. Addition of oral dapsone led to complete resolution of the lesions. We present this case to illustrate the subtle, indolent clinical presentation of EED and demonstrate the uncomplicated use of topical dapsone 5% gel for rapid improvement and subsequent successful treatment of localized disease.
J Drugs Dermatol. 2013;12(4):481-484.
Joseph Bikowski MD, Radhakrishnan Pillai PhD, Braham Shroot PhD
Many topical corticosteroids currently on the market contain a halogen substitution at the C6, C9, or the side-chain C21 position
of the corticosteroid skeleton. These modifications have enhanced the efficacy of corticosteroids as compared to hydrocortisone
as topical anti-inflammatory agents, but have often increased side effects such as skin atrophy, adrenal suppression,
and telangiectasia. These side effects have been attributed to the presence of halogens in the corticosteroid molecule and
have raised concerns regarding the safety of all halogenated corticosteroids. In this review, we assert that it is the position
and nature of the halogen atom(s) in the corticosteroid molecule that determine potency/toxicity, rather than their mere
presence. A greater understanding of the role of halogenation in determining corticosteroid potency and side effects will
clarify why all halogenated steroids are not the same.
Peter W. Hashim MD MHS,a John K. Nia MD,a David Terrano MD,a Gary Goldenberg MD,a and Leon H. Kircik MDa,b,c
BACKGROUND: Topical corticosteroids are known to impair the epidermal barrier, even after short-term use, whereas topical vitamin D analogues can have a reparative effect. Combination products using corticosteroids and vitamin D analogues have gained popularity in recent years and may provide a means to minimize skin atrophy in patients treated with topical corticosteroids.
OBJECTIVE: To compare epidermal barrier function and cutaneous atrophy after 4 weeks of calcipotriene 0.005% and betamethasone dipropionate 0.064% topical suspension (Taclonex® TS) versus betamethasone dipropionate 0.05% lotion (Diprosone®).
METHODS: Ten subjects with moderate plaque psoriasis were enrolled. Patients were randomized to apply calcipotriene 0.005%/betamethasone dipropionate 0.064% once daily to psoriasis plaques on one side of the body and betamethasone dipropionate 0.05% lotion twice daily to plaques on the other side. Biopsies were performed at baseline and after four weeks of treatment to evaluate for epidermal and dermal changes.
RESULTS: Treatment with betamethasone lotion resulted in significant decreases in epidermal thickness and dermal thickness. In contrast, treatment with calcipotriene/betamethasone did not lead to significant decreases in epidermal thickness or dermal thickness. Comparing betamethasone and calcipotriene/betamethasone, there was a significantly greater reduction in epidermal thickness with betamethasone lotion versus calcipotriene/betamethasone (P less than .0001). Relative differences in dermal thickness and transepidermal water loss (TEWL) did not reach statistical significance.
CONCLUSION: This study is the first to demonstrate that treatment of plaque psoriasis with a combination topical corticosteriod and calcipotriene product results in greater preservation of the skin layers relative to topical corticosteroid use alone. These results hold important ramifications for minimizing cutaneous atrophy in patients receiving treatment with topical corticosteroids.
J Drugs Dermatol. 2017;16(8):747-752.
Put Your Best Foot Forward: Advances in the Management of Tinea Pedis
Dermatophyte infections account for over 4 million physician visits each year in the United States. Moreover, recent analysis of data from the National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey for the period from 1995 to 2004 have found that improper treatment of tinea pedis, tinea corporis, and tinea cruris is common and expensive. However, the selection of inappropriate agents is just one impediment to effective care. Therapeutic non-adherence by patients, and especially failure to continue therapy until the infectious organisms are completely eradicated, are additional challenges. Naftifine cream 2% is a topical allylamine antifungal agent for the treatment of superficial dermatomycoses, and this novel topical formulation is a welcome new option. A study of naftifine cream 2% for the treatment of tinea pedis found that 2 weeks of treatment was significantly more effective than vehicle and equivalent to 4 weeks of treatment with naftifine 1% gel. Naftifine 2% cream offers a cosmetically elegant, once-daily topical treatment option for dermatomycoses that may lead to better compliance and better treatment outcome in patients.
Rosemarie H. Liu MD, Beth Becker MD, Juliet Gunkel MD, Joyce Teng, MD, PhD
Collodion baby is a rare congenital disorder whereby affected infants are born encased in a thick, taut, shiny, translucent membrane.
The majority of babies with collodion membrane have associated disorders, most commonly nonbullous congenital ichthyosiform
erythroderma and lamellar ichthyosis. The authors report a case of collodion baby with rare complication of acral contracture, ischemia
and nail dystrophy. Topical treatment with tazarotene 0.1% gel resulted in rapid improvement. The patient developed normal
nail plates and full motor function in both hands and feet following treatment. To the authors’ knowledge, this is the first report
demonstrating the benefit of topical tazarotene for management of this rare condition in a neonate.
Deborah S. Sarnoff MD FAAD FACPa and Robert H. Gotkin MD FACSb
We report significant changes in the appearance of the periorbital area, beyond eyelash enhancement, induced by the topical application
of bimatoprost ophthalmic solution, 0.03% (Latisse®, Allergan, Inc., Irvine, CA). To our knowledge, this is the first report
in the dermatology or plastic surgery literature describing the rejuvenating effect and overall improvement in the appearance of the
periorbital area resulting from applying Latisse to the upper eyelid margins. To date, reports in the literature discuss side-effects and
potential complications of topical bimatoprost therapy causing a constellation of findings known as PAP (prostaglandin-associated
periorbitopathy). While periorbitopathy implies pathology or a state of disease, we report changes that can be perceived as an
improvement in the overall appearance of the periorbital area. We, therefore, propose a name change from PAP to PAPS – prostaglandin-
associated periorbital syndrome. This better describes the beneficial, as well as the possible negative effects of topical
bimatoprost. Although there is a risk for periorbital disfigurement, when used bilaterally, in properly selected candidates and titrated
appropriately, bimatoprost can be beneficial. The striking improvement in the appearance of some individuals warrants further research
into the potential use of topical bimatoprost to achieve a “chemical blepharoplasty.”
J Drugs Dermatol. 2015;14(5):472-477.
Joseph F. Fowler Jr. MD
Research into the pathophysiology of rosacea suggests a central role for inflammatory mediators such as nitric oxide
(NO), reactive oxygen species (ROS), and matrix metalloproteinases (MMPs). Effective treatments for rosacea,
including topical metronidazole and systemic antibiotics, have anti-inflammatory activity, which may be more important
than their antimicrobial activity in this setting. Phase III studies have substantiated the efficacy of anti-inflammatory
dose doxycycline (40-mg doxycycline monohydrate controlled-release capsules) administered once daily for the
treatment of inflammatory lesions of rosacea. Results of a 16-week, randomized, double-blind, placebo-controlled study
of anti-inflammatory dose doxycycline plus topical metronidazole gel 1% for mild to moderate rosacea are presented here.
At week 12, metronidazole was discontinued and patients continued on either placebo or doxycycline. Combination
therapy significantly reduced inflammatory lesion counts as early as week 4 and through week 12 compared to topical
metronidazole 1% gel monotherapy. The combined therapy appeared effective and well-tolerated.
Raymond L. Garcia MD,a Jerry L. McCullough PhD,b Barry Reece MS MBA,c Frank J. Massino BS LESd
Objective: To evaluate the efficacy and tolerance of topical 4HBAP (para-topolin [6-(4-hydroxybenzylamino) purine], a new aromatic cytokinin, in subjects with mild to moderate facial photodamage.
Methods: In this single-center, 12-week study subjects (n=39) applied topical 0.10% 4HBAP (the test article) and sunblock (SPF30) twice daily, in the early morning and in the evening. The efficacy and safety of the treatment were evaluated at study entry (baseline) and at 2, 4, 8 and 12 weeks. Results were evaluated by investigators and subjects using high resolution photography and objectively by transepidermal water loss (skin barrier function), and a Novameter® (skin moisture content).
Results: Topical 4HBAP significantly improved the appearance of coarse wrinkles after 4, 8, and 12 weeks of continued use without irritating the skin or eliciting erythema. Topical 4HBAP also improved the appearance of fine wrinkles, hyperpigmentation, and skin roughness while significantly reducing facial erythema and the overall severity of acne lesions. The investigators global assessment, the overall severity of skin aging and skin color, showed significant improvement at weeks 8 and 12. Subject-assessed improvements were also highly favorable. In the 25 subjects that had acne at baseline, the number of non-inflammatory lesions and the total number of acne lesions decreased significantly at weeks 8 and 12. Topical 4HBAP significantly increased skin hydration at weeks 2, 8, and 12.
Conclusion: Topical 4HBAP (0.10%) significantly improves the appearance of fine lines and coarse wrinkles, reduces skin roughness, hyperpigmentation, facial erythema, and non-inflammatory acne lesions, and improves skin hydration without any observed side effects.
J Drugs Dermatol. 2018;17(7):772-779.
James Q. del Rosso, Do, FAOCD
The use of topical agents for treatment of most dermatologic disorders is integral to the practice of dermatology. The
innate properties and therapeutic mechanisms of the active component(s) of a topical preparation and the ability of the
vehicle formulation to deliver adequate concentrations of drug to the site of disease directly affect clinical efficacy.
Other factors influencing efficacy in clinical practice correlate closely with the extent of patient compliance, including
the degree of local tolerability and patient acceptability of the product, frequency of application and duration of therapy.
The following provides a discussion of newer medical therapies for the treatment of actinic keratosis based on current literature
and clinical experience.
Timothy J. Poterucha BS,a Sinead L. Murphy BS,b Mark D. P. Davis MD,c Paola Sandroni MD PhD,d Richard H. Rho MD,e Roger A. Warndahl RPh,f and William T. Weiss RPhf
BACKGROUND: Erythromelalgia is an uncommon neurovascular disorder characterized by redness, increased skin temperature, and pain that usually occurs in the extremities. Treatment remains challenging because of its varying response to medical therapy. The objective of this study was to assess the response of erythromelalgia to compounded topical amitriptyline-ketamine.
METHODS: We retrospectively evaluated 36 patients with erythromelalgia who were treated with compounded topical amitriptyline-ketamine from January 1, 2004, through January 31, 2011.
RESULTS: Thirty-two patients (89%) were female. Mean (standard deviation) age was 44.7 (15.8) years (range, 5-74 years). Patients applied the medication 1 to 6 times per day (median, 5 times). One patient (3%) had complete relief from symptoms, 14 (39%) had substantial relief, 12 (33%) had some relief, 7 (19%) had no relief, and 2 (6%) had local worsening of symptoms. No patients had systemic adverse effects.
CONCLUSIONS: A majority of patients with erythromelalgia (75%) reported improvement in pain with topical application of a compounded amitriptyline-ketamine formulation. The medication was well tolerated.
J Drugs Dermatol. 2013;12(3):308-310.
Joe Gorelick MSN FNP-BC,a Wendy Cantrell DNP CRNP,b Kristine Kucera PA-C MPAS DHS,c Karen A. Veverka PhD,d Kara Gooding MMS PA-Ce
Psoriasis is a chronic, immune-mediated inflammatory disease characterized by localized scaling and plaques associated with itching and pain. In some cases, topical therapies are effective to treat mild to moderate psoriasis. Topical agents can be used concomitantly with other treatments for moderate and severe or treatment-resistant psoriasis. Patient adherence to medication regimens remains a major challenge in therapy, especially with topical agents, for which adherence can be affected by the amount of time needed for application, the treatment formulation, cost, and cosmetic characteristics. This study was conducted to obtain feedback from patients clinically diagnosed with psoriasis regarding their satisfaction following once-daily topical application of the fixed combination calcipotriene (Cal) 0.005% and betamethasone dipropionate (BD) 0.064% foam for 15 days. Patients completed a 13-question online survey. In this community-based setting of patients with mild to severe psoriasis, patients were satisfied with Cal/BD foam after 15 days of use; 94% were satisfied or highly satisfied with symptom relief. Most of the patients (88%) were satisfied with how Cal/BD foam felt on their skin. After 15 days of use, 94% of patients would recommend Cal/BD foam to other patients with psoriasis, with 73% being very likely to do so. These findings may have important implications for optimizing medical decision-making, treatment adherence, and health outcomes in clinical practice. The cosmetic acceptability of the fixed combination Cal/BD foam formulation and patient satisfaction may make Cal/BD aerosol foam a more acceptable topical treatment than other currently available vehicles for patients with plaque psoriasis.
J Drugs Dermatol. 2018;17(8):880-884.
Jashin J. Wu MD,a Kwun-Yee T. Poon MS,b and Judith D. Bebchuk ScDb
OBJECTIVE: We sought to assess whether the type of TNF inhibitor therapy (soluble receptor versus monoclonal antibody) has an effect on MI risk; and determine whether length of TNF inhibitor therapy has an effect on MI risk.
DESIGN: Retrospective cohort study
SETTING: Between January 1, 2004 and November 30, 2010
PARTICIPANTS: At least 3 ICD9 codes for psoriasis (696.1) or psoriatic arthritis (696.0) (without antecedent MI).
MAIN OUTCOME MEASURE: Incident MI
RESULTS: In the 3 subgroups of TNF inhibitors, 976 received etanercept; 217 received monoclonal antibody; and 480 received etanercept or monoclonal antibody, in addition, 5075 received topical therapy and 2097 received oral therapy. In the Cox proportional hazards analysis, etanercept (HR, 0.53; 95% CI, 0.31-0.92) was associated with a significant reduction of MI risk, compared to topical agents and, monoclonal antibody only (HR, 0.25; 95% CI, 0.06-1.03), and etanercept or monoclonal antibody (HR, 0.53; 95% CI, 0.27-1.06) were associated with a non-significant reduction of MI risk compared to topical agents. Using year 1 as reference, those who received TNF inhibitor therapy at year 2 (HR, 1.15; 95% CI, 0.30-4.44), at year 3 (HR, 1.89; 95% CI, 0.64-5.58), and at year 4 and above (HR, 1.16; 95% CI, 0.46-2.94) had a non-significant increase of MI risk.
CONCLUSIONS: Treatment with etanercept, compared to treatment with topical agents, was associated with a significant decreased risk of MI in psoriasis patients. Treatment with monoclonal antibody and etanercept or monoclonal antibody, compared to treatment with topical agents, was associated with a non-significant decreased risk of MI risk in psoriasis patients. There were no statistically significant changes in risk of MI associated with length of TNF inhibitor treatment.
J Drugs Dermatol. 2013;12(8):899-903.
Antibiotic resistance is described as “a global public health challenge” and a “major health security challenge of the 21st century”
by global health authorities,1 and there is a growing need for dermatologists to counteract it in their treatments of acne.3,4 Antibiotic
limiting regimens, such as a combination of topical retinoids and benzoyl peroxide, have shown effectiveness in the treatment of
acne; and topical probiotics could also play a needed role.
J Drugs Dermatol. 2014;13(suppl 6):s66-s70.
Tracey C. Vlahovic DPM
In recent years, new topical antifungals have emerged for the treatment and management of tinea pedis, but all have been investigated and approved for the treatment of interdigital tinea pedis. Moccasin tinea pedis has not been recognized by governing bodies as a definable and treatable disease entity separate from interdigital tinea pedis at this time. Thus, creating randomized, controlled clinical trials to investigate moccasin tinea pedis is a challenge without an agreed upon definition of the disease state, treatment regimen, and treatment course. Considering systemic therapy issues and the lack of data from large trials demonstrating safety and efficacy in the topical management of this clinical presentation, an unmet need has been created for a topical antifungal agent that can treat moccasin tinea pedis. Naftifine 2% gel, an allylamine, was studied in a clinical trial that enrolled patients who had interdigital or both interdigital and moccasin-type tinea pedis. In the moccasin group, the primary efficacy endpoint of complete cure at week 2 (end of treatment) was 1.7% (gel) vs 0.9% (vehicle) and week 6 (four weeks post-treatment) was 19.2% (gel) vs 0.9% (vehicle). Naftifine 2% cream in combination with urea 39% also showed improvement in hyperkeratotic moccasin tinea pedis.
J Drugs Dermatol. 2016;15(Suppl 2):s56-59.
Rita Patel MD, Monica Halem MD, Martin Zaiac MD
Background: Palmar hyperhidrosis is an uncomfortable condition that can severely affect a patient’s quality of life. Injections of
botulinum toxin have proven to be an efficient treatment modality, however the pain associated with palmar injections has limited
the use of this therapy.
Objective: The authors describe a novel method of analgesia combining topical analgesic cream and forced cold air during botulinum
injection treatment of palmar hyperhidrosis.
Case Report: This is a case report of a patient with a 10-year history of palmar hyperhidrosis. Both hands were pretreated with
topical anesthetic cream and the right hand was additionally treated with forced cold air at a distance of 1 cm for up to 30 seconds
before injection administration. After the botulinum injection was administered to both hands, the patient was subjectively asked
about pain during injection.
Results: The patient subjectively reported a 75% decrease in the intensity of pain with the combination use of topical anesthetic
cream and forced cold air, which she said made the injections more tolerable. No epidermal changes were noted at the time of
treatment or at follow-up.
Conclusion: The use of botulinum toxin for the treatment of palmar hyperhidrosis is limited due to the pain associated with injections
of the palm. In this case report, we describe the successful use of forced cold air with topical anesthetic cream to lessen the pain of
botulinum toxin injections during the treatment of hyperhidrosis.
Michael J. Bernhardt MDa and Matthew F. Myntti PhDb
The traditional disease model of acne has been one of follicular plugging due to ‘sticky epithelial cells’ associated with increased sebum production with deep follicular anaerobic conditions favoring P. acnes- generated inflammation. P. acnes biofilms have been found more frequently in patients with acne than controls. Biofilms are genetically coded to create adhesion to the pilosebaceous unit followed by production of a mucopolysaccharide coating capable of binding to lipid surfaces. Traditional therapies for acne have involved mixtures of oral and topical antibiotics admixed with topical keratolytics and retinoids, which are aimed at traditional bacterial reduction as well as downregulating the inflammatory cascade. These approaches are limited by side effect and compliance/tolerability issues. As the P. acnes biofilm may, in fact, be the instigator of this process, we studied the use of a topical agent designed to reduce the P. acnes biofilm to see if reducing the biofilm would be therapeutically efficacious. We present data of a proprietary topical non-prescription agent with a novel pharmaco mechanism designed to attack the biofilm produced by P. acnes. Our data shows a decrease of inflammatory lesions by 44% and non-inflammatory lesions by 32% after 12 weeks and also provided for a meaningful improvement in the quality of life of the patients in the study. These improvements were achieved with a product that was not associated with burning, chafing, irritation, or erythema, which can be seen with topical treatments. It is apparent from this study that by addressing the biofilm which protects the P. acnes bacteria through the use of the Acne Gel, the incidence of acne symptoms can be greatly reduced, while having no negative impacts on the patients’ skin (ClinicalTrials.gov registry number NCT02404285).
J Drugs Dermatol. 2016;15(6):677-683.
Given the multifactorial and complex contributors to acne development, combination therapy is standard of care. By addressing multiple pathogenic factors, combination therapy provides a quicker and more efficacious treatment outcome than monotherapy. Topical retinoids normalize follicular keratinocyte differentiation and are anti-inflammatory. Their use is limited by the potential for cutaneous irritation. Antimicrobials reduce Propionibacterium acnes colonization on the skin and reduce the bacteria's proinflammatory effects. Topical antibiotics and benzoyl peroxide (BPO) are commonly employed in fixed-dose combination products or two separate medications. BPO has the added benefit of being comedolytic and can minimize the risk for bacterial antibiotic resistance. Like topical retinoids, BPO may cause skin irritation, burning, erythema, and peeling. Managing cutaneous side effects when using multiple products that cause irritation can be a challenge. Careful product selection, dose titration, and patient-directed regimens can help to optimize outcomes. This review presents the latest data on two topical acne products that have demonstrated excellent efficacy and tolerability profiles. In addition, their in vitro profiles suggest the potential for combination use, affording greater dosing flexibility.
J Drugs Dermatol. 2012;11(3):313-317.
Angela Moore MD,a Steven Kempers MD,b George Murakawa MD,c Jonathan Weiss MD,d Amanda Tauscher MD,e Leonard Swinyer MD,f Hong Liu MSc,g and Matthew Leoni MDg on behalf of the Brimonidine LTS Study Group
Once-daily topical brimonidine tartrate (BT) gel 0.5% was shown to be efficacious and safe for the treatment of erythema of rosacea in previous studies including a 4-week treatment phase. In the present 1-year study, we aimed to assess the long-term safety and efficacy of the treatment. Subjects with moderate to severe erythema of rosacea were instructed to apply topical BT gel 0.5% once daily for 12 months. Severity of erythema and adverse events (AEs) were evaluated. Approximately 345 subject years of exposure to BT gel 0.5% was achieved in the study. The incidence of AEs and AEs judged to be related to the study drug was higher at the beginning and decreased over the course of the study. Similar safety profiles were observed between the subjects who had received or not received concomitant therapies for the inflammatory lesions of rosacea. Effect of topical BT gel 0.5% on erythema severity was observed after the first application and the durability of the effect was maintained until the end of the study at month 12, with no tachyphylaxis observed. In conclusion, once-daily topical BT gel 0.5% is safe and consistently effective for the long-term treatment of moderate to severe erythema of rosacea, even in the presence of concomitant therapies for the inflammatory lesions of rosacea.
J Drugs Dermatol. 2014;13(1):56-61.
Stacy Smith, MD; Dan Piacquadio, MD; Vera Morhenn, MD; Deborah Atkin, MD and Richard Fitzpatrick, ND
The efficacy of photodynamic therapy (PDT) using broad area treatment with 5-aminolevulinic acid (ALA) has not been compared
to topical 5-fluorouracil (5-FU) in the treatment of actinic keratoses (AK).
The purpose of this study was to compare the efficacy and tolerability of PDT using short incubation time, broad area treatment
with ALA plus activation with either blue light or laser light to topical 5-FU in the treatment of AK of the face and scalp.
Thirty-six subjects with AK of either the face or scalp were randomized to receive either application of ALA for 1 hour followed by
activation with blue light or pulsed dye laser or topical 5-FU. Efficacy was evaluated by grading AK lesions and photoaging signs.
Tolerability was assessed by scoring crusting /erosions, erythema and stinging /burning.
Treatment with PDT using ALA plus blue light was as effective as topical 5-FU in clearing AK. PDT using ALA plus laser light was
the least effective treatment. All treatments made improvements in the signs of photoaging. Both PDT treatments were better tolerated
In conclusion, broad area PDT treatment with ALA plus activation with blue light appears to be as effective as 5–FU in the treatment
of AK. ALA plus laser light is somewhat less effective than the above therapies. Efficacy could likely be improved with further
study of laser parameters and incubation tim
Stacy R. Smith MD, Vera B. Morhenn MD, Daniel J. Piacquadio MD
Actinic keratoses (AKs) are a common precancerous condition and are said to account for 14% of visits to dermatologists in
the US each year. Along with cryotherapy, topical treatments are a mainstay of therapy for these lesions. One of the potential
benefits of topical therapy is less pain and irritation as compared to cryotherapy. Additionally, topical therapies have a
perceived benefit of treating subclinical lesions along with clinically evident keratoses. We conducted a bilateral comparison
study of the efficacy and tolerability of diclofenac 3% gel used for 90 days and 5% fluorouracil cream used for 28 days in thirty
patients with AK of the face and scalp. The diclofenac gel and 5-fluorouracil cream each demonstrated substantial efficacy
in the number of lesions cleared and the proportion of patients with significant lesion clearing. In most patients, diclofenac
induced only mild signs of inflammation compared to 5-fluoruracil, despite a longer treatment period. A greater number of
patients expressed significant satisfaction with diclofenac gel compared to the 5-fluorouracil cream.
James Q. Del Rosso DO
Dermatological research continues to move toward the goal of developing an effective psoriasis treatment that would rapidly
clear lesions and provide long-term freedom from visible signs and symptoms. Currently, topical corticosteroids remain a
pivotal treatment due to their effective anti-inflammatory properties; however, potential adverse effects associated with
chronic application limit long-term continuous therapy. Vitamin D analogues provide another mechanism of action, reducing
lesions through effects on both keratinocytes and on the cytokine environment. A topical combination of corticosteroid
and vitamin D derivative appears to provide a balanced approach to psoriasis treatment. The development of clobetasol
propionate foam 0.05% (clobetasol propionate foam/Olux) offers a convenient topical corticosteroid that can be used
concomitantly, that is, immediately followed by application of calcipotriene ointment 0.005% (Dovonex). This regimen has
been shown to offer an increased short-term efficacy compared with either agent alone. Continued application of
calcipotriene ointment on weekdays supplemented by long-term clobetasol propionate foam pulse therapy on weekends
appears to provide an enhanced maintenance of remission compared with calcipotriene monotherapy.
Sam Hanna MD DABD,a Anneke Andriessen PhD,b Jennifer Beecker MD CCFP (EM) FRCPC DABD,c Martin Gilbert MD FRCPC,d Eric Goldstein MD FRCPC,e Sunil Kalia MD FRCPC,f Aaron King MD FRCPC,g John Kraft MD,h Carrie Lynde MD FRCPC,i Davindra Singh MD FRCPC,j Irina Turchin MD FRCPC,k and Catherine Zip MD FRCPC l
BACKGROUND: Recently, experience and knowledge have been gained using effective topical treatment for onychomycosis, a difficult-to-treat infection.
METHODS: This project aims to help understand and improve patient-focused quality of care for fungal nail infections. A panel of dermatologists who treat onychomycosis convened on several occasions to review and discuss recent learnings in the treatment of onychomycosis. The panel developed and conducted a survey on diagnosis, treatment and prevention, discussed the results, and provided recommendations.
RESULTS: The survey was sent out digitally to the Canadian Dermatology community. Ninety-two dermatologists completed the questionnaires, which were included in the analysis. The survey respondents and panel members agreed that the diagnosis of toe onychomycosis should be confirmed with a positive microscopic examination for fungus or a positive mycological culture when oral therapy and/or topical treatment is prescribed, except when it is not clinically feasible, in which case topical therapy could be started based on clinical presentation. The panel and survey respondents also agreed that treatment is to be based on percentage of nail involvement: less than 20%=topical efinaconazole; 20%-60%=topical efinaconazole±oral terbinafine (for greater than 3 nails); greater than 60%=oral terbinafine±topical therapy.
CONCLUSIONS: The current treatment paradigm for onychomycosis may have shifted from mainly oral antifungals to topical treatment, improving patient-focused quality of care.
J Drugs Dermatol. 2018;17(3):253-262.
J. Mark Jackson MDa and Michelle Pelle MDb
Many topical medications are available for the treatment of papulopustular rosacea. While treatments contain metronidazole, azelaic
acid, or sodium sulfacetamide-sulfur as the active ingredient, the composition of the vehicle formulations varies widely. These vehicles
come in gels, creams, lotions and foams; some ingredients are common to many vehicles, while some vehicles contain unique
ingredients designed to optimize skin penetration and delivery of the active drug to its target. Vehicles can also influence tolerability,
which is always a concern in patients with heightened skin sensitivity, and compliance, which is typically lower for topical treatments
than oral treatments. Ideally, the vehicle of any rosacea treatment should enhance drug delivery, be nonirritating and be easy to use.
Ingredients that help repair barrier function are also desirable. This review will focus on the key components of the vehicles from
the most commonly used topical therapies for papulopustular rosacea and how vehicle formulations influence the delivery of active
ingredient, skin barrier repair, tolerability and compliance.
J Drugs Dermatol. 2011;10(6):627-633.
C. Ryan Kirkland MD, Christopher B. Yelverton MD MBA, Alan B. Fleischer Jr. MD, Fabian T. Camacho MS, Steven R. Feldman MD PhD
Background: It has been thought that topical gels are inherently more irritating than topical creams. Nevertheless, the
irritancies of topical products are potentially quite variable, and a priori assumptions about relative irritancy of gels versus
creams may not be accurate.
Purpose: To determine whether a metronidazole gel formulation is more or less irritating to the skin compared to metronidazole
Methods: A total of 32 normal, healthy volunteers were tested using irritancy patches with 0.75% metronidazole gel and
cream, 1% metronidazole cream, and petrolatum (used as the “negative control”). Blinded observers evaluated the
application sites for signs of irritancy. A numerical score was assigned to these irritancy patch sites each day for 21 days, or
until significant irritation developed, and cumulative irritancy scores were calculated for the study period. A mixed model
of variance analysis was performed.
Results: After 21 days of evaluation, analysis of the mean cumulative irritancy scores for each of the agents used showed
there to be no statistical difference in irritancy potential between the metronidazole gel and the metronidazole creams.
However, the 1% metronidazole cream was significantly more irritating than petrolatum.
Conclusion: There was no significant difference in the cumulative irritancy potential of cream and gel preparations of
metronidazole. The irritancy of topical formulations for treating rosacea should be considered on a case by case basis.
Lauren K. Hoffman BSa and Leon Kircik MDb
BACKGROUND: Atopic dermatitis (AD) is a chronic, relapsing, inflammatory skin disorder. One of the most disturbing symptoms of AD is pruritus. The first line treatment for AD is topical corticosteroids, topical immunomodulators, topical barrier creams, oral antihistamines, and systemic treatments. Desoximetasone 0.25% spray is a superpotent topical corticosteroid delivered in a novel way and it may be a suitable option for the treatment of pruritus in adult atopic dermatitis patients.
STUDY DESIGN: A single-center, open labeled pilot study was conducted to investigate the efficacy and safety of desoximetasone 0.25% spray for pruritus in adult atopic dermatitis patients.
RESULTS: Twice daily application of desoximetasone 0.25% spray to affected areas resulted in a significant reduction in all outcomes (IGA, pruritus, VAS assessment of pruritus) within 1 week of initiation of treatment. The reductions exhibited were sustained throughout the study period of 4 weeks. Significant improvements in quality of life, as measured by the DLQI, were observed. No adverse events were reported.
CONCLUSION: Desoximetasone 0.25% spray is effective for treating pruritic symptoms of AD. Given its efficacy and convenience as a spray, desoximetasone 0.25% spray should continue to be evaluated as a treatment for AD in larger trials.
J Drugs Dermatol. 2017;16(9):919-922.
Dedee F. Murrell MD FRCP,a Kurt Gebauer MD,b Lynda Spelman MBBS FACD,c and Lee T. Zane MDd
BACKGROUND: A novel approach for treating atopic dermatitis (AD) is the inhibition of phosphodiesterase 4 (PDE4), an enzyme involved in the proinflammatory cascade. Crisaborole topical ointment, 2% is a novel, boron-based small-molecule PDE4 inhibitor with anti-inflammatory properties. The objective of this proof-of-concept study was to assess the efficacy and safety of crisaborole topical ointment,
2% in adults with mild to moderate AD.
METHODS: This phase 2a, randomized, double-blind, bilateral, 6-week study of crisaborole topical ointment, 2% was conducted in adult patients with mild to moderate AD with 2 comparable target AD lesions. Patients were randomly assigned to twice-daily application of crisaborole topical ointment, 2% or vehicle, each to 1 of the 2 target lesions. The primary efficacy endpoint was change from baseline in Atopic Dermatitis Severity Index (ADSI) score at day 28. Safety assessments included local tolerability and incidence of adverse events (AEs).
RESULTS: A total of 25 enrolled patients received study medication. At day 28, 17 patients (68%) experienced a greater decrease in ADSI score in the active-treated lesion than in the vehicle-treated lesion; 5 patients (20%) had a greater decrease in ADSI score in the vehicle-treated lesion than in the active-treated lesion. Local application-site reactions were reported in 3 patients (12%). A total of 29 AEs were reported in 11 patients; most (90%) were mild in intensity and unrelated to study medication. No serious or severe AEs were reported, and no patient discontinued due to an AE.
CONCLUSIONS: These findings provide preliminary evidence of the efficacy and safety of treatment with crisaborole topical ointment, 2% in adults with mild to moderate AD.
The study is registered on ClinicalTrials.gov (identifier NCT01301508).
J Drugs Dermatol. 2015;14(10):1108-1112.
Cutaneous T-cell lymphomas (CTCLs) are a relatively uncommon group of lymphoproliferative disorders in
which a malignant population of T cells is localized to the skin at presentation. Of the 4 classic CTCL phases
(patches, infiltrated plaques, tumors, Sézary syndrome), the majority of patients present with early stage patch
or plaque disease, which can usually be effectively managed using skin-directed therapies. Traditional skindirected
therapies include topical corticosteroids, topical chemotherapeutic agents (mechlorethamine, carmustine),
electron beam therapy (local and total skin), and phototherapy (UV-A, UV-B). Each of these has
demonstrated efficacy in early stage disease; however, with the exception of topical corticosteroids, all have
some disadvantages and are associated with significant adverse events, particularly secondary skin malignancies
and skin damage. Bexarotene is a synthetic retinoid analog that selectively activates retinoid X receptors. In
clinical trials, bexarotene gel demonstrated efficacy for the topical treatment of cutaneous lesions in patients
with stage IA or IB CTCL who have refractory or persistent disease following other therapies or who cannot
tolerate other therapies. Initial evidence indicates that bexarotene gel may be active as first-line therapy in
early stage disease. Its role in combination with other treatments remains to be determined. Topical bexarotene
gel is generally well tolerated and offers patients greater convenience compared with traditional skin-directed
therapies, with a flexible administration regimen. The availability of bexarotene gel provides patients and
physicians with a new skin-directed treatment option for early stage CTCL.
Atopic dermatitis (AD) is a chronic inflammatory skin condition affecting a predominantly pediatric population and characterized by a
cycle of flare and remission. Pruritus associated with AD results in substantial quality of life, societal, financial and emotional burdens
for patients and their caregivers. Daily management of AD is usually based on application of an emollient and a topical corticosteroid,
topical immunomodulator and/or oral antihistamine for the management of flares. A new nonsteroidal lamellar matrix cream has
been introduced for use in a variety of dermatologic conditions including AD. Its ingredients mimic stratum corneum components
which may help repair and restore skin barrier function and decrease transepidermal water loss. This article reviews the role of topical
therapy in AD management, and evaluates the usefulness of the lamellar matrix cream in reducing time to flare, limiting the use of
agents with greater side-effect profiles and lowering the overall cost of treatment.
Maria Rita Nasca MD PhD, Rocco De Pasquale MD, Giuseppe Micali MD
We report a case of a 43-year-old uncircumcised Caucasian, diabetic man with a 4-year history of Zoon’s balanitis unresponsive
to topical steroids, in whom control of the disease was achieved with topical imiquimod. A histopathological examination
of a biopsy specimen was performed before and after treatment with imiquimod 5% cream applied 3 times a
week. A moderate to marked increased local skin reaction occurred several times throughout the treatment period, necessitating
multiple rest periods of several days’ duration. Clinical but not histological resolution was obtained after 4 months
of treatment, with no relapses at an 18-month follow-up. This positive treatment outcome indicates that imiquimod may
have a role in the management of Zoon’s balanitis. However, the dose and duration of therapy required to achieve complete
clinical response still needs to be established. Also, the question of whether normalization of histology can be achieved
with topical imiquimod has yet to be answered.
Jashin J. Wu MD,a April Armstrong MD MPH,b Rakesh Singh PhD,c Martin Cloutier MSc,d Marjolaine Gauthier-Loiselle PhD,d Patrick Gagnon-Sanschagrin MSc,d Dilek Arikan MD,c Alan Fleischer MD,e Annie Guérin MSc,d Arijit Ganguli PhDc
OBJECTIVE: To assess the real-world risk of developing adverse medical conditions (AMCs) among patients with psoriasis treated with biologic therapies or conventional systemic/topical therapies (CST/topical).
METHODS: Adult patients with psoriasis were identified from the Truven MarketScan US claims database (2008 Q3–2015 Q3) and classified into cohorts based on treatment initiated on the index date (adalimumab [ADA], etanercept [ETN], ustekinumab [UST], infliximab [IFX], or CST/topical). Incident AMCs were identified while on treatment from diagnoses recorded in medical claims and included abnormal test results, infections, mental disorders, cardiovascular disease, malignancies (skin and non-skin), and respiratory disease. Cox proportional hazards models were used to compare AMC risk for (1) ADA, ETN, and UST (separately) vs CST/topical, and (2) ADA vs other biologic therapies (ETN, UST, and IFX combined). Regressions were adjusted for age, gender, region, insurance plan type, year, Charlson comorbidity index, and prior AMCs; and based on stepwise selection, comorbidities, specialist encounters, and frequently prescribed treatments.
RESULTS: A total of 42,981 patients were identified (ADA: 5,197; ETN: 3,311; UST: 1,370; IFX: 187; CST/topical: 32,916). Across cohorts, median age was 46–50 years, 46.2%–53.1% were female, and median follow-up duration was 3.3–7.9 months. For all cohorts, infection was the most frequent AMC (28.7%–41.8%). Compared with CST/topical, ADA, ETN, and UST were associated with a lower risk of infections (adjusted hazard ratio [aHR]: 0.93, 0.92, and 0.86, respectively, all P less than 0.05). ADA was associated with a lower risk of malignancies (aHR: 0.71, P less than 0.05), and ETN was associated with a lower risk of respiratory disease (aHR: 0.80, P less than 0.05). Compared with biologic therapies, ADA was not associated with higher risk of AMCs.
CONCLUSIONS: Compared to CST/topical, biologic therapies were associated with similar or lower risk of AMCs. Comparison between ADA and other biologic therapies suggests a similar safety profile with respect to the studied AMCs.
J Drugs Dermatol. 2018;17(11):1211-1218.
Barbara D. Garcia MD, Mitchel P. Goldman MD, Michael H. Gold MD
Photodynamic therapy (PDT) and intense pulsed light therapy (IPL) are commonly used in the setting of photorejuvenation.
Patient expectations for minimal to no downtime associated with these procedures has become an increasingly
important issue. In an attempt to define a topical skin care regimen that would reduce procedure-related symptoms and
possibly enhance therapeutic efficacy, 4 separate topical products were examined. Avène Thermal Spring Water (Laboratoires
Dermatologiques Avène, Les Cauquillous, France), NIA 24™ (Niadyne, Inc, Research Triangle Park, NC),
MimyX™ cream (Stiefel Laboratories, Coral Gables, FL), and Biafine® (OrthoNeutrogena, Los Angeles, CA) were studied
individually in the setting of either PDT or IPL treatments. The results of these studies indicate that a pre- and/or
postprocedure topical skin care regimen can be beneficial in reducing postprocedure symptoms.
Jennifer F. Conde BA, Christopher B. Yelverton MD MBA, Rajesh Balkrishnan PhD, Alan B. Fleischer Jr. MD, Steven R. Feldman MD PhD
Background: Rosacea is an extremely common chronic dermatosis affecting an estimated 14 million Americans. Rosacea
is most commonly managed with topical metronidazole, sometimes in combination with oral antibiotics.
Purpose: To review published studies about topical metronidazole therapy for rosacea, both as a monotherapy and in conjunction
with oral antibiotics.
Methods: Medline searches were conducted for clinical trials using metronidazole, tetracycline, and doxycycline for rosacea.
Results: Topical metronidazole has been well studied as a rosacea therapy. Twice-daily dosing of metronidazole 1.0% cream
is as effective as 250 mg tetracycline twice daily. Metronidazole 1.0% gel used once daily is as effective as azelaic acid 15%
gel dosed twice daily. When dosed at subantimicrobial levels, doxycycline 20 mg taken twice daily is effective in decreasing
inflammatory lesions and erythema associated with rosacea. Metronidazole 0.75% lotion is more effective when used in
combination with doxycycline 20 mg dosed twice daily.
Discussion: Metronidazole in 0.75% strength lotion, cream, and gel and 1.0% metronidazole cream and gel are all efficacious
in treating rosacea. Combination treatment with oral antibiotics at both antimicrobial and subantimicrobial doses
is an efficacious means of treating rosacea. Maintenance treatment with topical metronidazole decreases relapses and allows
for longer intervals between flares.
Guy F. Webster MD PhD
Topical fixed-combination products and topical retinoid monotherapy are established first-line treatments for mild-to-moderate acne vulgaris, yet adequate comparative data are lacking. The following evidence-based review addresses the question: "In patients with mild-to-moderate acne, are topical fixed-combination products or topical retinoids a more efficacious choice in reducing noninflammatory, inflammatory and total lesions after 12 weeks of treatment?" To identify relevant studies, a PubMed search was performed using "acne" and search terms for adapalene, tretinoin, tazarotene, benzoyl peroxide, clindamycin, or erythromycin. Forty-two studies from January 1991 to November 2009 were included. The studies were evaluated using the Strength of Recommendation Taxonomy, and all but seven received the highest level of evidence grade. To evaluate efficacy, a side-by-side comparison was made using reduction in acne lesion counts at week 12 for study groups treated with fixed-combination therapy or retinoid monotherapy. Twenty-nine studies containing relevant efficacy data for fixed-combination therapy and retinoid monotherapy are summarized here. Nine studies compared fixed-combination therapy with retinoid monotherapy; in eight of these studies, fixed-combination therapy was significantly more efficacious in reducing acne lesion counts. This evidence-based review analyzes clinical evidence to date for these therapies to provide guidance in determining appropriate treatment for patients with mild-to-moderate acne.
J Drugs Dermatol. 2011;10(6):636-644.
James M. Spencer MD MS,a Summer D. Moon BS,b Kara M. Trapp BA,c and Michael B. Morgan MDd-f
While the clinical attributes of photoaging are well characterized in the literature, the pathogenic mechanisms that underlie these changes are incompletely elucidated. At the molecular level, p53 tumor-suppressor gene product mediated excision repair of ultraviolet (UV)-induced DNA damage is a critical effector in xeroderma pigmentosum (XP) and potentially in conventional photoaging. We examined p53 activity and measured UV-induced DNA damage via cyclobutane pyrimidine dimers (CPDs) quantitatively in 20 volunteers before and after an 8-week, open-label prospective topical application of a proprietary DNA recovery serum (Celfix). There was a statistically significant decrease in immunohistochemically determined p53 and CPD levels. While these data are preliminary, the findings lend support to the theoretical possibility of a topical agent reversing the effects of photodamage at the molecular level and, potentially, an ameliorative outcome clinically.
J Drugs Dermatol. 2013;12(3):336-340.
Rajesh Balkrishnan PhD, Julia C. Sansbury MD, Rahul A. Shenolikar MS, Alan B. Fleischer Jr. MD, Steven R. Feldman MD PhD
Objective: Fears of potentially costly use of topical retinoids for cosmetic treatment of photodamaged skin have resulted
in many managed care organizations placing prior authorization requirements on this class of medications. The purpose
of this investigation was to examine whether prescribing patterns of a nationally representative sample of US
physicians shed light on the incidence of use of topical retinoids for indications other than acne.
Methods: A retrospective, cross-sectional study of data from the National Ambulatory Medical Care Survey (1996-
2000) was used to examine the impact of physician specialty as well as patient diagnosis of acne on the probability of
retinoid prescription in weighted multivariate logistic regression models.
Results: Topical retinoids were prescribed in 0.4% (14.7 million out of 3.67 billion) physician visits for any diagnosis
in the 5-year period from 1996 to 2000, and in nearly 31% (12.0 million out of 38.7 million) of physician visits for a
diagnosis of acne. Topical retinoids were prescribed for acne in 77.1% of the cases. This finding held when individual
retinoids (tretinoin and adapalene) were examined separately. Clear age-related prescription trends are observed, with
a significant decrease in prescriptions beyond the teen years. In older patients, tretinoin prescribing did not decrease as
much as adapalene prescribing.
Conclusions: These data suggest that managed care organizations may want to examine their own data to determine the
optimum criteria for operation of prior authorization (PA) programs for retinoids. PA requirements for these medications
appear unnecessary in young patients, given the very small probability of non-acne related use. PA in older
patients might be targeted to those patients on topical retinoids (such as tretinoin) for which there is evidence of efficacy
in treatment of cosmetic photoaging.
Michael H. Gold MD, Jaggi Rao MD, Mitchel P. Goldman MD, Tancy M. Bridges NP, Virginia L. Bradshaw NP, Molly M. Boring NP, April N Guilder RN
Background: Blue light sources have been shown to be effective in the treatment of mild to moderate inflammatory acne vulgaris
Objective: We evaluated the safety and efficacy of a new blue light source in the treatment of mild to moderate inflammatory
acne vulgaris in comparison to topical 1% clindamycin solution.
Results: Blue light therapy reduced inflammatory acne vulgaris lesions by an average of 34%, as compared to 14% for topical
1% clindamycin solution.
Conclusions: The blue light source presented in this report is a safe and effective treatment option available to our patients
with mild to moderate inflammatory acne lesions.
Michael E. Farhangian BA,a Amy J. McMichael MD,a Karen E. Huang MS,a and Steven R. Feldman MD PhDa,b,c
BACKGROUND: Alopecia Areata (AA) is a non-scarring alopecia that affects millions of Americans, however the way it is treated and which patients seek treatment is not well characterized.
OBJECTIVE: To better understand how AA was being treated in the United States, what type of patients are seen for AA, and what physicians treated them.
METHODS: We analyzed data from the National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS) from 2001 to 2010. We tabulated patient characteristics, the physicians who treated AA and what treatments were prescribed for AA.
RESULTS: There were an estimated 2.6 million outpatient visits for AA. Patients with AA were most commonly treated by a dermatologists
(84.8%). Patients were most commonly treated with topical and injected corticosteroids (61.0%) followed by minoxidil (5.9%) and topical tacrolimus (5.7%). Males made fewer visits per 1,000 capita compared to females (P=0.01).
LIMITATIONS: The NAMCS and NHAMCS do not record severity of disease data.
CONCLUSIONS: Topical and injected corticosteroids are the mainstay of treatment for AA, however the use of steroid sparing agents such as minoxidil is low. Despite no studies demonstrating efficacy, topical tacrolimus was used almost as frequently as minoxidil.
J Drugs Dermatol. 2015;14(9):1012-1014.
Joseph B. Bikowsky MD
Background: Retinoids comprise a family of compounds with structures and mechanisms of action that resemble those of vitamin A
(retinol), an essential nutrient which plays a role in cell growth and differentiation. The retinoids, which interact with nuclear
receptors and affect gene transcription, have enormous therapeutic potential, particularly if they are receptor- and functionselective.
Tretinoin was the first topical retinoid employed for the treatment of acne. In recent years, other topical retinoids
for the treatment of acne have been designed from a disease-specific approach, with enhanced receptor and function selectivity,
which translates to improved therapeutic effects and more favorable tolerability. The properties that differentiate the
topical retinoids tretinoin, adapalene, and tazarotene have permitted clinicians to tailor acne treatment regimens for maximum
Tretinoin (all-trans-retinoic acid), considered a first-generation retinoid, acts by altering the milieu of the microcomedo and
influences desquamation of abnormal epithelium. Two receptor-selective synthetic retinoids, adapalene and tazarotene, may
be classified as third-generation retinoids. Adapalene, a derivative of naphthoic acid, has comedolytic, antiproliferative, and
anti-inflammatory properties. Tazarotene is a prodrug metabolized to tazarotenic acid that modulates cellular differentiation,
desquamation, and inflammation.
