Search Results for "Topical Skincare"
Flor A. Mayoral MD,a Julie R. Kenner MD PhD,b and Zoe Diana Draelos MDc| |
J Drugs Dermatol. 2014;13(4):414-421.
Evidence-Based Skincare: The Importance of Offering Moisturization, Relief, and Protection in Common Skin Disorders
Leon H. Kircik MD| |
Heather Woolery-Lloyd, MD| |
An Open Label Clinical Trial of a Peptide Treatment Serum and Supporting Regimen Designed to Improve the Appearance of Aging Facial Skin
Zoe Diana Draelos MD,a Tatiana Kononov BS MBA,b and Theresa Fox BSb| |
J Drugs Dermatol. 2016;15(9):1100-1106.
Staci Brandt PA-C MBA MSa and Peter Lio MDb| |
J Drugs Dermatol. 2014;13(3):264-266.
Evidence-Based Skincare: The Importance of Offering Moisturization, Relief, and Protection in Common Skin Disorders
A New Approach in Topical Hyaluronic Acid: Going Beyond Instant Benefits to Restore Epidermal HA Homeostasis
J Drugs Dermatol. 2012;11(2):220-224.
Management of Rosacea-Prone Skin: Evaluation of a Skincare Product Containing Ambophenol, Neurosensine, and La Roche-PosayThermal Spring Water as Monotherapy or Adjunctive Therapy
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| |
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| |
J Drugs Dermatol. 2013;12(3):366-367.
Comparative Study of Professional vs Mass Market Topical Products for Treatment of Facial Photodamage
Hilary Reich MD,a,b Irmina Wallander BA,a Lacie Schulte MS BA,a Molly Goodier BS,a and Brian Zelickson MDa| |
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.
A Randomized, Investigator-Blinded Comparison of Two Topical Regimens in Fitzpatrick Skin Types III-VI With Moderate to Severe Facial Hyperpigmentation
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| |
J Drugs Dermatol. 2014;13(9):1108-1111.
Debbie M. Palmer DO and Jennifer Silverman Kitchin MD| |
J Drugs Dermatol. 2012;11(11):1296-1299.
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
J Drugs Dermatol. 2015;14(4):391-399.
James Q. Del Rosso DO FAOCD, Joseph Bikowski MD| |
Snehal P. Amin MD, David J. Goldberg MD| |
Safety and Efficacy of Two Anti-Acne/Anti-Aging Treatments in Subjects With Photodamaged Skin and Mild to Moderate Acne Vulgaris
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
Brad A. Yentzer MD, Richard W. McClain BS, Steven R. Feldman MD PhD| |
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 retinoids.
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.
Clinical Evaluation of a 4% Hydroquinone + 1% Retinol Treatment Regimen for Improving Melasma and Photodamage in Fitzpatrick Skin Types III-VI
Marta I. Rendon MD FAADa and Sylvia Barkovic BAb| |
Jennie B. Nally MD, Diane S. Berson MD| |
Leon H. Kircik MD| |
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| |
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| |
Steven B. Deliduka MD, Pearl C. Kwong MD PhD| |
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 abnormality.
Leon H. Kircik, MD| |
Divya Railan MD, Tina S. Alster MD| |
Nikhil G. Rao, BA and Robert J. Pariser, MD| |
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.
Study Results of Benzoyl Peroxide 5%/Clindamycin 1% Topical Gel, Adapalene 0.1% Gel and Use in Combination for Acne Vulgaris
James Q. Del Rosso DO FAOCD| |
Leon H. Kircik MDa and Panagiotis Zografos MScb| |
J Drugs Dermatol. 2015;14(10):1113-1116.
Steven R. Feldman MD PhD| |
J Drugs Dermatol. 2014;13(4):423-427.
Is Topical Dapsone Safe in Glucose-6-phosphate Dehydrogenase-deficient andSulfonamide-allergic Patients?
Guy F. Webster MD PhD| |
Savita Chaudhary MD Fellow ISDa and Surabhi Dayal MDb| |
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.
Managing Occupational Irritant Contact Dermatitis Using a Two-Step Skincare Regimen Designed to Prevent Skin Damage and Support Skin Recovery
Erika C. von Grote PhD, Kiruthi Palaniswamy PharmD, and Matthew H. Meckfessel PhD| |
Six Patients With Early-Stage Cutaneous T-cell Lymphoma Successfully Treated With Topical 5-fluorouracil
Ajith P. Kannangara MD, Denise Levitan MD, Alan B. Fleischer Jr. MD| |
Laura F. Sandoval DO,a Scott A. Davis MA,a and Steven R. Feldman MD PhDa,b,c| |
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.
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
J Drugs Dermatol. 2016;15(Suppl 4):s63-s71.
Zülal Erbagci MD, A. Almıla Tuncel MD, Ibrahim Erbagci MD| |
Excess Salt and Pepper Hair Treated with a Combination of Laser Hair Removal and Topical Eflornithine HCl
Laura K. Ganger MD, Iltefat H. Hamzavi MD| |
Steven L. Harlan MD FAAD| |
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%.
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| |
Jonathan S. Weiss, MD and Joel S. Savin, MD| |
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.
Efficacy of Topical 4% Quassia amara Gel in Facial Seborrheic Dermatitis:A Randomized, Double-Blind, Comparative Study
Christian Diehl MDa and Alicia Ferrari MDb| |
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| |
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| |
J Drugs Dermatol. 2013;12(6):638-642, e94-e105.
Case-Based Experience With the Simultaneous Use of a Fixed Topical Antibiotic/Benzoyl Peroxide Combination and a Topical Retinoid in theOptimization of Acne Management
Chérie M. Ditre MD| |
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| |
Esra Adışen MD, Yeşim Kaymak MD, Mehmet Ali Gurer MD, Elif Durukan PhD| |
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| |
Topical Clofibrate Improves Symptoms in Patients With Atopic Dermatitis and Reduces Serum TARC Levels: A Randomized, Double-Blind, Placebo-Controlled Pilot Study
Mototsugu Fukaya MDa and Hajime Kimata MD PHDb| |
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| |
J Drugs Dermatol. 2016;15(1 Suppl 1):s11-s16.
Leon H. Kircik MD| |
Effective Use of Topical Amitriptyline Hydrochloride 2.5% and Ketamine Hydrochloride 0.5% for Analgesia in Refractory Proctodynia
Julia S. Lehman MD, Gabriel F. Sciallis MD| |
Cindy Berthelot MD, Allison Rivera MD, Madeleine Duvic MD| |
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| |
Anna H. Zivkovich and Steven R. Feldman MD, PhD| |
The Therapeutic Effects of a Topical Tretinoin and Corticosteroid Combination for Vitiligo: A Placebo-Controlled, Paired-Comparison, Left-Right Study
Hyok Bu Kwon MD,a Yunseok Choi MD,a Hwa Jung Kim MD,b and Ai-Young Lee MDa| |
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| |
J Drugs Dermatol.2013;12(3 suppl 2):s53-s58.
Alan Menter, MD| |
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.
Marko Lens MD PhD,a Marie-Helen Podesta Marty PharmDb| |
J Drugs Dermatol. 2011;10(3):262-267.
Pain Management With a Topical Lidocaine and Tetracaine 7%/7% Cream With Laser Dermatologic Procedures
Joel L. Cohen MD| |
J Drugs Dermatol. 2013;12(9):986-989.