Hasan Khosravi MD,a Michael P. Siegel PhD,b Abby S. Van Voorhees MD,c and Joseph F. Merola MD MMSca,d
Inverse or intertriginous psoriasis commonly involves skin fold areas including the axillae, perianal skin, intergluteal cleft, inframammary, genital/inguinal, abdominal, and retroauricular folds. After reviewing the literature for new treatments, a task force was convened to update a consensus on inverse psoriasis therapy. Short-term treatment continues to be low-potency topical steroids. In order to avoid steroid-induced adverse effects, long-term therapy includes topical immunomodulators, calcitriol, and calcipotriene. Second and third-line therapies include antimicrobials, emollients, and tar-based products. Inverse psoriasis resistant to topical therapy has been shown to respond to botulinum toxin injections, excimer laser therapy, and certain systemic agents (such as anti-TNF and anti-IL12/IL23 therapy). Based on promising results from case reports and prior clinical experience, these systemic agents should be strongly considered in inverse psoriasis resistant to topical therapy. However, they need further evidence-based evaluation. The use of randomized trials and objective severity indices may allow for more robust therapeutic data.
J Drugs Dermatol. 2017;16(8):760-766.
Eduardo Anitua MD DDS,a,b Ander Pino MSc,b María Troya MScb
In this study, the stability of a novel autologous topical serum (ATS) derived from plasma rich in growth factors technology (PRGF) has been evaluated. As skin ages, mechanical, protective and restorative properties decrease leading to multiple clinical conditions. In recent years, topical administration of growth factors has emerged as a promising therapeutic alternative to promote wound healing and skin regeneration. Determination of stability is a crucial step in the formulation process in order to develop an effective product. Blood from 8 healthy donors was harvested and the autologous topical serum was obtained. Resulting ATS samples were either kept fresh or stored for 1, 2, and 3 months at 4ºC. Physical properties and growth factor content were determined in ATS samples at each time of storage. The effect on human dermal fibroblast proliferation and the sterility of the samples was also studied. All the analyzed parameters remained stable along the storage time while pH values increased slightly with respect to fresh samples. No microbial contamination was detected in any of the samples. Preservation of the autologous topical serum up to 3 months under refrigeration does not affect either its physical or mechanical properties or neither alters the growth factors´ composition, thus preserving its biological potential. This achievement enables patients with chronic disorders to maintain their treatment with a lower frequency of blood extractions without affecting the efficacy of PRGF therapy.
J Drugs Dermatol. 2018;17(10):1115-1121.
Thomas Lambert BA, Kimberly Mullinax MD, Jennifer Smith MD
A 73-year-old Caucasian male was treated in the dermatology clinic for squamous cell carcinoma (SCC) of the scalp by
Mohs micrographic surgery. The patient subsequently received radiation therapy because of possible calvarium invasion.
Approximately 2 years later, the patient developed Bowen’s disease within the previously irradiated skin flap. The lesion was
treated with topical 5-fluorouracil (5-FU) twice daily for 4 weeks, and subsequently developed a 2 x 2 cm full-thickness
ulceration with exposed calvarium.
Bacterial resistance became a true clinical concern for dermatologists in the 1980s, when the first reports emerged of the resistance of Propionibacterium acnes to oral antibiotics. Subsequent studies have documented acne treatment failure associated with resistance to topical antibiotics. Beyond dermatology practice, antibiotic resistance has now become recognized as a worldwide health concern. In contrast to antibiotics commonly used in the treatment of acne, benzoyl peroxide (BP)'s mechanism of action is different. Benzoyl peroxide is a bactericidal agent. Combining BP with a topical antibiotic in a stable formulation has been proven in clinical trials to reduce total P acnes count by 99.7% after 1 week of therapy, eliminating both susceptible and resistant strains of P acnes. However, we have recently noticed BP's benefits as monotherapy in the treatment of acne. Benzoyl peroxide works rapidly on P acnes without causing antibiotic resistance. Hence, we may have to reconsider the role of topical antibiotics such as clindamycin in the treatment paradigm of acne vulgaris.
J Drugs Dermatol. 2013;12(suppl 6):s73-s76.
Lawrence F. Eichenfield MD and Sheila Fallon Friedlander MD
Fungal infection of the nails is an increasingly recognized disease in infants and children. However, it can be difficult to distinguish clinically from other nail dystrophies. In addition, many mistakenly believe that onychomycosis does not occur in childhood. Under-recognition of this infectious disorder therefore occurs. Although many consider “nail fungus” a trivial cosmetic concern, it can lead to discomfort, risk of secondary infection, and a more significant health threat in immunocompromised or diabetic individuals. It should always be considered in the differential diagnosis of nail plate disorders in children as it is one of the more common causes.
Here we review the latest data on prevalence of the disease, reasons for its relatively low incidence compared with adults, and important predisposing factors. It is important to confirm the clinical diagnosis of onychomycosis in children, and affected individuals should be examined for concomitant tinea pedis. As familial disease often occurs, it is important to check parents and siblings as well for onychomycosis and tinea pedis.
Treatment of onychomycosis is challenging, and recurrence appears to be more common in children than in adults. Prolonged systemic antifungal therapy is commonly required. However, pediatric practitioners and parents alike hesitate when asked to treat young children with a systemic drug that requires laboratory monitoring and can have systemic toxicities. Due to their thinner, faster-growing nails, children are theoretically more likely to respond to topical monotherapy than adults, and therefore good candidates for topical antifungal therapy.
The clinical data on the use of topical antifungals in pediatric onychomycosis is scarce. We review data that exist from case reports and small clinical trials. New topical antifungals are now available that afford better nail penetration and additional delivery routes to the site of infection. Pediatric trials are now on-going, and should clarify the usefulness of these agents in children.
J Drugs Dermatol. 2017;16(2):105-109.
Efinaconazole is a Promising Treatment for Onychomycosis
Onychomycosis is a fungal infection of the nail unit that is caused by a variety of fungi including dermatophytes, nondermatophyte molds, and Candida. Efinaconazole 10% solution is a new topical treatment for onychomycosis that has a broad spectrum of activity against dermatophyte, nondermatophyte, and numerous yeast species. In clinical trials of mild to moderate onychomycosis, mycologic and complete cure rates for efinaconazole are comparable to those seen with oral itraconazole. Efinaconazole may be an important primary medication for those patients for whom effective topical treatment would be ideal, and could also be used in combination with an oral agent, or with adjunct therapies such as lasers and debridement.
Lissy Hu BA,a Christina Alexander BA,b Nicole F. Velez MD,c F. Clarissa Yang MD,c
Alvaro Laga Canales MD MMSc,c,d Stephanie Liu MD,c and Ruth Ann Vleugels MD MPHc,
Topical tacrolimus has been observed to induce granulomatous rosacea (GR) in prior case reports and series. In most cases, patients recover fully after withdrawing tacrolimus and initiating doxycycline or minocycline. Herein, we describe a case of severe GR, which required further therapy. Clinicians should be aware of this rare complication because of the frequent use of topical tacrolimus.
J Drugs Dermatol. 2015;14(6):628-630.
Leon H. Kircik MD FAAD
Dysfunction of the epidermal barrier is generally considered a precursor of cutaneous inflammation that can directly contribute to the pathogenesis of skin diseases, notably atopic dermatitis (AD). We also know that topical corticosteroids may actually impair the epidermal barrier by interfering with epidermal lipid synthesis. Therefore, it is important to utilize topical corticosteroids in vehicles that will help at least to enhance the already disrupted epidermal barrier in atopic dermatitis patients. Two studies of identical design were conducted to determine and compare the occlusivity and moisturizing potential of three topical corticosteroid products when applied to skin whose barrier integrity has been disrupted by dry shaving. Findings in both studies showed the clocortolone pivalate cream decreased TEWL better than non-treatment or treatment with hydrocortisone butyrate lotion. Skin surface hydration increased significantly (P<0.001) in all three treated sites, compared to the non-treated damaged control and non-treated normal skin. Clocortolone pivalate cream increased skin surface hydration significantly (P<0.001) better than hydrocortisone butyrate lipocream or hydrocortisone butyrate lotion. These studies showed that clocortolone pivalate cream enhances barrier function by providing occlusion.
While understanding of the structure and function of the stratum corneum (SC) and epidermal barrier function has evolved tremendously over the last several decades, and especially over the last 15 years,1 confusion and misinformation still persist. Dysfunction of the epidermal barrier is generally considered a precursor of cutaneous inflammation that can directly contribute to the pathogenesis of skin diseases, notably atopic dermatitis (AD).2,3 Topical steroids are standard of care in treatment of atopic dermatitis. However, we also know that topical corticosteroids may actually impair epidermal barrier by interfering with epidermal lipid synthesis.4,5 In addition to that, various penetration enhancers in the topical steroid formulations also contribute to the impairment of the epidermal barrier.4 Therefore, it is important to utilize topical corticosteroids in vehicles that will help at least to enhance the already disrupted epidermal barrier in atopic dermatitis patients. In this regard, these studies were designed to determine the hydrating effects of clocortolone pivalate cream 0.1% (Cloderm Cream, Promius Pharma).
J Drugs Dermatol. 2014;13(5):582-585.
Topical bimatoprost was FDA approved in December of 2008 for the treatment of eyelash hypotrichosis. Since its approval, some physicians have advocated the use of bimatoprost "off label" for hair growth in other areas, such as the scalp or eyebrows, but there has yet to be published scientific evidence to support this use. We report one of the first cases of significant eyebrow hair growth in a patient after use of topical bimatoprost for eyebrow hypotrichosis.
J Drugs Dermatol. 2012;11(1):106-108.
A 27-year-old male with a history of Crohn's disease was treated for chronic pyoderma gangrenosum at his stoma site. Treatment with topical application of crushed dapsone resulted in improvement of his pyoderma gangrenosum. Crushed dapsone may be an efficacious treatment with minimal systemic side effects. This appears to be the first case of pyoderma gangrenosum treated with crushed dapsone.
J Drugs Dermatol. 2011;10(9):1059-1061.
James Q. Del Rosso DO FAOCDa and Leon H. Kircik MDb
Azelaic acid (AzA) 15% gel has been available in the United States for slightly over a decade, approved for treatment of the inflammatory
lesions (papules and pustules) of rosacea. Efficacy and safety have been established in multiple studies both as monotherapy
and in combination with oral doxycycline. Azelaic acid 15% gel has been shown not to induce epidermal permeability barrier impairment,
and proper skin care reduces the likelihood of neurosensory adverse effects of stinging and burning that can affect a subset of
patients with rosacea. Azelaic acid 15% gel appears to produce a quicker onset of clinical effect than metronidazole in some patients
when either agent is used in combination with subantimicrobial dose doxycycline; however, both topical agents are effective when
used in this combination approach for papulopustular rosacea (PPR). Although more information is needed on the modes of action
of AzA in the treatment of rosacea, downregulation of the cathelicidin pathway appears to be one operative mode of action based
on in vitro and in vivo studies, including data from patients treated with AzA 15% gel for PPR. Azelaic acid 15% foam is currently in
the latter stages of development for PPR, with pivotal studies demonstrating efficacy and favorable tolerability, including a very low
incidence of stinging, burning, and itching even without the use of designated skin care products.
J Drugs Dermatol. 2014;13(suppl 12):s101-s107.
Alan B. Fleischer Jr. MD and Mark Boguniewicz MD
Persistent pruritus, or itch, is one of the earliest symptoms of atopic dermatitis (AD). When pruritus is untreated, the incessant
scratching response by the patient can increase the inflammatory response, resulting in aggravation of disease symptoms and severity,
increasing flares and worsening patient quality of life. Therefore, it is essential that pruritus be treated effectively, rapidly and
safely for optimal management of AD. In this article, the authors review clinical trials using tacrolimus ointment, a topical calcineurin
inhibitor, to treat adult and pediatric patients with AD over a wide range of disease severity focusing on its efficacy in rapidly reducing
pruritus. Furthermore, the authors evaluate trials in which tacrolimus ointment was directly compared with topical corticosteroids, the
mainstay of AD treatment, and pimecrolimus cream, another topical calcineurin inhibitor, as well as long-term safety trials in which
patients applied tacrolimus ointment for extended periods.
Katherine H. Flanagan MD, Rosemary King PA-C, Dee Anna Glaser MD
Severe hyperhidrosis affects 2.8% of the population and can be emotionally devastating. First-line therapy employs topical
agents such as aluminum chloride (AC), but efficacy and tolerability vary widely. Botulinum toxin type A (BTX-A)
is FDA-approved for the treatment of primary focal axillary hyperhidrosis unresponsive to topical therapy. A single-center,
randomized, parallel, open-label, 12-week study was performed to compare the efficacy and safety of BTX-A with 20%
AC for the treatment of primary focal axillary hyperhidrosis. Twenty-five subjects were randomized to either BTX-A or
AC treatment, and were evaluated for treatment response by an improvement of ≥2 grades on the Hyperhidrosis Disease
Severity Scale (HDSS). At week 4, 92% of the subjects in the BTX-A group achieved treatment response compared with
33% of the subjects in the AC group. Overall, treatment with BTX-A was more effective and provided greater patient
satisfaction than with AC. Treatment with AC was effective and tolerated in 29% of the subjects.
Chad J. Jessup MD MS, Shane C. Morgan PA-C, Lisa M. Cohen MD, Daniel E. Viders MD
Incontinentia pigmenti (IP), or Bloch-Sulzberger syndrome, is a rare X-linked dominant genodermatosis primarily affecting females.
Although IP affects many organ systems, the hallmark feature of this disease is its characteristic cutaneous eruption along the lines
of Blaschko that evolves through four distinct stages: inflammatory/vesiculobullous, verrucous, hyperpigmented and hypopigmented/
atrophic. We describe a case of IP in its vesicular stage that completely resolved with topical Protopic® (tacrolimus) 0.1% ointment.
The treatment successfully halted the progression of disease through its subsequent disfiguring stages.
Andrew F. Alexis MD MPH
The treatment of disorders of hyperpigmentation including
melasma, photoaging-related dyschromia, and postinflammatory
hyperpigmentation pose numerous challenges, especially in
patients with higher Fitzpatrick skin types (skin of color). Given
limitations in efficacy as well as safety and cost considerations
of available therapies, a “magic bullet” single treatment
modality for hyperpigmentation is currently lacking. Successful
treatment typically involves a combination of topical agents with
or without in-office procedures, exploiting the different mechanisms
of action of each agent or treatment modality. This article
will review recently published studies involving newer topical and
procedural approaches to this common dermatologic concern.
Kathani Amin MD, Christy C. Riddle MD, Daniel J. Aires MD, Eric S. Schweiger MD
Acne vulgaris is an extremely common disorder affecting many adolescents and adults throughout their lifetimes. The
pathogenesis of acne is multifactorial and is thought to involve excess sebum, follicular hyperkeratinization, bacterial
colonization, and inflammation. Many therapeutic options exist for treating acne, including topical benzoyl peroxide, topical
and oral antibiotics, topical and oral retinoids, and oral contraceptives. Oral antibiotics have been a mainstay in the
treatment of acne for decades and function by exerting an antibacterial effect by reducing the follicular colonization of
Propionibacterium acnes. Systemic antibiotics also have anti-inflammatory and immunomodulatory properties. This article
reviews the English language literature on the efficacy of various systemic antibiotics for treating acne vulgaris, including
second-line and less historically used medications. We discuss the tetracyclines, including subantimicrobial dose
doxycycline, macrolides (notably azithromycin), trimethoprim-sulfamethoxazole, cephalosporins, and fluoroquinolones
as treatment options for acne vulgaris.
Jonathan I. Silverberg MD PhD MPH and Nanette B. Silverberg MD
Background: Vitiligo vulgaris is a chronic autoimmune depigmenting disorder affecting individuals of all skin colors. Lesions are commonly noted in the periorificial face and over the upper and lower extremities in areas of friction. Although there have been many published reports of successful therapies for vitiligo, few have assessed differential response based on skin color.
Objective: To determine if topical tacrolimus is more effective at treating vitiligo in individuals of color.
Methods: An IRB-approved chart review of patients with a diagnosis of vitiligo was conducted including patients seen between May 2001 and April 2006. Patients with vitiligo were treated with tacrolimus 0.03% for children ages 2-15 years of age and tacrolimus 0.1% ointment for individuals 16 years of age or older, applied twice-daily to all hypopigmented or depigmented lesions. A review of clinical features, Fitzpatrick skin type and response to topical tacrolimus were recorded.
Results: Topical tacrolimus was effective in all Fitzpatrick skin types, with superior efficacy on body lesions in individuals of Fitzpatrick
types 3-4 (Fisher exact test, P=0.03). Further, individuals with Fitzpatrick type 3-4 skin had shorter interval to >75 percent improvement of lesions on the body (Kaplan-Meier Log-rank, P=0.03) and head and neck (P=0.016).
Conclusion: Topical tacrolimus is an effective treatment for vitiligo irrespective of skin tone, with greatest benefit in Fitzpatrick type 3-4 skin. Repigmentation of lesions on the head and neck is superior to repigmentation of the body and extremities in all racial subgroups.
J Drugs Dermatol. 2011;10(5):507-510.
Neil S. Sadick MD, Michel Le Maître MD, Christine Coutanceau MS,Vincent Sibaud MD, Christelle Merial-Kieny PhD
Background: Palmoplantar keratoderma (PPK) is a heterogeneous group of skin disorders characterized by symmetrical diffuse or
patchy areas of hyperkeratosis on the palms and soles. This study aimed to evaluate the efficacy and safety of a topical keratolytic treatment for localized hyperkeratosis.
Methods: International, randomized, vehicle‑controlled, double‑blind, intra‑individual comparative study.
Results: Clinical signs assessed by the investigator significantly improved in both group from baseline to day 10 and day 21 (P<0.001). Mean improvement was significantly more marked on the treated side than the control side (except pruritus) at day 10 for hyperkeratosis (‑0.58±0.59 versus ‑0.41±0.51, P=0.009), desquamation (‑0.62±0.69 versus ‑0.47±0.67, P=0.042) and dryness (‑0.75±0.67 versus ‑0.57±0.67, P=0.014). At day 21, dryness (‑1.16±0.80 versus ‑1.00±0.79, P=0.036) was significantly improved but only a trend for hyperkeratosis (‑0.86±0.76 versus ‑0.72±0.72, P=0.158) and desquamation (‑0.83±0.85 versus ‑0.65±0.85, P=0.057) was observed.
Tolerance was considered to be good or very good in more than 92 percent patients. Both patients and investigators were satisfied in more than 84 percent of cases with the topical keratolytic treatment efficacy. Safety profile was highly satisfactory.
Conclusion: This topical keratolytic treatment represents a valuable first‑line option for mild to moderate hyperkeratosis.
Robert Bissonnette MD,a Francisco Kerdel MD,b Luigi Naldi MD,c Kim Papp MD,d Claudia Galindo MD,e Wayne Langholff PhD,f K. L. Tang PhD,f Philippe Szapary MD MSCE,f Steven Fakharzadeh MD PhD,e Bhaskar Srivastava MD PhD,e Kavitha Goyal MD,e and Alice B. Gottlieb MD PhDg
BACKGROUND: Psoriasis is associated with increased risk of major adverse cardiovascular events (MACE).
OBJECTIVES: Compare MACE risk with biologics vs topical/phototherapy use.
METHODS: Psoriasis Longitudinal Assessment Registry (PSOLAR) is an international psoriasis registry of patients eligible to receive biologic/systemic treatments prospectively. MACE is defined as myocardial infarction, stroke, or cardiovascular death. Biologic cohorts, including tumor necrosis factor-alpha (TNF-α) inhibitors (ie, adalimumab, etanercept, and infliximab) and ustekinumab, combined and by class, were compared with a topical/phototherapy cohort. Incidence rates of MACE per 100-patient-years (100PY) with 95% confidence intervals (95% CI) are reported. Multivariate analyses were performed to evaluate the effect of treatment on the risk of MACE adjusting for confounders.
RESULTS: Analyses included 7550 patients: 6767 in the combined biologics cohort (3949 and 2818 in the TNF-α inhibitors and ustekinumab cohorts, respectively) and 783 in the topical/phototherapy cohort. Mean duration of exposure was approximately 2.8 years (combined biologics) and 4.1 years (topical/phototherapy). A total of 52 MACE were reported; MACE incidence rates were 0.22/100PY (95% CI: 0.16, 0.30) for the combined biologics cohort (TNF-α inhibitors [0.20/100PY (0.12, 0.31)] and ustekinumab [0.24/100PY (0.15, 0.37]) and 0.34/100PY (0.17, 0.61) for the topical/phototherapy cohort. For the combined biologics (hazard ratio=0.92; 95% CI [0.426, 1.988]), TNF-α inhibitor (0.85 [0.373, 1.928]), and ustekinumab (1.03[0.440, 2.402]) cohorts, treatment was not associated with increased risk of MACE versus the topical/phototherapy cohort.
CONCLUSION: Based on data accumulated to date in PSOLAR, treatment with biologics did not have an impact on the risk of MACE in patients with moderate-to-severe psoriasis.
J Drugs Dermatol. 2017;16 (10):1002-1013.
Jennifer Krejci-Manwaring MD, Martha Ann McCarty MS PA-C, Fabian Camacho MS MA, Janeen Manuel PhD,Jennifer Hartle MPH, Alan Fleischer Jr MD, Steven R. Feldman MD PhD
Background: Hand dermatitis is a chronic inflammatory skin disorder for which systemic immunosuppressive therapy is
often needed. Topical treatments could complement the use of systemic corticosteroids.
Objective: To evaluate symptoms of hand dermatitis in subjects treated with a prednisone taper combined with topical
tacrolimus 0.1% ointment versus vehicle.
Methods: Thirty-two subjects with moderate to severe hand dermatitis were enrolled in a randomized double-blind controlled
trial. Subjects received a 3-week taper of prednisone and was randomized 2:1 to apply topical tacrolimus or its vehicle
twice daily for 12 weeks. Disease severity was evaluated at baseline and at 5 follow-up visits (weeks 1-14). Any
occurrence of relapse was recorded by patients.
Results: Twenty-two of the 32 subjects (69%) had relapse of their disease. The mean time to recurrence for tacrolimus
versus vehicle was 48 versus 39 days, respectively (P=.78). A greater improvement of induration (P=.003) and scaling
(P=.003) for patients with tacrolimus compared to vehicle was detected, as well as subjective improvement (%) from week
1 to week 12 (P=.04) compared to vehicle. Improvement in erythema (P<.0001), fissuring (P=.0003), pruritus (P=.06),
and investigator’s global assessment (P<.0001) with tacrolimus was not found to exceed improvement with vehicle.
Limitations: Small sample size provides limited power to detect differences in response.
Conclusions: Topical tacrolimus improves induration and scaling, and there is a trend suggesting it prolongs the time to
BACKGROUND: Acne vulgaris is a common, chronic skin disease that requires long-term therapy. Oral antibiotics are a mainstay of treatment, but extended use is associated with the development of bacterial resistance. Topical therapies are often combined with oral antibiotics to achieve an initial improvement, after which the oral agents may be discontinued and the topical therapy used as maintenance.
OBJECTIVE: To assess the safety and efficacy of combination therapy with dapsone 5% gel with oral doxycycline hyclate 100mg, followed by monotherapy with dapsone 5% gel in improving and maintaining response in patients with moderate to severe acne.
METHODS: In this open-label study, all patients applied dapsone 5% gel twice daily along with doxycycline hyclate 100mg once daily for 12 weeks. Subjects who achieved a qualifying improvement at week 12 continued to the second phase of the study in which they applied only dapsone 5% gel twice daily for maintenance therapy of 12 more weeks. Subjects were evaluated for safety and efficacy at weeks 4, 8, 12, 16, 20, and 24.
RESULTS: All subjects (n=30) in the initial phase qualified to enter the maintenance phase. 82% of participants maintained their treatment response (Investigator’s Global Assessment score) at week 24. The regimen was safe and well tolerated.
CONCLUSIONS: The combination oral doxycycline hyclate 100 mg with topical dapsone 5% gel twice daily is an effective and well-tolerated regimen to treat moderate to severe acne vulgaris. After discontinuation of doxycycline, topical dapsone 5% gel is effective at maintaining a therapeutic response. These data suggest that topical dapsone 5% gel can be used effectively for long-term acne maintenance treatment without the risk of developing antibiotic resistance.
J Drugs Dermatol. 2016;15(2):191-195.
Kenneth R. Beer MD FAAD,a Stephanie Bayers BSBA,b and Jacob Beerc
The periorbital complex is a critical cosmetic unit. Treatments for this region range from topical prescriptions to enhance the brow hair to topical cosmeceuticals that improve the tone and texture of the skin. Lasers, radiofrequency, botulinum toxins, fillers, and a host of other treatments are used to treat the periorbital region. Judicious use of these treatments, alone or in combination, can greatly alter the appearance of the region. However, adverse events may also be associated with these treatments, and the clinician and patients need to consider both the risks and the benefits of treatment prior to embarking upon a regimen.
J Drugs Dermatol. 2014;13(suppl 1):s17-s20.
Mark S. Nestor MD PhD
The use of topical anesthesia for pain control for dermatologic procedures is widespread. In addition to clinical
procedures, such as skin biopsies, lesion removal, and electrocautery, topical anesthesia is used for pain control in a
variety of cutaneous cosmetic procedures including laser procedures and injection of filler substances and/or botulism
toxin. While the use of topical anesthesia is generally regarded as safe and effective, recent concern about lidocaine
toxicity from the use of compounded mixtures of lidocaine for cosmetic procedures has been reported. This study
evaluated the potential absorption and clinical toxicity of either 30 or 60 grams of occluded topical liposomal lidocaine
(LMX4) in 8 healthy volunteers. Blood was drawn to evaluate levels of lidocaine and monoethylglycinexylidide
(MEGX) metabolites prior to application of the occluded cream at 1 hour, 2 hours, 6 hours, and 24 hours post-application.
Additionally, the volunteers were assessed for any clinical signs of lidocaine toxicity. All blood samples showed
less than 0.5 mcg/mL of serum lidocaine and MEGX metabolite. Patients reported no systemic effects and did not show
any clinical signs of lidocaine toxicity. Conclusions were that moderate amounts (30 and 60 grams—amounts used in
a variety of cosmetic procedures) of occluded 4% lidocaine cream were safe; the test subjects showed no evidence of
clinical toxicity and blood levels showed no evidence of significant lidocaine or lidocaine metabolites.
Diane M. Thiboutot MD, Harald P. Gollnick MD
Acne vulgaris is an exceptionally common, chronic, and recurring disease. It involves multiple etiological factors including
follicular hyperkeratinization, increased sebum production, Propionibacterium acnes proliferation, and inflammation.
Presently, oral isotretinoin is the only single agent that is effective against all 4 major pathophysiologic features. However,
this drug is also responsible for several serious side effects, including teratogenicity. Therefore, it should be used in only the
most severe cases and alternative treatment approaches for inflammatory acne, such as initial combination therapy, should
be considered first. Combination therapy in inflammatory acne simultaneously targets multiple pathogenic factors. Current
guidelines recommend early initiation of combination therapy with a topical retinoid and antimicrobials for mild to
moderate inflammatory acne and topical retinoids with oral antibiotics (with or without the use of benzoyl peroxide) for
moderate to severe cases of acne, followed by maintenance therapy with topical retinoids. This review evaluates the
rationale and clinical evidence for the use of adapalene in combination therapy for inflammatory acne.
Stacy Smith MD, Vera Morhenn MD, Guy Webster MD
Topical drugs use a variety of ingredients to control the properties of the final product. Solid phase porous microspheres
(SPPM, Microsponge®) have been incorporated into several topical prescription products in an effort to improve performance
or tolerability. SPPMs provide a reservoir effect allowing more prolonged skin exposure to the active ingredient. They are used
in products for acne vulgaris, actinic keratoses, and pigmentary changes. The differences in clinical performance between existing
formulations of these common active ingredients and the formulations using SPPMs are compared and contrasted.
Leon Kircik MD, James Del Rosso DO FAOCD
Atopic dermatitis (AD) is a chronic cyclical inflammatory skin disease that is increasing in incidence. Twenty percent
of those affected with AD are infants and young children. Despite the development of newer nonsteroidal topical therapies,
such as calcineurin inhibitors, topical corticosteroids remain the gold standard for the treatment of active eczematous
disease and management of exacerbation due to established efficacy and safety with appropriate use. The xerotic,
sensitive skin of AD patients mandates the use of nonirritating and nondrying topical vehicles. Recently, phase III clinical
studies have demonstrated the safety and efficacy of a novel aqueous hydrogel vehicle for desonide delivery in mild
to moderate AD, which is free of fragrances and surfactants. Corneometry and transepidermal water loss studies have
demonstrated that this patented hydrogel vehicle alone offers advantages including moisturization and skin barrier enhancement,
both of which are significant when treating eczematous and xerotic skin. Patient and physician preference
surveys suggest that the novel properties of this vehicle may aid in patient compliance with AD therapy
Topical corticosteroids are used to treat a wide variety of eczematous and inflammatory skin disorders, such as atopic dermatitis. However, as topical products become available as generic formulations, patients often experience problems of increased allergies and irritancy, impairment of the epidermal barrier, and loss of efficacy. This is because although the active ingredient and its potency are the same, the vehicle excipients may differ. Dermatologists therefore report concerns in prescribing these generics to their patients.
Fortunately, Promius Pharma, one of the leaders in this field, has now brought to market a generic formulation of clocortolone pivalate 0.1% that is exactly the same as their original branded product. This has been shown to be effective and well tolerated in the management of several corticosteroid-responsive dermatoses, and is a welcome addition to the treatment armamentarium.
S.H. Babaeinejad MD and R.F. Fouladi MD
Topical treatments, such as adapalene and benzoyl peroxide (BPO), are popular in mild-to-moderate acne vulgaris. This study aimed to compare the efficacy, safety and tolerability of adapalene and BPO in mild acne vulgaris. In this single-center, randomized, double-blind, clinical trial, 60 patients with mild acne vulgaris received either topical adapalene 0.1% gel or topical BPO 2.5% gel on their face once daily for two months. The changes of acne lesion count (efficacy), any adverse effect (safety), and the patients’ overall satisfaction (tolerability) were compared after 3 months of follow-up. In both groups the mean number of noninflammatory, inflammatory and total lesions decreased significantly from baseline (10.77±5.54, 9.73±5.09, and 20.50±7.54, respectively in adapalene group; 11.50±5.92, 8.43±5.45, and 19.93±9.01, respectively in BPO group) to the third month (1.70±1.68, 0.33±0.66, and 0.50±0.78, respectively in adapalene group; 4.23±4.14, 0.33±0.71, and 4.13±4.44, respectively in BPO group; P<0.001 for all), posttreatment. Although the mean number of inflammatory lesions was significantly lower in BPO receivers only at first month (P =0.001), the mean number of noninflammatory and total lesions was significantly lower in adapalene group at second (P = 0.04 and 0.03, respectively) and third (P =0.02 and <0.001, respectively) months, posttreatment. The adverse events were minimal and self-limited (26.7% in adapalene group, 20% in BPO group, p=0.54). The patients’ overall satisfaction was good to excellent in 93.3% of adapalene receivers vs. 73.3% in BPO group (P=0.08). Both topical adapalene 0.1% and BPO 2.5% gels seem safe and effective in mild acne vulgaris, with a marginal tendency toward the former.
J Drugs Dermatol. 2013;12(7):790-794.
OBJECTIVE: To evaluate efficacy of efinaconazole topical solution, 10% in onychomycosis patients with early and long-standing disease.
METHODS: An analysis of 1655 patients, aged 18-70 years, randomized to receive efinaconazole topical solution, 10% or vehicle from
two identical multicenter, double-blind, vehicle-controlled 48-week studies evaluating safety and efficacy. The primary end point was
complete cure rate (0% clinical involvement of target toenail, and both negative potassium hydroxide examination and fungal culture)
at Week 52. Three groups were compared: those with early disease (<1year), patients with a baseline disease of 1-5 years, and those
with long-standing onychomycosis (>5years).
RESULTS: The majority of patients had long-standing disease; were older, male and white. While nail involvement of the target toenail
did not differ noticeably amongst the three groups, the number of nails involved did increase progressively with disease duration. Differences
were seen in terms of infecting pathogens in early disease that might have important treatment implications. Efinaconazole
was more effective in treating early disease, however more than 40% of patients with long-standing disease were considered treatment
LIMITATIONS: A period of 52 weeks may be too brief to evaluate a clinical cure in onychomycosis.
CONCLUSIONS: Treatment of onychomycosis early to avoid disease progression to other toenails is important. Once daily efinaconazole
topical solution, 10% is particularly effective in these patients.
J Drugs Dermatol. 2015;14(1):58-62.
Gary Grove PhD,a Charles Zerweck PhD,a and Jennifer Gwazdauskas MBAb
Benzoyl peroxide (BPO) is a cornerstone of acne therapy, often used in combination with a topical antibiotic and/or a retinoid. Three
independent 2-week studies were conducted in healthy subjects to compare the tolerability and irritation potential of topical treatment
with Duac® Gel (BPO 5%–clindamycin phosphate 1.2%) vs Acanya® Gel (BPO 2.5%–clindamycin phosphate 1.2%), Aczone® Gel (dapsone
5%), or Epiduo® Gel (BPO 2.5%–adapalene 0.1%). For each study, subjects were randomized to apply one of the comparative
products on one side of the face; the contralateral side remained untreated. Primary (erythema and dryness) and secondary tolerability
assessments were performed throughout the study. Independent blinded expert grader assessments of erythema found no significant
overall difference between any of the comparative groups. Treatment with Epiduo Gel resulted in a significant increase in dryness
and evaporative water loss values compared with Duac Gel. Overall, subject self-assessments were equally favorable across all study
groups, although the Epiduo Gel group reported a higher frequency of adverse perceptions (ie mild burning/stinging). In conclusion,
the four topical acne medications tested were well tolerated throughout the study period. Treatment with Epiduo Gel resulted in a
significant increase in dryness, evaporative water loss, and sensations of burning and stinging. No other significant differences in self-assessment
perceptions were observed between treatments.
J Drugs Dermatol. 2013;12(6):644-649.
Jason J. Emer MD, Amylynne Frankel MD, Andrew Sohn BS, Mark Lebwohl MD
Corticosteroids are the mainstay of therapy for atopic dermatitis, but long-term use is associated with adverse effects. We sought
to evaluate the clinical efficacy of two steroid-sparing creams for atopic dermatitis. Twenty patients were enrolled in an investigatorblinded,
bilateral comparison study. Patients applied pimecrolimus cream twice daily to a target lesion on one side of the body and
also applied a topical medical device cream three times daily on a symmetrical target lesion on the opposite side of the body for
four weeks. Clinical assessments including Physician Global Assessment (PGA), Target Lesion Symptom Score (TLSS), subject selfassessment
and digital photography were performed at the baseline, 2 week, and 4 week visits. Seventy-five percent of patients
(pimecrolimus, 15 of 20; topical medical device, 15 of 20) were rated "clear" (0) or "almost clear" (1) by PGA for both medications
after four weeks. Percent improvement of the PGA from randomization for pimecrolimus cream and the topical medical device cream
were 72.50 and 71.67 respectively (P=0.9283). PGA scores decreased significantly from baseline for both treatments (P=0.004).
Overall, there was no statistically significant difference between treatment groups for PGA scores throughout the study (P=0.8236).
No cutaneous side effects were noted. Our study was limited by a small sample size and lack of double-blinding; however, both
treatments were found to be safe and effective in treating atopic dermatitis over four weeks. Significant improvements were noted
for all efficacy variables. In conclusion, a lipid-rich, non-steroidal, topical medical device cream was as effective in improving atopic
dermatitis as pimecrolimus cream.
J Drugs Dermatol. 2011;10(7):735-743.
S.H. Babaeinejad MD and R.F. Fouladi MD
Topical treatments, such as adapalene and benzoyl peroxide (BPO), are popular in mild-to-moderate acne vulgaris. This study aimed to compare the efficacy, safety and tolerability of adapalene and BPO in mild acne vulgaris. In this single-center, randomized, double-blind, clinical trial, 60 patients with mild acne vulgaris received either topical adapalene 0.1% gel or topical BPO 2.5% gel on their face once daily for two months. The changes of acne lesion count (efficacy), any adverse effect (safety), and the patients’ overall satisfaction (tolerability) were compared after 3 months of follow-up. In both groups the mean number of noninflammatory, inflammatory and total lesions decreased significantly from baseline (10.77±5.54, 9.73±5.09, and 20.50±7.54, respectively in adapalene group; 11.50±5.92, 8.43±5.45, and 19.93±9.01, respectively in BPO group) to the third month (1.70±1.68, 0.33±0.66, and 0.50±0.78, respectively in adapalene group; 4.23±4.14, 0.33±0.71, and 4.13±4.44, respectively in BPO group; P<0.001 for all), posttreatment. Although the mean number of inflammatory lesions was significantly lower in BPO receivers only at first month (P=0.001), the mean number of noninflammatory and total lesions was significantly lower in adapalene group at second (P= 0.04 and 0.03, respectively) and third (P=0.02 and <0.001, respectively) months, posttreatment. The adverse events were minimal and self-limited (26.7% in adapalene group, 20% in BPO group, P=0.54). The patients’ overall satisfaction was good-excellent in 93.3% of adapalene receivers vs. 73.3% in BPO group (P=0.08). Both topical adapalene 0.1% and BPO 2.5% gels seem safe and effective in mild acne vulgaris, with a marginal tendency toward the former.
J Drugs Dermatol. 2013;12(9):1033-1038.
Sujatha Tadicherla MD, Kate Ross BS, Philip D. Shenefelt MD, Neil A. Fenske MD
Topical corticosteroids are the most commonly prescribed agents in the treatment of dermatologic conditions. They are used primarily
as monotherapy or in combination with other agents for enhanced efficacy. Several stronger preparations are now available since
their first introduction. They are also available in various vehicles altering the potency and giving the option of tailoring them for use
based on specific anatomic locations, area of involvement, age of the patient, and most importantly, severity of the condition. Several
local and systemic side effects have been associated with their inadvertent use. Allergic contact dermatitis to most of the preparations
has also been noticed. Judicious use with reinforced patient education lowers such risk for side effects, and can be of great
use in treating dermatologic conditions.
James Q. Del Rosso DO FAOCD, Suzanne Bruce MD, Michael Jarratt MD, Alan Menter MD, Gerald Staedtler
Rosacea is a leading reason why people seek the care of a dermatologist, accounting for nearly 7 million office visits annually. Pharmacologic
treatments include both topical and oral medications, which are increasingly being used in combination, especially at the
outset of therapy. This exploratory study assesses the safety, effectiveness and speed of onset of two common topical agents for
the treatment of rosacea—azelaic acid gel (AzA) 15% and metronidazole gel 1%—used in conjunction with anti-inflammatory dose
doxycycline (40 mg once daily).
Men and women (n=207) with mild-to-moderate papulopustular rosacea were enrolled and randomized to receive either AzA gel 15%
twice daily plus doxycycline 40 mg once daily (AzA group) or metronidazole gel 1% once daily plus doxycycline 40 mg once daily
(Metro group) for 12 weeks. Both regimens were safe, efficacious and well tolerated. Efficacy parameters revealed a possible trend
toward greater and earlier benefit with the AzA-based regimen than with the metronidazole-based regimen. These findings warrant
further investigation in a sufficiently powered study.
Sabine Laquieze MD, Janusz Czernielewski MD, Marie-José Rueda MD
Despite their beneficial effects on the treatment of acne vulgaris, topical and oral retinoids may cause severe local irritation
(retinoid dermatitis) due to their mechanism of action, thereby jeopardizing patient adherence, and thus compromising treatment
efficacy. Alleviating dryness and improving skin comfort by using a moisturizer concomitantly to retinoids could
enhance efficacy. In the present study, 30 subjects receiving either oral isotretinoin for at least 2 months or topical tretinoin
for at least one month applied a moisturizing cream (Cetaphil® Moisturizing Cream) twice daily for 15 days on one half of
the face while the other side remained untreated. Clinical assessments, confirmed by biophysical measurements, showed that
the moisturizer provided a significant improvement in skin dryness, roughness, and desquamation. Skin properties and skin
discomfort were also greatly improved and subjects were very satisfied with the product. Retinoid-induced skin irritation can
be relieved by the regular use of a gentle moisturizing cream as an adjunctive treatment.
Stephanie Kao BA,a Alexi Kiss MD,b Tatiana Efimova PhD,b,c Adam J. Friedman MDc,d
Seborrheic keratosis (SK) is the most common skin tumor seen by dermatologists in everyday practice. Although the lesions are mostly benign, many patients still elect to have asymptomatic SK removed. The historical standards of treatment are cryosurgery and electrocautery, two surgical options that are effective at lesion removal but have high rates of postoperative adverse events such as treatment-site scarring and pigmentary alterations. The cosmetic outcomes of SK treatment modalities are of keen interest to dermatologists, as the American population becomes increasingly more diverse. In this article, the inclusion of darker Fitzpatrick skin types into clinical studies investigating post-treatment side effects of SK therapy is reviewed. The recent approval of a 40% hydrogen peroxide topical formulation is discussed in light of these issues, and several non-invasive topical treatments that optimize cosmetic outcomes of SK lesion removal are highlighted. Finally, treatment strategies aimed at reducing cost and minimizing the burden of adverse sequelae are provided.
J Drugs Dermatol. 2018;17(9):933-940.
William R. Levis MD, Aton M. Holzer MD, Leonard L. Kaplan PhD
Background: CD4 T cell counts are recognized as the standard method for monitoring HIV-seropositive patients and, along
with viral load, are clinically important as indicators for initiating highly active antiretrovival therapy (HAART). Skin
reaction scores following topical application of diphenylcyclopropenone (DPC) also demonstrate diagnostic utility as
a functional measure of immune competence.
Methods: We used low sensitizing doses of DPC in 40 patients applied in a non-volatile, non-irritating topical delivery
system to assess immune competence in 40 HIV-seropositive subjects with a range of CD4 T cell counts. Standardized patch
test reading scores were used, with 2+ or greater scores (erythema and induration) indicative of a positive response. The patch
test scores were then compared with CD4 counts.
Results: Application of DPC in concentrations of 0.4% and 0.2% successfully resulted in 90% sensitivity skin reaction scores
in subjects with >300 CD4 T cells/microL, following a single 0.1 mL application to the inner aspect of the arm. Lower DPC
concentrations of 0.1% and 0.05% were too low for initial sensitization reactions. Three subjects with CD4 counts between
150 and 300 cells/microL showed positive skin reactions indicating that this DPC test gives the clinician information on
cellular immunity beyond the CD4 count.
Conclusion: We conclude that a single topical application of DPC at concentrations between 0.2% and 0.4% can serve as a
measure of immune competence in HIV-seropositive patients. As a functional measure of immunocompetence, this DPC test
provides information beyond a CD4 count, which is particularly relevant to HIV-positive subjects with CD4 counts between 200 and 350 cells/microL.
Nanotechnology is a rapidly developing discipline with enormous promise for consumers and patients. Currently, it is entering an inflection point in its growth phase—both in the number and diversity of products developed or soon to be available for society and medicine. It is no surprise that a vast number of patents have been issued for nanotechnology in the cosmetics arena as a means of enhancing topical delivery of a broad range of over-the-counter products. In fact, the skin is the first point of contact for a whole host of nanomaterials, ranging from topical preparations, articles of clothing and household products, to sporting goods and industrial manufactured goods. Very little is known about the safety aspects of the nano-engineered materials that are being released in the environment, as well as those in consumer and healthcare products.
No abstract details for the moment.
No abstract details for the moment.
Joseph Fowler Jr. MD,a J. Mark Jackson MD,a Angela Moore MD,b Michael Jarratt MD,c Terry Jones MD,d Kappa Meadows MD,e Martin Steinhoff MD,f Diane Rudisill BSc,g and Matthew Leoni MDg on behalf of the Brimonidine Phase III Study Group
BACKGROUND: Brimonidine tartrate, a highly selective α2-adrenergic receptor agonist with potent vasoconstrictive activity, was shown
to reduce erythema of rosacea.
OBJECTIVE: To assess the efficacy and safety of topical brimonidine tartrate gel 0.5% for the treatment of erythema of rosacea.
METHODS: Both studies were randomized, double-blind, and vehicle-controlled, with identical design. Subjects with moderate to severe erythema of rosacea were randomized 1:1 to apply topical brimonidine tartrate gel 0.5% or vehicle gel once-daily for 4 weeks, followed by a 4-week follow-up phase. Evaluations included severity of erythema based on Clinician’s Erythema Assessment and Patient’s Self-Assessment, as well as adverse events.
RESULTS: Topical brimonidine tartrate gel 0.5% was significantly more efficacious than vehicle gel throughout 12 hours on days 1, 15,
and 29, with significant difference observed as early as 30 minutes after the first application on day 1 (all P<.001). No tachyphylaxis,
rebound or aggravation of other disease signs were observed. Slightly higher incidence of adverse events was observed for topical
brimonidine tartrate gel 0.5% than for vehicle; however, most of the adverse events were dermatological, mild, and transient in nature.
LIMITATIONS: These data generated in controlled trials may be different from those in clinical practice.
CONCLUSIONS: Once-daily brimonidine tartrate gel 0.5% has a good safety profile and provides significantly greater efficacy relative to
vehicle gel for the treatment of moderate to severe erythema of rosacea, as early as 30 minutes after application.
J Drugs Dermatol. 2013;12(6):650-656.
Frank Martiniuk PhD, Diona L. Damian PhD, John F. Thompson MD,Richard A. Scolyer MD, Kam-Meng Tchou-Wong PhD,f William R. Levis MD
The authors provide an update on a previously reported patient with in-transit metastatic melanoma of the scalp treated with
topical diphencyprone (DPCP). Molecular studies implicate the thymus-derived TH17 lymphocyte subset in a remarkable immunotherapeutic regression. The authors performed RT-PCR of total RNA from paraffin-embedded tissue before and after treatment with DPCP. Before treatment with DPCP, the authors found elevated expression of IL17C/D/E/F; after treatment there was no detectable expression. Conversely, increased expression of PLZF/CD27 and CTLA4 was seen after treatment with no expression before treatment. No expression of IL17A/B, CD7, RORgT and FoxP3 were before or after treatment. Conclusions are limited to only the time samples were obtained. Remarkable regression of an in-transit metastatic melanoma treated with the immunomodulatory agent DPCP showed gain and loss of gene expression of the TH17 pathway. Further study of this pathway from NK to NK-T to TH17 and TH1 cells both with and without accessory or dendritic cells will improve understanding of contact sensitizers as topical immunomodulators
Ingenol mebutate is a diterpene ester derived from the plant Euphorbia peplus and is FDA approved for the topical treatment of actinic keratoses (AK). Shown to be efficacious with as little as a 3-day trial, this compound is being further tested for the topical treatment of other nonmelanoma skin cancers with promising preclinical data. In an effort to elucidate the molecular mechanism of this novel drug, Stahlhut et al.,(2012) suggest a role for calcium and apoptosis. Further studies are needed to evaluate the intracellular mechanisms of ingenol mebutate-mediated cytotoxicity. Additionally, studies such as this not only shed light on the mechanism of ingenol mebutate and its derivatives, but also pave the way for evaluating the involvement of the immune system in eliminating drug-treated cells and tissues. This has important implications
for the development of novel topical immune modulatory products and the field of topical immunotherapy.
J Drugs Dermatol. 2012;11(10):1156-1157.
Alan Menter MD,a Linda Stein Gold MD,b Michael Bukhalo MD,c Steven Grekin DO,d Steven Kempers MD,e Brent M. Boyce MD,f Cecilia Ganslandt MD, gJohn Villumsen MSc,h and Mark Lebwohl MDi
Background/Objectives: A combination topical suspension/gel containing calcipotriene plus betamethasone dipropionate has been developed as a safe and effective treatment for patients with psoriasis vulgaris of the scalp. This same preparation has the potential to be a convenient, effective, and cosmetically appealing formulation for psoriasis on the body. This trial evaluated the efficacy and safety of a topical suspension containing calcipotriene plus betamethasone dipropionate compared with its constituent components and topical suspension vehicle in the treatment of mild to moderate psoriasis on the trunk and limbs.
Methods: This was a randomized, double-blind, vehicle-controlled, 4-arm trial in 1,152 subjects. The co-primary efficacy end points were the proportion of subjects achieving controlled disease based on the Investigators' Global Assessment of disease severity at weeks 4 and 8. Adverse events, vital signs, and clinical laboratory measurements were also assessed.
Results: At week 4, a greater proportion of subjects in the calcipotriene plus betamethasone group achieved controlled disease compared with subjects in the calcipotriene-only and vehicle-only treatment groups. At week 8, a statistically significantly (P<.01) greater proportion of subjects in the calcipotriene plus betamethasone group achieved controlled disease compared with subjects in the 3 other treatment groups. Adverse events and other safety assessments were similar between the groups.
Conclusion: The topical suspension containing calcipotriene plus betamethasone dipropionate traditionally used for scalp psoriasis is also a safe and effective once-daily treatment for psoriasis vulgaris on the body.
J Drugs Dermatol. 2013;12(1):92-98.
Shaundre Terrell BS, Daniel Aires MD, Eric S. Schweiger MD
Background: Studies indicate photodynamic therapy is an effective treatment of infl ammatory acne lesions on patients with Fitzpatrick
skin types 1–3. There is a lack of evidence in the literature regarding the use of photodynamic therapy to treat acne vulgaris in
African American patients. This article reports the fi rst case of blue light photodynamic therapy to treat moderate infl ammatory facial
acne on an African American patient with type 5 skin.
Observations: This article describes a 26-year-old African American woman with moderate infl ammatory facial acne vulgaris. On
examination, she had over 15 infl ammatory papules on her face and post-infl ammatory hyperpigmentation. The patient had a history
of treatment failure with the following therapies: topical benzoyl peroxide, topical antibiotics, topical retinoids and oral antibiotics. At
presentation, the patient was using a combination topical benzoyl peroxide/clindamycin product in the morning and tazoratene gel in
the evening without success. The patient was treated with 20% aminolevulinic acid/blue-light photodynamic therapy spaced monthly
for a total of four treatments, a once-daily application of hydroquinone 4% cream and her existing topical regimen. The patient reported
signifi cant improvement of infl ammatory acne lesions and post-infl ammatory hyperpigmentation following two treatments
with photodynamic therapy and was virtually clear of all acne lesions after the third treatment.
Conclusion: Photodynamic therapy is an emerging remedy for patients with acne vulgaris resistant to standard treatment, particularly
in patients with skin of color who are more sensitive to post-infl ammatory hyperpigmentation. In this African-American patient,
20% aminolevulinic acid/blue-light photodynamic therapy was effective in treating facial acne vulgaris.
Christina Shwereb, Eve J Lowenstein MD PhD
Benzoyl peroxide (BP) has been a standard and effective topical treatment for acne vulgaris for the past 35 years. Previous studies
and case reports have documented benzoyl peroxide to be a strong irritant and a weak allergen, with many cases of tolerance induced
with repeat use of this irritant. While less common, numerous cases of BP-induced allergic contact dermatitis (delayed type hypersensitivity
reaction) have been reported in the literature. We report here an individual with an incipient edematous reaction to topical
BP used for acne therapy. This under-recognized presentation is discussed in the context of published literature on BP-induced
hypersensitivity and irritation.
Ulrike Blume-Peytavi MD,a Jerry Shapiro MD,b Andrew G. Messenger MD,c Maria K. Hordinsky MD,d Paul Zhang PhD,e Carlos Quiza MD,e Uday Doshi PhD,e and Elise A. Olsen MDf
BACKGROUND: A once-daily minoxidil topical foam (MTF) has been developed to treat female pattern hair loss.
OBJECTIVE: Determine noninferiority of once-daily 5% MTF versus twice-daily 2% minoxidil topical solution (MTS) based on the change from baseline in target area hair count (TAHC) at 24 weeks.
METHODS: In a randomized, phase III trial, women with female pattern hair loss received once-daily 5% MTF (n=161) or twice-daily 2% MTS (n=161) for 52 weeks. Primary endpoint was change from baseline in TAHC at 24 weeks. Secondary endpoint was change from baseline in TAHC at 12 weeks. Exploratory endpoints included change in total unit area density and change in overall scalp coverage.
RESULTS: Once-daily 5% MTF increased TAHC from baseline (adjusted mean ± standard error) by 23.9 ± 2.1 hairs/cm2 at week 24. Twice-daily 2% MTS increased TAHC 24.2 ± 2.1 hairs/cm2 at week 24. The treatment difference was –0.3 hairs/cm2 (95% CI = –6.0, 5.4). Since the lower bound of the 95% CI was less than –5.0, the prespecified noninferiority goal was not met. Both treatments were well tolerated.
CONCLUSIONS: Once-daily 5% MTF and twice-daily 2% MTS induced hair regrowth in female pattern hair loss, but prespecified noninferiority criteria were not met.
ClinicalTrials.gov identifier: NCT01145625
J Drugs Dermatol. 2016;15(7):883-889.
No abstract details for the moment.
Background: Impetigo is a highly contagious, superficial skin disease that is frequently seen in children. While data support the use
of topical antibiotics for treatment, the medications actually prescribed in practice are not well documented.
Objectives: To determine the prescribing pattern of dermatologists and nondermatologists when treating impetigo and the demographics
of the patients treated.
Methods: National Ambulatory Medical Care Survey data on office visits for impetigo were analyzed from 1997 to 2007. Patient
demographics and the treatments for impetigo were recorded.
Results: During this 10-year period, dermatologists managed an estimated 274,815 impetigo visits and nondermatologists an estimated
3,722,462 visits. Both dermatologists and nondermatologists most frequently prescribed oral antibiotics to treat impetigo.
Topical antibiotics were second most common, and a variety of combination treatments were used.
Conclusions: Oral antibiotics are the most common class of medications used to treat impetigo. There is an opportunity for physicians
to take advantage of the equally efficacious topical antibiotics for treating impetigo. A shift towards topical antibiotics would
likely decrease morbidity (resulting from adverse effects) associated with use of oral agents.
J Drugs Dermatol. 2012;11(4):489-494.
Tian-Hua Xu MD,a John ZS Chen MD,b Yuan-Hong Li MD,a Yan Wu MD,a Yao-Jia Luo MD,a Xing-Hua Gao MD,a Hong-Duo Chen MDa
Background: L−ascorbic acid has been widely used to treat photo-aged skin. However, its aqueous formula is prone to oxidation. Therefore, a new formula that contains 23.8% L−ascorbic acid and a chemical penetration enhancer was developed.
Objective: Observe the efficacy and safety of topical 23.8% L−ascorbic acid serum on photo-aged skin.
Methods: Twenty Chinese women with photo-aged skin were enrolled in this split-face study. They were treated with topical L−ascorbic acid serum with iontophoresis on one side of the face once a day for 2 weeks; the other side of the face was spared treatment through participants´ self-control. Changes in photo-aged skin were evaluated using a global evaluation, an overall self-assessment, a spectrophotometer, the phase-shift rapid in vivo measurement of skin (PRIMOS) 3D, and a corneometer.
Results: Sixteen of 20 patients (80%) experienced a score decrease of 2 or 3 grades, according to the dermatologist. Fifteen patients (75%) rated their overall satisfaction as excellent or good. Dyspigmentation, surface roughness, and fine lines on the treated side improved significantly.
Conclusion: Topical 23.8% L−ascorbic acid serum is effective for the treatment of photo-aged skin and does not cause any obvious side effects.
J Drugs Dermatol.2012;11(1):51-56.
Joshua Zeichner MDa and Sophie Seite PhDb
BACKGROUND: La Roche-Posay Thermal Spring Water (LRP-TSW) exhibits both probiotic and prebiotic properties enhancing the diversity of the skin microbiota.
METHODS: A review was undertaken to explore the role of LRP-TSW as a topical probiotic and prebiotic therapy in improving the diversity of the skin microbiota and reducing dryness and pruritus in inflammatory skin diseases.
RESULTS: The concentration of minerals and non-pathogenic microbes in LRP-TSW may explain its therapeutic benefit when used for inflammatory skin diseases. Clinical studies have shown that topical LRP-TSW treatment results in increases in Gram-negative bacteria with reduction of Gram-positive bacteria, and improvements in skin microbial diversity. At the same time skin condition in atopic dermatitis, psoriasis, and general dryness in otherwise healthy skin, has been shown to improve.
CONCLUSIONS: Enhancement of skin microbiota diversity using topical LRP-TSW may offer a valuable option for the treatment and maintenance of inflammatory skin diseases.
J Drugs Dermatol. 2018;17(6):657-662.
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Aditya K. Gupta MD PhD FRCPC FAADa,b and Radhakrishnan Pillai PhDc
BACKGROUND: Transungual nail penetrance has traditionally been considered to be the only route of delivery for topical antifungals in onychomycosis. Subungual penetrance may be an alternate route of delivery.
OBJECTIVE: To evaluate the ability of efinaconazole vehicle solution to reach the site of toenail onychomycosis through application to the hyponychium or hyponychium and dorsal nail surface, and assess the impact of the air gap between the nail plate and nail bed.
METHODS: Twenty-three participants with moderate to severe, mycologically-confirmed onychomycosis were enrolled (mean age, 48.5 years). Two separate applications of vehicle solution containing fluorescein for visualization were applied at the hyponychium or hyponychium
and dorsal nail surface. Affected nails were later clipped to allow examination of the nail bed and further examination of the ventral surface of the nail. Spread of formulation was assessed under visible and UV light conditions by photographing target toenails after vehicle application and after nail clipping.
RESULTS: There was a positive correlation between the size of the air gap and degree of affected nail involvement (R2=0.064). Assessments
under both visible and UV light indicated that the vehicle had spread to the site of infection, with deposition of fluorescein wherever vehicle had reached, irrespective of application methodology or size of air gap. Nail clippings also indicated absorption into the ventral surface of the nail plate.
LIMITATIONS: The relative contributions of subungual versus transungual application of drug to the nail plate to the efficacy of efinaconazole
topical solution, 10% in treating onychomycosis were not assessed.
CONCLUSIONS: This study suggests that the low surface tension vehicle developed for efinaconazole topical solution, 10% can reach the site of infection by application to the hyponychium, dorsal or ventral nail surface and nail folds. This multidirectional approach to drug delivery at the site of fungal infection may contribute to the magnitude of efficacy seen in clinical trials.
J Drugs Dermatol. 2015;14(8):859-863.
No abstract details for the moment.
Background: Current topical therapies for cold sores are only marginally beneficial due to poor skin penetration. We assessed the safety and efficacy of a novel topical antiviral nanoemulsion (NB-001) with high tissue bioavailability.
Objectives: The primary endpoint was the time to lesion healing.
Methods: 482 subjects with recurrent cold sores were randomized to self-initiate treatment with either vehicle or NB-001 (0.1%, 0.3% or 0.5%) at the first signs or symptoms of a cold sore episode. Lotion was applied 5 times per day, approximately 3 to 4 hours apart, for 4 days. Time to lesion healing was correlated with NB-001 bioavailability determined in human cadaver skin.
Results: Subjects treated with 0.3% NB-001 showed a 1.3-day improvement in the mean time to healing compared to vehicle (P=0.006). This was consistent with human cadaver skin data indicating that the 0.3% nanoemulsion had the highest bioavailability, compared to 0.1% and 0.5% emulsions. No significant safety or dermal irritation concerns or systemic absorption were noted with any of the doses.
Conclusions: Topical NB-001 (0.3%) was well tolerated and highly efficacious in shortening the time to healing of cold sores. The improvement in time to healing was similar to that reported for oral nucleoside analogues, but without systemic exposure. Topical agents for recurrent herpes labialis (cold sores) reduce healing time by one half day, compared to oral therapies that speed healing by a day or more. A topical antiviral nanoemulsion was well tolerated and improved cold sore healing time by over a day compared to vehicle control. Nanoemulsion (NB-001) could represent a more efficacious topical treatment for recurrent cold sores.
J Drugs Dermatol. 2012;11(8):970-977.
Michelle W. Cheng BS,a Amy Kehl MD,b Scott Worswick MD,a Carolyn Goh MDa
Alopecia areata is an autoimmune disease involving the hair follicle with a chronic, relapsing course. Tofacitinib is Janus kinase inhibitor approved for treatment of rheumatoid arthritis that has been shown to be effective in treatment of alopecia areata. We present a case series of 11 patients with severe alopecia areata on longstanding, regular to high dose oral tofacitinib with marked hair regrowth. Additionally, we present a case of moderate to severe alopecia areata successfully treated with topical tofacitinib cream.
J Drugs Dermatol. 2018;17(7):800-803.
Neal Bhatia MD,a Varsha Bhatt PhD,b Gina Martin MOT,b Radhakrishnan Pillai PhDb
Topical therapy of acne vulgaris (acne) is very common, however cutaneous tolerability can influence patient adherence, and concerns about skin irritation have lead to a number of comparative split-face studies. Advances in formulation technology have provided new fixed combinations with lower concentrations of potentially irritating ingredients without compromising efficacy. These developments now afford the opportunity to formulate fixed combinations with higher concentrations of active ingredients that may provide the greater efficacy needed in more severe disease with good tolerability.
Here, we compare the tolerability of two such developments, clindamycin-BP 3.75% gel and adapalene 0.3%-BP 2.5% gel, in healthy volunteers with no apparent facial redness or dryness over 21-days, using a split-face methodology.
Clindamycin-BP 3.75% gel was more tolerable than adapalene 0.3%-BP 2.5% gel over the duration of the two studies, with statistically significant differences in cumulative change from baseline starting as early as day 4 (stinging), day 5 (erythema, dryness, and scaling), day 6 (burning), and day 8 (itching); and in composite irritation index (stinging, erythema, dryness, scaling, burning, and itching) from day 4. Transepidermal water loss was less with clindamycin-BP 3.75% gel (statistically significant from day 8). Adverse events were twice as common with adapalene 0.3%-BP 2.5% gel.
These data suggest that clindamycin-BP 3.75% gel is likely to be better tolerated than adapalene 0.3%-BP 2.5% gel in moderate-to-severe acne.
J Drugs Dermatol. 2016;15(6):721-726.
Scott JM Lim DO, W Elliot Love MSIV
Lichen planus (LP) is a disease distinguished by pruitic violaceous planar papules containing reticulated white striae. It can occur
just about anywhere, but most commonly occurs in the mouth, genital, and distal extremity areas. The general treatment for LP consists
of topical or systemic steroids, although a standard accepted treatment is still to be determined. Pimecrolimus has generated
recognition as a topical non-steroidal drug labeled for treatment of atopic dermatitis. The proposed mechanism of action of pimecrolimus
is inhibition of cytokine production and proliferation. Cytokine obstruction results in the limitation of T-cell propagation,
which is the inciting factor in the pathological process of LP. This element may prove be advantageous in the treatment of LP.
William C. Ports DVM,a Steven R. Feldman MD PhD,b Pankaj Gupta PhD,a Huaming Tan PhD,a Theodore R. Johnson PhD,c and Robert Bissonnette MDd
Intra-subject, left-right, randomized, controlled study designs are often used for proof-of-concept studies in dermatology. This design was used to evaluate the safety and efficacy of a topical solution of tofacitinib (NCT00678561), a small-molecule Janus kinase inhibitor under investigation for the topical and oral treatment of patients with chronic plaque psoriasis. Eighty-one patients, each with matched left and right target plaques, were randomized to 2%, 0.2%, or 0.02% tofacitinib or vehicle solution once or twice daily. Patients treated one plaque as per their randomization group (2%, 0.2%, 0.02% tofacitinib, or vehicle solution), and used vehicle to treat the contralateral plaque for 4 weeks. Except during clinic visits, study drug applications were performed unsupervised outside the clinical trial site. Intra-subject, vehicle-adjusted mean percent change from baseline in Target Plaque Severity Score at week 4 (primary efficacy endpoint) was not significantly different from baseline for any treatment group (P values of 0.28–0.68). However, skin biopsy analyses detected tofacitinib in both tofacitinib- and vehicle-treated plaques of some patients, suggesting cross-contamination or solution misapplication.
Lack of efficacy with tofacitinib relative to vehicle may be due to the intra-subject study design with unsupervised applications.
These findings have potential implications for future intra-subject studies of topical treatments.
J Drugs Dermatol. 2015;14(8):777-784.
Lauren K. Hoffman BS,a Isabelle Raymond PhD,b and Leon Kircik MDa,c
BACKGROUND: Tinea pedis is the most common dermatophyte infection. Treatment is critical to alleviate pruritic symptoms, to reduce the risk for secondary bacterial infection, and to limit the spread of infection to other body sites or other individuals. The objective of this study was to compare the abilities of econazole nitrate topical foam, 1% and ketoconazole cream (2%) to reduce pruritus, thus improving quality of life, and to determine patient preference for the foam product versus the cream product in patients with interdigital tinea pedis.
STUDY DESIGN: A single-center, investigator-blinded, observational pilot study was conducted to compare econazole nitrate topical foam (1%) to ketoconazole cream (2%). In this split-body study, 20 subjects received both econazole nitrate topical foam and ketoconazole cream and applied the medications daily to either the right or left foot for 14 days. Improvements in patient quality of life (pruritus) and patient preference were measured using the pruritus visual analog scale (VAS), Skindex-16, and patient preference questionnaires.
RESULTS: Nineteen subjects completed the study and one subject was lost to follow-up. Reductions in VAS scores of econazole nitrate topical foam were significantly greater than those of ketoconazole cream, indicating the superiority of the econazole nitrate foam in reducing pruritus. Skindex-16 data showed significant reductions in total scores and individual domains, including patient symptom, emotional, and functional domains, by the final visit. Since each subject received both medications the questionnaire was not medication-specific. Responses to patient preference questionnaires showed that econazole nitrate topical foam,1% was rated as “good” or “excellent” in all measures assessed. One adverse event was noted.
CONCLUSION: In patients with interdigital tinea pedis, application of econazole nitrate topical foam 1% twice daily for two weeks was clinically effective and significantly superior to ketoconazole cream 2% in reducing pruritus.
J Drugs Dermatol. 2018;17(2):229-232.
Rahul C. Mehta PhD, Stacy R. Smith MD, Gary L. Grove PhD, Rosanne O. Ford BA, William Canﬁ eld, Lisa M. Donofrio MD, Timothy C. Flynn MD, James J. Leyden MD
A topical gel containing a proprietary mixture of over 110 growth factors, cytokines, and soluble matrix proteins secreted by human
dermal ﬁ broblasts was evaluated for safety and efﬁ cacy in the treatment of mild to severe facial photodamage. In a double-blind
study, 60 subjects were randomly assigned to receive either active gel or the vehicle and applied twice daily for 6 months along
with a moisturizing cleanser and sunscreen. Efﬁ cacy (proﬁ lometry, photography, and clinical assessment) and safety (adverse event
reporting) measures were evaluated at 0, 3, and 6 months. Treatment with the active gel for 3 months produced greater reduction
in ﬁ ne lines and wrinkles than the vehicle treatment as measured by objective and subjective assessment techniques. The results
were either statistically signiﬁ cant (P≤.05) or trending towards statistical signiﬁ cance (P≤.1). This study demonstrates that addition of
a topical formulation of growth factors and cytokines to a basic skin care regimen reduces the signs of photoaging.
Michael Kockaert, MD and Martino Neumann, MD, PhD
The rejuvenation of aging skin is a common desire for our patients, and several options are available. Although there are some systemic methods, the most commonly used treatments for rejuvenation of the skin are applied topically. The most frequently used topical drugs include retinoids, alpha hydroxy acids (AHAs), vitamin C, beta hydroxy acids, anti-oxidants, and tocopherol. Combination therapy is frequently used; particularly common is the combination of retinoids and AHAs1. Systemic therapies available include oral retinoids and vitamin C. Other available therapies such as chemical peels, face-lifts, collagen, and botulinum toxin injections are not discussed in this article.
Richard K. Scher MD,a Antonella Tosti MD,b Warren S. Joseph DPM,c Tracey C. Vlahovic DPM,d
Jesse Plasencia DPM,e Bryan C. Markinson DPM,f and David M. Pariser MDg
Onychomycosis prevalence is expected to rise as the population ages and the prevalence of diabetes, peripheral vascular disease, and other significant risk factors rise. Until recently, treatment options were limited due to safety concerns with oral antifungals and low efficacy with available topical agents. Efinaconzole and tavaborole were approved by the FDA in 2014 for onychomycosis treatment and provide additional effective topical treatment options for patients with mild-to-moderate disease. Dermatologists and podiatrists both regularly treat onychomycosis, yet there are striking differences between specialties in approach to diagnosis and treatment. In order to explore these differences a joint dermatology-podiatry roundtable of onychomycosis experts was convened. Although it has little effect on mycologic cure, debridement may be a valuable adjunct to oral or topical antifungal therapy, especially in patients with greater symptom burden. However, few dermatologists incorporate debridement into their treatment plans and referral to podiatry may be appropriate for some of these patients. Furthermore, podiatrists may be better equipped to manage patients with concurrent diabetes or peripheral vascular disease and elderly patients who are unable to maintain proper foot hygiene. Once cure is achieved, lifestyle and hygiene practices, maintenance/prophylactic onychomycosis treatment, and proactive tinea pedis treatment in patients and family members may help to maintain patients’ cured status.
J Drugs Dermatol. 2015;14(9):1016-1021.
Joshua W. Hagen MD PhDa and William R. Levis MDb
No abstract details for the moment.
No abstract details for the moment.
Jerry Bagel MD FAAD,1 Eugenia Levi, PharmD BCPS,2 Stephen Tyring MD PhD FAAD,3
and Melissa L.F. Knuckles MD FAAD4
BACKGROUND: Treatment with calcipotriene plus betamethasone dipropionate (CBD) fixed-combination topical suspension has been shown to be effective and well tolerated in patients with psoriasis vulgaris.
AIM: To document experiences with CBD topical suspension in a US clinical dermatology setting using patient-reported outcomes (PROs).
METHODS: In total, 147 patients were enrolled in this 8-week, prospective, noninterventional, multicenter, one-arm study. Data were collected at baseline and week 8 at the office, and at one time at home (week 2). PROs were assessed using the Dermatology Life Quality Index (DLQI), Patient’s Global Assessment of disease severity (PtGA) using a 5-point Likert scale, patient-reported level of itching using a 0–100 graduated visual analog scale, and Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9). Treatment adherence and adverse events (AEs) were assessed at week 8.
RESULTS: After 8 weeks of treatment, DLQI score significantly improved compared with baseline (–5.5 ± 5.93; P<.0001), starting as early as week 2 (–4.2 ± 5.28; P<.0001). The level of itching was significantly reduced from baseline to week 2 (–19% ± 25.94%; P<.0001) and week 8 (–28.6% ± 29.14%; P<.0001). The percentage of patients with “controlled disease” (PtGA score of “clear” or “very mild”) was 34.1% at week 2 and 60.2% at week 8. At the end of treatment, mean TSQM-9 scores for effectiveness, convenience, and satisfaction domains ranged from 68 to 74. Patients reported the need to use CBD topical suspension for an average of 53.62 ± 8.05 days. Treatment-emergent AEs occurred in 3 patients.
CONCLUSION: The results of this noninterventional study are consistent with previously reported data from interventional trials and suggest that treatment with CBD topical suspension is efficacious and well tolerated and improves quality of life in patients with psoriasis vulgaris.
J Drugs Dermatol. 2014;13(11):1374-1379.
Anne K. Miller BS, Reginald Dusing MD, Aaron Meggison MD, Daniel Aires MD
The prognosis for metastatic melanoma is grim, and treatment options are limited. Imiquimod is a topically applied immunemodulatorthat has been used to treat superficial cutaneous melanoma, but has not been reported to treat metastatic melanoma. We report a patient whose liver and iliac fossa melanoma metastases regressed after topical application of imiquimod cream to overlying skin. This supports further investigation of the potential use of imiquimod for metastatic melanoma.
J Drugs Dermatol. 2011;10(3):302-305.
Linda F. Stein Gold MD,a Tracey Vlahovic DPM,b Amit Verma DrPH,c Babajide Olayinka MSc,c
Alan B. Fleischer Jr. MDc
BACKGROUND: Naftifine hydrochloride (naftifine) is a topical antifungal of the allylamine class, displaying fungicidal and fungistatic activity. Naftifine is generally used to treat interdigital tinea pedis; however, systemic therapy is often prescribed by healthcare providers for moccasin tinea pedis. Well-controlled clinical data on topical antifungal therapy for moccasin tinea pedis is limited.
OBJECTIVE: The objective of this analysis is to present data from two pooled randomized, vehicle-controlled studies that evaluated efficacy of once daily topical naftifine gel 2% and vehicle at end of treatment (week 2) and at 4 weeks post-treatment in subjects with moccasin tinea pedis.
METHODS: At visit 1, subjects were randomized to naftifine gel 2% or vehicle groups and subjects underwent baseline mycology culture, KOH, and symptom (erythema, scaling, and pruritus) severity grading. Naftifine gel 2% and vehicle treatment were applied once daily for 2 weeks and the subjects returned at weeks 2 and 6 for efficacy evaluation (mycology culture and grading of symptom severity). A total of 1174 subjects were enrolled with interdigital tinea pedis with or without moccasin infection. Of these subjects, 674 subjects had interdigital presentation while 500 subjects had moccasin infection in addition to the interdigital presentation. All 1174 subjects with interdigital presentation satisfied the inclusion criteria of a minimum of moderate erythema and scaling, and mild pruritus. Of the 500 subjects who had moccasin presentation, 380 satisfied the same inclusion criteria as mentioned above. Since data was analyzed as observed cases, between 337 and 349 subjects had data available for analysis of efficacy. Mycologic cure is defined as a negative dermatophyte culture and KOH, treatment effectiveness is defined as mycologic cure and symptom severity scores of 0 or 1, and complete cure is defined as mycologic cure and symptoms severity scores of 0.
RESULTS: At week 6, the cure rates in the naftifine arm vs. the vehicle were statistically higher (P<0.0001) for mycological cure rate (65.8% vs. 7.8%), treatment effectiveness (51.4% vs 4.4%), and complete cure rate (19.2% vs 0.9%).
CONCLUSION: Two weeks application of topical naftifine gel 2% is an effective monotherapy treatment for moccasin tinea pedis.
J Drugs Dermatol. 2015;14(10):1138-1144.
During the last 10 to 15 years, complementary and alternative medicine (CAM) has become increasingly popular in the
US. Within this realm of health care, oral and topical herbal supplements have become some of the most frequently used
alternative therapies. Most herbal supplements are based on, or include, several botanical ingredients with long histories
of traditional or folk medicine usage. Among the numerous botanical ingredients available on the market today, several
are believed to confer dermatologic benefits. This article will focus on a select group of botanical compounds, many of
which have long traditions in Asian medicine, with potential or exhibited dermatologic applications, including curcumin,
Ginkgo biloba, ginseng, silymarin, soy, and tea tree oil. Other botanical agents, such as arnica, bromelain, chamomile, pomegranate,
caffeine, green tea, licorice, and resveratrol, are also briefly considered. Some of these ingredients have been incorporated
into topical formulations.
Brad A. Yentzer MD, Fabian T. Camacho MS, Trudye Young MD, Julie M. Fountain CCRC,Adele R. Clark PA-C, Steven R. Feldman MD PhD
Background: Patients with atopic dermatitis (AD) may have poor adherence for several reasons, including fear of side effects or
dislike of messy topical therapies.
Purpose: To assess adherence to and efficacy of a multifaceted program for atopic dermatitis using a lightweight, easy-to-apply
medication and more frequent return visits.
Methods: Forty-one subjects with mild-to-moderate atopic dermatitis were instructed to use desonide hydrogel 0.05% twice daily.
Disease severity was measured at baseline and weeks 1, 2 and 4. Subjects also received a follow-up phone call on day 3. Adherence
was assessed using electronic monitors. At the end of the study, subjects sampled and rated the vehicle attributes of six different
topical corticosteroid formulations.
Results: Mean adherence to twice-daily application slowly declined over time, from 81% on day 1 to 50% by day 27. An improvement
in pruritus was observed as early as day 3, and by week 4, mean pruritus and EASI scores improved from baseline by 60% and
61%, respectively. Mean SGA scores also improved to marked improvement/almost clear by week 4. In vehicle attribute surveys,
the hydrogel was consistently rated higher than the other vehicles in all categories.
Conclusion: Subjects responded very well to treatment, and adherence to desonide hydrogel 0.05% was much better than previously
reported with ointments. The early efficacy, favorable attributes of the hydrogel vehicle and judicious follow up likely increased
adherence to topical therapy. The use of ointments or more potent topical steroids as a first choice may be counterproductive in the
treatment of atopic dermatitis.
Stanley S. Shapiro PhD,a Miri Seiberg PhD,b and Curtis A. Cole PhDc
The 1925 classical observation that vitamin A deficiency leads to squamous metaplasia and epithelial keratinization, coupled with the later finding that excess vitamin A inhibits keratinization of chick embryo skin, set the foundation for the potential therapeutic use of retinoids in cutaneous conditions of keratinization. Significant progress has since been made understanding the molecular biology, biochemistry, pharmacology, and toxicology of vitamin A and its derivatives, collectively named retinoids. Natural and synthetic retinoids are now routinely used to treat acne, psoriasis, skin keratinization disorders, and photodamage. Retinoids also inhibit tumor formation and skin cancer development in experimental systems and in humans. Retinol and retinyl palmitate (RP) are found in cosmetic products and in foods and dietary supplements, which are all considered safe, by inclusion in the Generally Recognized as Safe Substances Database. However, the safety of topical retinoids was questioned in one publication and in a recent National Toxicology Program report of RP-containing topical preparations, suggesting the possible earlier onset of ultraviolet-induced squamous cell carcinomas in the hairless mouse photocarcinogenesis model. This suggestion contradicts a large body of data indicating that topical retinoids are chemoprotective in humans, and it was immediately challenged by new reviews on the safety of RP in general and within sunscreens. This paper will review the preclinical and clinical data supporting the safety and chemopreventive activity of retinoids, with an emphasis on RP, and will examine the experimental systems used to evaluate the safety of topical vitamin A preparations in order to provide perspective relative to human skin.
J Drugs Dermatol. 2013;12(4):458-463.
Jill S. Waibel MD,a Ashley Rudnick,a Carlos Nousari MD,b and Dhaval G. Bhanusali MDc
BACKGROUND: Topical drug delivery is the foundation of all dermatological therapy. Laser-assisted drug delivery
(LAD) using fractional ablative laser is an evolving modality that may allow for a greater precise depth of penetration
by existing topical medications, as well as more efficient transcutaneous delivery of large drug molecules. Additional
studies need to be performed using energy-driven methods that may enhance drug delivery in a synergistic manner. Processes such as iontophoresis, electroporation, sonophoresis, and the use of photomechanical waves aid in penetration. This study evaluated in vivo if there is increased efficacy of fractional CO2 ablative laser with immediate acoustic pressure wave device.
METHODS: Five patients were treated and biopsied at 4 treatment sites: 1) topically applied aminolevulinic acid (ALA) alone; 2) fractional ablative CO2 laser and topical ALA alone; 3) fractional ablative CO2 laser and transdermal acoustic pressure wave device delivery system; and 4) topical ALA with transdermal delivery system. The comparison of the difference in the magnitude
of diffusion with both lateral spread of ALA and depth diffusion of ALA was measured by fluorescence microscopy.
RESULTS: For fractional ablative CO2 laser, ALA, and transdermal acoustic pressure wave device, the protoporphyrin
IX lateral fluorescence was 0.024 mm on average vs 0.0084 mm for fractional ablative CO2 laser
and ALA alone. The diffusion for the acoustic pressure wave device was an order of magnitude greater.
CONCLUSION: We found that our combined approach of fractional ablative CO2 laser paired with the transdermal acoustic pressure wave device increased the depth of penetration of ALA.
J Drugs Dermatol. 2016;15(1):14-21.
Lisa H. Lam PharmDa and Jeffrey L. Sugarman MD PhDb
BACKGROUND: Topical corticosteroids (TCS) are typically used for extended periods of time for chronic skin conditions, including psoriasis. Chronic TCS use may result in side effects similar to those of systemic corticosteroids. Patients may have subclinical adrenal suppression and be unaware of their risk in the case of serious trauma.
OBJECTIVE: The objective of this study was to investigate the real world effects of chronic TCS use and its effects on adrenal suppression in a chronic disease such as psoriasis.
MATERIALS: This retrospective study utilized data from screening visits of a psoriasis clinical trial in which subjects had been on chronic TCS.
RESULTS: In this study, subjects with moderate to severe psoriasis affecting 16-20% of total body surface area (BSA) and using high-potency TCS at screening had a lower post-cosyntropin cortisol level (18.83 mcg/dL) compared to those with moderate psoriasis involving 10-15% of total BSA and using lower potency TCS at screening (23.22 mcg/dL; P=0.03). Both subject groups had lower post-cosyntropin cortisol levels compared to normal, healthy adults (P<0.001 for both).
CONCLUSION: This suggests that real world chronic use of high potency TCS over a larger BSA may result in silent adrenal suppression.
J Drugs Dermatol. 2016;15(8):945-948.
Yaxian Zhen MD PhD, Marianne Stoudemayer RN, George Vamvakias, Albert M. Kligman MD PhD
Topical therapies are effective in managing acne vulgaris but are associated with local adverse effects such as irritation
and dryness. This 4-week pilot study compared skin hydration in 36 healthy adult women randomized to treatment with
1 of 4 topical therapies: 2 different (jar and tube) clindamycin 1%/benzoyl peroxide 5% gels, sodium sulfacetamide 10%
lotion, or over-the-counter (OTC) moisturizing cream. Subjects treated with OTC moisturizer or sodium sulfacetamide
exhibited decreased water loss, increased water retention, similar or improved levels of skin hydration, and decreased desorption
rates. In contrast, subjects treated with jar or tube clindamycin/benzoyl peroxide had increased water loss, decreased
water retention, decreased hydration, and increased desorption rates. Skin dryness decreased slightly in the moisturizer
group. No serious adverse events occurred. Overall, the OTC moisturizer had the best skin hydration profile. Sodium sulfacetamide
demonstrated some moisturizing characteristics, and no clinically relevant differences were noted between jar
and tube clindamycin/benzoyl peroxide gels.
Galina Shistik MD, Amy V. Prakash MD, Neil A. Fenske MD, L. Frank Glass MD
We report a case of an 83-year-old female with locally metastatic melanoma treated with imiquimod and tazarotene. The
patient originally presented to our dermatology clinic with local metastases of malignant melanoma after having undergone
multiple surgical procedures and adjuvant radiation therapy for disease recurrence. At this juncture, she refused further
surgical management but was interested in topical therapy. A 4-week course of topical imiquimod therapy was initiated.
As no clinical response was noted at the end of the treatment period, tazarotene cream was introduced. The patient experienced
complete clinical clearance of the treated area after a 6-week course of combination imiquimod and tazarotene
therapy. The rationale for using both medications will be discussed.
James Q. Del Rosso DO FAOCDa and Leon H. Kircik MDb
Topical corticosteroids (TCSs) are a major part of the foundation of treatment for a wide variety of eczematous and inflammatory skin
disorders in both adults and children. Mid-potency TCSs represent an important category as they are often used to treat eczematous
dermatoses, such as atopic dermatitis. The TCS product must effectively release the active ingredient and promote cutaneous
penetration so that therapeutic activity can occur. As many topical products eventually become available as generic formulations, it
is important to recognize that although the active ingredient and its concentration are the same, the vehicle excipients may differ
significantly, occasionally leading to potential differences in irritancy, in allergenicity, in effects on epidermal permeability barrier
function, and, possibly, in efficacy. Clocortolone pivalate 0.1% cream is a mid-potency TCS formulated in an emollient formulation
that has been shown to be effective and well-tolerated in the management of several corticosteroid-responsive dermatoses. This
article outlines the pharmacologic and clinical data achieved with the original brand formulation of clocortolone pivalate 0.1% cream,
and discusses the establishment of an authorized generic formulation that is identical in formulation to the original brand.
J Drugs Dermatol. 2014;13(suppl 7):s77-s83.
Rachel Seidel BAa and Ronald L. Moy MD FAADa,b
BACKGROUND: Under-eye bags are a common manifestation of age and a frequent complaint among patients who no longer feel youthful.
Non-invasive topical agents are largely ineffective at reducing their appearance.
OBJECTIVE: We studied the ability of a topical serum containing epidermal growth factor (EGF) to minimize the appearance of
METHODS: A single-center clinical trial was performed on eighteen volunteer male and female patients with under-eye bags. Subjects
applied EGF serum to the infraorbital area twice daily for 12 weeks. At each visit, subjects were evaluated using clinical photography
and written self-assessment. A grade on the Merz Infraorbital Hollowness Scale was also given and two independent, blind investigators
assigned an Investigator’s Global Assessment (IGA) score. At the trial’s end, patients shared their final evaluation and perception
of results with a questionnaire.
RESULTS: Sixteen subjects completed the trial. The final average Merz grade was 1.63 (SEM = .273), statistically significantly lower
than the mean baseline average of 2.06 (SEM = .232) (P = .0019). A reduction in average IGA score was also significant (P < .0001).
Average initial IGA was 2.75 (SEM = .270) and average final IGA was 2.00 (SEM = .310). All but two subjects reported improvement
at the final visit. Improvement was quantified as 76-100% by two subjects, 50-75% by three subjects, and 25-49% by nine subjects.
Eleven subjects classified their under-eye bags as milder at the end of the trial compared to the first visit. Seven subjects reported
greater satisfaction with their overall facial appearance. Of the subjects who had used other topical treatments in the past, two
reported the serum to be “significantly better” and four said it was “better” in treating their under-eye bags.
CONCLUSION: Our results offer evidence that topical EGF can reduce the appearance of under-eye bags.
J Drugs Dermatol. 2015;14(4):405-410.
Frank Martiniuk PhD, David S. Lee MD, Anthony Gaspari MD, Herman Yee MD PhD, Luis Chiriboga PhD, Maryann Huie PhD, Kam-Meng Tchou-Wong PhD, and William R. Levis MD
Contact sensitizers are a major cause of inflammatory skin disease and as topical immunomodulators also have the potential for treat-
ing cancer, viral diseases and certain autoimmune disorders. In the present study, the authors identify the upregulation of the TH17
lymphocyte subset transcription factor retinoid orphan receptor gamma T (RORγT) and the CD70 costimulatory pathway in human
contact sensitivity (CS) using molecular techniques. Identification of this important new subset of T lymphocytes and a recognized
costimulatory pathway offers potential for ameliorating CS and insight into antitumor and antiviral mechanism of haptens as topical
Raza Aly PhD,a† Tate Winter PhD,b† Steve Hall PharmD,b Tracey Vlahovic DPMc
Dermatophytoma is a little-known, difficult to treat fungal infection that complicates onychomycosis. First described by Roberts and Evans in the late 1990’s, dermatophytoma presents as a dense concentration of fungal hyphae within or under the nail plate and is generally white or yellow/brown in color, and linear (streaks) or round (patches) in shape; primary etiologic organisms are dermatophytes. Oral antifungals have limited success in treating dermatophytoma owing to difficulties accessing and penetrating what is hypothesized to be a fungal biofilm. In this respect, dermatophytoma is generally treated with a combination therapy approach, often including both surgical and pharmacologic intervention for improved outcomes. A post-hoc assessment of Phase II tavaborole onychomycosis studies was conducted in order to assess the prevalence of dermatophytoma and outcomes in patients treated with topical tavaborole. Of the 366 subjects enrolled in the Phase II onychomycosis studies, we identified 102 cases of dermatophytoma; 21 of 86 (24.4%) subjects treated with tavaborole were able to achieve complete resolution of dermatophytoma by day 180, while no subjects on vehicle obtained resolution. Similarly, 23 of 86 subjects (26.7%) treated with tavaborole solution had complete resolution of dermatophytoma by day 360, while only 1 of 16 subjects (6.3%) on vehicle obtained resolution. Moreover, 13 of 19 subjects (68.4%) treated with tavaborole solution were able to sustain resolution, while only 6 of 19 (31.6%) had reoccurrence, of dermatophytoma during the 180-day washout period (day 360). We present 5 cases of dermatophytoma identified in Phase II trials that responded in a positive manner following treatment with tavaborole solution for onychomycosis of the great toenail. Although not representative of all subject outcomes, these findings provide insight into the use of topical tavaborole for dermatophytoma, a condition previously thought to respond only to oral or combination therapy.
J Drugs Dermatol. 2018;17(3):347-354.
Objective: This clinical study assessed the safety and efficacy of an investigational topical product for the treatment of onychomycosis (nail fungus).
Method: A prospective, multi-center, single-arm, self-controlled clinical investigation was done with adult subjects that met the inclusion criteria, primarily culture-confirmed dermatophyte infection of at least one great toe. Subjects self-treated in a weekly regimen of topical application for six months, with clinical assessment at one, three, and six months. Primary efficacy endpoint was clearance of fungal nail infection after six months of weekly treatment. Primary safety endpoint was freedom from product-related adverse events for the duration of the treatment term.
Results: Fifty males and 13 females, ages 24 to 65, infected with Trichophyton (n=62) or Epidermophyton (n=1) were enrolled; 53 completed six months of assessment. Sixty percent showed improvement in clinical parameters (nail color, nail plate involvement, onycholysis, thickness, and hyperkeratosis) at six months. Cumulative rates of dermatophyte-negative culture results (test of cure) were 28, 36, and 62 percent of subjects after one, three, and six months of treatment, respectively. Three minor adverse events were device-related, with no unanticipated or serious adverse events.
Limitations: This study was single-arm and self-controlled; 53 of 63 enrolled subjects completed the study.
Conclusion: This study describes a new topical medical device with safety and efficacy profiles that compare favorably to results reported for topically applied onychomycosis drug treatments.
J Drugs Dermatol. 2011;10(10):1186-1191.
Zoe Diana Draelos MD,a Linda F. Stein Gold MD,b Dedee F. Murrell MD,c Matilda H. Hughes CCRA,d and Lee T. Zane MDd
BACKGROUND: Two post hoc analyses assessed the antipruritic activity of crisaborole topical ointment, 2% (crisaborole; Anacor Pharmaceuticals,
Inc., Palo Alto, CA), a first-in-class boron-based phosphodiesterase-4 inhibitor in development for treatment of mild to moderate atopic dermatitis (AD).
METHODS: Two pooled analyses included data from 4 studies evaluating crisaborole in AD (study 1, phase 1b, systemic exposure, safety, and pharmacokinetics [PK] under maximal-use conditions in children and adolescents; study 2, phase 2a, safety and PK in adolescents;
study 3, phase 2a, efficacy and safety in adults; study 4, phase 2, efficacy and safety in adolescents). Pooled data from studies 1 and 2 included whole body assessments; studies 3 and 4 included target lesion assessments. Pruritus severity was evaluated using a 4-point rating scale (0=none to 3=severe). Efficacy assessments included percent change from baseline in pruritus severity scores at days 8 (first pooled assessment), 15, 22, and 29 (whole body assessments) or days 15 (first pooled assessment), 22, and 29 (target lesions). Paired t-tests comparing change from baseline against zero were used to calculate P values. Categorical shifts in pruritus severity were also assessed (no to mild pruritus, 0–1.5; moderate to severe pruritus, 2–3).
RESULTS: In the pooled analysis of studies 1 and 2 (N=57), the percent change from baseline in pruritus severity scores were 63.0% and 64.9% at days 8 and 29, respectively (P<0.001 for each). Similar results were observed in the pooled analysis of studies 3 and 4 (N=67). In both analyses, most patients had mild to no pruritus from the first time point assessed through the remainder of treatment.
CONCLUSIONS: Treatment with crisaborole topical ointment, 2% resulted in statistically significant reductions in pruritus severity at the first time point evaluated in both analyses. These findings provide preliminary evidence of the antipruritic activity of crisaborole topical ointment, 2%.
J Drugs Dermatol. 2016;15(2):172-176.
Jamie Rosen BA, Angelo Landriscina BA, and Adam J. Friedman MD
No abstract details for the moment.
Macrene Alexiades-Armenakas MD PhD
No abstract details for the moment.
No abstract details for the moment.
Leon H. Kircik MD FAAD
Combination therapy has become the standard for the management of acne, particularly for moderate-to-severe cases. Among these
combinations, those regimens containing benzoyl peroxide (BPO), clindamycin and a retinoid have been used frequently as they address
most aspects of acne pathogenesis. This study compares the effi cacy and safety of two common topical treatment regimens
in the treatment of a moderate to severe facial acne vulgaris: fi xed-combination gel containing BPO 5% and clindamycin 1% (BPO/C)
plus tretinoin microsphere gel 0.04% (RAM) versus a regimen of a fi xed-combination gel containing clindamycin phosphate 1.2%
and tretinoin 0.025% (CPT) plus a once-daily BPO 5% wash. While both regimens were safe and effective, regimen BPO/C+RAM
yielded a more rapid onset of effect versus regimen CPT+BPO against both non-infl ammatory and infl ammatory lesions. Both treatment
regimens were well-tolerated.
Caroline B. Costa-Orlandi PhD,a,b,* Breanne Mordorski BA,c,* Ludmila M. Baltazar PhD,b Maria José S. Mendes-Giannini PhD,a Joel M. Friedman MD PhD,d Joshua D. Nosanchuk MD,b Adam J. Friedman MDc,d,e
Topical antimicrobials are the ideal mode of onychomycosis treatment for efficient drug delivery and avoidance of sytemic effects associated with oral medications. However, high treatment costs, tissue penetration limitations, and low cure rates have continued to pose major challenges. To capitalize on the progress made by topical efinaconazole solution, efinaconazole was combined with inexpensive,
previously-characterized nitric oxide releasing nanoparticles (NO-np), which have been shown to offer sustained nitric oxide release over time and enhanced barrier penetration, while exerting broad spectrum antimicrobial and immunomodulating properties. NO-np were combined with efinaconazole in varying concentrations and applied against reference strains of Trichophyton rubrum using
a checkerboard method. Results demonstrated synergism of NO-np+efinaconazole against T. rubrum, which is noteworthy given the barriers present in the topical treatment of onychomycosis, and the multiple potential benefits offered by NO-np. Overall, this study illustrates the untapped potential of nanotechnology in the treatment of disorders of the skin, hair, and nails where drug delivery remains
J Drugs Dermatol. 2018;17(7):717-720.
Erin Lowe MSIVa and Scott Lim DOb
In 2013 brimonidine tartrate gel 0.33% (Mirvaso Gel, Galderma Laboratories, LP, Fort Worth, TX) was approved by the US Food and Drug Administration for the treatment of facial erythema of rosacea. It is the first and only drug on the market to address the hallmark redness of this chronic, inflammatory disease. Commonly reported adverse events include erythema/flushing worse than at baseline, most often occurring with the first application. We report a unique case of facial erythema of rosacea that responded to brimonidine gel with effective blanching for two years until the patient developed a paradoxical erythema reaction. This is an adverse reaction physicians should be aware of with continued prescription of brimonidine gel for their rosacea patients.
J Drugs Dermatol. 2016;15(6):763-765.