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| |
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.
Deirdre Cocks Eschler MD and Peter A. Klein MD| |
Joseph Jorizzo MD| |
Factors Affecting Prescription of Ultra-High Potency Topical Corticosteroids in Skin Disease: An Analysis of US National Practice Data
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| |
Summer D. Moon BS a and James M. Spencer MD MS b| |
J Drugs Dermatol. 2013;12(1):107-108.
Leon H. Kircik MD, James Q. Del Rosso DO, FAOCD, Matthew Zirwas MD| |
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| |
Comparison of Skin Concentrations Following Topical Versus Oral Corticosteroid Treatment: Reconsidering the Treatment of Common Inflammatory Dermatoses
Richard W. McClain BS, Brad A. Yentzer MD, Steven R. Feldman MD PhD| |
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 5% 5-Fluorouracil Cream in the Treatment of Plantar Warts: A Prospective, Randomized, and Controlled Clinical Study
Robert S. Salk DPM, Kirk A. Grogan DPM, Thomas J. Chang DPM| |
Kyle B. Bartlett MD,a Scott A. Davis MA,a and Steven R. Feldman MD PhDa,b,c| |
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| |
J Drugs Dermatol. 2015;14(5):524-526.
Tejaswi Mudigonda BS, William Kaufman MD, and Steven R. Feldman MD PhD| |
J Drugs Dermatol. 2016;15(1):114-115.
The Clinical Impact of Vehicle Technology Using a Patented Formulation of Benzoyl Peroxide 5%/Clindamycin 1% Gel Containing Dimethicone and Glycerin in Combination with Topical Retinoids and Sunscreens
James Q. Del Rosso DO FAOCD, Emil Tanghetti MD| |
Scott A. Davis MAa and Steven R. Feldman MD PhDa-c| |
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.
Central Serous Chorioretinopathy Associated With Topical Corticosteroids in a Patient With Psoriasis
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.
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.
Clinical Experience Results with Clindamycin 1% Benzoyl Peroxide 5% Gel (Duac®) as Monotherapy and in Combination
Joseph B. Bikowski MD| |
The Effects of a Daily Skincare Regimen on Maintaining the Benefits Obtained from Previous Chemical Resurfacing Treatments
Suzanne Bruce MD,a Wendy Roberts MD,b Craig Teller MD,c and Lora Colvan BSd| |
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.
A Randomized, Double-Blind, Placebo-Controlled Study of the Vasoconstrictor Potency of Topical 0.25% Desoximetasone Spray: A High to Super High Range of Potency (Class I to Class II) Corticosteroid Formulation
Elias Oussedik BS,a Mohammed D. Saleem MD,a Steven R. Feldman MD PhDa,b,c| |
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
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.
The Clinical Effects of Zinc as a Topical or Oral Agent on the Clinical Response and Pathophysiologic Mechanisms of Acne: A Systematic Review of the Literature
Staci Brandt PA-C MSMR MBA| |
J Drugs Dermatol. 2013;12(5):542-545.
Treatment of a Symptomatic Dermatofibroma With Fractionated Carbon Dioxide Laser and Topical Corticosteroids
Audrey S. Wang MD,a Larissa Larsen MD,a Shurong Chang MD PhD,a Tiffany Phan BA,a Jared Jagdeo MD MSa,b,c| |
J Drugs Dermatol. 2013;12(12):1483-1484.
Pharmacokinetic Comparison of Once-Daily Topical Minocycline Foam 4% vs Oral Minocycline for Moderate-to-Severe Acne
Terry M Jones MD,a Herman Ellman MD,b Tina deVries PhDb| |
J Drugs Dermatol. 2017;16(10):1022-1028.
A Phase 2, Randomized, Controlled, Dose-Ranging Study Evaluating Crisaborole Topical Ointment, 0.5% and 2% in Adolescents With Mild to Moderate Atopic Dermatitis
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| |
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| |
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.
Clinical Effects of a Novel Topical Composition on Persistent Redness Observed in Patients Who Had Been Successfully Treated With Topical or Oral Therapy for Papulopustular Rosacea
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
J Drugs Dermatol. 2014;13(3):326-331.
Charles W. Lynde MD FRCPC and Anneke Andriessen PhD| |
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.
A New Approach to Comparing Efficacy Results from Clinical Trials of Topical Acne Vulgaris Treatments
Joseph Bikowski MD FAAD| |
Aton M. Holzer MD, Leonard L. Kaplan PhD, William R. Levis MD| |
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| |
Topical Desoximetasone 0.25% Spray and Its Vehicle Have Little Potential for Irritation or Sensitization
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.
The Treatment of Melasma With Topical Creams Alone, CO2 Fractional AblativeResurfacing Alone, or a Combination of the Two: A Comparative Study
Mario A. Trelles MD PhD, Mariano Velez MD, Michael H. Gold MD| |
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.
Zoon Balanitis Revisited: Report of Balanitis Circumscripta Plasmacellularis Resolving With Topical Mupirocin Ointment Monotherapy
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.
Effective Topical Combination Therapy for Treatment of Lichen Striatus in Children: A Case Series and Review
J Drugs Dermatol. 2012;11(7):872-875.
Tracey C. Vlahovic DPMa and Warren S. Joseph DPM FIDSAb| |
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| |
Aanand N. Geria MD, Christina N. Lawson MD, Rebat M. Halder MD| |
J Drugs Dermatol. 2011;10(5):483-489.
Optimizing Topical Antifungal Therapy for Superficial Cutaneous Fungal Infections: Focus on Topical Naftifine for Cutaneous Dermatophytosis
James Q. Del Rosso DO FAOCDa and Leon H. Kircik MDb| |
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| |
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.
Prognostic Factors for Complete Cure Following Treatment of Mild and Moderate Toenail Onychomycosis With Efinaconazole Topical Solution 10%
Nathaniel J. Jellinek MD FAAD FACMSa and Andrew Korotzer PhDb| |
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.
Linda Stein Gold MD| |
J Drugs Dermatol. 2015;14(6):567-572.
Photodynamic Therapy with Topical Aminolevulinic Acid and Pulsed Dye Laser Irradiation for Sebaceous Hyperplasia
Tina S. Alster, MD and Elizabeth L. Tanzi, MD| |
Sumayah J. Taliaferro MD, George F. Cohen MD| |
Elena Maydan MD, Pavan K. Nootheti MD, Mitchel P. Goldman MD| |
Photorejuvination of Facial Skin with Topical 20% 5-Aminolevulinic Acid and Intense pulsed Light Treatment: A Split-Face Comparison
Tina S. Alster MD, Elizabeth L. Tanzi MD, Esperanza C. Welsh, MD| |
The Effects of Topical L-Selenomethionine on Protection Against UVB-Induced Skin Cancer When Given Before, During, and After UVB Exposure
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
J Drugs Dermatol. 2014;13(10):1214-1223.
Crisaborole Topical Ointment, 2%: A Nonsteroidal, Topical, Anti-Inflammatory Phosphodiesterase 4 Inhibitor in Clinical Development for the Treatment of Atopic Dermatitis
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| |
J Drugs Dermatol. 2016;15(4):390-396.