Hema Sundaram MD,a Nicolas Mackiewicz PhD,b Emeline Burton MSc,b Laurent Peno-Mazzarino BSc,c Elian Lati PhD,c and Stéphane Meunier PhDb
BACKGROUND: Hyaluronic acid (HA) is a popular ingredient in topical formulations for cosmetic improvement of the skin. Most formulations
contain linear, non-crosslinked HA oligomers, low molecular weight (LMW) HA, and/or high molecular weight (HMW) HA. Crosslinking
of HA enhances its clinical longevity and mechanical characteristics. The objective of this study was to characterize the topical effects of a new, crosslinked resilient HA (RHA) that is also available as a cohesive, tissue-integrating injectable filler, compared with non-crosslinked HMW HA and LMW HA. Living human skin explants that preserve the 3-dimensional structure of in vivo skin were used to maximize clinical relevance.
METHODS: Standardized doses of each HA product were applied daily for 9 days to human skin explant surfaces. Untreated explants served as controls. Water content of the stratum corneum and entire epidermis was analyzed by Raman spectroscopy. Transepidermal water loss (TEWL) was measured to assess skin barrier function. Explant morphology and microrelief were evaluated by optical and scanning electron microscopy.
RESULTS: Crosslinked RHA achieved a significant increase in epidermal water content (7.6%) over the control. Spectral cartography confirmed a higher epidermal water content with RHA than with HMW HA or LMW HA. TEWL was reduced by 27.8% with RHA, and by 15.6% with HMW HA, but increased by 55.5% with LMW HA. Cutaneous microrelief improved with RHA. Corneocyte cohesion improved with RHA and HMW HA.
CONCLUSIONS: This comparative, multimodal study demonstrated greater benefits of topical crosslinked RHA over linear HMW HA or LMW HA in reducing TEWL, retaining and redistributing water within the epidermis, maintaining skin integrity, and improving skin barrier
structure and function. RHA was a more efficacious humectant than LMW HA, and a more efficacious occlusive moisturizer than HMW HA. These integrative epidermal repair activities are of significant value for addressing primary deficits of aging skin, improving tolerance to retinoids and other topical agents, and optimizing procedural outcomes. A combination of topical and injectable HA provides
an elegant model of synergistic, multi-level skin restoration.
J Drugs Dermatol. 2016;15(4):434-441.
Scalp lesions are common among patients with psoriasis, seborrheic dermatitis and a number of other inflammatory and fungal conditions.
Topical corticosteroids are a mainstay of treatment for many scalp dermatoses and they significantly reduce erythema, scaling
and pruritus. Conventional corticosteroid formulations such as cream and ointments are often difficult or time consuming for patients
to apply and may produce undesirable cosmetic effects. Medicated shampoos provide a more convenient alternative for patients
who require topical administration of corticosteroids for scalp conditions. Tar shampoos have long been used to treat psoriasis and
are effective for the long-term maintenance of remission in patients who respond to therapy. Antifungal shampoos are effective
for the treatment of seborrheic dermatitis and other mycotic conditions. A shampoo formulation containing fluocinolone acetonide,
0.01% is also approved for the treatment of seborrheic dermatitis. One superpotent corticosteroid shampoo (clobetasol propionate
0.05%; Clobex® Shampoo) is approved in the United States (U.S.) for once-daily treatment of psoriasis of the scalp. The results of a
2007 pilot study also demonstrated that clobetasol propionate shampoo improved the signs and symptoms of seborrheic dermatitis.
These findings suggest that high-potency corticosteroid shampoos may provide an important option for topical corticosteroid therapy
in dermatologic conditions affecting the scalp
Steven R. Feldman MD PhD
Psoriasis is a common, frustrating problem for dermatologists and patients. Long-held notions about the need to use thick, greasy
corticosteroid ointments for psoriasis contributed to frustration for many patients. Fortunately, the general approach to managing
psoriasis is changing. The purpose of this article is to describe key components of psoriasis management with a focus on the
changing paradigm for treating the disease. In addition to making the right diagnosis and prescribing the right treatment, key
elements of psoriasis management include establishing a strong physician-patient relationship, educating patients about the disease
and recognizing the importance of adherence to topical treatment. In light of the tendency toward poor adherence, use of a fastacting
agent in a vehicle that patients are willing to use is critically important for successful disease management.
John R. Griffin MD and Mark D.P. Davis MD
Frequent causes of morbidity secondary to herpes zoster include acute pain, secondary infection, and postherpetic neuralgia. A
less documented complication is pruritus, which can be either acute or postinfectious when it persists more than 3 months after
the rash has healed. We discuss a case of severe, acute neuropathic pruritus and pain secondary to active herpes zoster that
was unresponsive to standard medical therapy, including oral antihistamines, topical lidocaine, oral gabapentin, and local wound
care. Modest control of the pruritus and pain was achieved with continued multimodal therapy and the addition of topical 2%
amitriptyline/0.5% ketamine gel.
J Drugs Dermatol. 2015;14(2):115-118.
Although there are few differences in the incidence and pathophysiology of acne across various races and ethnicities, there is some evidence that black patients may have larger sebaceous glands and increased sebum production. Of greater clinical relevance, patients with darker skin types are at increased risk for the development of post-inflammatory hyperpigmentation (PIH), which some
find as or more troubling than acne itself. This common and bothersome sequelum of acne can be difficult to manage in this population. Topical azelaic acid gel is recognized to have anti-tyrosinase activity, suggesting it may be a suitable treatment option for mild-to-moderate acne with associated moderate-to-severe PIH. This pilot study demonstrates the efficacy of topical AzA gel 15% when
applied twice daily for the reduction of both acne and PIH.
J Drugs Dermatol. 2011;10(6):586-590.
Gerald G. Krueger MD, Lawrence Eichenfield MD, J. John Goodman MD, Bernice R. Krafchik MD, Christopher S. Carlin MD, Mei-Lin Pang MD, Richard Croy MA, Mary Elizabeth Holum MS, Eileen Jaracz PharmD, Taiji Sawamoto PhD, James Keirns PhD
Objective: To characterize the pharmacokinetics of tacrolimus after topical application in adult and pediatric patients
with moderate to severe atopic dermatitis from all clinical trials in which tacrolimus blood levels were obtained.
Methods: Tacrolimus ointment 0.03% or 0.1% was applied twice daily. In the adult and pediatric pharmacokinetic studies,
serial blood samples were obtained after single and repeated topical application. During the 12 clinical efficacy trials
of tacrolimus ointment, single blood samples were obtained at various times relative to tacrolimus ointment
Results: In the pharmacokinetic studies, 89% to 95% of tacrolimus whole blood concentration samples were less than
1 ng/mL; mean maximum concentrations ranged from 0.2 to 1.6 ng/mL and mean area under the blood concentrationtime
curves (0-12 hours) ranged from 1.4 to 13.1 ng·hr/mL. Likewise, in the clinical efficacy trials, the majority (85%-
99%) of tacrolimus concentration samples were less than 1 ng/mL.
Conclusions: Tacrolimus ointment is associated with minimal systemic absorption and no evidence of systemic accumulation
in patients with moderate to severe atopic dermatitis and extensive disease.
Jordan B. Slutsky MD, Richard A. F. Clark MD, Alexander A. Remedios MD, Peter A. Klein MD
Background: There is a long history of using topical coal tar for the treatment of psoriasis and atopic dermatitis (AD).
Objective: To review the literature on coal tar and its derivatives, without the use of ultraviolet light, for the treatment of psoriasis
Methods: MEDLINE/PubMed and Cochrane Database of Systematic Reviews literature searches were performed to identify randomized
controlled trials and clinical trials of topical coal tar for the treatment of psoriasis or AD. Studies were graded according to
a modified version of Sackett’s criteria for clinical evidence and evaluated to determine if they support or do not support the use of
coal tar therapy.
Results: Twenty-five studies meeting the authors’ search criteria were identified, only two of which were placebo-controlled. The
majority (21, or 84%) supported the use of coal tar products in the treatment of psoriasis or AD, while four (16%) did not support the
use of coal tar products.
Conclusion: Most studies support the use of coal tar products, although their level of evidence is not strong. Topical coal tar was
found to be efficacious in the treatment of psoriasis in two placebo-controlled trials. Coal tar products appear to be therapeutic in
psoriasis and AD, are well tolerated with few side effects, and are cost-effective. Staining and odor are deterrents to coal tar therapy.
Large, randomized, double-blind, placebo-controlled studies with precise point estimates of treatment effect are needed to establish
the efficacy of coal tar preparations.
Trichophyton rubrum remains the most common pathogenic dermatophyte in the United States, Europe, and industrialized Asia, although other species are predminant elsewhere. Candida albicans is the most common pathogenic yeast, with other species occasionally encountered. Just a few of the 14 described species of Malassezia cause pityriasis versicolor worldwide. FDA approval does not always accurately reflect the potential utility of any given topical antifungal agent. Azole, hydroxypyridone, and allylamine agents are beneficial in the management of dermatophytosis; however, the allylamines may lead to faster symptom resolution and a higher degree of sustained response. Although in actual clinical use the allylamines have all shown some activity against superficial cutaneous candidiasis and pityriasis versicolor, the azole agents remain drugs of choice. Ciclopirox is an excellent broad-spectrum antifungal agent. Optimal topical therapy for superficial fungal infections cannot yet be reliably based upon in-vitro laboratory determination of sensitivity. Inherent antibacterial and anti-inflammatory properties possessed by some antifungal agents may be exploited for clinical purposes. Candida species may be azole-insensitive due to efflux pumps or an altered target enzyme. So-called “antifungal resistance” of dermatophyets is actually due to poor patient adherence (either in dosing or treatment duration), or to reinfection.
J Drugs Dermatol. 2016;15(Suppl 2):s49-55.
Jorge Ocampo-Candiani MD,a Osvaldo T. Vázquez-Martínez MD,a José Luis Iglesias Benavides MD,b Kristin Buske MD,c Annette Lehn,d and Clemens Acker MDd
BACKGROUND: Abdominal Cesarean sections (C-sections) are frequently associated with an increased risk of excessive or unpleasant
scarring. A topical scar gel containing extract of Allium cepae, allantoin and heparin (Contractubex®; Merz Pharmaceuticals GmbH,
Germany), has shown efficacy in improving the appearance of various scar types.
OBJECTIVE: To investigate the efficacy of the topical scar gel, Contractubex, in the early treatment of C-section scars.
MATERIALS & METHODS: A total of 61 females, aged ≥18 years, who had given birth by elective C-section for the first time within the last
5–10 days, were included in this prospective, randomized, single-center study. Patients were advised to apply the topical scar gel twice daily
(treatment group), or received no treatment (control group). Efficacy was evaluated at 6 and 12 weeks after a baseline visit using the Patient
and Observer Scar Assessment Scale (POSAS), a validated scar assessment tool comprised of a Patient Scale and an Observer Scale.
RESULTS: Analysis revealed a significant change in the POSAS Patient Scale total score, with a 14.2% improvement in the treatment
group compared with a decline of similar magnitude (−14.8%) in the control group at week 6. Significant improvements were also
seen for POSAS Patient Scale sub-items in the treatment group compared with the control group for scar color (13.6% vs −18.5%,
respectively, P=0.0284), stiffness (12.5% vs −34.6%, respectively, P=0.0029), and irregularity (29.4% vs −46.2%, respectively,
P=0.0140) after 6 weeks of treatment. No significant changes were observed for the POSAS Observer Scale total score or its subitems
after treatment with the topical scar gel, although there was a strong overall trend in favor of the treatment group. No significant
adverse events were observed during the study.
CONCLUSION: Contractubex represents an efficacious and well-tolerated preventative treatment that rapidly and significantly improves
the color, stiffness and irregularity of C-section scars.
J Drugs Dermatol. 2014;13(1):176-182.
Dilek Seckin MD, Asli Aksu Cerman MD, Ayfer Yildiz MD, Tulin Ergun MD
Background: Recent research demonstrated that vitamin D, apart from calcium-related actions, has antiproliferative, prodifferentiative
and immunomodulatory activities.
Objective: To determine whether actinic keratoses may benefit from the antiproliferative and prodifferentiative effects of topical
Materials and Methods: The study was an investigator-blinded, half-side comparison trial. Patients applied calcipotriol cream to one
side and Ultrabase® cream as placebo to the other side of the scalp and/or face for 12 weeks. The total number of actinic keratoses
(AKs), diameters and total scores of the target lesions were determined at each visit.
Results: Nine patients were included, eight of whom completed the treatment. There was a statistically significant difference between
the total number of AKs at baseline and at week 12 on calcipotriol applied side whereas no difference was detected on placebo
applied side (p=0.028 vs p=1.00). The mean total score of the target lesions reduced significantly at week 12 on calcipotriol side;
however, no significant reduction was found on placebo side (p=0.017 vs p=0.056). Although side effects were more common on
calcipotriol side, the difference was not statistically significant.
Conclusion: Topical calcipotriol may show promise in the treatment of actinic keratoses. More studies are needed to confirm its
Patricia Farris MD,a Margarita Yatskayer MS,b Nannan Chen PhD,b Yevgeniy Krol BS,c Christian Oresajo PhDb
Resveratrol is an effective anti-aging molecule with diverse biologic activity. It functions as a dual antioxidant that can neutralize free
radicals and increase intrinsic antioxidant capacity. Additionally resveratrol increases mitochondrial biogenesis and has anti-inflammatory,
anti-diabetic, and anti-cancer activity. In this paper we will focus on the use of topically applied resveratrol using a proprietary blend
containing 1% resveratrol, 0.5% baicalin, and 1% vitamin E. This stabilized high concentration formulation demonstrates percutaneous
absorption and alterations in gene expression such as hemoxygenase-1 (HO-1), vascular endothelial growth factor (VEGFA), and collagen
3 (COL3A1). Clinical assessment showed a statistically significant improvement in fine lines and wrinkles, skin firmness, skin elasticity,
skin laxity, hyperpigmentation, radiance, and skin roughness over baseline in 12 weeks. Ultrasound measurements in the periorbital area
showed an average improvement of 18.9% in dermal thickness suggesting significant dermal remodeling. These studies confirm that
topical resveratrol, baicalin, and vitamin E are valuable ingredient that can be used for skin rejuvenation.
J Drugs Dermatol. 2014;13(12):1467-1472.
Shlomo Chamny MD,a Dan Miron MD,b Nadia Lumelsky MD,c Hana Shalev MD,d Elana Gazal PhD,e Rita Keynan,e Avner Shemer MD,f and Dov Tamarkin PhDe
BACKGROUND: Currently available treatment options for impetigo are limited by either systemic side effects (for oral therapy) or lack of ease of use (for topical ointment). A novel foam formulation of minocycline for topical use may improve convenience and treatment utilization for pediatric patients with impetigo.
OBJECTIVE: To evaluate the safety and efficacy of topically applied minocycline foam (FMX-102 1% and 4%) in the treatment of impetigo and to determine the optimal therapeutic active ingredient concentration.
METHODS: In this randomized, parallel-group, double-blind, comparative clinical trial, 32 subjects aged ≥2 years with a clinical diagnosis of pure impetigo, impetigo contagiosa, or uncomplicated blistering impetigo were randomized to treatment with FMX-102 1% or 4%, twice daily for 7 days. Subjects were followed for up to 7 days post-treatment.
RESULTS: Clinical cure, defined as ≥80% cured lesions (fully recovered lesions, visually determined by investigators), was achieved by 57.1% and 50.0% of FMX-102 1% and 4% subjects, respectively, at the end of treatment (visit 3). Clinical success, defined as the absence of lesions, or the drying or improvement of treated lesions (decrease in size of affected area, lesion number, or both), was demonstrated in 81.3% and 78.6% of FMX-102 1% and 4% subjects, respectively, following 3 days of treatment (visit 2), in 92.3% and 100% of the respective subjects at the end of treatment, and in 100% in both groups at follow-up (visit 4). Bacteriologic success rates at the end of treatment, defined as complete pathogen eradication, were 85% and 74% in the FMX-102 1% and 4% groups, respectively. The bacteriologic success rate for MRSA infections was 100% (11/11), with no recurrences. Both FMX-102 1% and 4% were considered well tolerated and safe.
CONCLUSION: Topical minocycline foam may be a safe and effective new treatment option for impetigo in children, including those with MRSA.
J Drugs Dermatol. 2016;15(10):1238-1243.
Yasmeen Kabir MD,a Rachel Seidel BA,b Braden Mcknight BS,c Ronald Moy MDc
The incidence of skin cancer continues to increase annually despite preventative measures. Non-melanoma skin cancer affects more than 1,000,000 people in the United States every year.1 The current preventative measures, such as sunscreens and topical antioxidants, have not shown to be effective in blocking the effects of UV radiation based on these statistics. The level of antioxidants contained in the majority of skin creams is not sufficient to majorly impact free radical damage. Sunscreens absorb only a portion of UV radiation and often are not photostable. In this review article, we present the novel use of exogenous DNA repair enzymes and describe their role in combating photocarcinogenesis and photoaging. Topical application of these enzymes serves to supplement intrinsic DNA repair mechanisms. The direct repair of DNA damage by endogenous repair enzymes lessens rates of mutagenesis and strengthens the immune response to tumor cells. However, these innate mechanisms are not 100% efficient. The use of exogenous DNA repair enzymes presents a novel way to supplement intrinsic mechanisms and improve their efficacy. Several DNA repair enzymes critical to the prevention of cutaneous malignancies have been isolated and added to topical preparations designed for skin cancer prevention. These DNA repair enzymes maximize the rate of DNA repair and provide a more efficient response to carcinogenesis.
J Drugs Dermatol. 2015;14(3):297-301.
Etanercept is approved for the treatment of plaque psoriasis at a subcutaneous (SC) dosage of 50 mg twice-weekly for three months, followed
by 50 mg SC once-weekly thereafter. It is of note, however, that many patients experience loss of efficacy when they step down to etanercept 50 mg/week, often instigating a switch to another biological. The current pilot study investigated the adjunctive use of a topical calcipotriene 0.005% and betamethasone dipropionate 0.064% combination ointment, approved for the treatment of psoriasis, to sustain the original efficacy of etanercept by augmenting response to the 50 mg/week SC dose, thus stabilizing the disease.
Trial Design: In this single-center, open-label study, subjects (n=20) underwent 12 weeks treatment with etanercept 100 mg/week (50 mg, 2x week; weeks –12 to -1), followed by etanercept 50 mg/week maintenance therapy for 40 weeks (weeks 0 to 40). Subjects were followed at four-week intervals. Starting at week 4, subjects who demonstrated an increase from baseline (week 0) body surface area (BSA) of >2% initiated therapy with calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment for four weeks. The study is limited by its small sample size, open-label nature, and lack of blinding.
Findings: Mean BSA involvement decreased significantly from week –12 to 0 with etanercept 50 mg twice a week. At week 4, on the etanercept 50 mg/week dose, mean BSA increased to 9.42±9.39 compared to week 0. With introduction of calcipotriene 0.005%/betamethasone dipropionate 0.064% ointment at week 4, mean BSA decreased to 4.62±8.19 by week 24 and was relatively stable for the remainder of the study period. Similarly, mean PASI (Psoriasis Area and Severity Index) scores improved from week -12 to week 0, increased at week 4, then decreased significantly by week 24 with adjunctive topical treatment.
Conclusion: Topical calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment is a safe and effective adjunct to etanercept
50 mg/week maintenance therapy.
J Drugs Dermatol. 2011;10(8):881-885.
Aditya K. Gupta MD PhD FRCPC,a Boni E. Elewski MD,b Ted Rosen MD,c Bryan Caldwell DPM,dd David M Pariser MD,e Leon H. Kircik MD,f Neal Bhatia MD,g and Antonella Tosti MDh
Recurrence (relapse or re-infection) in onychomycosis is common, occurring in 10% to 53% of patients. However, data on prevalence is limited as few clinical studies follow patients beyond 12 months. It has been suggested that recurrence after continuous terbinafine treatment may be less common than with intermittent or continuous itraconazole therapy, probably due to the fungicidal activity of terbinafine, although these differences tended not to be significant. Relapse rates also increase with time, peaking at month 36. Although
a number of factors have been suggested to play a role in recurrence, only the co-existence of diabetes has been shown to have a significant impact. Data with topical therapy is sparse; a small study showed amorolfine prophylaxis may delay recurrence. High concentrations of efinaconazole have been reported in the nail two weeks’ post-treatment suggesting twice monthly prophylaxis with topical treatments may be a realistic option, and may be an important consideration in diabetic patients with onychomycosis. Data suggest that prophylaxis may need to be continued for up to three years for optimal effect. Treating tinea pedis and any immediate family members is also critical. Other preventative strategies include avoiding communal areas where infection can spread (such as swimming pools), and decontaminating footwear.
J Drugs Dermatol. 2016;15(3):279-282.
Dina Coronado BS, Tejal Merchant MPharm, Sanjay Chanda PhD, and Lee T. Zane MD
An effective topical antifungal medication must penetrate through the nail plate at sufficient concentrations to eradicate the fungal infection. Tavaborole topical solution, 5% is a novel boron-based pharmaceutical approved for the treatment of toenail onychomycosis
due to Trichophyton rubrum or T mentagrophytes. Four in vitro studies assessed the antifungal activity and nail penetration of tavaborole. In Study 1, tavaborole demonstrated minimum inhibitory concentration (MIC) values ranging from 0.25–2 μg/mL against all fungi tested; addition of 5% keratin powder did not affect the MIC against T rubrum. The minimum fungicidal concentration (MFC) values for tavaborole against T rubrum and T mentagrophytes were 8 and 16 μg/mL, respectively. In Study 2, tavaborole effectively penetrated through the nail plate; mean concentrations in the ventral/intermediate nail layer were significantly higher than ciclopirox at day 15. In Study 3, mean cumulative tavaborole penetration through ex vivo human nails was significantly higher than ciclopirox at day 15. In Study 4, tavaborole demonstrated superior nail penetration and fungicidal activity, as measured by zones of inhibition. These studies demonstrated the superior penetration of tavaborole through the nail plate vs ciclopirox. Tavaborole demonstrated robust antifungal activity, with low MIC and MFC values, even in the presence of keratin.
J Drugs Dermatol. 2015;14(6):609-614.
Sean P. McGregor DO PharmD, Michael E. Farhangian MD, Karen E. Huang MS, and Steven R. Feldman MD PhD
Introduction: Atopic dermatitis (AD) affects both adult and pediatric patients, and multiple practitioners encounter and manage AD. However, differences with regard to the treatment of AD between specialties are not well characterized.
Objective: The primary objective of this study was to determine if there is a difference between dermatologists and non-dermatology specialties with regard to treatment strategies for AD and to describe those differences.
Methods: Data from the 1993-2010 National Ambulatory Medical Care (NAMCS) and National Hospital Ambulatory Care (NHAMCS) Surveys were used to characterize outpatient visits made for AD. Differences in demographic, geographic and seasonal characteristics were obtained and compared. Additionally, the frequency of medications prescribed at dermatologist visits were compared to other specialties.
Primary Outcome Measures: Frequency of modalities used in the treatment of atopic dermatitis between dermatologists and non-dermatology specialties. Results: An estimated 3.7 million visits for AD were made to outpatient offices and hospital departments from 1993 to 2010. The rates per capita of visits for atopic dermatitis were similar when evaluated by gender and season. However, Caucasians were almost 50% less likely than African Americans or individuals of other minority races to have visits for AD. Topical corticosteroids (TCS) were mentioned at 52% of visits, and dermatologists were more likely than non-dermatologists to prescribe TCS, emollients, and topical calcineurin inhibitors.
Conclusions: Dermatologists were more likely to recommend TCS, emollients, and topical calciuneurin inhibitors for the treatment of AD. Dermatologists were also more likely to prescribe higher potency TCS in comparison to non-dermatology specialties, and these differences may ultimately affect patient care. As a result, there remains a disparity between dermatologists and non-dermatology specialties with regard to evidence-based approaches to the treatment of AD.
J Drugs Dermatol. 2017;16(3):250-255.
Pedram Ghasri BS,a Brad A. Yentzer MD,a Tushar S. Dabade MD,a Steven R. Feldman MD, PhDa,b,c
Background: Combination therapy is a common and appropriate treatment strategy for moderate-to-severe psoriasis, as it provides for enhanced efficacy and decreased toxicity compared to the use of a single agent. Acitretin is an effective oral retinoid for psoriasis that seems to find its greatest value when complemented by other topical and systemic treatments.
Objective: The primary aim of this study is to assess the use of acitretin in combination with other treatments for psoriasis.
Methods: We assessed the use of acitretin for the treatment of psoriasis using nationally representative survey data from the
National Ambulatory Medical Care Survey (NAMCS).
Results: Among visits where acitretin was listed in the NAMCS, other psoriasis medications were co-prescribed in 62 percent of visits. The co-prescribed medications included topical corticosteroids (51%), calcipotriene (31%), biologics (6%), cyclosporine (5%), methotrexate (5%) and tazarotene (2%).
Conclusion: The use of acitretin in combination with other psoriasis treatments, particularly topical corticosteroids and calcipotriene, is a common practice. Acitretin is co-prescribed with the biologics, likely because of the relative lack of overlapping effects on immune
function. The immune-sparing method of action of acitretin makes combination treatment with the systemic agents an attractive
treatment option, especially in patients where further immunosuppression is unwarranted.
J Drugs Dermatol. 2011;10(8):876-880.
Boni E. Elewski MD,a Wendy Cantrell DNP CRNP,a and Tina Lin PharmDb
BACKGROUND: Onychomycosis is a common disease that remains a difficult disorder to treat despite the introduction of new topical agents; and not all patients are cured. Clinical experience leads us to suggest a number of host-related factors can affect the chance of cure, but studies supporting these observations are currently lacking. Although many studies, particularly on topical agents, rely on severity classification when selecting patients for inclusion, a pilot study was unable to demonstrate any prognostic value of the extension of nail involvement. In addition, no universal severity classification exists, and most studies do not report prognostic factors.
OBJECTIVE: To investigate the efficacy of efinaconazole topical solution, 10% in patients with mild-to-moderate onychomycosis and determine the impact of baseline severity on treatment outcome.
METHODS: Post hoc pooled analysis of two identical, multicenter, randomized, double-blind, vehicle-controlled studies in 1655 patients aged 18-70 years with a clinical and mycological diagnosis of mild-to-moderate dermatophyte toenail onychomycosis (20-50% clinical involvement). Patients were randomized (3:1) to efinaconazole 10% solution or vehicle, once-daily for 48 weeks, with 4-week post treatment follow-up. Efficacy criteria included clear nail (0% target nail plate involvement), almost clear nail (≤5% target nail plate involvement), and clinical treatment success (≤10% target nail plate involvement) at week 52. For the post hoc analysis, patients were classified as mild (20%-29% nail involvement), moderate (30%-39%), and moderately severe (40%-50%) at baseline.
RESULTS: Overall, 25%, 23%, and 52% of patients had mild, moderate, or moderately severe disease at baseline. Baseline nail involvement did not appear to predict treatment outcomes. The proportion of patients with mild disease who had a clear nail progressively reduced by week 36 (58%) and week 48 (41%), and even further by week 52 (37%). Of the 237 patients treated with efinaconazole who were ‘clear’ at week 52, 37%, 24%, and 39% had mild, moderate or moderately severe disease respectively at baseline. The majority of patients (N=634) saw at least a 50% improvement in their target toenail by week 52. Almost half of these patients (N=312, 49.2%) were moderately severe at baseline.
CONCLUSIONS: This post hoc analysis supports previous data showing good efficacy of efinaconazole in mild onychomycosis. The relative contribution to overall efficacy results at week 52 of patients with moderate or moderately severe disease was unexpected for a topical therapy, and warrants further study, especially as they represent the majority of patients enrolled in the two studies. It is possible that comparable efficacy can be achieved in these more severe patients with longer treatment courses, or follow-up.
J Drugs Dermatol. 2018;17(2):175-178.
Joseph Bikowski MD, Radhakrishnan Pillai PhD, Braham Shroot PhD
Multivesicular emulsion systems are a new patented technology for topical delivery of pharmaceutical and over-the-counter
actives. This novel technology involves the creation of a 2-phase, oil-in-water emulsion system that produces concentric
multilamellar spheres of oil and water. Active ingredients can be released from their respective layers upon application to the
skin. In addition to a controlled-release of active agents, the multivesicular emulsion base improves the biophysical properties
of the skin by reducing transepidermal water loss and enhancing skin hydration. This technology has been applied to 6%
salicylic acid formulations that in clinical experience show efficacy with high tolerance in several hyperkeratotic disorders.
Subjects’ self-assessment was clearly indicative of the excellent cosmetic elegance of the multivesicular emulsion system.
Geraldine Cheyana Ranasinghe BS and Adam J. Friedman MD
The seborrheic keratosis is the most common benign skin tumor of middle-aged and elderly adults, affecting nearly 83 million individuals in the US alone. Although these are benign lesions, many patients still undergo some form of treatment. Clinicians are frequently presented with a challenge when determining whether to remove a seborrheic keratosis, and which treatment modality to use when doing so. The most commonly used method of removal is cryotherapy, however there are numerous other options that can be employed with varying degrees of efficacy. In this article, we highlight the use of topical keratolytics, vitamin D analogues, and lasers, to name a few. We also address potential side effects associated with these treatment options, as well as discuss patients’ preferences and concerns. We conclude with the most recent advances in topical treatments currently under clinical investigation, and offer treatment strategies aimed at maximizing patient satisfaction.
J Drugs Dermatol. 2017;16(11):1064-1068.
Erica B. Wang MD,b,c Evan Austin BA,b,c Jared Jagdeo MD MSb,c,d
Background: As body contouring procedures have become more popular, post-procedural skin laxity is a concern. Non-invasive body contouring technologies may effectively reduce body fat, but modestly affect skin tightening.
Objective: To assess the efficacy and safety of a topical skin tightening agent in combination with hyperthermic diode laser lipolysis.
Methods: Herein, we describe five patients in which a skin tightening concentrate of 5% yeast extract, 2% hydrolyzed rice protein content, and 2.5% tripeptide was used after 1500-2100 J/cm2 of hyperthermic 1060 nm diode laser.
Results: Overall, all patients had a subjective positive response and high satisfaction with the combined treatment results of improvement in skin laxity and fat reduction. In all five cases, patients demonstrated visible fat reduction and skin improvement on photographs taken between weeks 6-18 compared to baseline. Blinded investigators correctly predicted the order of the photographs based on treatment results. No adverse events were reported.
Conclusion: This case series demonstrated that a combined topical skin tightening concentrate with a hyperthermic laser lipolysis device may achieve improved aesthetic outcomes without adverse events.
J Drugs Dermatol. 2018;17(7):780-785.
Rajiv I. Nijhawan MD,a Jeremy M. Hugh MD,b and Achiamah Osei-Tutu MDa
Increased cases of acquired epidermodysplasia verruciformis (EDV) have been reported in patients with human immunodeficiency virus (HIV). With regard to management, there are no randomized controlled trials in either immunocompetent or immunocompromised patients, and only a limited number of anecdotal treatment options. Systemic retinoids, either independently or in combination with other treatment modalities, have been used with limited success, demonstrating transient clinical response and recurrence of lesions after cessation of therapy. We report a case of an HIV-positive patient with acquired EDV who achieved sustained clinical resolution even after discontinuation of oral acitretin by applying topical imiquimod to prevent recurrence of his lesions.
J Drugs Dermatol. 2013;12(3):348-349.
Adam J. Friedman MD FAAD,a Erika C. von Grote PhD,b Matthew H. Meckfessel PhDb
Urea is an important hygroscopic component of the epidermis, where it participates in the maintenance of skin hydration as part of the skin’s source of natural moisturizing factor (NMF) in the outer most layers. Xerotic skin, which is frequently characterized as NMF-deficient, is a unifying trait of dermatoses such as atopic dermatitis (AD), psoriasis, and ichthyosis vulgaris. The reduced hygroscopic potential of pathologically dry skin leads to unregulated transepidermal water loss (TEWL), epidermal hyperproliferation, and inhibited desquamation; all which clinically translate to hyperkeratotic and possibly pruritic skin. Common underlying etiologies link these dermatoses to aberrant expression of genes encoding epidermal structural and catalytic proteins. Intervention of dry skin pathologies with topical moisturizer formulations is a foundational management strategy. For over a century urea-containing formulations have been used in a concentration-dependent manner to restore skin hydration, thin hyperkeratosis, debride dystrophic nails, and enhance topical drug penetration. Recently, urea’s role in skin hydration and repair has expanded to include regulation of epidermal genes necessary for proper barrier function. Taken together, urea’s versatility in topical formulations and broad range of therapeutic mechanism highlights its utility to clinicians and benefit to patients.
J Drugs Dermatol. 2016;15(5):633-639.
Acne therapies that are able to show efficacious treatment of acne lesions as well as to address the issues of oiliness and shine control
may be particularly appropriate for the treatment of patients with acne vulgaris that is accompanied by oily skin and facial shine. The
microsphere delivery system (MDS), a novel delivery technology for topical therapy, can be customized to optimize product attributes,
including oil absorption. Clinical trials have clearly established the efficacy and tolerability of such MDS formulations in the treatment of
acne. In addition, studies have shown that the use of products formulated with an MDS provides a more significant reduction in facial
shine than non-MDS acne therapy, as well as a reduction in facial sebum accumulation relative to control. Future clinical research should
aim to further delineate the effect of individual topical acne treatment formulations on oiliness and shine.
J Drugs Dermatol. 2013;12(11):1268-1270.
Ashish Bhatia MD,a Jeffrey TS Hsu MD,b and Basil M. Hantash MD PhDc
No abstract details for the moment.
Objective: Some literature reported that topical calcineurin inhibitors (TCIs) did not accelerate photocarcinogenesis in hairless mice after long-term simulated solar radiation. In this work, we investigate the effects of topical pimecrolimus 1% on long-term suberythemal ultraviolet
B (UVB)—irradiated epidermal Langerhans cells (LCs) in mice.
Methods:Thirty female mice were randomly divided into two groups, including four subgroups: (1A) control, (1B) pimecrolimus 1% only, (2A) 25 mJ/cm2 UVB only, (2B) UVB plus pimecrolimus. After being treated for 60 days, the dorsal skin was collected and given immunohistochemical
staining of active caspase 3, and immunofluorescence staining for cluster of differentiation 1a (CD1a).
Results:Our results show that, compared with the control subgroup, the CD1a+ LC number in the epidermal sheet of the UVB-only subgroup decreased substantially from 578.6 per mm2 to 227 per mm2 (P<.001). Compared with the UVB-only subgroup, the UVB plus pimecrolimus subgroup significantly restored the LC number from 227 per mm2 to 475.7 per mm2 (P<.001). Compared with other subgroups,
the LC morphology of the UVB-only subgroup became rounder, and the LC dendrites became shorter. There were no significant active caspase 3-positive cells in the epidermis in any of the four subgroups.
Conclusion:Our results show that topical pimecrolimus 1% reverses long-term UVB-induced epidermal LC reduction and morphologic changes in mice, where the exact mechanism is likely not related to apoptosis.
J Drugs Dermatol. 2012;11(9):e25-e27.
The sequential use of topical therapies and short-incubation photodynamic therapy for actinic keratosis (AK) has not been extensively
studied. The author reports on treatment with sequential 5-fluorouracil (5-FU) cream 0.5% and 5-aminolevulinic acid-photodynamic
therapy (ALA-PDT) in three older men with photodamaged skin and a history of AK. These findings suggest that this combination
therapy, when compared with short-contact (1 hour) ALA-PDT alone, is more effective, minimizes the recurrence of areas of field
cancerization and improves the appearance of the skin. The use of 5-FU cream 0.5% before and after photodynamic therapy is effective
in revealing the presence of both clinical and subclinical AK lesions.
J Drugs Dermatol. 2011;10(4):372-378.
Mary L. Stevenson MD,a Julie K. Karen MD,a,b and Elizabeth K. Hale MDa,b
Photodynamic therapy (PDT) uses a topical photosensitizing agent which is activated by a light source to cause destruction of specific cells. Commonly used for the treatment of actinic keratoses and photodamage, PDT can also be used for other conditions including acne and sebaceous hyperplasia. Here we report our experience with two treatment protocols. The first protocol utilizes laser assisted delivery of topical 5-aminolevulinic acid for enhanced efficacy of blue light photodynamic therapy in the treatment of actinic keratoses and photodamage. The second protocol utilizes red light photodynamic therapy followed by pulsed dye laser to effectively target sebaceous glands in patients with extensive sebaceous hyperplasia.
J Drugs Dermatol. 2017;16(4):329-331.
Actinic keratoses (AKs) are cutaneous areas of atypical squamous transformation that are considered to be an early step in the continuum of transformation from normal skin to invasive and metastatic cutaneous squamous cell carcinoma (SCC). Enhanced understanding of the pathophysiologic changes leading from AK to malignancy, combined with an increasing global prevalence of AK, has led to a new focus on the importance of combining local tretments that remove individual lesions with topical or procedural field therapies that treat the entire actinically damaged field — also known as field cancerization — which is important because it is impossible to predict which AK lesions will progress to SCC. Currently available topical field therapies include 5-fluorouracil cream (5%, 1%, 0.5%), imiquimod cream (5% and 3.75%), diclofenac sodium gel 3% with 2.5% hyaluronic gel, and ingenol mebutate gel (0.05% and 0.015%). Photodynamic therapy is a procedural field therapy. Important considerations when developing a comprehensive treatment plan include patient risk factors; the number and location of AK lesions; strategies for minimizing sun exposure; and the mechanism of action, clearance rate, adverse effect profile, and application of local and topical therapies.
J Drugs Dermatol 2012;11(12):1462-1467.
Onychomycosis is a very common nail disorder seen in dermatological practice. It is difficult to treat successfully for a multitude of
reasons, and although topical antifungal therapy might be considered ideal for mild to moderate onychomycosis, efficacy has been
limited by poor nail penetration of active ingredient through the nail plate into the nail bed and nail matrix to the site of infection. The
intrinsic properties of an antifungal and its vehicle formulation are both considered important contributors to effective treatment.
Here we review the formulation approach to efinaconazole topical solution, 10% an effective and well-tolerated treatment for onychomycosis.
We demonstrate that the low surface tension formulation affords better penetration of efinaconazole through the nail
plate, and also to the site of infection by spreading into the space between the nail and nail bed.
J Drugs Dermatol. 2014;13(12):1457-1461.
Darrell Rigel MD, Christopher Nelson MD, Stacy Smith MD, Neil Swanson MD, John Wolf, MD
A clearance rate of all occurrences ?75% for actinic keratoses (AK) lesions is an accepted efficacy endpoint for topical agents. This
efficacy endpoint has not been assessed for 3.0% diclofenac sodium gel (Solaraze™).
We evaluated the efficacy and tolerability of 3.0% diclofenac sodium gel in the treatment of AK for a treatment period of 90 days and
a 30-day follow-up period.
This is a multicenter, single-arm, open-label study in patients diagnosed with five or more AK lesions contained in 1 to 3 blocks (5
cm2) on the forehead, central face, or scalp. Patients were treated twice daily with a topical application of 3.0% diclofenac sodium gel
for a period of 90 days with a follow-up assessment at 30 days post-treatment. The presence or absence of target lesions and new
lesions was assessed at each visit a long with a global improvement index score.
Of the 76 patients who entered the study, 67 (88%) patients completed the study. At Day 90 of treatment, 78% of patients had ?75%
AK lesion clearance based on the target lesion number score (TLNS). Improving to 85% of patients demonstrating ?75% AK lesion
clearance at Day 120 (follow-up). Improvement was also demonstrated by 100% AK lesion clearance based on the TLNS clearance
(Day 90 of treatment: 41%; Day 120 [follow-up]: 58%). Similar improvements were shown in cumulative lesion number score (CLNS),
which included new as well as targeted AK lesions within the designated treatment areas, at Day 90 and Day 120 (follow-up).
Investigators’ assessment based on Investigator Global Improvement Index (IGII) confirmed the efficacy of 3.0% diclofenac gel in the
clearance of AK lesions. A total of 39 patients (51%) experienced at least 1 adverse event considered to be related to 3.0% diclofenac
sodium gel during the study. Dry skin and rash at the application site were most common reported adverse events, and most of
these adverse events were mild or moderate in severity.
The topical application of 3.0% diclofenac sodium gel provides a safe and effective approach for the treatment of AK.
Background: Topical Acyclovir has moderate efficacy on recurrent HSV symptoms, requiring repeat applications for several days. Topical Dynamiclear, which requires only a single dose application, may provide a more effective and convenient treatment option for symptomatic management of HSV.
Objectives: The study assessed the comparative efficacy and tolerability of a single use, topical formulation containing copper sulfate pentahydrate and Hypericum perforatum that is marketed as Dynamiclear™ to a topical 5% Acyclovir cream standard preparation and use.
Methods: A prospective, randomized, multi-centered, comparative, open-label clinical study was conducted. A total of 149 participants between 18 and 55 years of age with active HSV-1 and HSV-2 lesions were recruited for the 14-day clinical trial. Participants were randomized into two groups: A (n=61), those receiving the Dynamiclear formulation, and B (n=59), those receiving 5% Acyclovir. Efficacy parameters were assessed via physical examination at baseline (day 1), day 2, 3, 8, and 14. Laboratory safety tests were conducted at baseline and on day 14.
Results: Use of the Dynamiclear formulation was found to have no significant adverse effects and was well tolerated by participants. All hematological and biochemical markers were within normal range for the Dynamiclear group. Statistically, odds for being affected by burning and stinging sensation were 1.9 times greater in the Acyclovir group in comparison to the Dynamiclear group. Similarly, the odds of being affected by symptoms of acute pain, erythema and vesiculation were 1.8, 2.4, and 4.4 times higher in the Acyclovir group in comparison to the Dynamiclear group.
Conclusions: The Dynamiclear formulation was well tolerated, and efficacy was demonstrated in a number of measured parameters, which are helpful in the symptomatic management of HSV-1 and HSV-2 lesions in adult patients. Remarkably, the effects seen from this product came from a single application.
J Drugs Dermatol. 2012;11(2):209-215.
Tracey C. Vlahovic DPM,a Dina Coronado BS,b Sanjay Chanda PhD,b Tejal Merchant MPharm,b and Lee T. Zane MDb
INTRODUCTION: Patients with onychomycosis may mask infected nails with polish. Tavaborole topical solution, 5% is a boron-based, small-molecule pharmaceutical approved for the treatment of toenail onychomycosis caused by Trichophyton rubrum and Trichophyton mentagrophytes; efinaconazole topical solution, 10% is approved for the same indication. Nail polish appearance after application of tavaborole (dropper) or efinaconazole (brush); respective applicator appearance; presence of color transfer from respective applicators; and color transfer to remaining solutions after dosing of polished nails were evaluated.
METHODS: Twelve ex vivo human cadaver fingernails were cleaned, polished with two coats of L’Oréal® Nail Color, Devil Wears Red #420, and mounted on floral foam. Nails were treated with tavaborole or efinaconazole solutions once daily for 7 days. Dropper and brush applicators were applied to white watercolor paper immediately after dosing to evaluate color transfer from polished nails. On day 7, remaining solutions were transferred to clear glass vials to evaluate color transfer from applicators to solutions. Nails, applicators, and papers were photographed daily following application; remaining solutions were photographed after 7 days of dosing.
RESULTS: Tavaborole-treated polished nails showed no polish discoloration, and tavaborole applicators did not change in appearance during treatment. No color transfer from polished nails was evident to applicator, paper, or remaining solution. Efinaconazole-treated polished nails showed substantial polish changes after the first day of treatment, with polish appearance and discoloration progressively
worsening over 7 days of treatment. Color transfer from nails was evident to applicator, paper, and remaining solution.
CONCLUSIONS: Daily dropper application of tavaborole to ex vivo polished nails did not alter polish appearance. Brush application of efinaconazole
produced visible changes in polish appearance and color transfer to applicators, paper, and remaining solution. Tavaborole topical solution, 5% may not alter nail polish appearance; the impact of nail polish on tavaborole clinical efficacy has not been evaluated.
J Drugs Dermatol. 2016;15(1):89-94.
Jaggi Rao MD, Kristina E Paabo PA-S, and Mitchel P Goldman MD
Cellulite is the unsightly dimpling and nodularity frequently found on the thighs and buttocks of post-adolescent women. The anatomy
and pathophysiology of this unwanted condition is poorly understood. The paucity of research studies to date has led to a dormancy
of scientifically based therapeutic options that are effective and tolerable.
The purpose of this study is to evaluate the tolerability and efficacy of a novel topical agent based on a plausible pathophysiologic
mechanism in the treatment of cellulite, and to compare the efficacy of this agent used in combination with an occlusive bioceramiccoated
neoprene garment, to the agent used alone without occlusion. We will also review the current understanding of the etiology
and nature of cellulite and summarize available treatment options.
Twenty women with a moderate degree of cellulite were entered into a four-week, double-blinded, randomized trial where an anti-cellulite
cream was applied to the affected sites on a nightly basis. Each subject was randomized to receive occlusion by a bioceramiccoated
neoprene garment on either the right or left leg, with the contralateral side serving as a control with no occlusion. High-quality
digital photography was taken before treatment and after four weeks at various angles, with tangential full-spectrum lighting. Four
blinded, independent dermatologist reviewers assessed the photographs for improvement. Subjects completed questionnaire forms
to assess tolerability and efficacy.
Of the 17 subjects who completed the study, 76% noticed an overall improvement in their cellulite, with 54% reporting greater improvement
in the thigh that received garment occlusion. The average measured decrease in thigh circumference was 1.2 cm, noting a 1.3
cm reduction with occlusion and a 1.1 cm reduction without occlusion. Upon review of the pre- and post-study photographs, the
dermatologist evaluators found an improvement in 65% of treated legs with occlusion, and 59% of treated legs without occlusion.
Further, the evaluators found the occluded thighs to show greater improvement than the non-occluded thighs in 65% of subjects.
The topical agent used in this study was found to be effective in reducing the appearance of cellulite. Bioceramic-coated neoprene
garment occlusion potentiates the effect of this topical agent in cellulite reduction. The success of this study validates the pathophysiologic
mechanism used to formulate the topical agent used.
Pooja Khera MD, John Y. Koo MD
Retinoids, a group of compounds encompassing Vitamin A and its analogs, have been shown to inhibit tumor growth
in laboratory studies. Based on these findings, a number of clinical trials have been conducted to investigate the chemoprotective
and chemotherapeutic effects of retinoids. This paper reviews the current database regarding the use of oral
and topical retinoids in the prevention and treatment of cutaneous and internal malignancies. Clinical studies have
shown that retinoids have beneficial effects in the prevention and treatment of certain neoplasms. In view of the
heightened concern of malignancy associated with the use of biologic agents in the treatment of psoriasis, retinoids may
be an attractive option for combination therapy with the biologic agents. Future clinical investigations are needed to
precisely define how this combination will fit into the treatment algorithm for moderate-to-severe psoriasis.
Joseph Maloney BA,a Gary S. Rogers MD,b,c and Mitesh Kapadia MD PhDd
BACKGROUND: The use of medical adhesives for topical wound closure is gaining in popularity over conventional wound closure
materials such as sutures and staples. Adhesives provide advantages in both wound closure and patient management with good
cosmetic outcome and surgeon and patient satisfaction reported.
OBJECTIVE: To compare the use of two currently marketed medical adhesives; LiquiBand® Flow Control and High Viscosity Dermabond
™ for the topical closure of surgical incisions.