Benzoyl Peroxide Development, Pharmacology, Formulation and Clinical Uses in Topical Fixed-combinations
Julie C. Harper MD| |
Vehicle or Placebo? Investigators Use Incorrect Terminology in Randomized Controlled Trials Half of the Time: A Systematic Review of Randomized Controlled Trials Published in Three Major Dermatology Journals
Norashikin Shamsudin MRC P and Alan B. Fleischer Jr. MD| |
Joshua A. Zeichner MD| |
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| |
J Drugs Dermatol. 2013;12(4):481-484.
Joseph Bikowski MD, Radhakrishnan Pillai PhD, Braham Shroot PhD| |
A Comparative Study to Evaluate Epidermal Barrier Integrity of Psoriasis Patients Treated With Calcipotriene/Betamethasone Topical Suspension Versus Betamethasone Dipropionate 0.05% Lotion
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.
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.
Rapid Improvement in Digital Ischemia and AcralContracture in a Collodion Baby Treated With Topical Tazarotene
Rosemarie H. Liu MD, Beth Becker MD, Juliet Gunkel MD, Joyce Teng, MD, PhD| |
Deborah S. Sarnoff MD FAAD FACPa and Robert H. Gotkin MD FACSb| |
J Drugs Dermatol. 2015;14(5):472-477.
Combined Effect of Anti-inflammatory Dose Doxycycline (40-mg Doxycycline, USP Monohydrate Controlled-Release Capsules) and Metronidazole Topical Gel 1% in the Treatment of Rosacea
Joseph F. Fowler Jr. MD| |
James Q. del Rosso, Do, FAOCD| |
Topical Amitriptyline Combined With Ketamine for the Treatment of Erythromelalgia: A Retrospective Study of 36 Patients at Mayo Clinic
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| |
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.
Association Between the Type and Length of Tumor Necrosis Factor Inhibitor Therapy and Myocardial Infarction Risk in Patients With Psoriasis
Jashin J. Wu MD,a Kwun-Yee T. Poon MS,b and Judith D. Bebchuk ScDb| |
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.
Whitney P. Bowe MD| |
J Drugs Dermatol. 2014;13(suppl 6):s66-s70.
Tracey C. Vlahovic DPM| |
J Drugs Dermatol. 2016;15(Suppl 2):s56-59.
The Combined Use of Forced Cold Air and Topical Anesthetic Cream for Analgesia During the Treatment of Palmar Hyperhydrosis With Botulinum Toxin Injections
Rita Patel MD, Monica Halem MD, Martin Zaiac MD| |
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.
Topical Treatment With an Agent Disruptive to P. acnes Biofilm Provides Positive Therapeutic Response: Results of a Randomized Clinical Trial
Michael J. Bernhardt MDa and Matthew F. Myntti PhDb| |
J Drugs Dermatol. 2016;15(6):677-683.
J Drugs Dermatol. 2012;11(3):313-317.
Long-Term Safety and Efficacy of Once-Daily Topical Brimonidine Tartrate Gel 0.5% for the Treatment of Moderate to Severe Facial Erythema of Rosacea: Results of a 1-Year Open-Label Study
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| |
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 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 than 5-FU.
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
Bilateral Comparison of the Efficacy and Tolerability of 3% Diclofenac Sodium Gel and 5% 5-Fluorouracil Cream in the Treatment of Actinic Keratoses of the Face and Scalp
Stacy R. Smith MD, Vera B. Morhenn MD, Daniel J. Piacquadio MD| |
James Q. Del Rosso DO| |
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| |
Purpose: To determine whether a metronidazole gel formulation is more or less irritating to the skin compared to metronidazole creams.
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| |
J Drugs Dermatol. 2017;16(9):919-922.
Crisaborole Topical Ointment, 2% in Adults With Atopic Dermatitis: A Phase 2a, Vehicle-Controlled, Proof-of-Concept Study
Dedee F. Murrell MD FRCP,a Kurt Gebauer MD,b Lynda Spelman MBBS FACD,c and Lee T. Zane MDd| |
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.
Ann G. Martin. MD| |
A Nonsteroidal Lamellar Matrix Cream Containing Palmyitoyethanolamide for theTreatment of Atopic Dermatitis
Leon Kircik MD| |
Maria Rita Nasca MD PhD, Rocco De Pasquale MD, Giuseppe Micali MD| |
Comparison of Pre- and/or Postphotodynamic Therapy and Intense Pulsed Light Treatment Protocols for the Reduction of Postprocedure-Associated Symptoms and Enhancement of Therapeutic Efficacy
Barbara D. Garcia MD, Mitchel P. Goldman MD, Michael H. Gold MD| |
Managing Rosacea: A Review of the Use of Metronidazole Alone and in Combination with Oral Antibiotics
Jennifer F. Conde BA, Christopher B. Yelverton MD MBA, Rajesh Balkrishnan PhD, Alan B. Fleischer Jr. MD, Steven R. Feldman MD PhD| |
Guy F. Webster MD PhD| |
J Drugs Dermatol. 2011;10(6):636-644.
Topical Formulation Engendered Alteration in p53 and Cyclobutane Pyrimidine Dimer Expression in Chronic Photodamaged Patients
James M. Spencer MD MS,a Summer D. Moon BS,b Kara M. Trapp BA,c and Michael B. Morgan MDd-f| |
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| |
A Multicenter Clinical Evaluation of the Treatment of Mild to Moderate Inflammatory Acne Vulgaris of the Face with Visible Blue Light in Comparison to Topical Clindamycin Antibiotic Solution
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| |
Michael E. Farhangian BA,a Amy J. McMichael MD,a Karen E. Huang MS,a and Steven R. Feldman MD PhDa,b,c| |
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| |
Treatment of Inverse/Intertriginous Psoriasis: Updated Guidelines from the Medical Board of the National Psoriasis Foundation
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.
Thomas Lambert BA, Kimberly Mullinax MD, Jennifer Smith MD| |
Leon H. Kircik MD| |
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.
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,
J Drugs Dermatol. 2015;14(6):628-630.
A Study to Assess the Occlusivity and Moisturization Potential of Three Topical Corticosteroid Products Using the Skin Trauma After Razor Shaving (STARS) Bioassay
Leon H. Kircik MD FAAD| |
J Drugs Dermatol. 2014;13(5):582-585.
J Drugs Dermatol. 2012;11(1):106-108.
Update on the Management of Rosacea: A Status Report on the Current Role and New Horizons With Topical Azelaic Acid
James Q. Del Rosso DO FAOCDa and Leon H. Kircik MDb| |
J Drugs Dermatol. 2014;13(suppl 12):s101-s107.
An Approach to Pruritus in Atopic Dermatitis: A Critical Systematic Review of theTacrolimus Ointment Literature
Alan B. Fleischer Jr. MD and Mark Boguniewicz MD| |
Botulinum Toxin Type A Versus Topical 20% Aluminum Chloride for the Treatment of Moderate to SeverePrimary Focal Axillary Hyperhidrosis
Katherine H. Flanagan MD, Rosemary King PA-C, Dee Anna Glaser MD| |
Chad J. Jessup MD MS, Shane C. Morgan PA-C, Lisa M. Cohen MD, Daniel E. Viders MD| |
Andrew F. Alexis MD MPH| |
Kathani Amin MD, Christy C. Riddle MD, Daniel J. Aires MD, Eric S. Schweiger MD| |
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| |
Evaluation of Risk of Major Adverse Cardiovascular Events With Biologic Therapy in Patients With Psoriasis
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| |
J Drugs Dermatol. 2017;16 (10):1002-1013.