METHODS: In a prospective blinded manner, subjects were randomly assigned LiquiBand® or DermabondTM for topical closure of a
surgical incision. Variables compared included ease of use, time taken to close wound, subject and surgeon satisfaction with device
and wound closure, cosmetic outcome at 90 days, and complication rates.
RESULTS: Use of both devices resulted in effective wound closure with similar high levels of cosmesis subject and surgeon satisfaction,
with only minor complications reported. There was no statistically significant difference between the devices for all the parameters
studied, with the exception that the Liquiband device was found to significantly reduce the amount of time required for closure.
CONCLUSION: As the two devices appear substantially equivalent in terms of key surgeon and patient variables, product cost should
be the primary determinant in selection of the tissue glue device.
J Drugs Dermatol. 2013;12(7):810-814.
Enzo Emanuele MD PhD,a James M. Spencer MD MS,b and Martin Braun MDc
The exposure to ultraviolet radiation (UVR) is a major risk factor for skin aging and the development of non-melanoma skin cancer (NMSC). Although traditional sunscreens remain the mainstay for the prevention of UVR-induced skin damage, they cannot ensure a complete protection against the whole spectrum of molecular lesions associated with UVR exposure. The formation of helix-distorting photoproducts such as cyclobutane pyrimidine dimers (CPD), as well as oxidative damage to DNA bases, including the formation of 8-oxo-7,8-dihydro-2’-deoxyguanosine (8OHdG) are among the key DNA lesions associated with photoaging and tumorigenesis. Besides DNA lesions, UVR-induced formation of free radicals can result in protein carbonylation (PC), a major form of irreversible protein damage that inactivates their biological function. This study compares a complex novel topical product (TPF50) consisting of three actives, ie, 1) traditional physical sunscreens (SPF 50), 2) a liposome-encapsulated DNA repair enzymes complex (photolyase, endonuclease, and 8-oxoguanine glycosylase [OGG1]), and 3) a potent antioxidant complex (carnosine, arazine, ergothionine) to existing products. Specifically, we assessed the ability of TFP50 vs those of DNA repair and antioxidant and growth factor topical products used with SPF 50 sunscreens in preventing CPD, 8OHdG, and PC formation in human skin biopsies after experimental irradiations. In head-to-head comparison studies, TPF50 showed the best efficacy in reducing all of the three molecular markers. The results indicated that the three TPF50 components had a synergistic effect in reducing CPD and PC, but not 8OHdG. Taken together, our results indicate that TPF50 improves the genomic and proteomic integrity of skin cells after repeated exposure to UVR, ultimately reducing the risk of skin aging and NMSC.
J Drugs Dermatol. 2014;13(3):309-314.
Atopic dermatitis (AD) is a common chronic inflammatory skin disease caused by a combination of genetic susceptibility,
epidermal barrier dysfunction and immune dysregulation. The intense pruritus associated with the disease causes an
itch-scratch cycle that worsens symptoms and can cause significant discomfort for the patient. Recently, the focus of the
atopic dermatitis treatment paradigm has shifted from targeting inflammation to the use of agents that normalize the skin
barrier, which may reduce the current dependence on topical steroids and immunomodulators. A new barrier repair cream
(EpiCeram® Skin Barrier Cream, Promius Pharma, Bridgewater, NJ) is a prescription topical agent indicated for the treatment
of dry skin conditions and the relief of itching and burning associated with various dermatoses. This article describes the
pathogenic rationale for using a barrier repair cream for the treatment of AD and discusses case report results focused on its
clinical benefit for AD.
Emil A. Tanghetti MD,a Jeffrey S. Dover MD FRCPC,b David J. Goldberg MD,c Sunil S. Dhawan MD,d Lei Luo MPH,e David R. Berk MD,e Gurpreet Ahluwalia PhD,e and Nancy Alvandi PhDe
BACKGROUND: Persistent facial erythema is a clinically challenging feature of rosacea.
OBJECTIVE: To evaluate persistent erythema reduction on the first day of treatment from pooled data from two pivotal trials of topical oxymetazoline cream 1.0% (oxymetazoline) in persistent facial erythema of rosacea.
METHODS: In two identically designed, phase 3, multicenter trials, adults with moderate to severe persistent facial erythema of rosacea (Clinician Erythema Assessment [CEA] grade ≥3 and Subject Self-Assessment [SSA] grade ≥3) were randomized 1:1 to once-daily topical oxymetazoline or vehicle; the primary efficacy endpoint was ≥2-grade composite CEA and SSA improvement from baseline on day 29. This post hoc analysis evaluated the proportion of patients achieving ≥1-grade composite and individual CEA and SSA improvement at 1, 3, 6, 9, and 12 hours postdose on day 1 (N=885).
RESULTS: Significantly more patients achieved ≥1-grade composite and individual CEA and SSA improvement with the first application of oxymetazoline than with vehicle (P less than 0.001) at all postdose time points, beginning with hour 1. Day 1 safety assessments were similar between treatments.
LIMITATIONS: Short-term, post hoc analysis.
CONCLUSIONS: A ≥1-grade improvement in persistent erythema achieved after the first dose of once-daily topical oxymetazoline demonstrated clinically meaningful improvement from the beginning of therapy.
J Drugs Dermatol. 2018;17(6):621-626.
Ricardo Ruiz-Rodriguez MD PhD, Laura Lopez MD, Daniel Candelas MD, Javier Pedraz MD
Background: Photodynamic therapy has been proved to be effective in skin rejuvenation.
Objective: To evaluate clinical efficacy and side effects of photodynamic therapy using topical 5-methyl aminolevulinate
and red light for photorejuvenation.
Methods: A randomized, prospective, split-face comparison study of 10 white, adult patients with moderate photodamage,
Fitzpatrick skin types 2 or 3, and no occurrence of actinic keratosis was performed. Three treatments using topical
methyl aminolevulinate cream, applied for 1 hour on one half of the face and 3 hours on the other half before illumination
with red light. A blinded investigator prior to treatment and 2 months after the third treatment evaluated each side
of the subject’s faces.
Results: A moderate improvement in fine lines, tactile roughness, and skin tightness was observed in most of the patients,
mostly on the 3-hour time side. There were no changes in mottled pigmentation or telangiectasias. Side effects were observed
in all subjects (erythema, edema, scaling) mainly in the 3-hour incubation time side.
Limitations: The small number of patients and the lack of placebo group.
Conclusion: Methyl aminolevulinic-photodynamic therapy with red light can improve fine lines, tactile roughness and
skin tightness in patients with moderate photoaging and no occurrence of actinic keratosis.
Irene J. Vergilis-Kalner MD and Joel Cohen MD
No abstract details for the moment.
Daniel Aires MD JD,a Tarek Shaath BS,c Garth Fraga MD,b
Anand Rajpara MD,a Ryan Fischer MD,a Deede Liu MD,a
No abstract details for the moment.
Jennifer Urban BS,a Arunee H. Siripunvarapon MD,b Adam Meekings BS,c
Amy Kalowitz BS,b and Orit Markowitz MD FAADb
BACKGROUND: Patients with moderate to severe rosacea often seek treatment to reduce erythema and vascular markings. Few studies
have looked at the effectiveness of the novel treatment, brimonidine topical gel 0.33%, trademark name Mirvaso®, in the treatment
of rosacea. We report the use of optical coherence tomography (OCT) scanning to monitor the effectiveness of Mirvaso® on in
vivo skin. OCT is a non-invasive optical imaging technique that can provide high-resolution imaging of vessel and cellular morphology.
OCT may be useful as a pre-treatment assessment tool for identifying possible morphologic features in the skin that may serve as
outcome predictors. OCT may also serve as a monitoring tool in the treatment of rosacea.
OBJECTIVE: To examine and describe how OCT skin morphology changes when exposed to brimonidine topical gel 0.33% in the
treatment of erythematotelangiectatic rosacea.
METHODS: Normal in vivo telangiectasias and erythematous patches and papules were examined prior to treatment clinically, dermatoscopically,
and through OCT scans. Brimonidine topical gel 0.33% was applied to the face and OCT images were acquired
at defined time intervals: baseline; immediately (<5 minutes) after application; 4 hours after application; and after 2 weeks’ once
daily application. OCT morphology was then described.
RESULTS: OCT imaging showed an increase in the mean gray value (MGV), a measure of dermal reflectivity, corresponding to a decrease in
dermal edema. MGV measurements for the nasal telangiectasia were: baseline, MGV 10,471 (standard deviation [SD] 6,847); immediate,
MGV 15,634 (SD 8,983); after 4 hours, MGV 16,357 (SD 7,647); and after 2 weeks, MGV 15,505 (SD 6,870). MGV measurements for the
chin erythema were: baseline, MGV 8,850 (SD 4,969); immediate, MGV 10,799 (SD 5,266); after 4 hours, MGV 12,419 (SD 6,714); and
after 2 weeks, MGV 13,395 (SD 6,170). No significant change in vessel lumen diameter was appreciated. Vessel lumen diameter for the
facial papule ranged from 0.13 mm at baseline, 0.09 mm immediately after treatment, 0.09 mm after 4 hours, and 0.11 mm after 2 weeks.
CONCLUSIONS: OCT scanning showed a decrease in the dermal hyporeflectivity of the dermis consistent with a decrease in dermal
edema. The OCT scans obtained did not show any significant change in vessel lumen diameter. These results may reflect an increase
in vascular tone, which can be attributable to the clinical improvement and decreased erythema noted in the patient. This
technology could potentially be used for the non-invasive in vivo monitoring of other topical treatments.
J Drugs Dermatol. 2014;13(7):821-826.
Todd E. Schlesinger MD FAADa and Callie Rowland Powell BSN RNb
OBJECTIVE: Rosacea is a chronic cutaneous disorder characterized by flushing, erythema, telangiectasia, edema, papules, and pustules.
The cause of this inflammatory disorder is unknown, but is thought to be multifaceted. Primary treatments for rosacea are typically oral
antibiotics and topical therapies. Hyaluronic acid sodium salt cream 0.2% is a topical device containing low molecular weight hyaluronic
acid (LMW-HA) that is effective in normalizing the cutaneous inflammatory response. The objective of this study was to evaluate the
efficacy and safety of hyaluronic acid sodium salt cream 0.2%.
DESIGN and SETTING: Prospective, observational, non-blinded efficacy and tolerability study in an outpatient setting.
PARTICIPANTS: Individuals 18 to 75 years of age with mild to moderate facial rosacea.
MEASUREMENTS: Outcome measures included papules, pustules, erythema, edema, telangiectasia, burning or stinging, dryness and provider
global assessment (PGA), which were all measured on a five-point scale. Subjects were assessed at baseline, week 2, week 4, and week 8.
RESULTS: Final data for 14 of 15 subjects are presented. Through visual grading assessments, hyaluronic acid sodium salt cream 0.2%
was shown to improve the provider global assessment by 47.5 percent from baseline to week 4. Reductions in papules, erythema,
burning or stinging, and dryness were 47, 51.7, 65, and 78.8 percent, respectively at week 4. At week 8, the provider global assessment
was improved from baseline in 78.5 percent of subjects.
CONCLUSION: Improvement was noted in measured clinical parameters with use of topical low molecular weight hyaluronic acid. Topical
low molecular weight hyaluronic acid is another option that may be considered for the treatment of rosacea in the adult population.
Compliance and tolerance were excellent. Consideration should be given to use for individuals with rosacea characterized by an erythematous
and/or papular component.
J Drugs Dermatol. 2013;12(6):664-667.
Ivan Bristow PhD,a Robert Baran MD,b and Michelle Score BSc (Hons)c
Onychomycosis continues to be a common and intractable problem in adults, often responding poorly to topical treatment due to limited drug penetration of the nail plate. Improving penetration has been attempted previously by chemical and physical means with some success. The authors present three cases of toenail onychomycosis treated topical terbinafine 1% solution using controlled micro-penetration of the nail using a novel intelligent nail drill system which is able to drill nail plate without penetrating the delicate nail bed beneath. The cases illustrate how the device has been successfully employed to deliver the anti-fungal drug directly and rapidly to the site of infection with minimal side effects or complications, whilst maintaining the nail integrity.
J Drugs Dermatol. 2016;15(8):974-978.
The scalp is one of the regions of the body most commonly affected by psoriatic lesions. While the head represents only 10 percent
of the body’s surface area, the consequences of scalp psoriasis are disproportionate to the area, as it can be seriously debilitating and
presents social and emotional distress to the affected individual. Scalp lesions are often well-demarcated and may have thick gray
or white scale; patients with scalp psoriasis frequently complain of pruritus and shedding of scale. Current treatment modalities—
including phototherapy, topical corticosteroids, topical vitamin D analogues and conventional systemic therapies—have produced
unsatisfactory results for patients with moderate-to-severe scalp psoriasis due to difficulties in administration to the disease site,
poor compliance, toxicity and inadequate long-term efficacy. The emergence of biologic therapies as an effective modality for the
treatment of plaque psoriasis may provide another option for patients suffering from plaque psoriasis of the scalp.
Ritu Saini MD FAAD, Deborah S. Sarnoff MD FAAD FACP
Basal cell carcinoma (BCC) is the most common human malignancy, which often occurs as a result of ultraviolet light
on sun-exposed areas. A more rare location for the presentation of BCC is the non-sun−exposed genital area, where squamous
cell cancer occurs frequently in the setting of human papilloma virus and chronic inflammatory lesions (ie, lichen
sclerosus et atrophicus). Consequently, such tumors may escape detection by the dermatologist and be mistaken by the
gynecologist for an inflammatory condition. A delay in diagnosis can result in wider surgical margins and potential recurrences.
We present a case of BCC of the vulva with involvement of the clitoris presenting with unilateral pruritus and
treated as an allergic contact dermatitis with topical corticosteroids. The patient was treated with Mohs micrographic surgery
in conjunction with topical imiquimod to spare surrounding tissue.
Tarek Fakhouri BS, Brad A. Yentzer MD, Steven R. Feldman MD PhD
Background: Antibiotic resistance of Propionibacterium acnes (P. acnes) is a growing phenomenon in the wake of widespread use of
topical and systemic antibiotics for acne vulgaris. Benzoyl peroxide has a proven track record of safety and effi cacy, and can decrease
reliance on antibiotics in the treatment of acne.
Purpose: To review the literature for methods to increase the effi cacy and tolerability of benzoyl peroxide (BPO).
Methods: A PubMed literature search was done using the terms “benzoyl peroxide,” “vehicle,” “mechanism,” and “delivery system.”
Relevant papers were reviewed for methods of increasing BPO effi cacy and tolerability.
Results: BPO in concentrations of 2.5%, 5% and 10% are equally effective at treating infl ammatory acne. However, higher concentrations
are associated with more adverse effects. The effi cacy of BPO may be enhanced by the presence of Vitamin E and tertiary
amines. BPO is also more effi cacious if used in combination with topical retinoids than as a monotherapy. Novel vehicles including a
microparticle delivery system and those with a hydrophase or urea base increase the tolerability of BPO without sacrifi cing effi cacy.
Conclusion: Benzoyl peroxide has a proven track record of safety and effi cacy for the treatment of acne. Recent discoveries have
provided new methods of increasing the effi cacy and tolerability of topical BPO, making it useful as monotherapy for mild acne or as
an adjunct in the treatment of moderate to severe acne vulgaris.
James Q. Del Rosso DO FAOCDa and Leon H. Kircik MDb
Midpotency topical corticosteroids (TCSs) are frequently used for the treatment of common eczematous and inflammatory skin disorders in both adults and children. There are several commercially available products in this category, and many vehicles and formulations for the clinician to choose from. Clocortolone pivalate 0.1% cream is a midpotency TCS formulated in an emollient formulation that has been shown to be effective and well tolerated when used appropriately in the management of several corticosteroid-responsive dermatoses. This article discusses the physiochemical properties of the compound; the characteristics of its emollient cream formulation; the functions of individual excipients; and the efficacy, tolerability, and safety data supporting its use in adults and children, including for facial involvement.
J Drugs Dermatol. 2013;12(2)(suppl):s5-s10.
Joel Hua-Liang Lim MRCP,a Kar-Seng Lim MRCP,b and Wei-Sheng Chong FRCPc
No abstract details for the moment.
J. Mark Jackson MD,a Joseph Fowler MD,a Angela Moore MD,b Michael Jarratt MD,c Terry Jones MD,d
Kappa Meadows MD,e Martin Steinhoff MD,f Diane Rudisill BSc,g and Matthew Leoni MDg
on behalf of the Brimonidine Phase III Study Group
BACKGROUND: Brimonidine tartrate (BT) 0.5% gel demonstrated significantly greater efficacy versus vehicle gel once-daily for the treatment of moderate to severe erythema of rosacea.
OBJECTIVES: To assess the 30-minute speed of onset of topical BT 0.5% gel in reducing facial erythema in Phase III studies as measured by subject and clinician assessments of erythema.
METHODS: Two Phase III, randomized, controlled studies with identical design in which subjects with moderate erythema of rosacea (study A: n=260; study B: n=293) were randomized 1:1 to apply topical BT 0.5% or vehicle gel once-daily for 4 weeks. Evaluations included severity of erythema based on Clinician’s Erythema Assessment (CEA) and Patient’s Self-Assessment (PSA) prior to study drug application and at 30 minutes after application on days 1, 15, and 29.
RESULTS: 97.7% and 96.6% of subjects reported normal study completion for studies A and B, respectively. The percentage of subjects achieving a 1-grade improvement in both CEA and PSA was significantly increased at 30 minutes post-dosing with BT 0.5% gel compared to vehicle gel on visit days (day 1: 27.9 vs 6.9%, P<0.001; day 15: 55.9 vs 21.1%, P<0.001; Day 29: 58.3 vs 32.0%, P<0.001 for BT 0.5% gel vs vehicle) in study A. Similar results were shown for study B.
CONCLUSIONS: Once-daily topical BT gel 0.5% is not only efficacious at reducing facial erythema but also exhibits response within 30 minutes of application in a significant number of patients throughout both Phase III studies.
J Drugs Dermatol. 2014;13(6):699-704.
Megan A. Kinney MHAM BS,a Brad A. Yentzer MD,a Alan B. Fleischer Jr. MD,a Steven R. Feldman MD PhDa,b,c
Background: Acne vulgaris has been treated with long-term courses of antibiotics since the 1960s. Antibiotic-resistance of Propionibacterium
acnes (P. acnes) was first documented in the late 1970s, and, over 20 years later, the problem of antibiotic resistance
Purpose: The aim of this study was to assess trends in prescribing antibiotics for acne from 1997−2006.
Methods: The authors examined the National Ambulatory Medical Care Survey (NAMCS) database and recorded medications at all
visits to the physician in which acne vulgaris (ICD-9-CM code 706.1) was the only diagnosis from 1997−2006.
Results: Declines in the use of erythromycin and isotretinoin (both P<0.001) for acne were noted for all physicians. Tetracyclines saw
significant increases in use by both dermatologists and non-dermatologists (P<0.01 and P=0.05, respectively). Prescribing of benzoyl
peroxide monotherapy was unchanged for non-dermatologists (P=0.22) and is on the decline for dermatologists (P<0.001). The use
of BPO + clindamycin combination topical treatments rose sharply for all physicians (P<0.001), resulting in greater use of both total
BPO and total clindamycin for acne over time (P<0.001). Topical retinoid use increased among dermatologists (P<0.05) but appeared
to be on the decline among non-dermatologists (P=0.067).
Conclusion: The development of antibiotic resistance is of concern. Greater awareness of retinoid use for maintenance therapy,
using topical benzoyl peroxide to prevent resistance, and limiting use of oral antibiotics to as short a time period as possible are measures
to contribute to better eco-responsible acne treatment.
Keyvan Nouri, MD; Christopher O'Connell; Maria Patricia Rivas, MD
Topical imiquimod is an immune response modifier FDA approved for the treatment of anogenital warts. Recent studies have reported
its effectiveness in the treatment of some types of basal cell carcinomas. There have also been some case reports and case series
reporting success treating of squamous cell carcinoma in situ with imiquimod. We report two patients with squamous cell carcinoma
in situ and one with invasive squamous cell carcinoma treated with 5% imiquimod cream. Lesions were located on shin, posterior
shoulder, and nasal tip. 5% imiquimod cream was applied at night for six weeks. Side effects included erythema and crusting in
one patient. Biopsies taken four weeks after treatment revealed no residual squamous cell carcinoma in situ or squamous cell carcinoma.
Topical 5% imiquimod cream is becoming established as a promising treatment for squamous cell carcinoma in situ. It also
seems to be an alternative treatment for some cases of squamous cell carcinoma.
Aimee Krausz,a Holly Gunn MD,b and Adam Friedman MD FAADa,c
Herbal products have steadily gained popularity as alternatives to conventional, synthetic medications and are sought after by patients
for the treatment of chronic dermatologic diseases and for cosmeceutical use. The production and distribution of botanical extracts is
largely unregulated and therefore extensive research into their mechanism of action, safety, physiologic stability, and optimal dosing
has been overlooked. One of the major pathways through which natural supplements, particularly polyphenols, act is via inhibition of
oxidative stress and its downstream mediators. Endogenous defense mechanisms are inadequate to combat oxidative stress and
therefore dietary and/or topical supplementation with polyphenols are an important complementary preventative and therapeutic
strategy. This review focuses on the molecular targets of common polyphenols used in topical preparations, particularly soy, green tea,
oats, curcumin, and silymarin. Continued research into bioavailability and function of these agents will help translate their therapeutic
potential to treat clinical disease.
J Drugs Dermatol. 2014;13(8):937-943.
Boni E. Elewski MD,a Richard A. Pollak, DPM MS,b Radhakrishnan Pillai PhD,c Jason T. Olin PhDd
OBJECTIVE: To evaluate the ability of efinaconazole vehicle to reach the site of toenail onychomycosis by spreading through the subungual space between the nail plate and nail bed. Lacquer-based vehicles are primarily limited to application on the nail plate and dependent on nail plate permeation.
METHODS: 11 patients (mean age 48.5 years) were entered with clinically determined onychomycosis. Presence of fungal infection was confirmed by KOH testing in eight patients. Two separate applications of vehicle (with fluorescein incorporated for better visualization) were applied at the hyponychium, avoiding application to the exterior nail plate surface. Affected nails were later clipped to allow examination of the nail bed and further examination of the underside of the nail. Spread of formulation was assessed under visible and UV light conditions by photographing target toenails after vehicle application, and after nail clipping.
RESULTS: Assessments under both visible and UV light indicated that the vehicle had spread into the subungual space, with deposition of flourescein wherever vehicle had reached, including in the nail bed. Nail clippings also indicated deposition to the underside of the nail plate.
LIMITATIONS: The relative contributions of spreading into the subungual space, or permeation through the nail plate to the efficacy of efinaconazole topical solution, 10% in treating onychomycosis were not assessed.
CONCLUSIONS: This study suggests that the vehicle developed for efinaconazole topical solution, 10%, when applied at the hyponychium, spreads into the subungual space between the nail plate and nail bed, reaching the site of infection.
J Drugs Dermatol. 2014;13(11):1394-1398.
Clinicians treating corticosteroid-responsive dermatoses, such as eczema and atopic dermatitis, contact dermatitis, seborrheic dermatitis, and psoriasis, have numerous treatment options. The decision to choose a topical corticosteroid depends on several different factors, such as potency, formulation, dosage, cosmetic elegance, cost, etc. Among these, Promius Pharma's Cloderm (clocortolone pivalate cream 0.1%) was introduced into the market more than 3 decades ago, and it remains a versatile treatment option for dermatoses. Phase 3 clinical trial data have demonstrated the efficacy and tolerability of Cloderm in several steroid responsive dermatoses. In studies for eczema and atopic dermatitis, statistically significant improvement relative to placebo was seen at day 4 with Cloderm. In psoriasis trials, Cloderm cream demonstrated superiority to placebo by day 7, continuing at days 14, 21, and 28. Thus, Cloderm's early onset of action will contribute to increased compliance for patients.
Deborah S. Sarnoff MD FAAD FACP, Ritu Saini MD FAAD
Epidermolytic hyperkeratosis is a rare genetic disorder of keratinization. In childhood, patients are erythrodermic and have
a compromised stratum corneum, replaced with generalized hyperkeratosis as the patients age. Treatment consists of topical
emollients as well as, topical and oral retinoids. Ultraviolet (UV) light, often in combination with psoralen ultraviolet
A (PUVA) is widely used as a therapeutic modality for a multitude of hyperproliferative disorders. Although not strictly
indicated for epidermolytic hyperkeratosis, it has been utilized as experimental treatment, particularly in the days prior
to retinoids. Psoralen ultraviolet A has also been implicated in the development of nonmelanoma skin cancers, especially,
squamous cell carcinoma (SCC). Retinoids are well-known to protect against nonmelanoma skin. A patient with epidermolytic
hyperkeratosis with multiple nonmelanoma skin cancers, previously treated with PUVA and long-standing oral
retinoids is reported.
Jerry L. McCullough PhD, Raymond L. Garcia MD, Barry Reece
Objective: Pyratine 6™ has been shown to have antiaging effects in human skin cells. The purpose of this study is to determine
the cosmetic efficacy and tolerance of topical Pyratine 6 (0.10%) over 12 weeks for improving the baseline clinical
signs and symptoms of photodamaged facial skin.
Methods: A single-arm longitudinal study with observations at 2, 4, 8, and 12 weeks was conducted. Forty healthy women
with mild to moderate signs of photodamaged facial skin applied Pyratine 6 twice daily for 12 weeks. Efficacy and safety
were evaluated by clinical observations, digital photography, transepidermal water loss (TEWL), skin capacitance, and
silicon replicas at each time point.
Results: Topical Pyratine 6 achieved significant improvement from baseline in roughness and skin moisture content after
2 weeks. After 4 weeks, significant improvement in fine wrinkles, mottled hyperpigmentation, and TEWL were observed.
Improvements in most parameters were maintained throughout the remaining weeks of the study. For most silicon replica
parameters, changes were consistent with increased skin smoothing. Facial erythema was reduced at 2 weeks and further
reduced at 4, 8, and 12 weeks. Adverse effects were minimal and transient.
Conclusions: Treatment with Pyratine 6 over 12 weeks improves roughness and skin moisturization in 2 weeks compared
to baseline and mottled hyperpigmentation and fine wrinkles in 4 weeks compared to baseline. Reduction in facial erythema occurs as early as 2 weeks. Adverse effects are minimal and transient.
Shane Silver MD,a Raj Tuppal MD,b Aditya K Gupta MD,c Fabrice Clonier MSc,d
Martin Olesen MD,e Randy Leeder PhD,e and Victoria Taraska MDf
BACKGROUND: The two-compound topical suspension/gel containing calcipotriene plus betamethasone dipropionate is effective and safe in the treatment of psoriasis on the body and scalp within the general psoriasis patient population.
OBJECTIVE: To evaluate the systemic effects of once-daily use of two-compound topical suspension/gel on the hypothalamic-pituitary-adrenal (HPA) axis and calcium homeostasis in subjects with extensive psoriasis vulgaris.
METHODS: An open-label, single-group, 8-week trial in 43 subjects with extensive psoriasis covering 15–30% of the body surface area. Blood and 24-hour urine samples were collected and a standard-dose adrenocorticotropic hormone (ACTH) stimulation test was performed at baseline, weeks 4 and 8. Primary endpoints were serum cortisol 30 minutes after ACTH injection (HPA axis response abnormal at serum cortisol ≤18 μg/dL) and changes from baseline in albumin-corrected serum calcium (sCa), 24-hour urinary calcium excretion (24hCa) and urine calcium:creatinine ratio (Ca:Crea).
RESULTS: Two (4.7%) subjects showed signs of adrenal suppression based on the ACTH stimulation test results at week 4; both were withdrawn from treatment and had normal serum cortisol 30-minute values at follow-up 4 weeks later. None of the subjects who continued treatment to week 8 showed signs of adrenal suppression. There were no clinically relevant mean changes from baseline to weeks 4 and 8 in sCa, 24hCa or Ca:Crea and no subject had sCa above the reference range.
CONCLUSION: The two-compound topical suspension/gel containing calcipotriene plus betamethasone dipropionate may be applied once daily to extensive psoriasis vulgaris without generally causing adrenal suppression or disturbance of calcium homeostasis, consistent with previous findings. In a small number of patients with extensive psoriasis treated with large volumes of topical suspension, adrenal suppression may be observed. In the real-world setting, it is anticipated that systemic side-effects would occur in only a few cases within the general psoriasis patient population.
J Drugs Dermatol. 2013;12(8):882-887.
ClinicalTrials.gov Identifier: NCT 01229098
Kavita Beri MDa and Sandy S. Milgraum MDb
INTRODUCTION: As we enter a new age of increasing demand in novel cosmetic therapies, we are challenged to provide excellent results with minimal downtime and safety in all skin types. In this open case series we are studying the improvement in rhytides by combining
a novel, FDA-approved, non-ablative fractionated Q-switched ND: YAG 1,064-nm laser that acts in the deep dermis, with a topical containing plant stem cell extract and N-acetyl glucosamine (NAG) that acts in the superficial dermis.
METHOD: Six healthy females (Skin types III - V) were selected for the study with mean average age of 56 years +/- 11 years. The rhytides on the face and neck were assessed using a comprehensive grading scale. Patients were then divided into two groups, one received only laser treatment with the fractionated QSW 1,064 nm laser and the other group received combined treatment with the laser and topical. Patients were assessed again at 4 and 8 weeks.
RESULTS: We observed an enhanced anti-aging effect of the laser in the patients with combined treatment.
DISCUSSION: Understanding the effect of this novel laser therapy on human stem cells and investigating the basis of its synergistic effect with plant stem cell extract and NAG will lead us to better understand stem cell activity. Non-ablative tissue regeneration is the next step in providing optimal anti-aging treatments.
J Drugs Dermatol. 2015;14(11):1342-1346.
Telia DeBoyes MD, David Kouba MD, David Ozog MD, Edgar Fincher MD, Lauren Moy, Kathryn Iwata, Ronald Moy MD
Background: Actinic keratosis is regarded as a carcinoma in situ by some dermatologists and its incidence continues to rise. Exposure to ultraviolet (UV) radiation is considered to be an important risk factor for developing these pre-malignant lesions. DNA repair enzymes have been shown to reverse sun-damage, resulting in reduced rates of actinic keratoses and non-melanoma skin cancers in specific patient populations.
Methods: Seventeen patients were evaluated for differences in actinic keratoses following topical application of T4N5 liposome lotion over 48 weeks.
Results: Compared to baseline, a statistically significant reduction in the number of actinic keratoses was seen following the treatment period.
Discussion: This study suggests that DNA repair enzyme creams effectively reduce the number of actinic keratoses in normal individuals with moderate-to-severe photodamaged skin.
Kalindi Raval PharmD, Jennifer H. Lofland PharmD MPH PhD, Heidi C. Waters MS MBA, Catherine Tak Piech MBA
Plaque psoriasis is a chronic, inflammatory skin disease that can be difficult to treat. Traditional systemic agents, topical agents,
phototherapy and biologic therapies can be used for patients with psoriasis. The authors reviewed published results from a variety
of sources in order to better understand the effects of psoriasis treatments on patient satisfaction, patient adherence, healthcare
resource utilization and productivity. Patients with psoriasis consider many factors when evaluating therapies, including the time for
the therapy to be effective, cosmetic issues common with topical therapies and travel to and from phototherapy centers. Satisfaction
with and adherence to biologic therapies appears to be greater than for traditional therapies. Although biologic therapies are generally
more expensive than are traditional, these agents may contribute to decreased healthcare utilization and increased productivity.
J Drugs Dermatol. 2011;10(2):189-196.
Theodore Rosen MD,a Sheila Fallon Friedlander MD,b Leon Kircik MD,c Matthew J. Zirwas MD,d
Linda Stein Gold MD,e Neal Bhatia MD,f Aditya K. Gupta MD PhD MBAg
Onychomycosis is an often overlooked and/or undertreated disease. This may be in part due to an under appreciation among both physicians and patients of its impact on quality of life and the potential for significant complications, from tinea corporis and cruris, to bacterial superinfection. Some health care providers are unaware of the effective low-risk treatments currently available. Changing demographic characteristics such as the relative aging of the population; the increasing prevalence of diabetes and peripheral vascular disease, and widespread iatrogenic immunosuppression; and changes in lifestyle practices such as earlier and greater participation in sports, are likely to lead to an increased prevalence of onychomycosis in both adults and children. Two topical onychomycosis treatments, efinaconazole 10% solution, and tavaborole 5% solution were recently approved by the FDA. This article reviews the state of knowledge and describes, briefly, these new treatment options.
J Drugs Dermatol. 2015;14(3):223-228.
Emil A. Tanghetti MD,1 J. Mark Jackson MD,2 Kevin Tate Belasco DO MS,3 Amanda Friedrichs MD,4 Firas Hougier MD,5 Sandra Marchese Johnson MD,6 Francisco A. Kerdel MD,7 Dimitry Palceski DO FAOCD,8 H. Chih-ho Hong MD FRCPC,9 Anna Hinek MD MSc FRCPC,10 Maria Jose Rueda Cadena MD11
Rosacea is a chronic inflammatory disease with a complex pathophysiology that manifests with central facial redness with or
without papulopustular lesions. Often, patients with rosacea present with a constellation of signs and symptoms; for best results,
the treatment plan should take into account all symptoms manifesting in the individual patient. The first available pharmacologic
treatment to address the redness associated with rosacea is topical brimonidine. In the United States, brimonidine topical gel
0.33% is indicated for persistent facial erythema of rosacea; approval was based on clinically significant efficacy and good safety
data from large-scale clinical trials. Use of brimonidine in routine clinical practice has yielded new insights that elaborate on the
findings from clinical trials. For example, real-world use has shown that a percentage of patients (in our experience, approximately
10 to 20%) treated with brimonidine experience a worsening of erythema that has been called “rebound.” Our routine use of
this agent for >1 year has yielded strategies to set patient expectations, optimize treatment initiation, and minimize potential
problems; this article details those strategies. Because we believe that the term “rebound” has been used to describe several
physiologically distinct events, we have also proposed more specific terminology for such events.
J Drugs Dermatol. 2015;14(1):33-40.
Monya L. Sigler PhD, and Thomas J. Stephens PhD
BACKGROUND: Chronic exposure to the sun causes the skin to prematurely age. Photodamaged skin is characterized by progressive
damage to the dermal extracellular matrix with loss of collagen and degradation of elastin. Clinical manifestations of such photoaged
or photodamaged skin include wrinkles and irregular pigmentation. Various cosmetic treatments including topical retinoids, growth
factors, and skin lighteners have shown some benefit. Salts of copper chlorophyllin complex are semi-synthetic naturally derived compounds
with anti-oxidant and wound healing activity that has not been previously tested in photodamaged skin.
OBJECTIVES: This single-center pilot study was conducted to assess the efficacy and safety of a liposomal dispersion of topically applied
sodium copper chlorophyllin complex in women with mild-moderate fine lines and wrinkles in the periocular areas and facial solar
lentigenes over a course of 8 weeks.
METHODS: Subjects were supplied with the test product, a topical gel containing chlorophyllin complex salts (0.066%), with directions to
apply a pea-sized amount to the periocular areas, cheeks and nose every morning and evening. Clinical assessments were performed at
screening/baseline and at week 8. Standardized digital photographs were taken and self-assessment questionnaires were conducted.
RESULTS: Ten subjects completed the 8-week study. All clinical efficacy parameters showed statistically significant improvements over
baseline at week 8. The study product was well tolerated. Subject questionnaires showed the test product was highly rated.
CONCLUSIONS: In this pilot study, a topical formulation containing a liposomal dispersion of sodium copper chlorophyllin complex was shown
to be clinically effective and well tolerated for the treatment of mild-moderate photodamage and solar lentigenes when used for 8 weeks.
J Drugs Dermatol. 2015;14(4):401-404.
Emily M. Berger BA, Hassan I. Galadari MD, Alice B. Gottlieb MD PhD
Hailey-Hailey disease is an autosomal dominant skin condition characterized by waxing and waning painful and pruritic
vesicles and plaques affecting the intertriginous areas. Its pathogenesis involves inherited abnormalities in a cutaneous calcium
pump. Most patients are managed conservatively with topical corticosteroids as well as topical and oral anti-infective
agents. Scarce reports in the literature describe the use of oral retinoid therapy to manage refractory cases. We present
a case of Hailey-Hailey disease in a 64-year-old man who was refractory to conservative management but improved dramatically
over 6 months of oral therapy with 25 mg of acitretin daily. The mechanism by which such therapy improves
disease manifestations is unknown. A potential mechanism is based on the influence of retinoids on epidermal differentiation
and may involve cutaneous calcium homeostasis. Hailey-Hailey disease is discussed and the use of oral retinoid treatment
for Hailey-Hailey disease is reviewed.
Sara M. James BS,a Dane E. Hill MD,a and Steven R. Feldman MD PhDa,b,c
BACKGROUND: Costs for psoriasis have increased in recent years, in part due to the introduction of biologic agents.
OBJECTIVE: To identify the most common and most costly (from the payer perspective) drugs used in the treatment of psoriasis.
METHODS: We analyzed patient data from a large claims-based database in order to identify the most common and most costly medications
used in the treatment of psoriasis from 2010 to 2014.
RESULTS: The three most common psoriasis medications, accounting for 81.1% of all psoriasis medications, were topical corticosteroids.
The three most costly drugs, accounting for only 9.6% of all psoriasis medications, were biologics, accounting for 86% of the cost of psoriasis medications.
CONCLUSIONS: Biologic agents are used far less commonly in the treatment of psoriasis than topical treatments. Despite the relatively small number of patients using biologic agents, biologics are responsible for a large proportion of the cost of psoriasis pharmacotherapy.
J Drugs Dermatol. 2016;15(3):305-308.
Topical corticosteroids have been the mainstay of treatment for atopic dermatitis (AD) over the last decade, especially in the setting
of acute flares. However, heavy and prolonged use of topical corticosteroid is undesirable as it is associated with side effects such
as, skin atrophy, telangiectasia, striae, steroid-induced dermatoses, rosacea, acne exacerbation, and in some severe and rare cases,
systemic effects such as hypothalamic-pituitary-adrenal axis suppression, growth retardation and ocular problems. Non-steroidal antinflammatory
agents specific for the treatment of AD (topical calcineurin inhibitors, or TCIs) are now available and they are a viable
alternative to topical corticosteroids in treating dermatitis of the face, neck, eyelids, and intertriginous areas where there is a greater
risk of the steroid-induced side effects. More recently, medical device emollients have entered the marketplace. These medical devices
provide, but are not limited to, anti-oxidant, anti-protease, anti-inflammatory activity, and aid in restoring the natural balance of
lipids, which is one of the causes of the epidermal abnormalities seen with AD. The present study evaluated the short-term effectiveness
and appeal of a non-steroidal medicated device foam as compared to pimecrolimus cream 1% in the treatment of AD within a
wide age group of subjects with active disease at baseline. In this study, both pimecrolimus and the medical device foam exhibited
efficacy in mild-to-moderate AD. Primary efficacy was measured by IGA. After four weeks of treatment with the medical device
foam, 82% of target lesions were scored "clear" (0) or "almost clear" (1) compared to 71% of target lesions under the pimecrolimus
arm. This study confirmed that pimecrolimus cream 1% and the medical device foam work well in the treatment of AD in both adults
and children with no associated adverse effects.
J Drugs Dermatol. 2011;10(6):666-672.
James Leyden MD, Gary Grove PhD, Charles Zerweck PhD
The facial tolerability of various topical retinoids was evaluated in 253 healthy volunteers in a series of split-face, randomized, investigator-
masked studies—all conducted at the same site by the same investigator. Four variables were evaluated to determine if they
influenced tolerability—retinoid concentration, formulation vehicle, skin sensitivity, and individual retinoid. Lower retinoid concentrations
were associated with less irritation. Vehicle influenced tolerability but whether a gel or cream formulation was better tolerated
varied from retinoid to retinoid. Tolerability was superior on normal skin than “sensitive skin.” On normal skin, tazarotene
cream was better tolerated than tretinoin cream whereas adapalene and tretinoin microsponge gels were better tolerated than
tazarotene gel. On sensitive skin, tazarotene and adapalene creams were better tolerated than tretinoin cream whereas adapalene gel
was better tolerated than tazarotene gel. Retinoid concentration, vehicle, skin sensitivity, and retinoid can all affect facial tolerability.
Skin vulnerability may be the most important factor.
Doris Day MD,a Cheryl M. Burgess MD,b Leon H. Kircik MDc
Background: Melatonin is an endogenous hormone commonly associated with regulation of sleep. However, over the last two decades, research has elucidated a range of effects associated with the compound, including anti-inflammatory, both direct and indirect antioxidant activity, tissue regenerative benefits, and preservation of mitochondrial function. Melatonin’s anti-inflammatory and antioxidant support, coupled with its mitochondrial support, make it an intriguing target for use to support skin health. Human skin and hair follicles express functional melatonin receptors. They also engage in substantial melatonin synthesis. By supporting cutaneous homeostasis, melatonin and its metabolites are thought to attenuate carcinogenesis and possibly other pathological processes, including hyperproliferative/inflammatory conditions.
The primary extrinsic driver of aging has been considered to be exposure to ultraviolet (UV) light, which is well-established to contribute to sunburn, immunosuppression, skin aging, and carcinogenesis. Topically applied melatonin has been shown to reduce markers of reactive oxygen species formation and to reverse signs of skin aging.
As the global population continues to age, photo-damage remains a significant cutaneous concern. While use of sunscreens and UV avoidance strategies are essential to mitigate skin cancer risks, the potential to protect the skin and improve the appearance of photo-damage through the use of topical antioxidant support is appealing. The evidence suggests that melatonin deserves consideration for topical use as an anti-aging and skin protective agent. It is shown to be both safe and effective when topically applied.
J Drugs Dermatol. 2018;17(8):966-969.
Alan Shalita MD, Judith A. Myers, Lincoln Krochmak MD, Alex Yaroshinsky PhD
Clindamycin phosphate is the most widely used topical antibacterial agent for acne treatment. Treatment of patients with mild
to moderate acne vulgaris with a new foam formulation (clindamycin foam, CF) for 12 weeks was at least as effective as clindamycin
gel (CG) based on the Investigator’s Static Global Assessment (ISGA) score. CF was superior to CG based on the
reduction from baseline in total (P = .0014), inflammatory (P = .0478), and noninflammatory (P = .0037) acne lesion counts.
Additionally, CF achieved efficacy that was superior to that of vehicle foam based on ISGA score (P = .0025) and all 3 lesion
counts (all P < .05). Adverse experiences in the active treatment groups were mild or moderate and transient in nature. Thus
the foam formulation of clindamycin is a safe and effective acne treatment; the unique foam delivery vehicle may offer cosmetic
benefits to the patient and thus increase compliance
Andrew F. Alexis MD MPH,a Lori A. Johnson PhD,b Nabil Kerrouche MSc,c and Valerie D. Callender MDd
Three multicenter, randomized, double blind, parallel-group, placebo controlled studies involving 3,855 subjects established the
safety and efficacy of an adapalene benzoyl peroxide topical gel in the treatment of acne for all skin types. The data from these 3
studies were pooled and the subgroup of self-identified black subjects was analyzed separately. Significantly more black subjects
had IGA success with adapalene-BPO than with vehicle at week 12. Significantly more black subjects also had decreased total, inflammatory,
and noninflammatory lesion counts with adapalene-BPO that were seen as early as week 1. Adapalene-BPO was well
tolerated in the black subjects included in this analysis and no cases of treatment-related PIH were observed. Similar results were
obtained for this subgroup as the overall population from the 3 studies. Based on the results from this analysis, adapalene-BPO is a
safe and effective treatment for acne in black skin.
J Drugs Dermatol. 2014;13(2):170-174.
Alexiades-Armenakas MD PhD
Background: Acne patients who fail to respond to conventional treatments have been treated with isotretinoin, an effective
treatment coming under strict regulation due to the risk of significant side effects. Photodynamic therapy (PDT) may be a
viable alternative treatment for recalcitrant acne of various types and levels of severity.
Objective: To determine the safety and efficacy of combination PDT with topical 5-aminolevulinic acid (ALA) and activation
by long-pulsed, pulsed dye laser (LP PDL, 595 nm) energy with topical therapy in patients with mild to severe acne.
Methods: A prospective, controlled pilot, proof-of-principle study of 19 consecutive patients (aged 16-47 years, Fitzpatrick
skin types I-VI) with mild to severe cystic, inflammatory, or comedonal acne of the face was conducted. All patients had
failed conventional therapy, including oral antibiotics, topical treatments, hormonal therapy, laser procedures (without
ALA), and/or oral isotretinoin. Fifteen patients were treated with ALA PDT and 4 patients served as controls; all were
continued on topical medications. Patients undergoing PDT were initially randomized to receive either blue light or laser
energy. Because recrudescence occurred in 1 patient while undergoing multiple treatments with ALA and blue light, all
subsequent patients were treated with ALA and laser energy. The total number of patients treated with LP PDL-mediated
ALA PDT was 14. ALA was applied for a short 45-minute incubation followed by 1 minimally overlapping pass with the LP
PDL (595 nm, 7.0-7.5 J/cm2 fluence, 10-ms pulse duration, 10-mm spot size, and dynamic cooling spray of 30 ms with a 30-
ms delay). Patients treated with conventional therapy (oral antibiotics, oral contraceptives, and topical medications) or laser
energy without ALA PDT served as control groups. Patients were followed monthly for up to 13 months.
Results: Complete clearance was achieved in 100% (14 out of 14) patients in the LP PDL PDT-treated group. A mean of
2.9 treatments (range 1-6; 2.0-3.7, 95% CI; n=14) was required to achieve complete clearance for a mean follow-up time of
6.4 months (range 1-13; 3.8-8.9 95% CI; n=14). The patient mean percent lesional clearance rate per treatment was 77%
(64%-90%, 95% CI; n=14). Improvement in acne lesions became apparent within 1 to 2 weeks after the first treatment.
Clearance in the LP PDL PDT group was superior to control groups. In the LP PDL-only control group (n=2), the patient
mean percent lesional clearance rate per treatment was 32% without complete clearance after 3 to 4 treatments. In the oral
antibiotics, oral contraceptives, and topicals control group (n=2), the clearance rate per treatment was 20%, the mean clearance
rate per month was 4%, and complete clearance was not achieved after 6 to 10 months. In the LP PDL-mediated PDT
group, treatments were well-tolerated with minimal erythema lasting 1 to 2 days. No cases of crusting, blistering, purpura,
scarring, or dyspigmentation occurred. A reduction in the erythema in erythematous acne scars was observed.
Conclusion: For teenage to adult patients with recalcitrant comedonal, inflammatory, or cystic acne of various degrees
of severity, ALA PDT with activation by LP PDL appears to be a safe and effective treatment with minimal side effects.
LP PDL-mediated PDT may serve as an important alternative to isotretinoin. Cosmetically well-accepted, LP PDL PDT
combined with topical therapy is the first PDT modality to achieve complete clearance with long-term follow-up as
compared to controls.
New Technologies for the Rejuvenation of the Periorbital Region
As one of the most powerful and versatile features of the human face, the eyebrow informs the perception of beauty and plays a critical role in sexual dimorphism, facial recognition, and non-verbal communication. Eyebrow hair also serves many important biologic functions, including sensory transmission and protection from the elements, as well as playing an important role in cosmesis and expression.
New technologies to tighten and resurface the skin, to grow the hair of the eyelashes and eyebrows, to smooth-en and lighten the skin, and to replace volume lost from this area have created opportunities for rejuvenation that were not possible until recently. These include prostaglandin analogues that not only increase the length and width of the eyelashes but also improve the length and girth of eyebrow hair. Use of topical bimatoprost daily resulted in an improvement of eyelashes in 78.1% of subjects after 16 weeks. Using it in conjunction with botulinum toxins, light sources, topical cosmeceuticals, and fillers such as hyaluronic acid has vastly improved physicians' ability to treat the periorbital region.
Sarina B. Elmariah MD PhDa and Roopal V. Kundu MDb
Progressive macular hypomelanosis is an under-recognized disorder characterized by the presence of numerous ill-defined hypopigmented
macules and patches on the trunk of young adults. Although common, particularly in Fitzpatrick skin types IV-VI, this condition
is frequently misdiagnosed and treated inadequately with antifungals or topical steroids resulting in patient frustration. The exact pathogenesis of progressive macular hypomelanosis is unknown; however, recent studies suggest hypopigmentation results from decreased melanin formation and altered melanosome distribution in response to Proprionibacterium. While there are no well-established
or consistently effective therapies for progressive macular hypomelanosis, our growing understanding of its pathogenesis urges consideration of alternative treatment strategies. Here, we report five patients with progressive macular hypomelanosis who benefitted from topical and systemic antimicrobial therapy and summarize the current clinical, pathological and treatment paradigms of this disorder.
J Drugs Dermatol. 2011;10(5):502-506.
The skin of patients with rosacea is extremely sensitive and hyper-reactive to dietary, environmental, and topical factors.
Accordingly, the management of rosacea involves not only choosing appropriate medication and treatment for
daily skin care, but also avoiding known trigger factors. Recently, 1% metronidazole, a mainstay of topical rosacea therapy,
was reformulated in a gel vehicle that contains hydrosolubilizing agents (HSA) niacinamide, beta cyclodextrin,
and a low concentration of propylene glycol. It is designed to solubilize greater concentrations of metronidazole than
is possible in water alone while reducing the potential for irritation and barrier disruption. A 2-week study was undertaken
by the author to evaluate the effect of the new 1% metronidazole gel on the skin barrier in 25 women with mild
to moderate rosacea. Statistically significant improvement in disease severity, erythema, desquamation, and skin irritation
was noted by the investigator by the end of week 1, which continued throughout the study. After 2 weeks, subjects
noted improvements in skin condition and rosacea. Results of noninvasive assessments showed no disruption of the skin
barrier. Furthermore, there was an increasing trend in skin hydration that approached statistical significance.
Raza Aly PhD,a Aditya K. Gupta MD PhD,b,c Tate Winter PhD,d Lee T. Zane MD,e Tracey Vlahovic DPMf
Toenail onychomycosis is a chronic fungal infection that often requires prolonged treatment in order to effectively manage pathogenic organisms and obtain a clear nail. Traditionally, certain clinical features of onychomycosis, including the presence of substantial lateral disease, focal fungal masses, yellow/brown streaks, and extensive nail involvement (ie, >50%), indicate a poor treatment prognosis and have proven difficult-to-treat with oral or traditional topical therapies. Owing to the novel features of topical tavaborole, we sought to understand the potential utility of tavaborole in difficult-to-treat onychomycosis. A blinded, post-hoc assessment of Phase III trials was conducted, focusing on initial presentation, midpoint assessment (24 weeks), and final outcomes (52 weeks) in subjects identified as having difficult-to-treat onychomycosis and treated for 48 weeks with once-daily application of either tavaborole 5% solution or vehicle. Our post-hoc analysis identified 84 difficult-to-treat cases (tavaborole 5%; n=60; vehicle, n=24) in subjects with toenail onychomycosis due to Trichophyton rubrum or Trichophyton mentagrophytes. No subjects identified as difficult-to-treat and treated with vehicle achieved a complete cure, while 6 subjects treated with tavaborole 5% attained a completely clear nail and negative mycology. Similarly, 7 subjects treated with tavaborole 5% solution achieved an almost complete cure (≤10% involvement and negative mycology) while 1 subject on vehicle achieved an almost complete cure. We present a case series of 4 patients, of varying age and difficult-to-treat clinical features, which responded positively to tavaborole 5% solution. Three of the subjects achieved complete cure after being treated with tavaborole 5%, with one additional subject (an 88-year-old female) achieving an almost complete clear nail by treatment end. The outcomes presented here may not be reflective of patients that may present with these clinical characteristics. Additional investigations would be useful in order to assess the value of topical tavaborole 5% solution in difficult-to-treat clinical presentations of onychomycosis.
J Drugs Dermatol. 2017;16(10):1016-1021.
Toni C. Stockton MD,a Emil A. Tanghetti MD,b Edward Lain MD,c Joshua A. Zeichner MD,d and Nancy Alvandi PhDe
BACKGROUND: Dapsone gel, 7.5% is a topical medication approved for acne in patients aged 12 years and older. Clinical trials have demonstrated the safety and efficacy of once-daily dapsone gel, 7.5% in patients with moderate acne.
OBJECTIVE: The objective of this report is to describe the clinical course of 8 patients who participated in a 12-week program using once-daily dapsone gel, 7.5% as monotherapy for acne in a real-world clinical setting.
MONOTHERAPY PROGRAM: Male and female adults and adolescents with facial acne, representing a broad range of ages, skin phototypes, and ethnicities, and with no prior use of dapsone gel, 7.5% applied the product once daily for 12 weeks as monotherapy for acne. Photographs were taken at baseline and at 12 weeks. The treating dermatologists recorded observations of baseline disease, treatment tolerability, and outcomes. An independent rater assessed Global Acne Assessment Score (GAAS) at baseline and at 12 weeks based on photographs. Patients provided testimonials of their experience with treatment.
PROGRAM OUTCOMES: Acne improvement was evident in the photographs of the 8 patients. Changes in GAAS at week 12 of treatment, as assessed by an independent rater, ranged from 1- to 3-grade improvement from baseline.
CONCLUSION: Photographs, dermatologist reports, and patient commentary in an office-based practice demonstrated that 12 weeks of treatment with only topical dapsone gel, 7.5%, applied once daily, was effective and well tolerated as a stand-alone treatment in 8 patients with facial acne vulgaris, with results that are consistent with the phase 3 pivotal trials.
J Drugs Dermatol. 2018;17(6):602-608.
This randomized, controlled, investigator-blinded study performed by an independent research organization evaluated the appearance of periorbital and perioral wrinkles following twice-daily application of a specific blend of matrikines and matrikine-like synthetic peptides
for skin rejuvenation over a 6-month period. Fine lines and wrinkles of 133 women, aged 38 years to 65 years, were assessed by an independent expert evaluator using a 5-point visual analogue score. Subjects were divided into 3 groups and randomized to receive either the matrikine-based technology (MPC) or 1 of the 2 materials containing traditional growth factors. Test materials were well tolerated, and all 3 significantly reduced the appearance of periorbital and perioral wrinkles after 3 and 6 months. In the group receiving
the matrikine-based technology, periorbital wrinkles improved (≥ 1 unit) in 28% of subjects after 1 month, in 65% after 3 months, and in 81% after 6 months. Perioral wrinkles improved (≥ 1 unit) in 39% of subjects after 1 month, in 41% after 3 months, and in 59% after 6 months. Improvements in skin firmness, tactile roughness, and pore appearance were also observed with each test material. Use of MPC was associated with significantly improved skin elasticity after 2 months (20%) and at 6 months (16%), whereas the comparator materials had no significant effects on elasticity. This study demonstrates that topical use of a specific blend of matrikines and matrikine-like peptides is suitable for skin rejuvenation. It also provides evidence that topical use of this novel technology provides comparable results to other technologies that use traditional growth factors for skin rejuvenation, with an additional potential benefit of improved skin elasticity.
J Drugs Dermatol. 2016;15(4):457-464.
Leon Kircik MD and James Q. Del Rosso DO
This study compared the safety and efficacy of a non-prescription topical hemostatic powder (THP) containing a hydrophilic polymer
and a potassium-based salt (group 1) to a sterile, compressed surgical sponge (group 2) for second intention healing (SIH) in 24 subjects
following Mohs micrographic surgery (MMS) for the removal of non-melanoma skin cancers of the head and neck with a final
defect size of 0.5 mm–2.0 cm. At least 50% of the subjects were receiving ongoing anti-coagulants. Hemostasis, rate of healing,
wound size, global assessments of healing and application-site reactions were assessed. Time to hemostasis was measured at the
time of surgery. Group 1 achieved hemostasis at a median of 52.5 seconds after the first stage of MMS versus 60 seconds in group
2. By week 12, wound size was reduced by a median of 182 mm2 in group 1 and 161.5 mm2 in group 2. A case series of subjects
treated with THP following 4-mm punch biopsies is also discussed.
Adelaide A. Hebert MD,a Nuria Albareda MD,b Theodore Rosen MD,c Antonio Torrelo MD,d Ramon Grimalt MD,e Noah Rosenberg MD,f Ilonka Zsolt MD,b Xavier Masramon MDg
Ozenoxacin is a novel topical antibacterial agent with potent bactericidal activity against Gram-positive bacteria that has been developed as a 1% cream for treatment of impetigo. This article presents pooled results of pivotal clinical trials of ozenoxacin with the objective of evaluating the efficacy, safety, and tolerability of ozenoxacin 1% cream after twice-daily topical treatment for 5 days in patients with impetigo. A pooled analysis was performed of individual patient data from two multicenter, randomized, double-blind, vehicle-controlled phase 3 registration studies conducted in patients with impetigo. Both clinical trials followed a similar methodology. Patients were randomized 1:1 to ozenoxacin or vehicle. One trial included retapamulin as an internal control. Efficacy was measured using the Skin Infection Rating Scale and microbiological culture. Safety and tolerability were evaluated. Ozenoxacin demonstrated superior clinical success versus vehicle after 5 days of therapy, superior microbiological success versus vehicle after 2 days of therapy, and was safe and well-tolerated. Ozenoxacin showed superior clinical and microbiological response versus vehicle in children as young as 2 months of age, and adults, with impetigo.
Clinical Trial Registration: ClinicalTrials.gov identifier: NCT01397461 and NCT02090764; European Clinical Trials Database Number: 2011-003032-31 and 2014-000228-52.
J Drugs Dermatol. 2018;17(10):1051-1057.
Thomas J. Stephens PhD,a John P. McCook BS,b and James H. Herndon Jr. MDc
BACKGROUND: Acne vulgaris is one of the most common skin diseases treated by dermatologists. Salts of copper chlorophyllin complex are semi-synthetic naturally-derived compounds with antioxidant, anti-inflammatory and wound healing activity that have not been previously tested topically in the treatment of acne-prone skin with enlarged pores.
OBJECTIVES: This single-center pilot study was conducted to assess the efficacy and safety of a liposomal dispersion of topically applied sodium copper chlorophyllin complex in subjects with mild-moderate acne and large, visible pores over a course of 3 weeks.
METHODS: Subjects were supplied with the test product, a topical gel containing a liposomal dispersion of sodium copper chlorophyllin complex (0.1%) with directions to apply a small amount to the facial area twice daily. Clinical assessments were performed at screening/baseline and at week 3. VISIA readings were taken and self-assessment questionnaires were conducted.
RESULTS: 10 subjects were enrolled and completed the 3-week study. All clinical efficacy parameters showed statistically significant improvements over baseline at week 3. The study product was well tolerated. Subject questionnaires showed the test product was highly rated.
CONCLUSIONS: In this pilot study, a topical formulation containing a liposomal dispersion of sodium copper chlorophyllin complex was shown to be clinically effective and well tolerated for the treatment of mild-moderate acne and large, visible pores when used for 3 weeks.
J Drugs Dermatol. 2015;14(6):589-592.
Won-Jeong Kim MD, aJung-Min Park MD,a Hyun-Chang Ko MD,a,b Byung-Soo Kim MD PhD,a,c Moon-Bum Kim MD PhD, a,c and Margaret Song MDa
No abstract details for the moment.
This supplement to the Journal of Drugs in Dermatology
was supported by an independent educational grant from Obagi Medical
Marie Alexia Stoddard BS,a Jennifer Herrmann MD,b,c,d Lauren Moy MD,e and Ronald Moy MDb,f
BACKGROUND: Atrophic scarring in skin of color is a common, permanent, and distressing result of uncontrolled acne vulgaris. Ablative lasers and chemical peels are frequently used to improve the appearance of atrophic scars, primarily through the stimulation of collagen and elastin; however, these treatment modalities are associated with risks, such as dyspigmentation and hypertrophic scarring, especially in patients with darker skin.
OBJECTIVE: We evaluated the efficacy of topically applied synthetic epidermal growth factor (EGF) serum in reducing the appearance of atrophic acne scars in skin of color.
METHODS: A single-center clinical trial was performed on twelve healthy men and women (average age 32.5) with Fitzpatrick Type IV-V skin and evidence of facial grade II-IV atrophic acne scars. Subjects applied topical EGF serum to the full-face twice daily for 12 weeks. Scar improvement was investigated at each visit using an Investigator Global Assessment (IGA), a Goodman grade, clinical photography, and patient self-assessment.
RESULTS: Eleven subjects completed the trial. Compared to baseline, there was an improvement in mean IGA score from 3.36 (SEM = 0.15) to 2.18 (SEM = 0.33). Mean Goodman grade was reduced from 2.73 (SEM = 0.19) to 2.55 (SEM = 0.21). Of the eleven pairs of before and after photographs, nine were correctly chosen as the post-treatment image by a blind investigator. On self-assessment, 81% reported a “good” to “excellent” improvement in their scars compared to baseline (P = 0.004).
CONCLUSION: Topical EGF may improve the appearance of atrophic acne scars in skin of color. Additional, larger studies should be conducted to better characterize improvement.
J Drugs Dermatol. 2017;16(4):322-326.
Macrene Alexiades MD PhDa,b
BACKGROUND: Fractional laser resurfacing enhances trans-epidermal delivery (TED), however laser penetration depths >250- μm fail to substantively increase drug delivery.
AIM: Evaluate the safety and efficacy of a novel acoustic pressure wave ultrasound device following fractional ablative Er:YAG 2940-nm laser (FELR) and topical agents for rhytids, melasma, and acne scars.
STUDY DESIGN: Randomized, blinded, parallel group split-face side-by-side, controlled study evaluating FELR and topical anti-aging and anti-pigment agents to entire face succeeded by ultrasound to randomized side. Fifteen subjects were enrolled to three treatment arms:rhytids, melasma, and acne scars. Two monthly treatments were administered with 1, 3, and 6 month follow-up. Efficacy was assessed by Comprehensive Grading Scale of Rhytids, Laxity, and Photoaging by Investigator and two blinded physician evaluators. Subject assessments, digital photographs, and reflectance spectroscopic analyses were obtained.
RESULTS: Rhytid severity was reduced from a mean of 3.25 to 2.60 on the 4-point grading scale. Spectrophotometric analysis demonstrated
increases in lightness (L*) and reductions in redness (a*) and pigment (b*), with greater improvements on the ultrasound side as compared to FELR and topicals alone. Moderate erythema post-treatment resolved in 7 days and no serious adverse events were observed.
CONCLUSION: In this randomized, paired split-face clinical study, FELR-facilitated TED of topical anti-aging actives with ultrasound treatment
is safe and effective with improvement in rhytids, melasma, and acne scars. Statistically significant greater improvement in pigment
levels was observed on the ultrasound side as compared to FELR-TED and topical agents alone.
J Drugs Dermatol. 2015;14(11):1191-1198.
Lisa T. Goberdhan BA, Lora Colvan BA, Elizabeth T. Makino BS CCRA MBA, Caroline Aguilar RN BSN, and Rahul C. Mehta PhD
The combination of in-office procedures such as chemical peels with topical maintenance therapies has been shown to provide greater efficacy than either treatment by itself in the management of melasma. A series of 3 case studies were conducted to evaluate the efficacy and tolerability of one superficial chemical peel (containing a proprietary blend of resorcinol, lactic acid, salicylic acid, and retinol) combined with a topical multimodal, hydroquinone-free skin brightener as postpeel maintenance therapy. Patients presented with moderate to severe facial hyperpigmentation. At baseline, subjects received the superficial chemical peel treatment followed by a standard postpeel skin care regimen (cleanser, moisturizer, and SPF 30+ sunscreen). Approximately 1 week after the peel procedure, subjects initiated twice-daily application of the skin brightener. Subjects were then evaluated for Global Improvement in Hyperpigmentation by the investigator for up to 7 weeks postpeel. Standardized digital photographs of the subjects facial skin and in vivo reflectance confocal microscopy (RCM) images were taken of a target hyperpigmented lesion at baseline and at follow-up. Standardized photography and in vivo RCM images at baseline and at postpeel show the improvements observed by the investigator. Results from these case studies suggest that the combination of a superficial chemical peel with topical maintenance and the multimodal skin brightener may provide an effective treatment approach for subjects with moderate to severe facial hyperpigmentation.
J Drugs Dermatol. 2013;12(3 suppl 1):s38-s41.
Topical antifungal treatment is a mainstay of therapy for Seborrehic Dermatitis (SD). Although the amidazole and ciclopyridine antifungals have been extensively studied, few clinical efficacy data are available for topical allylamine therapy in SD. The objective of
this open-label exploratory study was to evaluate the efficacy and safety of natifine HCl 1% gel applied twice daily for 4 weeks, as
topical treatment of moderate SD of the scalp. Nine subjects (5 men, 4 women) with a mean age of 56 (33-81) years with SD of
the scalp were enrolled and made 4 visits to the site. At Visit 1 (Week 0), subjects were screened, enrolled, baseline efficacy data
were obtained, and treatment was initiated. Subjects returned at Week 2, Week 4 (end of treatment), and Week 6 for efficacy and
safety assessments. Efficacy was evaluated by changes from baseline in investigator-rated scores on 0-5-grade scales: (1) SD Global
Evaluation Scale (SDGES), (2) Erythema Severity Scale, (3) Scaling Severity Scale, (4) % Scalp Involvement Scale, and subject-rated
scores on the (4) Itching Severity Scale, and (5) Global Improvement Scale, where 0=none and 5=most severe. Mean severity
scores for the SDGES and % Scalp Involvement scales progressively declined (improved) 66% and 54% from respective baseline
levels at Week 6. Mean erythema rating decreased 38% from baseline and scaling decreased 50% from baseline by Weeks 4 and 6.
Itching improved in 5 of 9 (56%) subjects by the end of treatment. A total of 8 of 9 (89%) subjects rated their symptoms as improved
from baseline at the end of treatment and Week 6. There were no treatment-related adverse events during the study. These results
suggest that naftifine 1% gel applied twice daily for 4 weeks is effective and safe topical treatment for moderate SD of the scalp.
J Drugs Dermatol.2012;11(4):514-518.
Yan Wu MD PhD,a* Xin Zheng,a* Xue-Gang Xu MD,a Yuan-Hong Li MD PhD,a Bin Wang PhD,a Xing-Hua Gao MD PhD,a Hong-Duo Chen MD,a Margarita Yatskayer MS,b and Christian Oresajo PhDb,c
OBJECTIVE: The objective of the study was to investigate whether a topical antioxidant complex containing vitamins C and E and ferulic acid can protect solar-simulated ultraviolet irradiation (ssUVR)-induced acute photodamage in human skin.
METHOD: Twelve healthy female Chinese subjects were enrolled in this study. Four unexposed sites on dorsal skin were marked for the experiment. The products containing antioxidant complex and vehicle were applied onto 2 sites, respectively, for 4 consecutive days. On day 4, the antioxidant complex-treated site, the vehicle-treated site, and the untreated site (positive control) received ssUVR (5 times the minimal erythema dose). The fourth site (negative control) received neither ssUVR nor treatment. Digital photographs were taken, and skin color was measured pre- and postirradiation. Skin biopsies were obtained 24 hours after exposure to ssUVR, for hematoxylin and eosin and immunohistochemical staining.
RESULTS: A single, 5 times the minimal erythema dose of ssUVR substantially induced large amounts of sunburn cell formation, thymine dimer formation, overexpression of p53 protein, and depletion of CD1a+ Langerhans cells. The antioxidant complex containing vitamins C and E and ferulic acid conferred significant protection against biological events compared with other irradiated sites.
CONCLUSION: A topical antioxidant complex containing vitamins C and E and ferulic acid has potential photoprotective effects against ssUVR-induced acute photodamage in human skin.
J Drugs Dermatol. 2013;12(4):464-468.
INTRODUCTION: Irritation, such as burning and stinging, on the site of application, is a common side effect of topical dermatologic products including creams, lotions, sprays, and foams. This effect may be more pronounced when applying products to atopic or psoriatic skin. The composition of the vehicle may affect the extent of the irritation. This study compared the irritation and erythema potential of 7 different topical dermatologic products to determine the products with the least likelihood of causing discomfort when applied.
METHODS: Seven sites on the anterior leg of 30 subjects were dry shaven with 10 upward strokes. Subjects rated the stinging of petrolatum (negative control), isopropyl alcohol (positive control), Cetaphil Lotion, triamcinolone 0.1% cream, triamcinolone 0.2% spray, betamethasone foam, and clobetasol 0.05% spray, 1 minute after product application, using a scale of 0 (no symptoms) to 10 (intolerable stinging/burning). The investigator assessed erythema at the sites 30 minutes after application of the products using a scale of 0 (none) to 4 (severe).
RESULTS: Stinging rating score of each product was statistically significant from one another. Petrolatum produced the least stinging (0) and isopropyl alcohol the most (10). Stinging with triamcinolone spray, Cetaphil Lotion, and triamcinolone cream ranked in the lower half of the rating scale (all below 5). Betamethasone foam and clobetal spray ranked the highest at >7. When corrected for the erythema caused by shaving, triamcinolone spray and Cetaphil Lotion produced the least amount of erythema of all the products tested.
DISCUSSION: Rapid evaporation of the volatile vehicle of triamcinolone spray and the non-irriating nature of the medication left behind may contribute to its low erythema and stinging. This product may be an appropriate choice for patients with compromised skin but who require the advantages and conveniences of a spray vehicle.
J Drugs Dermatol. 2016;15(7):870-873.
Neal D. Bhatia MDa and James Q. Del Rosso DO FAOCDb
The pathophysiology of papulopustular rosacea (PPR) is primarily characterized by inflammation associated with several factors such
as abnormal innate immune response, neurovascular dysregulation, stratum corneum barrier dysfunction, and depletion of antioxidant
reserve, with no definitive evidence supporting an underlying microbial etiology. Several molecular inflammatory pathways have now
been identified that enable the development of therapeutic agents that target the signs and symptoms of disease by modifying specific
pathophysiological mechanisms. Available evidence demonstrates that topical and oral agents commonly used to treat PPR appear
to modify some of these pathophysiological mechanisms and may prove to be complimentary when used in combination potentially
leading to better therapeutic outcomes.
During the past two decades, six clinical studies have been published on the benefits of combining oral and topical therapies for PPR.
Four studies suggest that doxycycline, including anti-inflammatory dose doxycycline (doxycycline 40 mg modified-release capsule
once daily) can be combined with topical metronidazole or azelaic acid in patients with PPR to achieve more rapid control of a flare. At
present, subantimicrobial dosing of a tetracycline agent that also maintains anti-inflammatory activity has only been established with
doxycycline. Although antibiotic doses of tetracycline agents (such as doxycycline, minocycline, and tetracycline) are known to be effective
for PPR, the use of subantimicrobial dosing of doxycycline avoids the risk of antibiotic resistance.
J Drugs Dermatol. 2012;11(7):838-844.
Leon H. Kircik MD,a Varsha Bhatt PhD,b Gina Martin MOT,b and Radhakrishnan Pillai PhDb
The use of fixed combinations in acne vulgaris (acne) is very common, however comparative clinical trial data are limited. Cutaneous tolerability can influence patient compliance, and concerns about skin irritation with topical acne treatments have lead to a number of comparative split-face studies.
Recently, a new fixed combination product was introduced (clin 1.0%-BP 3.75% gel) that was shown to be effective in reducing both inflammatory and noninflammatory lesions in moderate to severe acne. Here, we assess the tolerability of clin 1.0%-BP 3.75% gel compared with adap 0.1%-BP 2.5% gel in healthy volunteers with no apparent facial redness or dryness over 21-days, using a split-face methodology.
Especially over the first two weeks of treatment, clin 1.0%-BP 3.75% gel was more tolerable than adap 0.1%-BP 2.5% gel, with statistically significant differences in cumulative change from baseline starting as early as day 8 (dryness) and day 9 (erythema), and composite index on days 8-12 and 16. Transepidermal water loss was less with clin 1.0%-BP 3.75% gel, although the difference was not statistically significant.
J Drugs Dermatol. 2016;15(2):178-182.
Stephen W. Dusza MPH, Ruby Delgado MD, Klaus J. Busam MD, Ashfaq A. Marghoob MD, Allan C. Halpern MD
Objective: To assess the clinical and histologic effects of topical imiquimod therapy on dysplastic nevi, and to determine the
feasibility of using in vivo confocal microscopy (CSLM) to non-invasively monitor histological response of
dysplastic nevi to imiquimod therapy.
Design: Single-blinded pilot study with patients not blinded as to treatment status.
Setting: Dermatology Outpatient Clinic, Memorial Sloan-Kettering Cancer Center, New York, NY.
Patients: The study population comprised of 10 patients with clinically dysplastic (atypical) nevi and at least 8 large nevi,
(?5 mm) on their trunk.
Intervention: Sixteen weeks of imiquimod 5% cream applied to treatment lesions 3 times per week.
Main Outcome Measure: Clinical response as gauged by comparison of baseline and week 20 1:1 standardized photographs
for all study nevi and histological assessment of each patient’s 4 largest study nevi at completion of therapy.
Results: There were no obvious clinical changes in the size and morphology of the study nevi. Subtle changes in nevus color
could not be assessed due to imperfect spectral registration of images over the course of the study. Histologically, 4 of 14 treated
nevi and 0 of 14 untreated nevi p=0.03 showed a significant relative reduction of junctional and intraepidermal nevocytes
accompanied by papillary dermal fibroses and variable inflammation suggestive of partial regression. Non-invasive CSLM
imaging of study nevi demonstrated previously reported in vivo features of dysplastic nevi. but the imaging equipment and
protocol utilized proved inconsistent across lesions and time.
Conclusions: The histological changes seen in a subset of treated nevi suggest a possible role for the use of topical immune
response modifiers for the treatment of dysplastic nevi with the intent of melanoma chemoprevention. The dose regimen of
topical imiquimod utilized in this study failed to induce sufficient clinical or histological responses to warrant further study.
Targeting of dysplastic nevi and intermediate endpoints for melanoma chemoprevention with more intense and/or prolonged
treatment regimens with imiquimod or the use of other immune response modifiers seems promising. Technical improvements
are required for the use of non-invasive CSLM imaging in lieu of invasive histology for the study of topical nevus
Amit Verma DrPH MPH, Babajide Olayinka MSc, Alan B. Fleischer Jr. MD
BACKGROUND: Tinea pedis is the most common superficial fungal infection. Naftifine hydrochloride is a topical antifungal of the allylamine
class, displaying fungicidal activity and clinically significant anti-bacterial and anti-inflammatory effects. Clinical data on topical antifungal therapy using naftifine for tinea pedis in a pediatric population is limited.
OBJECTIVE: To assess trends in efficacy, tolerability, safety, and to quantify the pharmacokinetics (PK) of topical naftifine hydrochloride gel 2% in pediatric subjects with tinea pedis.
METHODS: Twenty-eight subjects (22 pediatric and 6 adult controls) were enrolled and treated in the study. Approximately 2 grams of naftifine hydrochloride gel 2% was applied to each foot (4 grams total) for subjects with tinea pedis. Pharmacokinetic blood and urine samples were collected at various time points throughout the study. Efficacy was assessed based on potassium hydroxide, dermatophyte
culture, and signs and symptom results at days 7, 14, and 28. Adverse event information was collected routinely.
RESULTS: The rate and extent of systemic exposure among the pediatric and adult control subjects was low. Adverse events were minimal
and were not related to treatment. Positive results were observed as early as day 7; however the proportion of subjects achieving success generally increased over time through day 28 in both treatment groups.
CONCLUSIONS: Naftifine hydrochloride gel 2% was found to be well tolerated and safe. Trends in clinical benefit were observed throughout
the treatment period; however, continued improvement in efficacy rates were observed during the post-treatment period.
J Drugs Dermatol. 2015;14(7):686-691.
Chai Sue Lee MD and John Koo MD
Background: This study compared the efficacy of a novel, topical class I synthetic, 0.10% fluocinonide corticosteroid with two other
class I corticosteroids and placebo for the treatment of plaque psoriasis.
Methods: A 0.5 gram dose of fluocinonide 0.1% cream, clobetasol propionate 0.05% cream, halobetasol propionate 0.05% cream,
and placebo ointment were applied to test sites on one psoriatic plaque per patient (n=5). Test sites were outlined according to the
Scholtz-Dumas bioassay. Test sites were assessed by a blinded evaluator (1=psoriasis worsened to 5=psoriasis clear or almost
clear), cleaned and medications were reapplied on days 3, 5, 7, 10 and 12.
Results & Conclusion: The three class I corticosteroid products were comparably effective, numerically and statistically, in clearing
the psoriatic plaques. Upon completion of treatment, 60–80% of active-treated sites were clear or almost clear of psoriasis compared
to zero with the placebo.
Elnaz F. Firoz BA, Bahar F. Firoz MD MPH, James F. Williams PA-C, Jeffrey S. Henning DO
Burn patients with extensive involvement of body surface area (BSA >30%) represent a challenge in wound treatment.
Multiple topical agents may be used for cleansing, barrier protection, and antimicrobial control leading to complications
of contact and/or irritant dermatitis, which may further complicate re-epithelization and eventual wound healing. We present
4 patients who sustained extensive burns during Operation Iraqi Freedom/Operation Enduring Freedom and later
developed contact dermatitis to mafenide acetate, a common topical antimicrobial used in burn care treatment, also known
as Sulfamylon® (alpha-amino-p-toluenesulfonamide monoacetate). All patients who were patch tested to mafenide
acetate 7% solution were positive. A rechallenge with mafenide acetate resulted in recrudescence of the eruption in 2 out
of the 4 patients. Though cutaneous reactions to mafenide acetate were reported by Yaffe and Dressler in 1969, the most
recent case reports are from 1995. This paper presents more recent examples of cutaneous reactions to mafenide acetate,
while also reviewing the literature.
Eugene H. Gans PhD, Iqbal Sadiq MS, Tracy Stoudemayer, Marianne Stoudemayer BS, Albert M. Kligman MD PhD
Purpose: Prolonged topical corticosteroid use is often associated with atrophic skin changes. This trial compared signs
of skin atrophy related to 3 super-high-potency corticosteroids: fluocinonide 0.1% cream, clobetasol propionate 0.05%
cream, and 0.05% foam.
Patients and Methods: The test treatments were applied to the forearms 10 females twice daily for 21 days. Skin characteristics
were assessed pretreatment and posttreatment for atrophic changes. Further punch biopsies obtained from 5
subjects were assessed histologically.
Results: Clobetasol foam produced mild changes in noninvasive tests, but stained skin biopsies revealed structural changes
nearly comparable to clobetasol cream, which showed substantial atrophic changes. Fluocinonide cream was the least
atrophogenic, producing no or only mild effects that were slightly greater than vehicle.
Conclusions: Fluocinonide cream has a lower potential to produce atrophic changes of the skin than either clobetasol
cream or clobetasol propionate foam.
No abstract details for the moment.
Tracey Vlahovic DPM,a Tejal Merchant MPharm,b Sanjay Chanda PhD,b Lee T. Zane MD,b and Dina Coronado BSb
BACKGROUND: Onychomycosis is a common infection of the toenails that causes nail thickening and discoloration. The physical appearance
of the infected nail can diminish self-image and negatively impact quality of life. Patients may use nail polish to mask the appearance of infected nails.
OBJECTIVE: To evaluate the in vitro nail penetration properties of tavaborole topical solution, 5%, through nail polish using ex vivo, non-diseased human fingernails.
METHODS: In study 1, tavaborole penetration was evaluated over 20 days of dosing using the Franz finite dose technique and modified
Franz diffusion cells. Nails received either 1 coat of over-the-counter (OTC) typical polish or were left unpolished (controls). In study 2, tavaborole penetration was measured over 14 days of dosing using the finite dose technique and vertical diffusion cells. Nails were polished with either 4 coats or 1 coat of salon typical polish or with 2 coats or 1 coat of OTC typical polish, or they were left unpolished.
RESULTS: In study 1, the mean ± standard deviation (SD) cumulative tavaborole penetration at day 21 was numerically higher,
though not statistically significant, through polished nails (3,526 ± 1,433 μg/cm2) vs unpolished nails (2,661 ± 1,319 μg/cm2). In study 2, the mean cumulative tavaborole penetration was also numerically higher (statistical significance not assessed) through all nails that received polish vs unpolished nails. At day 15, mean ± SD cumulative tavaborole nail penetration
was 1,179 ± 554 μg/cm2 through 4 coats of salon typical polish, 1,227 ± 974 μg/cm2 through 1 coat of salon typical polish, 1,493 ± 1,322 μg/cm2 through 2 coats of OTC typical polish, 1,428 ± 841 μg/cm2 through 1 coat of OTC typical polish, and
566 ± 318 μg/cm2 through unpolished nails.
CONCLUSION: Results from these in vitro studies demonstrated that tavaborole penetrated through human nails with up to 4 layers of nail polish.
J Drugs Dermatol. 2015;14(7):675-678.
Hema Sundaram MD FAAD,a Angnieszka Cegielska MD,b Agnieszka Wojciechowska,b and Patrice Delobel PhDc
Background: This split-face, controlled study investigated the ability of a topical crosslinked hyaluronic acid formulation (RHA serum) to enhance clinical results from fillers, microneedling, or chemical peeling of aging skin. Previous comparative skin explant studies demonstrated greater efficacy of RHA serum than topical non-crosslinked high or low molecular weight hyaluronic acid in decreasing trans-epidermal water loss, increasing epidermal hydration, and improving corneocyte microstructure.
Methods: 24 female subjects aged 35 to 55 were enrolled. 8 received intradermal hyaluronic acid filler injection, 8 received microneedling, and 8 received superficial mandelic acid chemical peeling. Subjects initiated twice-daily, standardized application of RHA serum to one side of the face 2 days after the procedure. Topographical imaging, bioinstrumental, and blinded clinical evaluations were performed at days 0, 14, and 28.
Results: Areas treated with RHA serum showed statistically significant improvements in skin surface topography and hydration compared to untreated areas. Blinded investigator scoring showed greater improvement of RHA serum-treated skin in moisture, tone/complexion, radiance, texture, uniformity, and global appearance. Subjects’ questionnaire responses correlated with these findings. Subjects expressed greater satisfaction with appearance of the treated hemiface. No adverse events were observed during the study.
Conclusions: When initiated post-procedurally, topical RHA serum was well-tolerated and enhanced biomechanical properties, quality, and clinical appearance of the skin. Based on these data, RHA serum may be of value in improving patient outcomes and satisfaction following minimally invasive aesthetic procedures. The availability of the same hyaluronic acid technology also as a cohesive, tissue-integrating injectable filler enables synergistic, multi-level treatment plans to be devised.
J Drugs Dermatol. 2018;17(4):442-450.
Miriam S. Bettencourt MD
BACKGROUND: Ingenol mebutate gel is a topical field treatment for actinic keratosis (AK) approved for a 2- or 3-day duration of application.
OBJECTIVE: This chart review examined the efficacy and safety of ingenol mebutate gel for treatment of AK in patients from a community dermatology practice.
METHODS: A retrospective chart review was conducted for all patients with AK treated with ingenol mebutate gel.
RESULTS: A total of 135 patients with a prolonged history of AK were treated from April 2012 to January 2013. The majority received cryosurgery to all visible lesions, followed 2 weeks later by ingenol mebutate; areas treated with ingenol mebutate were typically >25 cm2 in size. Local skin reactions, consisting of mild to moderate erythema and flaking/scaling, were significantly improved by 1 week after peak inflammation and were not treated in most patients. At 1 to 4 months after treatment of AKs on the face, nearly all patients (99%) achieved ≥75% clearance of baseline and emergent AKs. After treatment of AKs on the scalp or forearm and/or hand, >80% of patients demonstrated ≥75% clearance.
LIMITATIONS: This was a retrospective chart review of patients from a single practice.
CONCLUSION: Ingenol mebutate is an effective, well-tolerated topical treatment for AK in sun-damaged skin.
J Drugs Dermatol. 2014;13(3):269-273.
Margit L.W. Juhasz MD,a,b Melissa K. Levin MD,a and Ellen S. Marmur MDa,c
“Fractionated photodynamic therapy (PDT)” is a new term being used by dermatologists to describe advances in PDT technology including fractionated light or the adjuvant use of fractional lasers. Although dermatologists have used PDT since the early 1990s for the treatment of photodamage and precancerous lesions, newer developments in technology have allowed for the treatment of non-melanoma skin cancers (NMSCs), in ammatory disorders, and even uses in the eld of anti-aging. Recent developments in fractionated light therapy have allowed for PDT with dark intervals and two-fold illumination schemes to increase cellular damage and apoptosis. Combining PDT with fractional laser technology has allowed for enhanced dermal penetration of topical photosensitizers including 5-aminolevulinic acid (ALA) and methyl aminolevulinate (MAL), as well as increased ef cacy of treatment. These advances in PDT technology will allow for increased convenience, decreased treatment time, only one application of topical photosensitizer, and decreased cost to the patient and dermatologist.
J Drugs Dermatol. 2016;15(11):1324-1328.
Marie Stoddard BS,a Jennifer Herrmann MD,b,c,d Lauren Moy MD,eand Ronald Moy MDb,c
Background: Actinic keratoses (AKs) are proliferations of abnormal keratinocytes, which may progress into non-melanoma skin cancers. Although multiple treatment modalities exist for AKs, their incidence continues to rise, making new methods of both prevention and treatment necessary. DNA repair enzymes have been shown to reverse sun-damage, resulting in reduced rates of AKs and non-melanoma skin cancer (NMSC) in specific patient populations.
Objective: We investigated the efficacy of a topical DNA repair enzyme lotion as a field therapy for AKs.
Methods: In a single center, randomized double-blind study, we randomly assigned 15 patients with AKs on their face or scalp to receive topical DNA repair enzyme lotion or placebo (Eucerin Professional lotion). Lotion was self-applied to a treatment field twice daily for 8 consecutive weeks. Complete clearance (primary outcome) was assessed at week 8, and local reactions were quantitatively measured. Follow-up at week 12 assessed for continued clearance of AKs.
Results: Thirteen subjects completed the trial. Compared to baseline, patients who used the repair enzyme had significantly fewer AKs than those using the control lotion after 8-weeks treatment. Specifically, there was a 46.6% percent decrease in AKs the DNA repair enzyme lotion group compared to a 32.7% decrease in the placebo group. Significance between the two groups was noted at the12 week follow-up, where there was an additional 29.2% decrease in AK percentage in the DNA repair enzyme group, while the placebo group had a 31.4% increase in AKs (P=0.0026). On final self-assessment, 85% of subjects reported being at least “satisfied” with the ability of the medication to decrease their AK burden. No side effects were reported.
Conclusion: These results suggest that topical DNA repair enzymes may help reduce the number of AKs in individuals with moderate-to-severe photodamaged skin. Additionally, there may be a lasting effect of the DNA repair if application is discontinued. Further, cutaneous malignancies were not detected in any of the subjects during the study period. Despite the brevity of the study, these preliminary results suggest the role of DNA repair enzymes for not only treatment, but also skin cancer prevention. Further study and more objective evaluation measures are required for definitive conclusions to be drawn.
J Drugs Dermatol. 2017;16(10):1030-1034.
Misao Sakamoto MS,a Noriaki Sugimoto MS,b Hideki Kawabata MS,a Eiko Yamakawa MS,a
Nobuyuki Kodera MS,a Radhakrishnan Pillai PhD,c and Yoshiyuki Tatsumi PhDd
BACKGROUND: Effective transungual delivery of topical antifungal agents in onychomycosis has been hampered by poor nail permeation. To be effective they must have antifungal efficacy, and effectively permeate through the dense keratinized nail plate to the site of infection in the nail bed and nail matrix. The therapeutic efficacy of efinaconazole topical solution, 10% has been established in two phase 3 clinical trials in distal lateral subungual onychomycosis.
OBJECTIVE: To investigate the transungual delivery of efinaconazole in onychomycosis patients and its fungicidal activity in the toenail.
METHODS: Concentrations of efinaconazole were determined as part of a multi-center, open label study in forty onychomycosis patients following repeated application of efinaconazole topical solution, 5% and 10% to the toenails over 28 days, with a 2-week follow-up. Fungicidal activity against T. rubrum in the ventral layer of human nails was determined using an in vitro human nail infection model (ChubTur®).
RESULTS: Efinaconazole concentrations in the nail were four orders of magnitude higher than MIC values of efinaconazole against dermatophytes. Further, nail drug concentrations were not influenced by the presence of disease or nail thickness, and maintained at high antifungal levels post-treatment. Efinaconazole was effective in reducing fungal viability, suggesting that sufficient amounts of efinaconazole were being delivered into the ventral layer of the nail plate.
CONCLUSIONS: Effective transungual delivery of efinaconazole was demonstrated. The high efinaconazole concentrations in patient toenails and fungicidal activity in vitro potentially contribute to the clinical efficacy reported in phase 3 studies.
J Drugs Dermatol. 2014;13(11)1388-1392.
Laura McDermott BA,a Raman Madan MD,a Reena Rupani MD,b and Daniel Siegel MDa
INTRODUCTION: Nail psoriasis is challenging to treat. The few currently available therapies are limited in efficacy, and often produce unfavorable
side effects. A plant extract widely used in Traditional Chinese Medicine, indigo naturalis (Qing Dai), is presented in this review as an alternative topical treatment for skin and nail psoriasis. The purpose of this article is to present information on a viable alternative treatment with a favorable side effect profile for a difficult disease to treat.
METHODS: A PubMed search for the term “indigo naturalis” was performed, and literature from 2006 to the present relevant to indigo naturalis and treatment of psoriasis and nail psoriasis was reviewed.
RESULTS: Indigo naturalis shares several therapeutic mechanisms with current psoriasis treatments, such as regulation of keratinocyte proliferation and differentiation, restoration of epidermal barrier function, and reduction of inflammatory processes. Clinically, it is well tolerated.
CONCLUSION: Recent research of indigo naturalis suggests that it is a safe, inexpensive, and effective alternative topical treatment for skin and nail psoriasis.
J Drugs Dermatol. 2016;15(3):319-323.
Michael T. Jarratt MD,a Terry M. Jones MD,b Joan-En Chang-Lin PhD,c Warren Tong PharmD MS,c David R. Berk MD,c Vince Lin PhD,c and Alexandre Kaoukhov MDc
BACKGROUND: Reducing the dosing frequency of topical acne treatments to once daily may improve adherence.
OBJECTIVE: Evaluate pharmacokinetics (PK), safety, and tolerability of 3 formulations of once-daily dapsone gel, 7.5% and of twice-daily dapsone gel, 5% over 28 days in patients with moderate acne vulgaris.
METHODS: This phase 1, multicenter, parallel-group study randomized males and females aged 16 to 35 years to 1 of 3 dapsone gel, 7.5% formulations (DAP-11078, DAP-11079, or DAP-11080 double-blind; applied once daily) or to dapsone gel, 5% (investigator-blinded only, applied twice-daily). Blood samples were collected for PK assessments of dapsone and its metabolites, N-acetyl dapsone (NAD) and dapsone hydroxylamine (DHA), before the morning dose on days 1, 7, 14, 18, 21, 26, 27, and 28, and at several follow-up time points (days 29–32). Safety profile assessments included adverse events (AEs), physical examinations, laboratory tests, and local tolerability assessments.
RESULTS: Steady-state dapsone, NAD, and DHA concentrations were reached within 7 days of the first dose in all treatment groups. Daily systemic exposures of the 3 dapsone gel, 7.5% formulations were approximately 25% to 40% lower than that for dapsone gel, 5%, and these differences were statistically significant. Among the 3 dapsone gel, 7.5% formulations, the highest daily exposure of dapsone (per the AUC) was observed with DAP-11080, with respective Cmax and AUC0-24 being approximately 28.6% and 28.7% lower relative to dapsone gel, 5%.
Most AEs were mild to moderate in intensity. The safety profiles for all 3 formulations of once-daily dapsone, 7.5% gel and twice-daily dapsone gel, 5% were similar following 28 days of topical administration. All 4 dapsone formulations were well tolerated.
CONCLUSIONS: This study demonstrated lower systemic exposure with all 3 once-daily dapsone gel, 7.5% formulations than with twice-daily dapsone gel, 5%. All 4 formulations were well tolerated and demonstrated similar safety profiles.
J Drugs Dermatol. 2016;15(10):1250-1259.
Anthony Chiaravalloti MDa and Michael Payette MD MBAb
IMPORTANCE: Hailey-Hailey disease, or familial benign chronic pemphigus, is a rare genodermatosis that can be challenging for both patients and dermatologists as the disease can significantly impact patients’ quality of life and is often difficult to control. In recalcitrant cases, multiple treatment modalities are often needed to obtain benefit. Unfortunately, most of the available evidence pertaining to treatment is scattered across case reports and retrospective analyses.
OBJECTIVE: To review successful treatments of Hailey-Hailey, synthesize the evidence, and provide recommendations for therapy.
Findings: The best evidence exists for treatment with topical steroids and topical antimicrobials. Refractory disease has shown the most benefit with addition of oral antibiotics, excisional procedures and botulinum toxin A. Other therapies are described but with much less supporting evidence.
CONCLUSIONS: Herein we review the literature to identify successful treatments for Hailey-Hailey disease. We have outlined the treatments with the most evidence. The difficult nature of treating this disease requires that clinicians approach each patient differently. The literature shows that no one regiment works for all patients.
J Drugs Dermatol. 2014;13(10):1254-1257.
Kristie L. Akamine MD,a Cheryl J. Gustafson MD,a Brad A. Yentzer MD,a Brenda L. Edison BA,d Barbara A. Green RPh MS,d Scott A. Davis MA,a and Steven R. Feldman MD PhDa,b,c
BACKGROUND: Salicylic acid is a topical keratolytic agent used to reduce scaling and hyperkeratosis associated with psoriasis vulgaris. However, its use is limited due to potential systemic toxicity. Hydroxyacids also modulate keratinization and desquamation. Therefore, they may serve a beneficial role in the treatment of hyperkeratotic conditions. To date, there are no clinical studies in the literature regarding the efficacy of hydroxyacids for psoriasis treatment.
PURPOSE: To evaluate the therapeutic efficacy of topical 20% alpha-hydroxy/polyhydroxy acid versus standard salicylic acid to reduce scaling in patients with moderate, chronic psoriasis.
METHODS: Twenty-five subjects with moderate, chronic psoriasis were enrolled in a 2-week, double-blind, left-right, randomized, bilateral comparison clinical trial to compare the efficacy of 20% alpha-hydroxy/polyhydroxy acid emollient versus 6% salicylic acid cream and 24 were randomized/completed. Clinical evaluations to assess the severity of psoriasis and scaling were performed using a 6-point scale prior to treatment, as well as following 1 and 2 weeks of therapy.
RESULTS: Twenty-four participants completed the study. Both 20% alpha-hydroxy/polyhydroxy acid emollient and 6% salicylic acid cream were efficacious in reducing scale of psoriatic lesions. The topical 20% alpha-hydroxy/polyhydroxyacid reduced scaling at a faster rate; however, following 2 weeks of treatment the efficacy of both products were relatively the same.