Topical Tacrolimus 0.1% Improves Symptoms of Hand Dermatitis in Patients Treated With a Prednisone Taper
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| |
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 recurrence.
Use of Dapsone 5% Gel as Maintenance Treatment of Acne Vulgaris Following Completion of Oral Doxycycline and Dapsone 5% Gel Combination Treatment
Leon H. Kircik MD| |
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| |
J Drugs Dermatol. 2014;13(suppl 1):s17-s20.
Mark S. Nestor MD PhD| |
Treatment Considerations for Inflammatory Acne: Clinical Evidence for Adapalene 0.1% in Combination Therapies
Diane M. Thiboutot MD, Harald P. Gollnick MD| |
Stacy Smith MD, Vera Morhenn MD, Guy Webster MD| |
Leon Kircik MD, James Del Rosso DO FAOCD| |
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.
The Efficacy, Safety, and Tolerability of Adapalene Versus Benzoyl Peroxide in the Treatment of Mild Acne Vulgaris: A Randomized Trial
S.H. Babaeinejad MD and R.F. Fouladi MD| |
J Drugs Dermatol. 2013;12(7):790-794.
Phoebe Rich MD| |
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 successes.
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| |
J Drugs Dermatol. 2013;12(6):644-649.
A Bilateral Comparison Study of Pimecrolimus Cream 1% and a Topical Medical Device Cream in the Treatment of Patients With Atopic Dermatitis
Jason J. Emer MD, Amylynne Frankel MD, Andrew Sohn BS, Mark Lebwohl MD| |
J Drugs Dermatol. 2011;10(7):735-743.
The Efficacy, Safety and Tolerability of Adapalene Versus Benzoyl Peroxide in the Treatment of Mild Acne Vulgaris; A Randomized Trial
S.H. Babaeinejad MD and R.F. Fouladi MD| |
J Drugs Dermatol. 2013;12(9):1033-1038.
Sujatha Tadicherla MD, Kate Ross BS, Philip D. Shenefelt MD, Neil A. Fenske MD| |
Efficacy of Topical Azelaic Acid (AzA) Gel 15% Plus Oral Doxycycline 40 mg Versus Metronidazole Gel 1% Plus Oral Doxycycline 40 mg in Mild-to-Moderate Papulopustular Rosacea
James Q. Del Rosso DO FAOCD, Suzanne Bruce MD, Michael Jarratt MD, Alan Menter MD, Gerald Staedtler| |
Beneficial Effect of a Moisturizing Cream as Adjunctive Treatment to Oral Isotretinoin or Topical Tretinoin in the Management of Acne
Sabine Laquieze MD, Janusz Czernielewski MD, Marie-José Rueda MD| |
William R. Levis MD, Aton M. Holzer MD, Leonard L. Kaplan PhD| |
Improvement of Actinic Keratoses Using Topical DNA Repair Enzymes: A Randomized Placebo-Controlled Trial
Improvement of Actinic Keratoses Using Topical DNA Repair Enzymes: A Randomized Placebo-Controlled Trial
Efficacy and Safety of Once-Daily Topical Brimonidine Tartrate Gel 0.5% for the Treatment of Moderate to Severe Facial Erythema of Rosacea: Results of Two Randomized, Double-blind, and Vehicle-Controlled Pivotal Studies
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| |
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.
TH 17 is Involved in the Remarkable Regression of Metastatic Malignant Melanoma to Topical Diphencyprone
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| |
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.
Calcipotriene Plus Betamethasone Dipropionate Topical Suspension for the Treatment of Mild to Moderate Psoriasis Vulgaris on the Body: A Randomized, Double-Blind, Vehicle-Controlled Trial
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| |
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| |
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| |
Efficacy and Safety of Once-Daily Minoxidil Foam 5% Versus Twice-Daily Minoxidil Solution 2% in Female Pattern Hair Loss: A Phase III, Randomized, Investigator-Blinded Study
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| |
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.
Leon H. Kircik MD| |
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.
The Presence of an Air Gap Between the Nail Plate and Nail Bed in Onychomycosis Patients: Treatment Implications for Topical Therapy
Aditya K. Gupta MD PhD FRCPC FAADa,b and Radhakrishnan Pillai PhDc| |
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.
Leon H. Kircik MD| |
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.
Two Randomized, Double-Blind, Split-Face Studies to Compare the Irritation Potential of Two Topical Acne Fixed Combinations Over a 21-Day Treatment Period
Neal Bhatia MD,a Varsha Bhatt PhD,b Gina Martin MOT,b Radhakrishnan Pillai PhDb| |
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| |
Randomized Pilot Clinical Trial of Tofacitinib Solution for Plaque Psoriasis: Challenges of the Intra-Subject Study Design
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| |
J Drugs Dermatol. 2015;14(8):777-784.
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| |
Michael Kockaert, MD and Martino Neumann, MD, PhD| |
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
J Drugs Dermatol. 2015;14(9):1016-1021.
Joshua W. Hagen MD PhDa and William R. Levis MDb| |
Leon H. Kircik MD| |
Real-Life Treatment Profile of Calcipotriene and Betamethasone Dipropionate Topical Suspension in Patients With Psoriasis Vulgaris
Jerry Bagel MD FAAD,1 Eugenia Levi, PharmD BCPS,2 Stephen Tyring MD PhD FAAD,3
and Melissa L.F. Knuckles MD FAAD4
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.
Regression of Internal Melanoma Metastases Following Application of Topical Imiquimod to Overlying Skin
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
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.
Leslie Baumann MD| |
Good Adherence and Early Efficacy Using Desonide Hydrogel for Atopic Dermatitis:Results From a Program Addressing Patient Compliance
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| |
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.
Vitamin A and Its Derivatives in Experimental Photocarcinogenesis: Preventive Effects and Relevance to Humans
Stanley S. Shapiro PhD,a Miri Seiberg PhD,b and Curtis A. Cole PhDc| |
J Drugs Dermatol. 2013;12(4):458-463.
Fractional Ablative Laser Followed by Transdermal Acoustic Pressure Wave Device to Enhance the Drug Delivery of Aminolevulinic Acid: In Vivo Fluorescence Microscopy Study
Jill S. Waibel MD,a Ashley Rudnick,a Carlos Nousari MD,b and Dhaval G. Bhanusali MDc| |
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| |
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| |
Galina Shistik MD, Amy V. Prakash MD, Neil A. Fenske MD, L. Frank Glass MD| |
Transitioning From Brand to Generic With Topical Products and the Importance of Maintaining the Formulation and Therapeutic Profiles of the Original Product: Focus on Clocortolone Pivalate 0.1% Cream
James Q. Del Rosso DO FAOCDa and Leon H. Kircik MDb| |
J Drugs Dermatol. 2014;13(suppl 7):s77-s83.
Reduced Appearance of Under-eye Bags With Twice-daily Application of Epidermal Growth Factor (EGF) Serum: A Pilot Study
Rachel Seidel BAa and Ronald L. Moy MD FAADa,b| |
OBJECTIVE: We studied the ability of a topical serum containing epidermal growth factor (EGF) to minimize the appearance of under-eye bags.
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| |
Post Hoc Analyses of the Effect of Crisaborole Topical Ointment, 2% on Atopic Dermatitis: Associated Pruritus from Phase 1 and 2 Clinical Studies
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| |
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| |
Macrene Alexiades-Armenakas MD PhD| |
Do We Really Need Topical Antibiotics in Our New Treatment Paradigm of Acne Vulgaris? A Novel Question to Consider Based on an Updated Model of Pathogenesis
Leon H. Kircik MD| |
Leon H. Kircik MD FAAD| |
Paradoxical Erythema Reaction of Long-term Topical Brimonidine Gel for the Treatment of Facial Erythema of Rosacea
Erin Lowe MSIVa and Scott Lim DOb| |
J Drugs Dermatol. 2016;15(6):763-765.
Pilot Comparative Study of the Topical Action of a Novel, Crosslinked Resilient Hyaluronic Acid on Skin Hydration and Barrier Function in a Dynamic, Three-Dimensional Human Explant Model
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| |
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.
Leon Kircik MD| |
Approaching Psoriasis Differently: Patient-Physician Relationships, Patient Education and Choosing the Right Topical Vehicle
Steven R. Feldman MD PhD| |
John R. Griffin MD and Mark D.P. Davis MD| |
J Drugs Dermatol. 2015;14(2):115-118.
Efficacy and Safety of Azelaic Acid (AzA) Gel 15% in the Treatment of Post-Inflammatory Hyperpigmentation and Acne: A 16-Week, Baseline-Controlled Study
Leon H. Kircik, MD| |
J Drugs Dermatol. 2011;10(6):586-590.
Pharmacokinetics of Tacrolimus Following Topical Application of Tacrolimus Ointment in Adult and Pediatric Patients with Moderate to Severe Atopic Dermatitis
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| |
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 application.
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.
An Evidence-based Review of the Efficacy of Coal Tar Preparations in the Treatment of Psoriasis and Atopic Dermatitis
Jordan B. Slutsky MD, Richard A. F. Clark MD, Alexander A. Remedios MD, Peter A. Klein MD| |
Ted Rosen MD| |
J Drugs Dermatol. 2016;15(Suppl 2):s49-55.
The Prophylactic Use of a Topical Scar Gel Containing Extract of Allium Cepae, Allantoin, and Heparin Improves Symptoms and Appearance of Cesarean-Section Scars Compared With Untreated Scars
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| |
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 vitamin D.
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 efficacy.
Evaluation of Efficacy and Tolerance of a Nighttime Topical Antioxidant Containing Resveratrol, Baicalin, and Vitamin E for Treatment of Mild to Moderately Photodamaged Skin
Patricia Farris MD,a Margarita Yatskayer MS,b Nannan Chen PhD,b Yevgeniy Krol BS,c Christian Oresajo PhDb| |
J Drugs Dermatol. 2014;13(12):1467-1472.
Topical Minocycline Foam for the Treatment of Impetigo in Children: Results of a Randomized, Double-Blind, Phase 2 Study
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| |
J Drugs Dermatol. 2016;15(10):1238-1243.
DNA Repair Enzymes: An Important Role in Skin Cancer Prevention and Reversal of Photodamage‑ A Review of the Literature
Yasmeen Kabir MD,a Rachel Seidel BA,b Braden Mcknight BS,c Ronald Moy MDc| |
J Drugs Dermatol. 2015;14(3):297-301.
Topical Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Maintains Efficacy of Etanercept After Step-Down Dose in Patients With Moderate-to-Severe Plaque Psoriasis: Results of an Open Label Trial
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| |
J Drugs Dermatol. 2016;15(3):279-282.
Dina Coronado BS, Tejal Merchant MPharm, Sanjay Chanda PhD, and Lee T. Zane MD| |
J Drugs Dermatol. 2015;14(6):609-614.
Treatment of Atopic Dermatitis in the United States: Analysis of Data from the National Ambulatory Medical Care Survey
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.
Multivesicular Emulsion: A Novel, Controlled-Release Delivery System for Topical Dermatological Agents
Joseph Bikowski MD, Radhakrishnan Pillai PhD, Braham Shroot PhD| |
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.
Sustained Clinical Resolution of Acquired Epidermodysplasia Verruciformis in an Immunocompromised Patient After Discontinuation of Oral Acitretin With Topical Imiquimod
Rajiv I. Nijhawan MD,a Jeremy M. Hugh MD,b and Achiamah Osei-Tutu MDa| |
J Drugs Dermatol. 2013;12(3):348-349.
Adam J. Friedman MD FAAD,a Erika C. von Grote PhD,b Matthew H. Meckfessel PhDb| |
J Drugs Dermatol. 2016;15(5):633-639.
Leon H. Kircik MD| |
J Drugs Dermatol. 2013;12(11):1268-1270.
Combined Topical Delivery and Dermalinfusion of Decapeptide-12 Accelerates Resolution of Post-Inflammatory Hyperpigmentation in Skin of Color
Ashish Bhatia MD,a Jeffrey TS Hsu MD,b and Basil M. Hantash MD PhDc| |
Topical Pimecrolimus 1% Reverses Long-term Suberythemal Ultraviolet B—induced Epidermal Langerhans Cell Reduction and Morphologic Changes 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.
Prospective, Case-Based Assessment of Sequential Therapy With Topical Fluorouracil Cream 0.5% and ALA-PDT for the Treatment of Actinic Keratosis
George Martin, MD| |
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.
J Drugs Dermatol 2012;11(12):1462-1467.
Enhancing Transungual Delivery and Spreading of Efinaconazole Under the Nail Plate Through a Unique Formulation Approach
Leon H. Kircik MD| |
J Drugs Dermatol. 2014;13(12):1457-1461.
Phase IV, Open-Label Assessment of the Treatment of Actinic Keratosis With 3.0% Diclofenac Sodium Topical Gel (Solaraze™)
Darrell Rigel MD, Christopher Nelson MD, Stacy Smith MD, Neil Swanson MD, John Wolf, MD| |
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.
Efficacy and Tolerability Assessment of a Topical Formulation Containing Copper Sulfate and Hypericum perforatum on Patients With Herpes Skin Lesions: A Comparative, Randomized Controlled Trial
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.
Evaluation of the Appearance of Nail Polish Following Daily Treatment of Ex Vivo Human Fingernails With Topical Solutions of Tavaborole or Efinaconazole
Tracey C. Vlahovic DPM,a Dina Coronado BS,b Sanjay Chanda PhD,b Tejal Merchant MPharm,b and Lee T. Zane MDb| |
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.
A Double-Blinded Randomized Trial Testing the Tolerability and Efficacy of a Novel Topical Agent With and Without Occlusion for the Treatment of Cellulite: A Study and Review of the Literature
Jaggi Rao MD, Kristina E Paabo PA-S, and Mitchel P Goldman MD| |
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.
A Review of the Chemopreventive and Chemotherapeutic Effects of Topical and Oral Retinoids for both Cutaneous and Internal Neoplasms
Pooja Khera MD, John Y. Koo MD| |
Surgical Corner: A Prospective Randomized Evaluation of Cyanoacrylate Glue Devices in the Closure of Surgical Wounds
Joseph Maloney BA,a Gary S. Rogers MD,b,c and Mitesh Kapadia MD PhDd| |
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.