CONCLUSION: 20% alpha-hydroxy/polyhydroxyacid is as efficacious as salicylic acid in regards to the de-scaling of psoriatic plaques. Additionally, 20% alpha-hydroxy/polyhydroxyacid cream may yield quicker results and less toxicity than salicylic acid.
J Drugs Dermatol. 2013;12(8):855-859.
Julian Mackay-Wiggan MD MS,a Jackleen Marji MD PhD,a John G. Walt MBA,b Angela Campbell,a Carol
Coppola,a Bibhas Chakraborty PhD,c David A. Hollander MD MBA,b and Scott M. Whitcup MDb
BACKGROUND: Limited options are available for the treatment of brittle nail syndrome.
OBJECTIVE: To assess the efficacy and safety of topical cyclosporine emulsion (CsAE) versus emulsion (vehicle) alone in the treatment of brittle nail syndrome.
RESULTS: Twenty-four patients were randomized to topical CsAE emulsion or emulsion (vehicle) for 24 weeks. Four fingernails of each patient were included; the 2 most severe brittle nails and the second most normal nail were treated with the same medication. The fourth nail, the most normal nail, remained untreated and was used to assess nail growth. The prespecified primary endpoint was change from baseline in Physician Global Assessment (PGA) score (0 to 5 scale) at each follow-up visit. Safety evaluations were conducted at each visit.
RESULTS: In the intent-to-treat population (n=12 for each treatment arm), the PGA score for treated nails improved from baseline (CsAE, 0.7 to 1.4; emulsion, 0.7 to 1.5; P<0.05 for each), with no significant between-group differences. Untreated nails did not improve in overall appearance (0.0 to 0.3 grade; P>0.05). Statistically and clinically significant improvement from baseline was reported for nail length/appearance in both CsAE and vehicle groups.
LIMITATIONS: Sample size was relatively small. The difference in PGA between treated and untreated nails was not analyzed. Baseline disease severity may have been too mild, limiting detection of efficacy.
CONCLUSIONS: Both CsAE and emulsion vehicle applied topically appeared to improve signs and symptoms of brittle nail syndrome and were well tolerated. These findings warrant corroboration in a larger population and inclusion of comparison with an inactive control and a higher concentration of CsAE, the former which may help in distinguishing the efficacy of vehicle emulsion from CsAE.
J Drugs Dermatol. 2014;13(10):1232-1239.
Azelaic acid (AzA) 15% gel is approved for the treatment of rosacea in the US, but also has approval for the treatment of
acne vulgaris in many European countries where it has demonstrated success. Two randomized, multicenter, controlled clinical
trials compared the effects of AzA 15% gel with those of topical benzoyl peroxide 5% or topical clindamycin 1%, all
using a twice-daily dosing regimen. The primary endpoint in the intent-to-treat analysis was a reduction in inflammatory
papules and pustules. AzA 15% gel resulted in a 70% to 71% median reduction of facial papules and pustules compared
with a 77% reduction with benzoyl peroxide 5% gel and a 63% reduction with clindamycin. AzA 15% gel was well-tolerated.
In addition, a 1-year European observational study conducted by dermatologists in private practice evaluated the safety
and efficacy of AzA 15% gel used as monotherapy or in combination with other agents in more than 1,200 patients with
acne. Most physicians (81.9%) described an improvement in patients’ symptoms after an average of 34.6 days, and 93.9%
of physicians reported patient improvement after an average of 73.1 days. Both physicians and patients assessed AzA 15%
gel to be effective with 74% of patients being “very satisfied” at the end of therapy. AzA 15% gel was considered “welltolerated”
or “very well-tolerated” by 95.7% of patients. The majority of patients were more satisfied with AzA than with
previous therapies. AzA 15% gel represents a new therapeutic option for the treatment of acne vulgaris.
Nevien Samy PhDa and Maha Fadel PhDb
BACKGROUND: Blond and white hair removal by laser is a complicated task with weak satisfactory results due to the deficiency in laser-absorbing chromophore.
OBJECTIVE: To investigate if repetitive sessions of photodynamic therapy (PDT) using external application of liposomal Rose bengal (RB) photosensitizer followed by intense pulsed light (IPL) exposure enables removal of gray and white hair.
MATERIALS and METHODS: Rose bengal loaded in liposomes (LRB) was constructed, prepared in hydrogel, and was studied for some pharmaceutical properties. Penetration and selective hair follicle damage in mice skin were studied. Topical gel containing LRB was used for treating fifteen adult females who were complaining of facial white terminal hair. Unwanted facial hair was treated for three sessions at intervals of 4–6 weeks using intense pulsed light (IPL). At each session, the treatment area was pre-treated with topical LRB gel, while a control group of another 15 patients applied placebo gel before IPL treatment. Evaluations included hair regrowth, which was measured 4 weeks after each treatment session and at 6 months follow-up by counting the number of terminal hair compared with baseline pretreatment values. Treatment outcomes and complications if any were also reported.
RESULTS: Average hair regrowth in the LRB group was 56% after 3 treatment cycles. After six-months follow up, average terminal hair count compared with baseline pretreatment showed 40% reduction and no recorded side effects.
A significant difference (P<0.05) was seen compared with the control group; the clinical results were promising.
CONCLUSIONS: Photodynamic hair removal using rose bengal-encapsulated liposomal gel in combination with IPL treatment showed significant efficacy in the treatment of white hair compared with a control group.
J Drugs Dermatol. 2014;13(4):436-442.
Yik Weng Yew MD MPH,a Yi Chun Lai MD MPH,b Yen Loo Lim MD,a Wei-Sheng Chong MD,a and Colin Theng MDa
BACKGROUND: Photodynamic therapy (PDT) using topical application of aminolevulinic acid (ALA) is an effective treatment for acne vulgaris. However, there is no clear consensus on the treatment regime in Asians.
AIM: To determine the efficacy, safety and tolerability of 5% ALA PDT in the treatment of truncal acne in Asians.
METHODS: Patients with truncal acne were treated with 5%-ALA under occlusion for 3 hours. All were subsequently treated with a red light source at wavelength 630 nm and an irradiance of 38mW/cm2 giving a total dose of 37 J/cm2. The numbers of acne lesions were recorded at baseline and regular intervals after treatment together with any adverse effects.
RESULTS: Fifteen patients were recruited. Overall, there was a 64.2% reduction in the inflammatory lesions count and a 24.3% reduction in the non-inflammatory lesions count at the end of the 12 weeks follow-up. Both mean lesions counts were significantly lower than baseline at all follow-up time points with paired t tests (all P values <0.05). Pain was well tolerated among our patients.
CONCLUSION: A single treatment session of 5%-ALA PDT was effective for the treatment of truncal acne with little side effects and acceptable in our Asian patients.
J Drugs Dermatol. 2016;15(6):727-732.
Elizabeth Gallup MD JD MBA, The Ciclopirox TS Investigators, Todd Plott MD
Ciclopirox is a broad-spectrum antifungal, antibacterial, and anti-inflammatory agent. This open-label study investigated the
safety and efficacy of ciclopirox topical suspension 0.77% in the treatment of diaper dermatitis due to Candida albicans (C. albicans).
Forty-four male and female subjects aged 6 to 29 months were included in the study. Study medication was applied
topically to the affected diaper area twice daily for 1 week. Subjects were clinically evaluated at baseline and days 3, 7, and
14 (7 days post-treatment). Safety and efficacy variables included adverse events, mycological culture studies, KOH tests,
Severity Scores, and Global Evaluation of Clinical Response. All adverse events were mild to moderate and considered not
related to the study medication. Treatment provided statistically significant improvement (P < .05) for both the rate of mycological
cure and reduction of Severity Score at each time point compared with baseline. Ciclopirox was safe and effective in
the treatment of diaper dermatitis due to C. albicans
INTRODUCTION: Successful treatment of onychomycosis is both a clinical and therapeutic challenge. Effective patient education and reassurance are critical. This post hoc analysis aims to provide some guidance to physicians based on initial disease severity and influencing factors.
METHODS: A post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled studies evaluating the efficacy and safety of efinaconazole topical solution, 10% in mild to moderate onychomycosis. Outcomes were assessed based on baseline severity (20%-29%, 30%-39%, 40%-49%, and ≥50% affected target toenail).
RESULTS: Overall, the mean percent affected toenail following efinaconazole treatment decreased from 36.4% to 20.6% (a 43% reduction). The percent reduction in mean percent affected toenail (range, 43.6% to 59.8%) with efinaconazole was similar irrespective of baseline severity. Improvement was only seen in the very mildest patients with vehicle and not before week 36. Improvement was influenced by gender (females did better) and disease duration (long standing disease responding less well).
CONCLUSIONS: Our onychomycosis patients treated with efinaconazole might expect a 50% improvement in their disease within a year, and this will be seen as significant by many, especially those who have suffered for many years. Many will do better, but they will need to be reminded of the slow growth of the toenail.
J Drugs Dermatol. 2015;14(7):694-698.
Background: Psoriasis is a common skin disease in Caucasians but less common in African-Americans.
Aims: Our aim is to evaluate caregiver opinions regarding the clinical presentations and treatment of psoriasis in African-Americans
compared to Caucasians.
Patients/Methods: A survey was sent to 29 dermatologists who are opinion leaders in the field of psoriasis. The survey included a
number of questions regarding the characteristics of the patients seen in their practice.
Results: A total of 29 surveys were completed and returned. All of the dermatologists use the extent of disease as a criterion to
determine the severity of the disease. Other criteria include scale, thickness, erythema, associated general symptoms, and dyspigmentation.
About 66% of the respondents reported the different manifestations of disease, such as more dyspigmentation, thicker
plaques, and less erythema in African-Americans. The most common first-line treatments for mild to moderate disease were highpotency
topical steroids (68%) followed by topical vitamin D analogues (41%). For moderate to severe disease, the most commonly
used first-line treatments were high-potency topical steroids (54%) and phototherapy (46%).
Conclusions: The clinical manifestations of psoriasis in African-Americans are not exactly the same as in Caucasians. Physicians
should be aware of the difference in clinical manifestations in African-Americans. Further research and large-scale studies are necessary
to elucidate the differences in the clinical presentation, natural course of the disease, and the criteria used for the evaluation
of severity among ethnic groups.
J Drugs Dermatol. 2012;11(4):478-482.
Severe childhood atopic dermatitis refers to the presence of recurrent, widespread, eczematous dermatitis that significantly interferes with the daily activities and/or the quality of life of the affected child and family. The vast majority of children with severe, long-standing atopic dermatitis can be managed with the appropriate use of topical treatments, including long-term maintenance therapy and adjunctive treatments. In the recalcitrant patient, second line therapies such as narrowband ultraviolet light therapy and systemic immunosuppressants such as cyclosporine, azathioprine, mycophenolate moefetil, and methotrexate have been shown to be safe and effective in children with severe atopic dermatitis and can lead to sustained clinical improvement. To date, biologic therapy has not been uniformly effective in childhood atopic dermatitis. Management of severe childhood atopic dermatitis, including topical and adjunctive treatments and second-line therapies including systemic immunosuppressants will be reviewed here.
J Drugs Dermatol. 2012;11(10):1158-1165.
Jonathan S. Dosik MD, Lori A. Johnson PhD
Background: Topical retinoids, including adapalene and tazarotene, are a primary treatment choice for patients with acne.
Adapalene is currently marketed in a 0.1% concentration in gel and cream formulation. A new gel containing a higher
concentration (0.3%) of adapalene has been developed. In clinical studies, adapalene 0.1% concentration has proven
to be better tolerated than other retinoids in skin treatment. However, the tolerability of adapalene gel 0.3% has yet to
be compared to other topical retinoids.
Purpose: The purpose of this study was to compare the local cutaneous tolerability of adapalene gel 0.3% once daily versus
tazarotene cream 0.05% once daily.
Methods: Subjects reported to the investigative site each day Monday through Friday, cleansed the faced and then applied
adapalene 0.3% gel to one side of the face and tazarotene 0.05% cream to the other in the presence of study personnel.
For the weekends, subjects were instructed to apply the treatment at home according to the same procedure.
Tolerability was assessed during each weekday visit. The study lasted for 3 weeks.
Result: Tolerability results for adapalene 0.3% gel and tazarotene 0.05% cream were statistically similar throughout the study. Investigator-assessed overall tolerability was in favor of adapalene at days 19 and 22 (P=.043). A cosmetic acceptability survey also showed results were better for adapalene 0.3% gel.
Conclusion: Adapalene gel 0.3% is very well-tolerated with good cosmetic acceptability.
Boni E. Elewski MDa and Tracey C. Vlahovic DPMb
BACKGROUND: Econazole nitrate is a broad-spectrum topical antifungal with activity against a variety of dermatophytes and yeasts. A
new topical dosage form, econazole nitrate topical foam 1%, utilizing patented Proderm Technology® has been developed for treatment
of interdigital tinea pedis.
OBJECTIVE: To evaluate econazole nitrate foam 1% versus foam vehicle for treatment of interdigital tinea pedis.
METHODS: Two randomized, double-blind, parallel-group, vehicle-controlled, multicenter studies enrolled males and females ≥12 years
old with a clinical diagnosis of interdigital tinea pedis and baseline fungal culture positive for a dermatophyte. Subjects applied econazole
nitrate foam 1% (n=246) or foam vehicle (n=249) once daily for 4 weeks. The primary endpoint was proportion of subjects achieving
a complete cure (negative KOH, negative fungal culture, complete resolution of all signs and symptoms) at 2 weeks post-treatment
(Day 43). Secondary endpoints included mycologic cure (negative KOH and negative culture) and effective treatment (mycologic cure +
no or mild erythema and/or scaling and all other signs and symptoms absent).
RESULTS: The complete cure rate at Day 43 was 24.3% for econazole nitrate foam 1% vs 3.6% for foam vehicle. In addition, higher rates
of mycologic cure (67.6% vs 16.9%) and effective treatment (48.6% vs 10.8%) were observed with econazole nitrate foam 1% versus
the foam vehicle. There were few adverse events and only nasopharyngitis and headache were experienced by >1% of subjects. No
serious adverse events were reported for econazole nitrate foam 1%.
CONCLUSIONS: Econazole nitrate foam 1% exhibited superiority over foam vehicle for the primary and secondary endpoints with a high
mycologic cure rate for all pathogens evaluated. Econazole nitrate foam 1% was safe and well tolerated with a safety profile comparable
with the foam vehicle. Econazole nitrate foam 1% presents a novel alternative for the management of tinea pedis.
J Drugs Dermatol. 2014;13(7):803-808.
Thomas Dirschka MD,a,b Lutz Schmitz MD,a,c and Ágota Bartha MDa
We report the case of a German female patient presenting with papulopustular rosacea (PPR) with a high count of facial inflammatory lesions and severe erythema who had not responded well to treatment with traditional therapies for a decade. In this patient, a sequential therapy consisting of oral modified-release doxycycline 40 mg (initially as monotherapy, then in combination with topical metronidazole), followed by topical ivermectin 10 mg/g was both rapidly active and effective. Following reduction of the inflammation with modified-release doxycycline 40 mg upfront and the disease becoming moderate in severity, the dose of this agent could be reduced and combination therapy with metronidazole 7.5 mg/g lotion started to continue decreasing inflammatory lesions count and erythema severity, before treatment with the recently approved agent ivermectin 10 mg/g was implemented to provide almost complete clearance. This sequential treatment was effective in reducing both the number of papules and pustules and the severity of erythema, with a good safety profile. In addition, a large improvement was documented in the patient’s DLQI score, contributing to her overall wellbeing.
J Drugs Dermatol. 2016;15(6):769-771.
Background: Melasma is a cutaneous disorder associated with an overproduction of melanin by the tyrosinase enzyme. A proprietary oligopeptide (Lumixyl TM ) was previously shown to competitively inhibit mushroom and human tyrosinase in vitro without the
associated cytotoxicity of hydroquinone and to diminish the appearance of facial melasma.
Objective: The aim of this case study was to determine if the Lumixyl Topical Brightening System (0.01% oligopeptide cream, an
antioxidant cleanser, 20% glycolic acid lotion and physical sunscreen) accelerates clearance of mild-to-moderate melasma.
Results: All patients showed improvement in their facial melasma with 1 of 4 patients showing complete clearance after just 6
Conclusions: Results suggest that this regimen may be a useful new tool to treat mild to moderate melasma.
J Drugs Dermatol.2012;11(5):660-662.
Stephen K. Tyring MD PhD,a Theodore Rosen MD,b Brian Berman MD PhD,c Nathan Stasko PhD,d Todd Durham PhD,d Tomoko Maeda-Chubachi MD PhD MBAd
BACKGROUND: Nitric oxide (NO), a free radical gas, is endogenously produced in human cells. In high concentration, NO neutralizes many disease-causing microbes. The topical investigational drug SB206 releases NO and has the potential to treat skin diseases caused by viruses. Genital warts (condyloma acuminata) are primarily caused by human papillomavirus (HPV) types 6 and 11. Available treatments have low tolerability and efficacy rates and are inconvenient for the patient. Genital warts can recur if HPV is incompletely eradicated during treatment.
OBJECTIVE: Topical SB206 (berdazimer sodium plus carboxymethyl cellulose hydrogel) was assessed for tolerability, safety, and efficacy for up to12 weeks in patients with external genital and/or perianal warts (EGW/PAW) in a phase 2, double-blind, randomized, dose-escalation study.
METHODS: Patients (N=108) were randomly assigned to SB206 or vehicle in a 3:1 ratio: SB206 4% once (QD) or twice daily (BID), 8% QD, 12% QD, or corresponding vehicle. Treatment duration was up to 84 days. The primary efficacy endpoint was complete clearance of baseline EGW/PAW at or before week 12. Pearson’s Chi Square tests compared the efficacy of active vs vehicle treatments. Safety was assessed through adverse event and tolerability reports, physical examination findings, and clinical laboratory test results.
RESULTS: In the Intent-to-Treat population, the percentage of patients with complete clearance of baseline EGW/PAW at or before week 12 was higher for SB206 groups than for vehicle groups, with the greatest difference between SB206 12% QD (33.3%; P=0.010) and vehicle QD (4.3%).
CONCLUSION: Berdazimer sodium (SB206) plus hydrogel was efficacious and well tolerated in the treatment of EGW/PAW.
J Drugs Dermatol. 2018;17(10):1100-1105.
Janna M. Vassantachart MD,a Teo Soleymani MD,b and Jashin J. Wu MD FAADc
Psoriasis is a common, chronic immune-mediated inflammatory skin disorder that significantly impacts quality of life and has potential systemic complications. The majority of psoriatic patients have mild to moderate disease and are adequately controlled with topical medications. However, approximately 20% of patients have moderate-to-severe disease. Phototherapy has remained a mainstay option for patients with moderate-to-severe psoriasis resistant to topical treatments due to its efficacy, cost-effectiveness, and relative lack of side effects, in particular a lack of systemic immunosuppression seen with traditional and biologic systemic therapies. There are several well-established guidelines for phototherapy treatment of psoriasis proposed in the United States by the American Academy of Dermatology (AAD), in Europe by the European S3, and in the United Kingdom by the National Institute for Health and Care Excellence (NICE). The guidelines set by these groups are largely based on current evidence or expert panel consensus where evidence is lacking. This article reviews and compares the current recommendations of these guidelines for psoriasis phototherapy in regards to the initial clinical encounter, dosage, adverse reactions, and special considerations.
J Drugs Dermatol. 2016;15(8):995-1000.
Francisco Camacho, MD and Jose Mazuecos, MD
BACKGROUND: Vitiligo is a hypopigmented skin condition that usually requires a combination of treatment options.
AIM: To demonstrate the effectiveness of topical and oral L-phenylalanine in combination with light plus 0.025% clobetasol propionate at night.
PATIENTS AND METHODS: We have performed an open trial on a group of 70 patients with evolutive vitiligo. Participants were treated with oral (100 mg/Kg/day) and tropical (gel at 10%) L-phenylalanine, exposed to sunlight (spring-summer) or UVA lamps (autumn-winter), and given 0.025% clobetasol propionate at night. All patients were revisited every 6 months while in the study, with a maximum of 4 revisits. Biochemical studies were performed at the beginning of the treatment and at each revisit.
RESULTS: Overall, 90.9% of participants showed improvement, with 68.5% of patients achieving an improvement of 75% or more. This 75% improvement rate was reached 87.9% of the time on the face, 60.4% on the trunk, and 54.6% on the limbs. However, there was a moderate response to the treatment in patients with focal and segmental vitiligo. There was a slight additional improvement in patients receiving UVA lamp light. No biochemical abnormalities were found in any patients.
CONCLUSION:L-phenylalanine in combination with 0.025% clobetasol propionate and sunlight during sunny months or UVA lamps in winter, appears to improve evolutive vitiligo without side effects, and therefore is especially recommended on the face or for children.
Objectives: To assess the benefit of adjunctive use of a SPF 30 moisturizing lotion in reducing local side effects associated with atopical tretinoin cream.
Methods:This was a randomized, investigator/evaluator-blinded, split-face comparison in subjects with healthy skin. Subjects applied tretinoin
cream 0.05% once daily to the whole face and Cetaphil® Dermacontrol Moisturizer (CDM) once daily to one side of the face based on randomization. Tolerability, perference and skin hydration were evaluated at each week, and a cosmetic acceptability questionnaire regarding CDM was completed at the end of the study.
Results: The majority (about 83% to 86%) of subjects experienced skin irritations on both sides of their face, though predominantly mild for the CDM + tretinoin treated side. Tolerability preferences favored the CDM+tretinoin sides. Adjunctive use of CDM with a topical tretinoin
cream improves tolerance of the treatment.
J Drugs Dermatol. 2012;11(9):1104-1107.
Aditya K. Gupta MD PhD FRCPC a,b and Andrew Korotzer PhDc
BACKGROUND: Although a completely normal nail would be the ideal outcome when treating onychomycosis, this is not always achievable and long treatment courses or patient expectations can impact patient adherence.
METHODS: We analyzed cure rates from a number of subpopulations derived from the two pivotal phase III studies with efinaconazole topical solution (10%) to provide some insights into clinically meaningful treatment outcomes and support for effective long-term management programs.
RESULTS: Efinaconazole affords greater efficacy in milder disease, female patients, and those patients whose disease is relatively recent and confined to the great toenail, following 48 weeks’ treatment. With longer treatment courses, similar results may be achieved in other subpopulations. Clinically meaningful results (a 40% improvement in the involvement of the diseased nail) were achieved with efinaconazole within six months in half the patients treated, and in over 90% of patients by study end. A greater proportion of female patients achieved clinically meaningful results at six months, although treatment success did not seem to be influenced by baseline disease severity.
CONCLUSIONS: The majority of patients treated with efinaconazole could expect to see clinically meaningful results within six months.
J Drugs Dermatol. 2016;15(10):1260-1266.
Aditya K. Gupta MD PhD FRCP(C)
This randomized, evaluator-blind, 3-arm parallel, comparator controlled, multicenter pilot study evaluated the safety
and efficacy of ciclopirox nail lacquer topical solution, 8% in combination with oral terbinafine for the treatment of
moderate to severe toenail onychomycosis (?60% disease involvement of target nail and/or lunula/matrix involvement)
(N = 73). Patients were randomized to 1 of 3 treatment arms: ciclopirox nail lacquer once daily for 48 weeks
plus 4 weeks of terbinafine 250 mg/day, followed by 4 weeks of rest (no terbinafine), then another 4 weeks of
terbinafine 250 mg/day (PL8); ciclopirox nail lacquer once daily for 48 weeks plus terbinafine 250 mg/day for 12 weeks
(PL12); or terbinafine 250 mg/day for 12 weeks (L12). At week 48, mycological cure (negative microscopy and culture)
occurred in 66.7% (14/21) (PL8), 70.4% (19/27) (PL12), and 56.0% (14/25) (L12) of patients confirmed dermatophyte
positive, respectively (P: not significant). At this time point, effective cure (simultaneous mycological cure and ?90%
reduction in the disease area) was observed in 40.0% (8/20), 33.3% (8/24), and 34.8% (8/23) of patients, respectively
(P: not significant). The PL8 regimen was well-tolerated and had high compliance. The data suggest that combination therapy (PL8) may be an alternative regimen to continuous terbinafine (L12) in the treatment of moderate to severe dermatophyte toenail onychomycosis.
Rachel Seidel BAa and Ronald L. Moy MD FAADb,c
BACKGROUND: Atrophic acne scars are a common and psychologically devastating sequela of acne vulgaris that are refractory to the vast majority of topical treatments.
OBJECTIVE: We evaluated the efficacy of a topically applied synthetic epidermal growth factor (EGF) serum in reducing the appearance of atrophic acne scars.
METHODS: A single-center clinical trial was performed on nine self-selected male and female patients with Goodman & Baron grade II-IV atrophic acne scars. Subjects followed a standardized treatment regimen, including twice-daily application of EGF serum to scarred areas over 12 weeks. Subject progress was evaluated at baseline and 4-week intervals by clinical photography, Investigator Global Assessment (IGA), Goodman grade and patient self-assessment. Final patient perceptions were shared by written self-assessment at the end of the study. Before and after photographs were also evaluated by a blind investigator.
RESULTS: Eight subjects completed the trial. Compared to baseline, there was an improvement in mean IGA score from 2.875 (SEM= .327) to 2.38 (SEM = .375). Mean Goodman grade was reduced from 3.00 (SEM = .309) to 2.75 (SEM = .25). Of the eight pairs of before and after photographs given to a blind investigator, five were correctly chosen as the post-treatment image. Two were assessed as “excellent” (76-100%) improvement and three were assessed as "good" (50-75%) improvement. A one-tailed paired student t-test (α = .05) using blind investigator ratings of scar severity for each before and after photograph yielded a P-value of .0019, confirming the difference as statistically significant. On final self-assessment, all but one patient reported “good” to “excellent” improvement in their scars compared to baseline. 75% of patients who received alternative treatments in prior years reported EGF serum to be more efficacious.
CONCLUSION: These results suggest that topical EGF may improve the appearance of atrophic acne scars, though further study and more objective evaluation measures are required for definitive conclusions to be drawn.
J Drugs Dermatol. 2015;14(9):1005-1010.
Amanda Dahl BS, Margarita Yatskayer MS, Susana Raab BS, and Christian Oresajo PhD
Hydroquinone (HQ) is the benchmark prescription agent for skin lightening. However, HQ use is recently banned in Europe and in parts of Asia because of potential long-term consequences, including carcinogenesis when orally consumed. This has resulted in development of alternative skin-lightening agents with comparable efficacy to HQ, but better safety profiles. This study examined the skin-lightening ability of a topical product containing 0.5% ellagic acid and 0.1% salicylic acid and compared its efficacy with that of a prescription generic 4% HQ product. Fifty-four multiethnic subjects were randomly assigned to use the topical test formulation or generic 4% HQ twice daily for 12 weeks to evaluate product tolerability and efficacy. Under the conditions of this double-blinded clinical study, the test product demonstrated comparable tolerance and efficacy to that of a benchmark product 4% HQ, as assessed by clinical grading, physical measurement of spot size using image analysis, and questionnaire response analysis. This study suggests that this new product provided comparable skin depigmentation benefit to the benchmark product. In addition, the product appears to have better esthetics (texture, pleasantness to use, skin feel) than the 4% HQ product.
J Drugs Dermatol. 2013;12(1):52-58.
Background: Many therapeutic modalities for scabies were available, topical sulfur ointment is a cost-effective and safe therapeutic agent. It is often applied for the whole body for three successive days.
Objective: To evaluate their therapeutic regimen of 8% and 10% topical precipitated sulfur in petrolatum ointment for single day, three successive nights or three successive days in management of scabies.
Patients and Methods: This single-blinded, comparative study was conducted in the Department of Dermatology-Baghdad Teaching Hospital from April 2008 through October 2009. A total of 97 patients with scabies were enrolled in this study. The diagnosis was established on clinical basis. The patients treated with 8% and 10% topical sulfur in petrolatum ointment were divided randomly into three groups: Group A: 33 patients treated for single day (24 hours); Group B: 32 patients treated for three successive nights (from 6 p.m. to 8 p.m. to 6 a.m. to 8 a.m. and bathing every day); and Group C: 32 patients treated for three successive days (bathing every 24 hours). The patients were seen regularly every two weeks for the duration of four weeks.
Results: Study included 58 (59.8%) males and 39 (40.2%) females, with a male to female ratio 1.4:1. The age range of males at presentation from 3 to 64 (26.74±15.98) years, while the females age ranged at presentation from 3 to 60 (24.05±14.53) years of age. At the end of the study, the response to treatment was: Group A, response in 14 (42.4%) patients and no response in 19 (57.6%); Group B, response in 29 (90.6%) patients and no response in 3 (9.4%); and Group C, response in 31 (96.9%) patients and no response in 1 (3.1%). There is significant statistical difference among the response of 3 groups with (P=0.00000011), but no statistically significant difference between the response of Group C and Group B, (P=0.6055). Mild burning sensation and irritating (sulfur) dermatitis were the only side effects of 8% and 10% sulfur. Pruritic rash occurred in Group C mainly, in 11 (34.4%) patients, 8 (25%) in Group B and 4 (12.1%) in Group A, with no significance (P=0.1058). Recurrence or relapse occurred in Group A mainly, with 4 (12.1%) patients, and in Group B, 1 patient, (3.1%), with no recurrence in group C, with significance (P=0.0060).
Conclusion: Three successive days and three successive nights of 8% and 10% sulfur ointment were effective regimens with no statistical difference in favor of three successive days, while single-day application was much less effective but with fewer side effects.
J Drugs Dermatol. 2012;11(3):357-364.
Efstathios Rallis MD, Afrodite Economidi MD, Constantinos Verros MD, Pavlos Papadakis MD
Cutaneous T cell lymphomas (CTCLs) are a heterogenous group of lymphoproliferative disorders caused by clonally-derived,
skin-invasive T cells. A variety of skin-directed and systemic therapies are available to treat mycosis fungoides/Sézary syndrome
(MF/SS), the therapeutic choices of which are guided by the stage of disease.
A 29-year-old man presented at our clinic with pruritic, erythematous macules located on the sternum and the lower back.
Histological findings and immunohistochemistry studies showed patch stage MF. The patient was treated with tacrolimus
ointment 0.1% twice daily for one month, achieving complete remission. Three months after the first episode a relapse was
successfully treated with the same therapeutic regimen.
Tacrolimus is an immunomodulatory macrolide that reduces the stimulatory capacity toward T cells and is therefore worth
investigating as a treatment of CTCL. Topical tacrolimus has been related to an unknown effect with the risk for secondary
malignancies including CTCL. Also, black box warnings have been proposed by the FDA for the topical calcineurin
inhibitors. Nevertheless, our results in the treatment of early stage MF are in agreement with other unpublished data that
have observed its efficacy. To our knowledge, there is no other case of patch type mycosis fungoides treated with tacrolimus
ointment 0.1% in the medical literature
Georgina Ferzli MD MS, Mital Patel MD, Natasha Phrsai BS, and Neil Brody MD PhD
BACKGROUND/OBJECTIVE: Many topical formulations include antioxidants to improve the antioxidant capability of the skin. This study evaluated the ability of a unique combination of antioxidants including resveratrol, green tea polyphenols, and caffeine to reduce facial redness.
METHODS: Subjects (n=16) presenting with facial redness applied the resveratrol-enriched product twice daily to the entire face. Reduction in redness was evaluated by trained staff members and dermatology house staff officers. Evaluators compared clinical photographs and spectrally enhanced images taken before treatment and at 2-week intervals for up to 12 weeks.
RESULTS: 16 of 16 clinical images showed improvement and 13 of 16 spectrally enhanced images were improved. Reduction in facial redness continued to evolve over the duration of the study period but was generally detectable by 6 weeks of treatment. Adverse effects were not observed in any subject.
CONCLUSION: The skin product combination of resveratrol, green tea polyphenols, and caffeine safely reduces facial redness in most patients by 6 weeks of continuous treatment and may provide further improvement with additional treatment.
J Drugs Dermatol. 2013;12(7):770-774.
LCDR Sean J Murphy MC USN, CPT Clifton R Dobbs MC USA
A 32-year-old Philippino male presented to the clinic with a penile rash of 2 months duration. The rash was diagnosed as lichen
nitidus and was successfully treated with the non-indicated therapy of Protopic 0.1% (Tacrolimus) for 4 weeks.
Michael H. Gold, MD; Molly M. Boring, RN, MSN, FNP-C; Tancy Bridges, RN, MSN, FNP-C and Vriginia L. Bradshaw, RN, MSN, GNP-C
Photodynamic therapy (PDT) with topical 5-aminolevulinic acid (ALA) has been shown to be safe and effective for a variety of skin
concerns. The case report described is the first successfully documented use of ALA/PDT in the therapy of recalcitrant molluscum
contagiosum in HIV-positive individuals.
Ekaterina Kraeva MD,a,b Derek Ho MD,a,b and Jared Jagdeo MD MSa,b,c
Keloids are fibrous growths that occur as a result of abnormal response to dermal injury. Keloids are cosmetically disfiguring and may impair function, often resulting in decreased patient quality-of-life. Treatment of keloids remains challenging, and rate of recurrence is high. We present a case of a 39-year-old African-American man (Fitzpatrick VI) with a 10-year history of keloid, who was successfully treated with eight sessions of fractionated carbon dioxide (CO2) laser immediately followed by laser-assisted drug delivery (LADD) of topical triamcinolone acetonide (TAC) ointment and review the medical literature on fractionated CO2 laser treatment of keloids. To the best of our knowledge, this is the first report of successful treatment of a keloid using combination therapy of fractionated CO2 laser and LADD with topical TAC ointment in an African-American man (Fitzpatrick VI) with excellent cosmetic results sustained at 22 months post-treatment. We believe that this combination treatment modality may be safe and efficacious for keloids in skin of color (Fitzpatrick IV-VI) and other patients. This case highlights the ability of laser surgeons to safely use fractionated CO2 lasers in patients of all skin colors.
J Drugs Dermatol. 2017;16(9):925-927.
James Q. Del Rosso DO,a Julie Harper MD,b Leon Kircik MD,c Glynis Albon MD,d Diane Berson MD,e Adelaide Hebert MD,f Doris Day MDg
Atopic dermatitis (AD) is well-recognized as a very common chronic and relapsing pruritic skin disorder affecting both children and adults worldwide. The adverse effects on the quality of life of affected individuals and their families is well-established. The pathophysiology of AD is complex, leading to interindividual variations in clinical presentation and severity. The chronicity of AD, characterized by periods of exacerbation and remission, supports a strong need to develop measures that can effectively and safely prolong remissions between flares of the disease. This article provides an overview of AD including prevalence, severity, and disease course/progression, succinct summaries of pathophysiology and medical management, and discussion of epidermal barrier dysfunction and skin microbiome shifting associated with AD. Additional emphasis is placed on adjunctive topical skin barrier approaches that may prolong disease-free remissions. Results from a panel of dermatologists queried about adjunctive approaches to AD, using a modified-Delphi approach, are also discussed.
J Drugs Dermatol. 2018;17(10):1070-1076.
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Deede Y. Liu MD,a* Tarek Shaath BA,b* Anand N. Rajpara MD,a Cody Hanson BS,c
Garth Fraga MD,d Ryan Fischer MD,a and Daniel J. Aires MDa
Cutaneous T-cell lymphoma is a cancer of skin-homing T cells, of which mycosis fungoides (MF) is the most common variant.
MF treatments range from topical steroids to systemic chemotherapy. Resistant cutaneous MF nodules can present a special
challenge in that typical topical therapies may not penetrate thick lesions, and increasing systemic therapy brings added risk of
side effects. We report successful use of intralesional steroids (ILS) for treatment-resistant MF, including tumor-stage plaques
and nodules in 4 consecutive patients with focally resistant MF. ILS have been widely used to treat a broad range of cutaneous
conditions such as alopecia areata and keloids. Side effects of ILS include hypopigmentation, atrophy, telangiectasias, lilac discoloration,
acne, and striae. Rarely, and in circumstances involving unusually large doses, ILS may cause Cushing’s syndrome,
hypothalamus-pituitary-adrenal axis suppression, and reduced bone mineral density. The MF patients tolerated treatment well
without any of the above side effects other than local hypopigmention in a single patient. These results point toward further exploration
into ILS as a treatment for focally resistant MF.
J Drugs Dermatol. 2015;14(5):466-470.
Douglas E. Kligman MD PhDa and Zoe D. Draelos MDb
BACKGROUND: Salicylic acid (SA) and retinoids, tretinoin (all-trans retinoic acid [ATRA]), and retinol (all-trans retinol) are widely used as topical agents for the improvement of photodamage and acne vulgaris. They can be used in daily take-home products or as part of an in-office procedure, combining the benefits of a keratolytic (SA) and a retinoid.
OBJECTIVE: The objective of this research was to compare the efficacy for ameliorating photodamage of topical tretinoin (0.25%) and retinol (0.25%) to baseline and with each other when applied after a 30% salicylic acid peel on human facial skin.
METHODS: Twenty female subjects received a full face 30% SA peel followed by the overnight application of tretinoin to a 1 randomized half-face and retinol to the opposite side (split-face study). The identical procedure was repeated at week 2. Double-blinded subject and investigator assessments of the results were captured at weeks 2 and 4.
RESULTS: By investigator evaluation, both peeling regimens were effective in improving photodamage parameters compared to baseline. (ATRA P-values at week 4 were: P=.00008 texture, P=.00013 roughness, P=.00221 pores, P=.00098 dryness, P=.02770 erythema, and P=.00008 overall appearance. Retinol P-values at week 4 were: P=.00019 texture, P=.00053 roughness,
P=.00221 pores, P=.00147 dryness, P=.02770 erythema, and P=.0043 overall appearance.) By subject self-assessment compared with baseline, both tretinoin and retinol were effective in improving overall appearance (ATRA P=.0229 and retinol P=.0190). By investigator evaluation comparing tretinoin with retinol, tretinoin was slightly better than retinol at week 4 in improving texture P=.00506, roughness P=.01171, and overall appearance P=.00506. By subject self-assessment comparing tretinoin with retinol, there was no difference in overall appearance (ATRA P=.2367 and retinol P=.3613).
CONCLUSION: Either topical tretinoin (0.25%) or retinol (0.25%) can be used safely and effectively when applied in office immediately after SA peeling to ameliorate signs of photoaging.
J Drugs Dermatol. 2016;15(4):442-450.
Julie A. Neville MD, Phillip M. Williford MD, Joseph L. Jorizzo MD
Background: Nodular basal cell carcinoma (nBCC) is the most common cutaneous malignancy and studies assessing the
use of topical imiquimod 5% cream as a monotherapy in the treatment of nBCC have resulted in less than optimal clearance
Objective: This pilot study was designed to evaluate the efficacy of imiquimod 5% cream on nodular basal cell carcinoma
lesions after initial treatment with curettage.
Methods: After obtaining informed consent, 17 nBCCs on 15 patients were included in this institutional review boardapproved,
open-label study with initial treatment using curettage without electrodesiccation followed by once-daily application
of imiquimod 5% cream 5 times per week for 6 weeks. The area was excised and examined histologically 6 weeks
after cessation of imiquimod cream.
Results: All 17 lesions (100%) showed no histologic evidence of residual tumor on the post-treatment excision. Local
site reactions necessitating a rest period from medication application were experienced by most patients (67%), but the
majority of patients stated that they would choose this treatment modality over excision if they developed a subsequent
Conclusion: Imiquimod 5% cream appears to be an effective treatment method for nodular basal cell carcinoma if combined
with curettage prior to application.
Stefano Veraldi MD PhD, Paolo De Micheli MSc, Rossana Schianchi MD, Luisa Lunardon MD
Atopiclair® (Zarzenda®) is a topical non-steroidal anti-inflammatory agent for the treatment of allergic diseases of the skin. Three main
ingredients are contained in this product: glycyrrhetinic acid, telmesteine and Vitis vinifera extracts. Other ingredients include: allantoin,
α−bisabolol, capryloyl glycine, hyaluronic acid, shea butter and tocopheryl acetate. Two previous randomized, double-blind,
vehicle-controlled clinical studies provided evidence that Atopiclair is effective in the treatment of atopic dermatitis. This article
presents an open, multicenter, sponsor-free, study on the anti-pruritic activity of this product in adult patients with mild-to-moderate
atopic dermatitis. The Median Visual Analogue Scale (VAS) values were: at the start of the study (T0), median VAS was 48.5 mm;
three weeks later (T1), median VAS was 34.1 mm (-14.4 mm from baseline); six weeks later (T2), median VAS was 24.6 mm (-23.9
mm from baseline). Statistical analysis revealed that differences between T0 versus T1, T0 versus T2 and T1 versus T2 were highly
significant (p<0.001). Side effects (local burning) were relatively common, although mild in severity. On the basis of the results of this
study, Atopiclair showed efficacy in relief of pruritus in adult patients with mild-to-moderate atopic dermatitis.
Joseph F. Fowler MD,a Ole Graff MD,b Abbas G. Hamedanib
Severe chronic hand eczema (sCHE) is a persistent, disfiguring disease that responds poorly to conventional treatment and causes substantial physical and psychological disability. The objective of this study was to evaluate efficacy and safety of oral alitretinoin in sCHE in a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study comparing alitretinoin with placebo. Efficacy was assessed every 4 weeks during treatment and 4 weeks after end of treatment (EOT, 24 weeks); responders were assessed every 4 weeks for a further 48 weeks after EOT. The study was conducted at academic and private dermatology centers. The participants were 596 patients with sCHE refractory to potent topical corticosteroids. Patients were treated with daily oral alitretinoin 30 mg or placebo for up to 24 weeks. Primary endpoint was proportion of responding patients based on Physician Global Assessment (PGA) of “clear” or “almost clear” at EOT. Key secondary endpoints: Patient Global Assessment (PaGA), change in modified Total Lesion Symptom Score (mTLSS), time to response (TTR), extent of disease at EOT, and duration of response (DOR). At EOT, 40% of alitretinoin-treated patients were responders vs 15% placebo-treated patients (odds ratio [OR] = 3.78; P < .001); a greater proportion of alitretinoin-treated patients achieved a PaGA of “cleared” or “almost cleared” (OR = 4.05; P < .001). A greater decrease in mTLSS occurred from baseline to EOT in alitretinoin- vs placebo-treated patients (treatment difference −24% P < .001). Median TTR for responders at EOT was shorter with alitretinoin vs placebo (65 vs 117 days; P < .001). Greater decreases in extent of disease at EOT were observed with alitretinoin vs placebo (treatment difference −22%; P < .001). The most common treatment-emergent adverse event was headache. Alitretinoin significantly improved signs/symptoms of sCHE, was well tolerated in patients refractory to potent topical corticosteroids, and may provide benefit to this population.
J Drugs Dermatol. 2014;13(10):1198-1204.
Emil Tanghetti MD, William Abramovits MD, Barry Solomon MD, Keith Loven MD, Alan Shalita MD
Topical retinoids offer highly effective treatment for both inflammatory and non-inflammatory acne, with tazarotene demonstrating
greater efficacy than other topical retinoids. A multicenter, double-blind, randomized, parallel-group trial has been
performed to evaluate whether the adjunctive use of clindamycin/benzoyl peroxide could enhance the efficacy of tazarotene
still further. Patients with moderate to severe inflammatory acne applied tazarotene 0.1% cream each evening and were
randomly assigned to morning applications of vehicle gel or a ready-to-dispense formulation of clindamycin 1%/benzoyl
peroxide 5% gel containing 2 emollients. Tazarotene/clindamycin/benzoyl peroxide achieved a significantly greater reduction
in comedo count than tazarotene monotherapy and, among patients with a baseline papule plus pustule count of ?25 (the
median value), a significantly greater reduction in inflammatory lesion count. The combination therapy was also at least as
well-tolerated as tazarotene monotherapy. The adjunctive use of clindamycin/benzoyl peroxide gel with tazarotene cream
promotes greater efficacy and may also enhance tolerability. Any improvements in tolerability could be due to the emollients
in the clindamycin/benzoyl peroxide gel formulation.
Macrene R Alexiades-Armenakas MD PhD, Roy G Geronemus MD
Actinic cheilitis (AC) is a common precancerous condition for which a safe, effective, rapid, and cosmetically favorable treatment is
needed. The objective of this study was to assess the safety and efficacy of the long-pulsed pulsed dye laser (LP PDL) (595 nm) with
photodynamic therapy (PDT) for the treatment of AC. This study was designed to be a prospective, proof-of concept pilot study to
assess safety and efficacy of LP PDL in conjunction with topical 20% 5-aminolevulinic acid solution PDT for the treatment of AC.
Control patients received LP PDL alone. The setting was an outpatient clinical research center. A volunteer sample of 21 patients
with biopsy-proven AC was enrolled (age range, 42-86 years; skin types I-III). All patients were refractory to prior therapies.
Patients with a history of herpes labialis were pre-treated with famcyclovir. Nineteen patients received one-to-three treatments of
topical 20% 5-aminolevulinic acid for 2-3 hours, followed by LP PDL (595 nm) at monthly intervals. Two control patients received
one treatment with LP PDL alone. Patients in the ALA-LP PDL group were followed at 1, 2, 3, 6, 9, and 12 months. Clearance of
AC was assessed by clinical evaluation. Control patients were followed to the one month interval.
We observed none-to-mild pain; slight-to-moderate erythema; no crusting, purpura, or scarring; treatment time of less than one
minute; and complete resolution of post-operative erythema by day three. Complete clearance was achieved in 13/19 (68%) of patients
following a mean of 1.8 treatments (7/13 (37%) after one, 2/13 (11%) after two, and 1/13 (21%) after three treatments). Patients were followed
for a mean of 4.1 (range 1-12) months. Among the remaining cases, partial clearing was achieved in two patients, recurrence during
the follow-up interval was observed in one patient, and failure to follow-up occurred in three patients. Post-operative impetiginization
occurred in three patients with erosive AC, which resolved with dicloxacillin therapy. Among the control patients, no clearing
Treatment of AC using LP PDL (595 nm) at nonpurpuric parameters following topical application of 5-aminolevulinic acid at short
incubation times is safe and effective. It may offer the advantages of rapid incubation, treatment, and recovery times, minimal discomfort,
excellent cosmetic outcome, and good efficacy rates. Patients with erosive AC should receive antibacterial prophylaxis.
Multiple treatments may be required for complete clearing.
Mirna E. Toledo-Bahena MD,a Alicia Bucko DO JD,b Jorge Ocampo-Candiani MD,c Maira E. Herz-Ruelas MD,c
Terry M. Jones MD,d Michael T. Jarratt MD,e Richard A. Pollak DPM MS,f Lee T. Zane MDg
OBJECTIVE: To assess the potential efficacy, safety, and optimal dosing concentration of tavaborole, a novel, boron-based pharmaceutical agent with broad-spectrum antifungal activity, for the treatment of onychomycosis of the toenail due to dermatophytes.
METHODS: One double-blind, randomized, vehicle-controlled study (study 1) and two open-label studies (studies 2 and 3) examined the efficacy, safety, and optimal dosing concentration of tavaborole topical solution applied once daily or three times weekly for 180 days at concentrations of 1.0%, 2.5%, 5.0%, or 7.5%. Patient cohort 3 of study 2 received open-label tavaborole 5.0% once daily for 360 days. All three studies assessed day 180 treatment success, defined as complete or partial clinical evidence of clear nail growth plus negative fungal culture.