An Experimental Double-Blind Irradiation Study of a Novel Topical Product (TPF 50) Compared to Other Topical Products With DNA Repair Enzymes, Antioxidants, and Growth Factors With Sunscreens: Implications for Preventing Skin Aging and Cancer
Enzo Emanuele MD PhD,a James M. Spencer MD MS,b and Martin Braun MDc| |
J Drugs Dermatol. 2014;13(3):309-314.
Joseph Bikowski MD| |
Ricardo Ruiz-Rodriguez MD PhD, Laura Lopez MD, Daniel Candelas MD, Javier Pedraz MD| |
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.
Response to the Possibility of the Application of Topical Photodynamic Therapy Leading to Development of More Histologically Aggressive Subtypes of Basal Cell Carcinomas
Irene J. Vergilis-Kalner MD and Joel Cohen MD| |
Safe and Efficacious Use of a Topical Retinoid Under Occlusion for the Treatment of Mycosis Fungoides
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
Optical Coherence Tomography Imaging of Erythematotelangiectatic Rosacea During Treatment With Brimonidine Topical Gel 0.33%: A Potential Method for Treatment Outcome Assessment
Jennifer Urban BS,a Arunee H. Siripunvarapon MD,b Adam Meekings BS,c
Amy Kalowitz BS,b and Orit Markowitz MD FAADb
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| |
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.
Rapid Treatment of Subungual Onychomycosis Using Controlled Micro Nail Penetration and Terbinafine Solution
Ivan Bristow PhD,a Robert Baran MD,b and Michelle Score BSc (Hons)c| |
J Drugs Dermatol. 2016;15(8):974-978.
Jeffrey Crowley, MD| |
Ritu Saini MD FAAD, Deborah S. Sarnoff MD FAAD FACP| |
Advancement in Benzoyl Peroxide-Based Acne Treatment: Methods to Increase Both Efficacy and Tolerability
Tarek Fakhouri BS, Brad A. Yentzer MD, Steven R. Feldman MD PhD| |
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.
The Role of a Midpotency Topical Corticosteroid and the Clinical Relevance of Formulation Characteristics in the Management of Commonly Encountered Eczematous and Inflammatory Dermatoses in Adults and Children:Focus on the Pharmacologic Properties of Clocortolone Pivalate 0.1% Cream
James Q. Del Rosso DO FAOCDa and Leon H. Kircik MDb| |
J Drugs Dermatol. 2013;12(2)(suppl):s5-s10.
Dramatic Clearance of HIV-Associated Bowenoid Papulosis Using Combined Oral Acitretin and Topical 5% Imiquimod
Joel Hua-Liang Lim MRCP,a Kar-Seng Lim MRCP,b and Wei-Sheng Chong FRCPc| |
Improvement in Facial Erythema Within 30 Minutes of Initial Application of Brimonidine Tartrate in Patients With Rosacea
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
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.
Trends in the Treatment of Acne Vulgaris: Are Measures Being Taken to Avoid Antimicrobial Resistance?
Megan A. Kinney MHAM BS,a Brad A. Yentzer MD,a Alan B. Fleischer Jr. MD,a Steven R. Feldman MD PhDa,b,c| |
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| |
Aimee Krausz,a Holly Gunn MD,b and Adam Friedman MD FAADa,c| |
J Drugs Dermatol. 2014;13(8):937-943.
Access of Efinaconazole Topical Solution, 10%, to the Infection Site by Spreading Through the Subungual Space
Boni E. Elewski MD,a Richard A. Pollak, DPM MS,b Radhakrishnan Pillai PhD,c Jason T. Olin PhDd| |
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.
Topical Corticosteroid Treatment Choice: A Clinical and Practical Discussion of Clocortolone Pivalate Cream
Multiple Nonmelanoma Skin Cancers in a Patient With Epidermolytic Hyperkeratosis on Long-standingRetinoid Therapy
Deborah S. Sarnoff MD FAAD FACP, Ritu Saini MD FAAD| |
Jerry L. McCullough PhD, Raymond L. Garcia MD, Barry Reece| |
Effect of Calcipotriene Plus Betamethasone Dipropionate Topical Suspension on the Hypothalamic-Pituitary-Adrenal Axis and Calcium Homeostasis in Subjects With Extensive Psoriasis Vulgaris: An Open, Non-Controlled, 8-week Trial
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
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
Neocollagenesis in Deep and Superficial Dermis by Combining Fractionated Q-Switched ND:YAG 1,064-nm With Topical Plant Stem Cell Extract and N-Acetyl Glucosamine: Open Case Series
Kavita Beri MDa and Sandy S. Milgraum MDb| |
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| |
Kalindi Raval PharmD, Jennifer H. Lofland PharmD MPH PhD, Heidi C. Waters MS MBA, Catherine Tak Piech MBA| |
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
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| |
J Drugs Dermatol. 2015;14(1):33-40.
Assessment of the Safety and Efficacy of Topical Copper Chlorophyllin in Women With Photodamaged Facial Skin
Monya L. Sigler PhD, and Thomas J. Stephens PhD| |
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| |
Sara M. James BS,a Dane E. Hill MD,a and Steven R. Feldman MD PhDa,b,c| |
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.
Bilateral Comparison Study of Pimecrolimus Cream 1% and a Ceramide-Hyaluronic Acid Emollient Foam in the Treatment of Patients With Atopic Dermatitis
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 Safety and Efficacy of Clindamycin Foam 1% versus Clindamycin Phosphate Topical Gel 1% for the Treatment of Acne Vulgaris
Alan Shalita MD, Judith A. Myers, Lincoln Krochmak MD, Alex Yaroshinsky PhD| |
A Subgroup Analysis to Evaluate the Efficacy and Safety of Adapalene-Benzoyl Peroxide Topical Gel in Black Subjects With Moderate Acne
Andrew F. Alexis MD MPH,a Lori A. Johnson PhD,b Nabil Kerrouche MSc,c and Valerie D. Callender MDd| |
J Drugs Dermatol. 2014;13(2):170-174.
Long-Pulsed Dye Laser-Mediated Photodynamic Therapy Combined with Topical Therapy for Mild to Severe Comedonal, Inflammatory, or Cystic Acne
Alexiades-Armenakas MD PhD| |
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.
Zoe D. Draelos MD| |
Raza Aly PhD,a Aditya K. Gupta MD PhD,b,c Tate Winter PhD,d Lee T. Zane MD,e Tracey Vlahovic DPMf| |
J Drugs Dermatol. 2017;16(10):1016-1021.
Frank Dreher PhD| |
J Drugs Dermatol. 2016;15(4):457-464.
Comparative Efficacy and Safety Results of Topical Hemostatic Powder and Sterile Compressed Foam Sponge in Second Intention Healing Following MohsMicrographic Surgery
Leon Kircik MD and James Q. Del Rosso DO| |
Thomas J. Stephens PhD,a John P. McCook BS,b and James H. Herndon Jr. MDc| |
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.
A Split-Faced, Observer-Blinded Comparison Study of Topical Adapalene/Benzoyl Peroxide and Adapalene in the Treatment of Asian Acne Patients
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| |
Skin Through the Ages: State-of-the-Art Options for the Topical Treatment of Acne, Photodamage, and Aging
Improvement of Atrophic Acne Scars in Skin of Color Using Topical Synthetic Epidermal Growth Factor (EGF) Serum: A Pilot Study
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.
Randomized, Double-Blind, Split-Face Study Evaluating Fractional Ablative Erbium:YAG Laser-Mediated Trans-Epidermal Delivery of Cosmetic Actives and a Novel Acoustic Pressure Wave Ultrasound Technology for the Treatment of Skin Aging, Melasma, and Acne Scars
Macrene Alexiades MD PhDa,b| |
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.
Assessment of a Superficial Chemical Peel Combined With a Multimodal, Hydroquinone-Free Skin Brightener Using In Vivo Reflectance Confocal Microscopy
Lisa T. Goberdhan BA, Lora Colvan BA, Elizabeth T. Makino BS CCRA MBA, Caroline Aguilar RN BSN, and Rahul C. Mehta PhD| |
J Drugs Dermatol. 2013;12(3 suppl 1):s38-s41.
An Open-Label Pilot Study of Naftifine 1% Gel in the Treatment of Seborrheic Dermatitis of the Scalp
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.
Protective Effects of a Topical Antioxidant Complex Containing Vitamins C and E and Ferulic Acid Against Ultraviolet Irradiation-InducedPhotodamage in Chinese Women
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| |
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.
Zoe Diana Draelos MD| |
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.
Randomized, Double-Blind, Split-Face Study to Compare the Irritation Potential of Two Topical Acne Formulations Over a 21-Day Treatment Period
Leon H. Kircik MD,a Varsha Bhatt PhD,b Gina Martin MOT,b and Radhakrishnan Pillai PhDb| |
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| |
An Open-Label, Multi-Center, Multiple-Application Pharmacokinetic Study of Naftifine HCl Gel 2% in Pediatric Subjects With Tinea Pedis
Amit Verma DrPH MPH, Babajide Olayinka MSc, Alan B. Fleischer Jr. MD| |
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.
The Efficacy of Three Class I Topical Synthetic Corticosteroids, Fluocinonide 0.1% Cream, Clobetasol 0.05% Cream and Halobetasol 0.05% Cream: A Scholtz-Dumas Bioassay Comparison
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| |
In Vivo Determination of the Skin Atrophy Potential of the Super-High-Potency Topical Corticosteroid Fluocinonide 0.1% Cream Compared with Clobetasol Propionate 0.05% Cream and Foam and a Vehicle
Eugene H. Gans PhD, Iqbal Sadiq MS, Tracy Stoudemayer, Marianne Stoudemayer BS, Albert M. Kligman MD PhD| |
In Vitro Nail Penetration of Tavaborole Topical Solution, 5%, Through Nail Polish on Ex Vivo Human Fingernails
Tracey Vlahovic DPM,a Tejal Merchant MPharm,b Sanjay Chanda PhD,b Lee T. Zane MD,b and Dina Coronado BSb| |
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.
Miriam S. Bettencourt MD| |
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.
The Two Faces of Fractionated Photodynamic Therapy: Increasing Efficacy With Light Fractionation or Adjuvant Use of Fractional Laser Technology
Margit L.W. Juhasz MD,a,b Melissa K. Levin MD,a and Ellen S. Marmur MDa,c| |
Improvement of Actinic Keratoses Using Topical DNA Repair Enzymes: A Randomized Placebo-Controlled Trial
Marie Stoddard BS,a Jennifer Herrmann MD,b,c,d Lauren Moy MD,eand Ronald Moy MDb,c| |
J Drugs Dermatol. 2017;16(10):1030-1034.
Transungual Delivery of Efinaconazole: Its Deposition in the Nail of Onychomycosis Patients and In Vitro Fungicidal Activity in Human Nails
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
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| |
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| |
J Drugs Dermatol. 2016;15(10):1250-1259.
Anthony Chiaravalloti MDa and Michael Payette MD MBAb| |
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.
A Double-Blind, Randomized Clinical Trial of 20% Alpha/Poly Hydroxy Acid Cream to Reduce Scaling of Lesions Associated With Moderate, Chronic Plaque Psoriasis
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| |
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.
Topical Cyclosporine Versus Emulsion Vehicle for the Treatment of Brittle Nails: A Randomized Controlled Pilot Study
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
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.
Diane Thiboutot MD| |
Topical Liposomal Rose Bengal for Photodynamic White Hair Removal: Randomized, Controlled, Double-Blind Study
Nevien Samy PhDa and Maha Fadel PhDb| |
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.
Photodynamic Therapy With Topical 5% 5-Aminolevulinic Acid for the Treatment of Truncal Acne in Asian Patients
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| |
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.
A Multicenter, Open-Label Study to Assess the Safety and Efficacy of Ciclopirox Topical Suspension 0.77% in the Treatment of Diaper Dermatitis Due to Candida Albicans
Elizabeth Gallup MD JD MBA, The Ciclopirox TS Investigators, Todd Plott MD| |
Managing Assessments and Expectations: Patient Responses Following Therapy With Efinaconazole Topical Solution, 10%
Neal Bhatia MD| |
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.
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.
J Drugs Dermatol. 2012;11(10):1158-1165.
Tolerability Comparison of Adapalene Gel, 0.3% versus Tazarotene Cream, 0.05% in Subjects with Healthy Skin
Jonathan S. Dosik MD, Lori A. Johnson PhD| |
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.
Econazole Nitrate Foam 1% for the Treatment of Tinea Pedis: Results from Two Double-Blind, Vehicle-Controlled, Phase 3 Clinical Trials
Boni E. Elewski MDa and Tracey C. Vlahovic DPMb| |
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.
A Sequential Approach to the Treatment of Severe Papulopustular Rosacea Not Responding to Traditional Treatment
Thomas Dirschka MD,a,b Lutz Schmitz MD,a,c and Ágota Bartha MDa| |
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 weeks.
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.
Janna M. Vassantachart MD,a Teo Soleymani MD,b and Jashin J. Wu MD FAADc| |
J Drugs Dermatol. 2016;15(8):995-1000.
Oral and Topical L-Phenylalanine, Clobetasol Propionate, and UVA/Sunlight - A New Study for the Treatment of Vitiligo
Francisco Camacho, MD and Jose Mazuecos, MD| |
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.
Adjunctive Use of a Facial Moisturizer SPF 30 Containing Ceramide Precursor Improves Tolerability of Topical Tretinoin 0.05%: A Randomized, Investigator-Blinded, Split-Face Study
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| |
J Drugs Dermatol. 2016;15(10):1260-1266.
Ciclopirox Topical Solution, 8% Combined with Oral Terbinafine to Treat Onychomycosis: A Randomized, Evaluator-Blinded Study
Aditya K. Gupta MD PhD FRCP(C)| |
Improvement in Atrophic Acne Scars Using Topical Synthetic Epidermal Growth Factor (EGF) Serum: A Pilot Study
Rachel Seidel BAa and Ronald L. Moy MD FAADb,c| |
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.
Tolerance and Efficacy of a Product Containing Ellagic and Salicylic Acids in Reducing Hyperpigmentation and Dark Spots in Comparison With 4% Hydroquinone
Amanda Dahl BS, Margarita Yatskayer MS, Susana Raab BS, and Christian Oresajo PhD| |
J Drugs Dermatol. 2013;12(1):52-58.