RESULTS: A total of 336 patients were included in the intent-to-treat (ITT) or modified ITT populations and efficacy analyses across the 3 studies. In study 1, treatment success rates at day 180 were higher with tavaborole 2.5%, 5.0%, and 7.5% vs vehicle (27%, 26%, and 32% vs 14%, respectively; slope P=0.030). In cohort 3 of study 2, 7% of patients achieved treatment success with tavaborole 5.0% at day 360. Negative culture rates at day 180 in study 1 were numerically higher for tavaborole 2.5%, 5.0%, and 7.5% vs vehicle (slope P=0.046). Application-site reactions of general irritation, erythema, scaling, and stinging/burning were most common with tavaborole 7.5%, were generally mild to moderate, and resolved with treatment discontinuation and/or a reduction in dosing frequency. No systemic safety concerns were observed.
CONCLUSION: Tavaborole solution demonstrated favorable efficacy and safety in phase 2 clinical studies. Based on these findings, tavaborole
topical solution, 5% was further investigated in larger, more definitive phase 3 studies. Results from these completed phase
3 studies will provide additional evidence regarding the safety and efficacy of tavaborole in the treatment of toenail onychomycosis.
J Drugs Dermatol. 2014;13(9):1124-1132.
Facial skin aging is accelerated in postmenopausal females due to decreased collagen, reduced hydration, and loss of skin elasticity constituting the characteristics of estrogen deficient skin (EDS). The presence of estrogen receptors on dermal fibroblasts and epidermal keratinocytes confirms the role of estrogen in skin health. This research examined the efficacy and tolerability of topical methyl estradiolpropanoate (MEP) as an anti-aging cosmeceutical with estrogen like cutaneous effects in postmenopausal women who had never taken hormone replacement therapy (HRT). MEP was applied to the face twice daily for 14 weeks but was metabolized in the skin to an inactive compound avoiding estrogen side effects, as demonstrated by the safety study. The efficacy study investigator noted MEP induced statistically significant improvement from baseline at week 14 in dryness (P less than 0.001), laxity (P=0.001), atrophy (P=0.003), and dullness (P less than 0.001) as compared to vehicle. Four of nine subjects in the biopsy sub study demonstrated an increase in fibroblasts estrogen receptor staining. The novel concept of a safe and efficacious soft estrogen facial cosmeceutical may provide appearance benefits for postmenopausal women.
J Drugs Dermatol. 2018;17(11):1186-1189.
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Psoriasis is a chronic inflammatory skin disease that is characterized by thickened red plaques covered with silvery scales. Excimer laser therapy is a cutting-edge advancement in UVB phototherapy. In contrast to traditional phototherapy, the 308 nm excimer laser only targets psoriasis plaques, while it spares uninvolved skin. It allows for treatment with a supra-erythmogenic dose of UVB irradiation. Targeted UVB therapy is a possible treatment especially for many who have failed topical treatments, systemic therapy, and traditional phototherapy. For safe and effective psoriasis treatment, a combination of therapies may be used, including a combination of laser treatment with topical medications. We present two cases demonstrating effective treatment with excimer laser in conjunction with clobetasol spray and calcitriol ointment for 12 weeks. Long-term near-clearance of psoriasis was sustained after 6 months and one-year follow up periods without further therapy.
J Drugs Dermatol. 2012;11(8):994-996.
Andrea L. Zaenglein MD,a Ava Shamban MD,b Guy Webster MD PhD,c James Del Rosso DO FAOCD,d Jeffrey S. Dover MD FRCPC,e Leonard Swinyer MD,f Linda Stein MD,g Xiaoming Lin MS RN,h Zoe Draelos MD,i Michael Gold MD,j and Diane Thiboutot MDa
BACKGROUND: Moderate to severe acne vulgaris is often treated with a combination of an oral antibiotic, topical antibiotic/retinoid, and benzoyl
peroxide (BP), but data are limited on the efficacy of this and other combination regimens that incorporate both oral and topical therapies.
METHODS: Patients were required to be aged 12–30 years with moderate to severe acne (grades 3–4 acne on the Investigator's Global
Assessment [IGA]) and deemed potential candidates for treatment with isotretinoin. Enrolled patients were given triple-combination
therapy, defined in this study as oral minocycline HCl extended release 1 mg/kg QD, 6% BP foaming cloths used QD, and clindamycin
phosphate 1.2%/tretinoin 0.025% gel applied QD, and were evaluated at baseline and weeks 2, 4, 8, and 12.
RESULTS: A total of 97 patients were enrolled in the study. At week 12, 89% of patients had at least a one-grade improvement from
baseline IGA and 96% had at least a one-grade improvement from baseline Global Aesthetic Improvement Scale score. Mean±SD in-
flammatory, non-inflammatory, and total lesion counts decreased from baseline by 61.8%±38.3%, 48.8%±34.5%, and 56.5%±29.9%,
respectively. The percentage of patients evaluated as candidates for isotretinoin by independent photographic review was 77% (69/90)
at baseline and only 16% (14/90) at week 12. Treatment-related adverse events (AEs) occurred in eight of 97 (8%) patients. Triplecombination
therapy was not associated with any serious AEs or AEs leading to discontinuation.
CONCLUSION: Triple-combination therapy was well tolerated and substantially reduced facial acne lesion counts, with 84% of patients
judged to no longer be candidates for isotretinoin therapy by study end. These data support the clinical observation that a triple-combination
regimen incorporating oral minocycline (dosed by patient weight), BP foaming cloths 6% QD, and clindamycin phosphate 1.2%/
tretinoin 0.025% gel QD can substantially improve moderate to severe acne vulgaris.
J Drugs Dermatol. 2013;12(6):619-625.
I read with interest the informative article by Spencer et al1 that describes the efficacious use as a novel skin lightening agent (LumaPro-C) for the treatment of patients with melasma.
Mital Patel MD, Whitney P. Bowe MD, Carol Heughebaert MD, Alan R. Shalita MD
Objective: To review recent studies on the use of antibiotics in acne vulgaris which provide insight into the development of antimicrobial
Data sources: Sources for this article were identified by searching the English literature by Medline for the period 1960 to March 2009.
Study selection: The following relevant terms were used: acne, acne vulgaris, acne and antibiotic therapy, acne and antimicrobial
resistance, acne and resistance mechanisms, acne and systemic infections, acne and antibiotic resistance and coagulase-negative
Staphylococcus aureus (S. aureus), acne and antibiotic resistance and upper respiratory infection.
Data synthesis: Both correct and incorrect use of antibiotics for acne vulgaris can promote antimicrobial resistance. The development
of this resistance is promoted by several factors, including antibiotic monotherapy, long-term administration of antibiotics, indiscriminate
use outside their strict indications, dosing below the recommended levels, and the administration of antibiotics without
concurrent benzoyl peroxide and/or topical retinoids.
Conclusion: Long-term use of antibiotics in the treatment of acne vulgaris can lead to antimicrobial resistance with serious and intractable
problems not limited to Propionibacterium acnes (P. acnes), the skin and acne vulgaris themselves, but also to other bacterial
species, with systemic consequences. These findings suggest that antibiotics should be prescribed in combination with benzoyl
peroxide and/or topical retinoids and be limited to a maximum of several months.
Siegfried Segaert MD PhDa and Mads Røpke PhDb
Topical corticosteroids and vitamin D analogs are well established as safe and effective first-line treatments for mild to moderate plaque psoriasis. They act via distinct and complementary mechanisms of action: vitamin D analogs primarily counter epidermal dysregulation, inhibiting epidermal hyperproliferation and inducing keratinocyte differentiation, whereas corticosteroids act primarily as immunosuppressors, targeting pro-inflammatory cytokines and chemokines. Furthermore, both agents have additional activity that may complement their main effects: vitamin D analogs have some immunomodulatory properties and corticosteroids may impact on keratinocyte differentiation. Based on their dominant mechanisms of action, there is a strong scientific rationale for the combination of corticosteroids and vitamin D analogs in the treatment of plaque psoriasis. Indeed, the combination has been shown to have a greater effect on the immune-mediated mechanisms of psoriasis than either monotherapy used alone. There is also a strong biological rationale for decreased side effects with the combination. Vitamin D may restore epidermal barrier function, which is impaired with corticosteroid use, and counteract steroid-induced skin atrophy. Corticosteroids may reduce perilesional skin irritation induced by vitamin D analogs. Although clinical data strongly support improved efficacy and tolerability with a combination of calcipotriol and betamethasone dipropionate, additional studies are needed to further investigate their underlying mechanisms.
J Drugs Dermatol. 2013;12(8):e129-e137.
Enzo Emanuele MD,a Velimir Altabas MD,b Karmela Altabas MD,b and Enzo Berardesca MDc
The exposure to ultraviolet radiation (UVR) is one of the most important risk factors for skin aging and increases the risk of malignant transformation. Telomere shortening and an altered expression of the proto-oncogene c-FOS are among the key molecular mechanisms associated with photoaging and tumorigenesis. Photolyase from A. nidulans and endonuclease from M. luteus are xenogenic DNA repair enzymes which can reverse the molecular events associated with skin aging and carcinogenosis caused by UVR exposure. Therefore, the purpose of this study was to investigate whether the topical application of preparations containing DNA repair enzymes may prevent UVR-induced acute telomere shortening and FOS gene hyperexpression in human skin biopsies. Twelve volunteers (Fitzpatrick skin types I and II) were enrolled for this experimental study, and six circular areas (10 mm diameter) were marked out on the nonexposed lower back of each participant. One site was left untreated (site 1: negative control), whereas the remaining five sites (designated sites 2–6) were exposed to solar-simulated UVR at 3 times the MED on four consecutive days. Site 2 received UVR only (site 2: positive control), whereas the following products were applied to sites 3–6, respectively: vehicle (moisturizer base cream; applied both 30 minutes before and immediately after each irradiation; site 3); a traditional sunscreen (SS, SPF 50) 30 minutes before irradiation and a vehicle immediately after irradiation (site 4); a SS 30 minutes before irradiation and an endonuclease preparation immediately after irradiation (site 5); a SS plus photolyase 30 minutes before irradiation and an endonuclease preparation immediately after irradiation (site 6). Skin biopsies were taken 24 h after the last irradiation. The degree of telomere shortening and c-FOS gene expression were measured in all specimens. Strikingly, the combined use of a SS plus photolyase 30 minutes before irradiation and an endonuclease preparation immediately after irradiation completely abrogated telomere shortening and c-FOS gene hyperexpression induced by the experimental irradiations. We conclude that the topical application of preparations containing both photolyase from A. nidulans and endonuclease from M. luteus may be clinically useful to prevent skin aging and carcinogenesis by abrogating UVR-induced telomere shortening and c-FOS gene hyperexpression.
J Drugs Dermatol. 2013;12(9):1017-1021.
Noel M. Prevost MPAS PA-C, Joseph C. English III MD
Lichen planus of the nails is a destructive inflammatory onychodystrophy that is often difficult to treat. We report a case
of treatment with combined topical therapy of tazarotene gel and clobetasol gel. This modality may be effective for
patients with nail lichen planus without the potential adverse affects of systemic treatments.
Hema Sundaram MD,a Michael Gold MD,b Heidi Waldorf MD,c Mary Lupo MD,d Vivien L. Nguyen PharmD,e and Jwala Karnik MDe
BACKGROUND: This multicenter, open-label pilot study evaluated safety, efficacy and tolerability of a topical formulation containing a multipotent growth factor resignaling complex (MRCx), when applied to infraorbital and lateral canthal skin.
METHODS: Thirty-nine female subjects with mean age of 56.8 years who had periorbital lines and wrinkles, uneven skin texture, puffiness,
and lack of skin firmness were enrolled, and 38 completed the study. All subjects applied the multipotent growth factor formulation
bilaterally to the periorbital area, twice daily for 60 days. Efficacy and treatment-related adverse events were evaluated at Baseline and days 14, 30, and 60. Investigators rated the periorbital areas based on 10-point scales.
RESULTS: Subjects’ self-reported compliance with treatment was greater than 99% throughout the study. At day 60, all subjects had improvement in infraorbital brightness (≥ 2 points), moistness (≥ 2 points), wrinkles (≥ 1 point), sallowness (≥ 1 point), crepiness (≥ 1 point), smooth texture (≥ 1 point), skin tightness (≥ 1 point), and skin tone (≥ 1 point). Investigator-rated assessments showed ≥ 1-point improvement for lateral canthal wrinkles, dyschromia/mottled pigmentation, skin tone, overall brightness, and moistness. Investigator-rated scoring on the Global Aesthetic Improvement Scale (GAIS) demonstrated that 67.6% of subjects were much improved/improved at day 14, and 63.1% remained improved at day 60. Overall, 76.2% and 79.0% of subjects were very pleased/pleased/mostly pleased with the appearance of their infraorbital and lateral canthal areas at day 60. Adverse events comprised one case of mild canthal erythema,
and one case of mild eye irritation, both of which were respectively resolved.
CONCLUSIONS: This pilot study demonstrated that the topical multipotent growth factor formulation was safe, effective and well tolerated for periorbital skin rejuvenation.
J Drugs Dermatol. 2015;14(12):1410-1417.
Aditya K. Gupta, MD, PhD, FRCP(C) and Robert Baran, MD
Onychomycosis in children is relatively uncommon, with a prevalence of approximately 0.3% worldwide. The most common
etiologic organism is Trichophyton rubrum. The oral antifungal agents terbinafine, itraconazole, and fluconazole, and
the topical nail lacquers ciclopirox and amorolfine, are not approved for use in treating onychomycosis in children.
However, these agents appear to be effective and safe in this indication.
Andrew Mamalis*,a,b Natallia Fiadorchanka MD*,c Lauren Adams MD,b Melissa Serravallo MD,c
Edward Heilman MD,c Daniel Siegel MD MS,c Neil Brody MD PhD,c and Jared Jagdeo MD MSa,b,c
Ultraviolet (UV) radiation results in a significant loss in years of healthy life, approximately 1.5 million disability-adjusted life years (DALYs), and is associated with greater than 60,000 deaths annually worldwide that are attributed to melanoma and other skin cancers. Currently, there are no standardized biomarkers or assay panels to assess oxidative stress skin injury patterns in human skin exposed to ionizing radiation. Using biopsy specimens from chronic solar UV-exposed and UV-protected skin, we demonstrate that UV radiation-induced oxidative skin injury can be evaluated by an immunohistochemical panel that stains 8-hydroxydeoxyguanosine (8-OH-dG) to assess DNA adducts, 4-hydroxy-2-nonenal (HNE) to assess lipid peroxidation, and advanced glycation end products (AGEs) to assess protein damage. We believe this panel contains the necessary cellular biomarkers to evaluate topical agents, such as sunscreens and anti-oxidants that are designed to prevent oxidative skin damage and may reduce UV-associated skin aging, carcinogenesis, and inflammatory skin diseases. We envision that this panel will become an important tool for researchers developing topical agents to protect against UV radiation and other oxidants and ultimately lead to reductions in lost years of healthy life, DALYs, and annual deaths associated with UV radiation.
J Drugs Dermatol. 2014;13(5):574-578.
Rosacea is a common, chronic, and poorly understood dermatological condition characterized by an inflammatory component composed
of papules and pustules and a vascular component composed of flushing and erythema. Current treatment options include
topical, systemic, and light-based methods, each of which focuses on either the inflammatory or the vascular component. Retinoids
are not routinely indicated as treatment because of the common conception that they would be too inflammatory for the sensitive
rosacea patient. However, photodamage may play a role in rosacea and tretinoin is well-known to repair photodamage. Thirty rosacea
subjects were enrolled to assess their response to the use of clindamycin phosphate 1.2% and tretinoin 0.025% gel (ZIANA; Medicis
Pharmaceutical Corporation, Scottsdale, AZ) for a period of 12 weeks. The results showed a dramatic decrease in pustules and papules
without any significant inflammation or overall intolerance. No improvement in facial redness was achieved. Based on our results, more
investigation of topical retinoids for rosacea treatment is prudent.
J Drugs Dermatol. 2012;11(12):1410-1414.
A.F. Nikkels MD PhD, P. Gillard MD, G.E. Pierard MD PhD
Introduction: Pityriasis lichenoides (PL) exhibits a protean clinical presentation, particularly in its overlapping form (OPL) combin-
ing aspects of the acute and chronic types. Some patients are drug multiresistant and pose a therapeutic dilemma. The anti-tumor
necrosis factor (TNF)-α agent etanercept, was recently introduced as an alternative treatment for psoriasis, rheumatoid arthritis, and
Case Report: A 65-year-old woman suffered from an overlapping form of pityriasis lichenoides (OPL) for 5 years. Several initial acute
episodes were controlled by successive courses of oral antibiotics, topical corticosteroids, and/or psoralen ultraviolet light-A (PUVA)
therapy. The disease progressively evolved to a more chronic form. Topical immune response modifiers and corticosteroids, as well
as PUVA, ultraviolet light-B (UVB), methotrexate, dapsone, and cyclosporine were introduced, but all proved ineffective. Due to the
therapy multiresistance, 2 weekly injections of etanercept were administered. After 2 months, a marked improvement was observed
in regards to the patient’s pruritus and inflammation. No treatment-related adverse effects were observed. Therapy was continued
for 4 months without any new lesion development. However, 1 month after stopping treatment new OPL lesions recurred.
Conclusion: At the time of publication, this is the first report of the effectiveness of etanercept in OPL. This drug might be consid-
ered as a therapeutic alternative for treatment multiresistant OPL.
Stefan C. Weiss MD MHSc, Josephine Nguyen MD, Susan Chon MD, Alexa B. Kimball MD MPH
Background: There are no published studies examining either the effectiveness of topical steroids in the treatment of
stasis dermatitis or indicating what steroid strength or duration of treatment is optimal to treat this common condition.
Objective: To investigate the efficacy of twice-daily application of the topical steroid betamethasone valerate 0.12%
foam for the treatment of stasis dermatitis.
Design: 42-day randomized, double-blinded, vehicle-controlled, pilot study.
Settings: Outpatient dermatology clinic at a university-affiliated clinic.
Subjects: 19 subjects, mean age of 73, with mild to moderate bilateral stasis dermatitis.
Intervention: Twice-daily application of betamethasone valerate 0.12% foam versus vehicle foam to bilateral randomly
assigned lower legs for 28 days with follow-up to day 42.
Main Outcome Measures: The primary clinical endpoints were the mean change in erythema, scale, swelling, petechiae,
post-inflammatory hyperpigmentation, and self-reported pruritus, assessed on a 5-point Likert scale (0 = clear, 1 =
almost clear, 2 = mild, 3 = moderate, 4 = severe). Secondary endpoints were changes in health related quality of life
(HRQL) using the EuroQol-5D (EQ-5D) utility score and visual analog scale (VAS) and the Dermatology Life Quality
Results: Although there was no overall difference between the foam and vehicle-treated leg at days 14 and 28, the
steroid-treated leg, but not the vehicle-treated leg, showed statistical improvement over baseline. Improvement in the
steroid-treated leg was statistically better than vehicle at days 14 and 28 in terms of erythema (P < .05) and petechiae
(P < .05). Improvement in VAS was notable at days 14 (7.1%), 28 (9.7%), and 42 (9.6%) (P < .001). Similarly, there
was a statistically significant improvement in the DLQI compared to baseline on visit days 14 (188.9%) and 28
(126.1%) (P < .001).
Conclusions: This study suggests that betamethasone valerate 0.12% foam is an effective and well-tolerated short-term
treatment of stasis dermatitis, but that higher potency steroids may be needed to achieve better efficacy. Furthermore,
these results are the first to suggest that the application of effective topical anti-inflammatory therapy can lead to
improvement in HRQL.
We report a case of solitary mastocytoma in a child which was successfully treated with a topical steroid of moderate potency. The
patient was an 18-month-old girl who presented with localized oval shape yellowish to hyperpigmented lesion on the medial aspect
of her right forearm noticed accidentally by the parents since the age of 6 months. The lesion was observed to get urticated mainly
after bathing, toweling, and scratching of the area, associated with reddening and itching confined to the lesion (Figure 1). No other
area of the body was affected with any similar lesion.
Examination of the skin revealed a yellow-tan oval shape patch 1 x 3 cm in diameter which was firm to the touch with intact overlying
skin. The lesion became swollen and itchy when it was rubbed vigorously (positive Darier’s sign). Systemic examination was
unremarkable. The patient investigations including complete blood count, routine biochemical data, plasma histamine level, and urinalysis
were within normal levels. Skin biopsy was cancelled because the parents refused, so our clinical diagnosis was solitary mastocytoma
even though it was not confirmed histologically. We started the patient on a moderate potency corticosteroid (betamethasone
valerate 0.1% cream) twice a day for six weeks after which the lesion became softer with a weak Darier’s sign. This treatment
was continued for another four months which led to resolution of the lesion with residual hyperpigmentation, negative Darier’s sign,
and no signs of atrophy (Figure 2). Follow up of the patient for another 8 weeks without treatment did not reveal any recurrence of
Ravi Jain MBBS MRCGP,a Gerardo Moreno Arias MD PhD,b Pablo Naranjo MD,c Max Murison MD,d Jose Luis López Estebaranz MD PhD,e Alina Fratila MD,f Welf Prager MD,g Carlos Guillén Barona MD,h Michael Weidmann MD,i Serge Dahan MD,j Hugues Cartier MD,k Gerhard Sattler MD,l and Maurizio Podda MD PhDm
Introduction: A variety of topical anesthetic creams are available to reduce pain associated with dermatological procedures. Pliaglis is a self-occluding eutectic mixture of lidocaine and tetracaine.
Study Objectives: To evaluate the post-marketing safety profile of Pliaglis and efficacy in terms of pain reduction, product satisfaction, and daily practice use prior to pre-defined dermatological procedures.
Methods: A prospective, non-interventional study conducted at 44 sites in four European countries; 581 patients were treated prior to dermatological procedures such as pulsed-dye laser therapy, laser-assisted hair removal, non-ablative laser resurfacing, dermal filler injections, and vascular access. Efficacy was assessed by patients and investigators and included pain intensity (visual analogue scale [VAS]), satisfaction, and adequacy of pain relief. Safety was evaluated by adverse event (AE) reporting.
Results: In 75% of the performed procedures, patients scored the pain experienced during the procedure as ≤30 mm on the VAS and most were very satisfied or satisfied with the pain reduction. The investigators assessed the product as providing adequate anesthesia in 97% of the performed procedures and were mostly very satisfied or satisfied with the convenience of use (79%) and tolerability (95%). Twenty-four AEs were reported in 18 (3%) patients.
Discussion: Most patients experienced mild pain only as evident by the ≤ 30 mm VAS scores. Patients and investigators were aligned with regards to both product satisfaction and their opinion on adequacy of pain reduction. The AE frequency was low compared to previous studies, possibly relating to different ways of collecting AEs.
Conclusion: Pliaglis was well-tolerated and provided adequate pain reduction prior to dermatological procedures. www.clinicaltrials.gov (NCT01800474).
J Drugs Dermatol. 2018;17(4):413-418.
Partial study data have been presented at the Anti-Aging Medicine European Congress (AMEC), Paris; October, 24-25, 2014, and the European Academy of Dermatology and Venereology (EADV), Istanbul; October 2-6, 2013.
Asli Aksu Çerman MD, Sezgi Sarıkaya Solak MD, İlknur Altunay MD, and Nihal Asli Küçükünal MD
BACKGROUND: Alopecia areata (AA) is considered a T-cell mediated autoimmune disease characterized by patchy loss of hair from scalp and other body parts with no definitive treatment. Calcipotriol is a vitamin D analogue and a potent immunomodulatuary molecule. In recent studies, low serum vitamin D levels have been observed in patients with AA and various autoimmune diseases. Previous reports have also described the effects of vitamin D on hair follicles.
OBJECTIVE : The aim of the study was to evaluate the efficacy and safety of topical calcipotriol for the treatment of mild-to-moderate patchy AA.
METHOD: Forty-eight patients with mild-to-moderate AA were enrolled in the retrospective, 12-week trial. Calcipotriol cream was applied to the affected areas twice a day. Severity of Alopecia Tool (SALT) score and hair regrowth rate were calculated at baseline and at 3, 6, 9, and 12 weeks.
RESULTS: At week 12, the total response was achieved in 69.2% of patients. When the mean SALT score of patients at week 12 was compared to that of patients at baseline, the value at week 12 was significantly lower (P= 0.001). A regrowth score (RGS) ≥ 3 (hair regrowth of ≥ 50%) was observed in 75% of patients, whereas a RGS ≥ 4 (hair regrowth of ≥ 75%) was observed in 62.5% of patients and the complete regrowth rate (hair regrowth= 100%) was 27.1%.
CONCLUSION: Calcipotriol may serve as a safe and effective treatment option in mild-to-moderate patchy AA, and calls for more extensive controlled studies with this treatment.
J Drugs Dermatol. 2015;14(6):616-620.
Sabrina Guillen Fabi MD,a Joel L. Cohen MD,b Jennifer D. Peterson MD,c Monika G. Kiripolsky MD,d and Mitchel P. Goldman MDa,e
BACKGROUND: Growth factors (GFs) are chemical messengers that regulate specific cellular activities such as cell proliferation and formation of the extracellular matrix. GFs may be derived from a variety of sources, including animals.
OBJECTIVE: Evaluate the safety and efficacy of a topical antiphotoaging product containing secretions of the snail Cryptomphalus aspersa (SCA) for the improvement of facial rhytides.
MATERIALS and METHODS: This was a 2-center, double-blind, randomized, 14-week study in which 25 patients with moderate to severe facial photodamage were treated with an emulsion (with 8% SCA) and liquid serum (with 40% SCA) on one side of the face and placebo on the contralateral side for 12 weeks. Silicone skin impressions of periocular rhytides were performed at baseline and after 12 weeks of treatment. Patient and physician assessments were also performed at 8, 12, and 14 weeks.
RESULTS: Periocular rhytides on the active ingredient side showed significant improvement after 12 weeks (P=.03) and improved texture to a greater degree than placebo at 8 and 12 weeks, as well as 2 weeks after discontinuing the product (14 weeks).
CONCLUSION: Daily application of topical products containing SCA proved effective and well tolerated for improvement in coarse periocular rhytides and fine facial rhytides. Subjects noted a significant degree of improvement in fines lines at the 8-week time point on the SCA-treated side (P≤.05) but did not report a significant difference in the quality of their skin.
J Drugs Dermatol. 2013;12(4):453-457.
Acne therapy should be based on pathogenesis. Current mainstays of therapy include topical retinoids, antibiotics, and benzoyl peroxide. Newer research has shown that inflammation may precede comedo formation. Gene array analysis of acne lesions has elucidated newer inflammatory mediators that may become future targets for therapeutic development.
J Drugs Dermatol. 2013;12(suppl 6):s70-s72.
Dornechia George MD, Ted Rosen MD
Various topical and systemic treatments have shown efﬁ cacy in plaque and palmoplantar psoriasis; however, studies regarding efﬁ -
cacy in inverse psoriasis are few. The authors present a case of a patient with severe inverse psoriasis who was successfully treated
with efalizumab, resulting in complete and sustained remission during prolonged maintenance therapy.
Amit S Kulkarini MS, Rajesh Balkrishnan PhD, fabian T Camacho MS, Roger T Anderson PhD, Steven R Feldman MD PhD
Objective: This study examined the relationship between depressive symptoms and related medication adherence and health care
costs in older adults (age ? 65 years) with psoriasis.
Design: Prospective longitudinal cohort study over a 2-year post enrollment period in a population of older adults with psoriasis
enrolled in managed care.
Setting: A Medicare Health Maintenance Organization (HMO) in southeastern United States with prescription benefits.
Participants: Sixty-three older adults with psoriasis using topical corticosteroids therapy and enrolled in a Medicare HMO for a 2-
year continuous period.
Measurement: Upon enrollment, each enrollee was mailed a comprehensive health status assessment battery, which included the
Center for Epidemiologic Studies Depression (CES-D) scale. Information on medication adherence (using medication possession
ratio) and total health care utilization/costs following enrollment were retrieved from the Medicare HMO database.
Results: Nearly one-fifth of the patient population had depressive symptoms. Patients with psoriasis who had depressive symptoms
at the time of enrollment were less likely to be adherent to topical corticosteroid medication (r= -0.29, p<0.01) and less likely to utilize
health care resources as evidenced by lower health care costs (r= -0.27, p<0.05), after confounder adjustment.
Conclusions: The prevalence of depressive symptoms in older adults with psoriasis is commonplace, with strong, yet unexplained correlations
between presence of depressive symptoms and lower rates of medication and health care service use among these patients.
Diane M. Thiboutot MD, Alan B. FleischerMD, James Q. Del Rosso DO,Phoebe Rich MD
This two-phase, multicenter study was undertaken to examine the safety and effi cacy of combination therapy with oral doxycycline
and topical azelaic acid (AzA) 15% gel in moderate-to-severe papulopustular rosacea and to determine the effect of subsequent
maintenance monotherapy with AzA 15% gel alone. In the initial open-label, non-randomized phase of the study, subjects (n=172)
received topical AzA 15% gel and oral doxycycline (100 mg), both twice daily, for ≤ 12 weeks. In the second, double-blind study
phase, subjects who had initially undergone at least four weeks of combination treatment in phase 1 and who achieved ≥75% infl ammatory
lesion count reduction (n=136) were randomized to receive either AzA 15% gel or its vehicle twice daily for an additional 24
weeks. Assessments of effi cacy were obtained at four-week intervals throughout both phases of the study and included change
in infl ammatory lesion count, investigator global assessment (IGA) of rosacea severity, and separate assessments of erythema and
telangiectasia severity. At the last visit for each phase of the study, the investigator and participant each rated overall improvement,
with the participant rating cosmetic acceptability and the investigator rating treatment as “success” or “failure” based on IGA score.
During the second phase of the trial, the rate of relapse—defi ned as either a 50% deterioration in the lesion count improvement from
phase 1, an increase in erythema intolerable to the subject or maintenance therapy failure as judged by the investigator and/or the
subject—was obtained. Safety assessments were conducted for both phases of the study and included analysis of adverse events
(AEs) and a rating of cutaneous tolerability by the subject.
By week 12 of the open-label phase of the study, 81.4% of subjects had reached a 75% or greater reduction in infl ammatory lesion
count, and 64% of patients achieved treatment success. During the second study phase (maintenance phase), AzA 15% gel consistently
provided a better maintenance response than vehicle, with maintenance of remission in 75% of patients over the six-month
duration of the maintenance phase. Additionally AzA 15% gel showed a statistically signifi cantly lower deterioration in absolute
infl ammatory lesion counts than did vehicle after 8, 16, 20 and 24 weeks of maintenance therapy. No serious treatment-related AEs
were encountered in the study, and 98.5% of subjects were satisfi ed with the local tolerability of both AzA gel and vehicle.
Garrett T. Prince BS,a Michael C. Cameron MD,a Ramin Fathi MD,b Theodore Alkousakis MDa
INTRODUCTION: 5-fluorouracil has proven to be an effective therapy in the treatment of a variety of dermatologic conditions. Approved by the United States Food and Drug Administration for the topical treatment of actinic keratoses and superficial basal cell carcinoma, 5-fluorouracil has also demonstrated efficacy in the treatment of a variety of other dermatologic diseases. While best known for its use as a topical medication, 5-fluorouracil can also be delivered intralesionally for the treatment of dermatologic disease. Recently, laser-assisted modalities for increased delivery of 5-fluorouracil have also been described
METHODS: A search of the MEDLINE standard computer database, MEDLINE advanced database, and EMBASE database was conducted.
RESULTS: 38 articles met criteria for inclusion in this review. These articles represented 14 randomized controlled trials and 24 case series. Each article was reviewed and summarized. The main limitation of this review is the limited number of large randomized controlled trials, as well as the non-uniformity in treatment regimens between studies.
DISCUSSION: Intralesional and laser-assisted 5-fluorouracil are used in a variety of dermatologic disease processes with a wide range of efficacy and levels of evidence. Based on extent and level of evidence, our disease-specific systematic review found that the evidence is strongest for intralesional 5-FU use in the treatment of keloids, hypertrophic scars, and keratoacanthomas. This review serves as a comprehensive summary of intralesional and laser-assisted 5-fluorouracil use in dermatology.
J Drugs Dermatol. 2018;17(3):274-280.
Eric S. Schweiger MD,a Christy C. Riddle MD,b Daniel J. Aires MDb
Background: The current standard of care for hidradenitis suppurativa (HS) includes antibiotics (oral/topical), retinoids (oral/topical)
and intralesional steroids and is unsatisfactory. Photodynamic therapy (PDT) with 20% 5-aminolevulinic acid (ALA) has been used
"off label" to treat acne vulgaris and may hold promise as a therapy for HS. This open-label, non-blinded study investigated the efficacy
and safety of ALA PDT for the treatment of HS using two blue light sources and intense pulsed light (IPL) for photoactivation.
Methods: Twelve subjects with active HS enrolled to undergo ALA PDT once weekly for four weeks with follow-up visits 4, 8, and 12
or more weeks later. Nine subjects completed the study through the week 8 follow-up visit. Lesions were counted at each treatment
visit at week 4, week 8 and at the final week.
Results: Mean lesion counts were 11.25 at baseline, 6.5 at 4 weeks (50.8% reduction), and 7.5 at 8 weeks (29.9% reduction). Mean
Global Severity Scores were 2.2 at baseline, 1.5 at 4 weeks, and 1.8 at 8 weeks. Mean DLQI scores were 17.3 at baseline, 13.1 at
4 weeks (27.2% improvement), 14.00 at 8 weeks (19.3% improvement) and 14.0 (19.3% improvement) at the final week (16-62
weeks). Three subjects (25%) had complete clearance and no active lesions 4 weeks after the final treatment. Treatments were more
tolerable for subjects treated with blue light than with IPL.
Conclusion: ALA PDT may be a safe and effective treatment of hidradenitis suppurativa.
J Drugs Dermatol. 2011;10(4):381-386.
Boni E. Elewski MD,a Leon H. Kircik MD,b Nathan Stasko PhD,c Emily De Leon MSCR,c Carolyn Enloe MPH,c Todd Durham PhD,c Tomoko Maeda-Chubachi MDc
Background: Tinea pedis, or athlete’s foot, is a superficial, skin infection caused by dermatophytes. It is usually topically treated. Nitric oxide is endogenously produced in humans and has a variety of physiologic and antimicrobial properties. SB208 is a novel topical treatment comprising berdazimer sodium (a nitric oxide-storing macromolecule) and a hydrogel. Admixing these two components releases nitric oxide to the application site.
Methods: A phase 2, double-blind, randomized trial evaluated the safety and efficacy of 3 doses of SB208 (2%, 4%, and 16%) vs matching vehicle, administered once daily for 14 days, in subjects with culture-confirmed interdigital tinea pedis. The primary efficacy outcome was the proportion of subjects with negative fungal cultures at end of treatment (day 14). Secondary outcomes at days 14 and 42 were the proportion of subjects with mycological cure (negative potassium hydroxide wet mount skin test and culture), clinical cure (reduced signs and symptoms from baseline graded on a 4-point scale). Safety was monitored through physical examinations, adverse events, and hemoglobin and methemoglobin levels. Efficacy outcomes were analyzed using a two-sided Cochran-Mantel-Haenszel test for general association, stratified by site.
Results: At day 14, a higher proportion of patients had negative fungal cultures in the pooled SB208-treated group (62%; P=0.04) than the vehicle-treated group (43%). Of SB208 groups, the 4% group had higher incidence of negative fungal cultures vs the vehicle group (67.6% vs 42.9%; P=0.03). At day 42, pooled SB208-treated groups had significantly more mycological cure vs vehicle group (47% vs 31%, respectively; P=0.08), and clinical cure was maintained in 23% of pooled SB208-treated patients vs 14% of vehicle-treated patients. No safety concerns were reported. Adverse events were mild, not serious, and considered unrelated to study medications.
Conclusions: Topical SB208 was effective and well tolerated in the treatment of tinea pedis.
J Drugs Dermatol. 2018;17(8):888-893.
Background: Topical combination therapy containing a retinoid and an antimicrobial is an effective treatment for acne vulgaris.
Objective: To evaluate the efficacy and safety of a new topical formulation containing clindamycin phosphate 1.2% and tretinoin 0.025% solubilized in an aqueous-based gel (CT gel).
Methods: 1,649 participants were randomized 2:2:2:1 to 12 weeks of double-blind treatment with CT gel, clindamycin, tretinoin, or vehicle gel administered once daily.
Results: Significantly more participants achieved 2-grade or greater improvement on the Investigator's Static Global Assessment score with CT gel versus clindamycin, tretinoin, or vehicle gel. CT gel produced a significantly greater reduction in absolute number of total lesions versus all other treatment groups, in total and noninflammatory lesions versus clindamycin, and in total and inflammatory lesions versus tretinoin. Local tolerability was similar to that of tretinoin alone; signs and symptoms of irritation were most notable at week 2. There were no more adverse events with CT gel than with tretinoin gel.
Conclusion: CT gel is more effective than clindamycin or tretinoin monotherapy, with a safety and tolerability profile similar to that of tretinoin.
J Drugs Dermatol. 2012;11(3):318-326.
James M. Spencer MD MSa,b and Scott A. Freeman PAb
INTRODUCTION: Photodynamic Therapy (PDT) with topical Levulan is an approved and efficacious method for treating actinic keratoses. This therapy depends on the ability of the Levulan (delta amino levulinic acid) to penetrate the stratum corneum and enter the cells of the epidermis. Microneedling is an increasing popular cosmetic therapy in which an array of tiny needles is used to make holes in the epidermis and presumably induce a wound healing cascade that leads to cosmetic improvement of the skin. We were interested to know if prior microneedling would enhance the penetration of topical Levulan and thus enhance the PDT treatment, and if a cosmetic improvement beyond the PDT alone would be seen when it is used in conjunction with microneedling.
METHODS: 20 patients each with at least 4 non hyperkeratotic AKs on each side of their face were enrolled. All patients were randomized to receive multiple passes with a microneedling device to ½ of their face, left or right, followed by application of Levulan to the entire face. The Levulan was allowed to incubate 1 hour followed by exposure to blue light (Blu U) for 1000 seconds.
RESULTS: 19 patients completed the study with 4-month follow up. The mean percentage reduction in AKs was 89.3% on the microneedling side versus 69.5% on the PDT alone side, a significant difference. A physician’s global cosmetic assessment was performed based on Canfield Visia photographs: 15 of the 19 patients had a noticeable improved cosmetic appearance on one side of the face versus the other, and in 13 of these patients the improved side was the microneedled side.
DISCUSSION: Prior microneedling significantly enhances the effect of Levulan PDT. It also seems to provide a cosmetic benefit above and beyond the PDT alone. It was safe and well tolerated in this study.
J Drugs Dermatol. 2016;15(9):1072-1074.
Topical imiquimod has opened an entirely new area of dermatology that previously did not exist: medical therapy for
skin cancers. While surgery will continue to play a vital role in treating more aggressive tumors and in patients who
may not be imiquimod candidates, the availability of a viable medical therapy that can be used independently or in
combination with other modalities will considerably enhance our ability to treat skin cancer successfully.
Sari Weinstein, MD and Ronald R. Branacaccio, MD
Although allergic contact dermatitis to topical preparations of doxepin has been published1-6,10, systemic contact
dermatitis from oral doxepin is more of a theoretical consideration and is rarely reported2. We report a case of
a patient with contact allergy to doxepin hydrochloride 5% cream who developed a systemic contact dermatitis
to oral doxepin.
Liza Brown DO and Stanley Skopit DO MSE FAOCD FAAD
KD is an 8 year-old male patient who presented to our clinic in December 2016 with a history of patchy hair loss for many months duration that was worsening. KD’s past medical history was notable for atopic dermatitis, and a positive family history of autoimmune thyroid disease. Upon examination he had well circumscribed areas of hair loss throughout his scalp, with exclamation mark hairs seen on dermoscopy. Eyebrows and eyelashes were intact, no epidermal changes of scale or erythema were noted on the scalp and no palpable lymph nodes were present. He was diagnosed with alopecia areata at this time and was treated with Clobetasol 0.05% solution QHS as well as Kenalog 2.5 mg/ml injections to the areas of hair loss. Patient followed up two months later with worsening of his alopecia at a rapid pace, presenting now with hair loss of the entire scalp and loss of the eyebrows. He was diagnosed with progression to alopecia universalis at that time, with a corresponding SALT (Severity of Alopecia Tool) score of 100.
Both KD and his mother stated the hair loss was causing much distress in the patient’s life both at school and at home. After a thorough discussion of treatment alternatives to include continued topical high dose steroids, intralesional injections, high dose oral methylprednisolone, topical irritation with anthralin, topical immunotherapy with diphenylcyclopropenone (DPCP) or squaric acid dibutylester (SADBE) and systemic immunosuppressives, both the mother, patient and clinician agreed to try tofacitinib 5 mg twice daily with continued usage of topical steroids. Patient and his family was counseled about support groups, and local meetings to ease the mental distress associated with this condition.
After baseline labs were obtained and reported within normal limits, to include CBC, CMP, thyroid studies, lipids and Quanitferon gold, KD was started on tofacitinib 5 mg BID. Labs were repeated one month later, and 3 months ongoing thereafter.
At KD’s 3 month follow up, after starting tofacitinib 5 mg twice daily, KD showed complete regrowth of the eyebrows with minimal hair growth of the posterior occiput (Figure 1 a-d). At KD’s 6 month follow up he had 100% regrowth of eyebrows and complete scalp regrowth, resulting in a SALT score of 0 (Figure 2).
KD reported no side effects until month 6, after full hair regrowth, when patient started to report mild headaches. Drug holiday was offered but the patients family chose to discontinue treatment at this time as they were concerned side effects were secondary to medication usage. Unfortunately, patient was lost to follow-up after the discontinuation of treatment. From previous case reports we can postulate that his alopecia returned to baseline after discontinuation of tofacitinib.
KD had an incredible response to treatment, as has been reported previously in literature of adolescents using these novel therapies. This is the youngest patient ever reported to be successfully treated with oral tofacitinib 5 mg twice daily for alopecia and its variants.
J Drugs Dermatol. 2018;17(8):914-917.
Mohamed L. Elsaie MD MBA,a,b Mahmoud F. Abdelhamid MD PhD,b
Lotfy T. Elsaaiee MD PhD FACTM,c and Hanaa M. Emam MD PhD b
Background: Botanical extracts and preparations have been used in different pathological conditions with success. An important group
of phytochemical phenolic compounds are the catechins found in green tea. Acne is a widely occurring inflammatory condition that is
estimated to affect 40 to 50 million Americans. Finding an effective, safe, cost-effective and well-tolerated treatment is the challenge.
Objective: To determine the efficacy of 2% green tea lotion in mild-to-moderate acne vulgaris.
Methods: Twenty patients fulfilling enrolment criteria were included. Green tea was given and applied twice daily for a period of 6
weeks. The patients were seen every 2 weeks to evaluate the lesions and any side effects. To determine efficacy on acne severity,
the authors used both total lesion count (TLC) and their devised severity index (SI). Total lesions count (TLC) was calculated as papules
+ pustules while SI was scaled with numbers (1, 2 or 3) correlating to TLC in order of increasing intensity. TLC < 10 was given
an SI of 1, TLC 10-20 was given an SI of 2 and TLC > 20 was given an SI of 3.
Results: The mean total lesion count (TLC) decreased from 24 before the treatment to 10 after 6 weeks after treatment, a reduction
of 58.33%. The difference was statistically significant (P < 0.0001, 95% confidence interval [CI] of the difference = 8.58 – 19.42).
The mean severity index (SI) decreased from 2.05 before treatment to 1.25 after 6 weeks treatment, a decrease of 39.02%. The difference
was statistically significant (P < 0.0001, confidence interval [CI] of the difference = 0.54-1.26).
Conclusion: Topical 2% green tea lotion is an effective, cost-effective treatment for mild-to-moderate acne vulgaris.
Rosacea is a common disorder that is both under recognized and undertreated. Prevalence figures indicate that it may be present in
1 of every 10 adults in a primary care waiting room. Untreated, patients with rosacea can suffer significant emotional, workplace, and
social impairments. While rosacea has been recognized since ancient times, only recently have investigators begun to identify the
pathophysiologic elements responsible for the characteristic erythema, flushing, dysesthesias, and papulopustular manifestations of
the disease. Although the etiology of rosacea is unclear, inflammation appears to be a central element. Experimental evidence suggests
that abnormalities of the skin's innate and adaptive immune responses may play pivotal roles. Once recognized, effective topical
and systemic therapies can be prescribed to lessen the impact of the disease on the patient's life. Although initially administered in an
empiric fashion, it now seems clear that the role of antibiotics in patients with rosacea depends upon their anti-inflammatory rather
than their antimicrobial properties. Consequently, practitioners have the opportunity to practice good antibiotic stewardship when treating
the disease, particularly with systemic therapies. Therapy with subantimicrobial dosing and with topical treatments can modulate
the inflammation of rosacea without exerting antibiotic pressure responsible for the emergence of antibiotic resistance.
J Drugs Dermatol.2012;11(6):725-730.
Jeannette Chantalat MS MBA, Elizabeth Bruning BSC LLB, Ying Sun PhD, Jue-Chen Liu PhD
Background: The first signs of facial skin photo-aging often occur in the skin of the periorbital area and include sagging, loss of firmness and definition, and sallowness. Epidermal wounds have been shown to alter the trans-epithelial electrical potential creating an electric signal that directs cell migration in epithelial wound healing; this electric field declines sharply with age. A topical galvanic zinc-copper complex, which couples elemental zinc and copper to create a biomimetic electric field, has demonstrated anti-inflammatory activity and extracellular matrix improvement in vitro, including collagen and elastin production.
Objectives: To evaluate the efficacy and tolerability of a galvanic zinc-copper complex on photo-aging parameters in a randomized, double-blind, placebo-controlled clinical trial.
Materials and Methods: In this eight-week study, women (40-65 years) with mild to moderate photo-aging were randomized to use placebo or 1 of 3 galvanic zinc-copper complex compositions (gel and activating moisturizer). Efficacy evaluations included clinical grading, specialized clinical imaging, and subject self-assessments performed at baseline, 15-30 minutes after product application and after 1, 2, 4, and 8 weeks. Tolerability was based on adverse events and clinical grading of irritation. Significance was set at P≤0.05 versus baseline and between treatment groups.
Results: The study was completed by 124 women. Compositions containing the galvanic zinc-copper complex showed statistically significant clinical improvements versus placebo and baseline rapidly (15-30 min) after application and through week 8. Clinical grading showed significant improvement versus placebo in skin radiance and under-eye dark circles 15-30 minutes after first application with continued improvement through week 8, and in overall photo-damage, fine lines, lifted appearance of the eyes, and under-eye wrinkles starting after two weeks and continuing through week 8. Test compositions were well tolerated.
Conclusion: This galvanic zinc-copper complex provided rapid and lasting improvements versus placebo in photo-aged skin, supporting its use in topical anti-aging formulations.
J Drugs Dermatol. 2012;11(1):30-37.
Amy W. Kuang PhD,a Janet DuBois MD,b Mayssa Attar PhD,a Gurpreet Ahluwalia PhDa
BACKGROUND: Oxymetazoline cream 1.0% is FDA-approved for the topical treatment of persistent facial erythema associated with rosacea in adults. This phase 2, multicenter, randomized, double-blind, parallel-group study assessed the pharmacokinetics, safety, and tolerability of oxymetazoline in patients with moderate to severe erythema associated with rosacea.
METHODS: Eligible patients were randomize