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| |
Reduction of Facial Redness With Resveratrol Added to Topical Product Containing Green Tea Polyphenols and Caffeine
Georgina Ferzli MD MS, Mital Patel MD, Natasha Phrsai BS, and Neil Brody MD PhD| |
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| |
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| |
Successful Treatment of Keloid With Fractionated Carbon Dioxide (CO2) Laser and Laser-Assisted Drug Delivery of Triamcinolone Acetonide Ointment in an African-American Man
Ekaterina Kraeva MD,a,b Derek Ho MD,a,b and Jared Jagdeo MD MSa,b,c| |
J Drugs Dermatol. 2017;16(9):925-927.
Safe and Efficacious Use of Intralesional Steroids for the Treatment of Focally Resistant Mycosis Fungoides
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
J Drugs Dermatol. 2015;14(5):466-470.
Douglas E. Kligman MD PhDa and Zoe D. Draelos MDb| |
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.
Pilot Study Using Topical Imiquimod 5% Cream in the Treatment of Nodular Basal Cell Carcinoma after Initial Treatment with Curettage
Julie A. Neville MD, Phillip M. Williford MD, Joseph L. Jorizzo MD| |
Stefano Veraldi MD PhD, Paolo De Micheli MSc, Rossana Schianchi MD, Luisa Lunardon MD| |
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Alitretinoin (BAL4079) in the Treatment of Severe Chronic Hand Eczema Refractory to Potent Topical Corticosteroid Therapy
Joseph F. Fowler MD,a Ole Graff MD,b Abbas G. Hamedanib| |
J Drugs Dermatol. 2014;13(10):1198-1204.
Tazarotene versus Tazarotene plus Clindamycin/Benzoyl Peroxide in the Treatment of Acne Vulgaris: A Multicenter, Double-Blind, Randomized, Parallel-Group Trial
Emil Tanghetti MD, William Abramovits MD, Barry Solomon MD, Keith Loven MD, Alan Shalita MD| |
Macrene R Alexiades-Armenakas MD PhD, Roy G Geronemus MD| |
The Efficacy and Safety of Tavaborole, a Novel, Boron-Based Pharmaceutical Agent: Phase 2 Studies Conducted for the Topical Treatment of Toenail Onychomycosis
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
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.
Treatment of Psoriasis and Long-term Maintenance Using 308 nm Excimer Laser, Clobetasol Spray, and Calcitriol Ointment: A Case Series
J Drugs Dermatol. 2012;11(8):994-996.
A Phase IV, Open-Label Study Evaluating the Use of Triple-Combination Therapy With Minocycline HCl Extended-Release Tablets, a Topical Antibiotic/Retinoid Preparation and Benzoyl Peroxide in Patients With Moderate to Severe Acne Vulgaris
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| |
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.
The Development of Antimicrobial Resistance Due to the Antibiotic Treatment of Acne Vulgaris: A Review
Mital Patel MD, Whitney P. Bowe MD, Carol Heughebaert MD, Alan R. Shalita MD| |
The Biological Rationale for Use of Vitamin D Analogs in Combination With Corticosteroids for the Topical Treatment of Plaque Psoriasis
Siegfried Segaert MD PhDa and Mads Røpke PhDb| |
J Drugs Dermatol. 2013;12(8):e129-e137.
Topical Application of Preparations Containing DNA Repair Enzymes Prevents Ultraviolet-Induced Telomere Shortening and c-FOS Proto-Oncogene Hyperexpression in Human Skin: An Experimental Pilot Study
Enzo Emanuele MD,a Velimir Altabas MD,b Karmela Altabas MD,b and Enzo Berardesca MDc| |
J Drugs Dermatol. 2013;12(9):1017-1021.
Noel M. Prevost MPAS PA-C, Joseph C. English III MD| |
Pilot, Multicenter, Open-Label Evaluation of Safety, Tolerability and Efficacy of a Novel, Topical Multipotent Growth Factor Formulation for the Periorbital Region
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| |
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| |
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
J Drugs Dermatol. 2014;13(5):574-578.
Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel for Rosacea: Summary of a Placebo-Controlled, Double-Blind Trial
J Drugs Dermatol. 2012;11(12):1410-1414.
A.F. Nikkels MD PhD, P. Gillard MD, G.E. Pierard MD PhD| |
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.
A Randomized Controlled Clinical Trial Assessing the Effect of Betamethasone Valerate 0.12% Foam on the Short-Term Treatment of Stasis Dermatitis
Stefan C. Weiss MD MHSc, Josephine Nguyen MD, Susan Chon MD, Alexa B. Kimball MD MPH| |
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 Index (DLQI).
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.
Igbal A. Bukhari, MD| |
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 the lesion.
Asli Aksu Çerman MD, Sezgi Sarıkaya Solak MD, İlknur Altunay MD, and Nihal Asli Küçükünal MD| |
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| |
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.
Jonathan S. Weiss MD| |
J Drugs Dermatol. 2013;12(suppl 6):s70-s72.
Dornechia George MD, Ted Rosen MD| |
Patricia K. Farris MD,a Nicole Rogers MD,a Amy McMichael MD,b Sophia Kogan MDc| |
Hair loss is a complicated problem that causes significant concern for those who are affected. Patients seeking medical treatment have limited options that include topical minoxidil and oral finasteride. While these treatments are backed by long term clinical use and research outcomes, many patients find topical minoxidil difficult to incorporate into their daily routine and some are concerned with the side effects associated with finasteride. In the office setting, patients may be treated with more invasive procedures such as platelet-rich plasma injections (PRP) and hair transplantation, treatments that often must be repeated and can lead to a costly investment. Consumers are increasingly interested in natural treatments for hair loss. Many turn to basic supplements only to be disappointed when they fail to deliver due to lack of standardization and efficacy. In this paper we review the benefits of a nutraceutical containing a specific blend of highly purified, standardized, bio-optimized, and bioavailable botanical extracts to treat hair loss. These phytoactives were selected because of their diverse multi-modal biologic activity against inflammation, DHT, stress mediators, oxidative damage, and intermediary signaling cascades. This supplement represents a paradigm shift as it addresses not only the factors that trigger hair loss but the downstream mediators of inflammation as well. Multi-center clinical studies are currently underway to confirm the efficacy and benefits of this unique nutraceutical.
J Drugs Dermatol. 2017;16(11 Suppl):s141-148.
Medication and Health Care Service Utilization Related to Depressive Symptoms in Older Adults with Psoriasis
Amit S Kulkarini MS, Rajesh Balkrishnan PhD, fabian T Camacho MS, Roger T Anderson PhD, Steven R Feldman MD PhD| |
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.
A Multicenter Study of Topical Azelaic Acid 15% Gelin Combination With Oral Doxycycline as Initial Therapy and Azelaic Acid 15% as Maintenance Monotherapy
Diane M. Thiboutot MD, Alan B. FleischerMD, James Q. Del Rosso DO,Phoebe Rich MD| |
Treatment of Hidradenitis Suppurativa by Photodynamic Therapy With Aminolevulinic Acid: Preliminary Results
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.
Efficacy and Safety of Clindamycin-Tretinoin Gel Versus Clindamycin or Tretinoin Alone in Acne Vulgaris: A Randomized, Double-Blind,Vehicle-Controlled Study
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.
Microneedling Prior to Levulan PDT for the Treatment of Actinic Keratoses: A Split-Face, Blinded Trial
James M. Spencer MD MSa,b and Scott A. Freeman PAb| |
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.
Mark Naylor MD| |
Sari Weinstein, MD and Ronald R. Branacaccio, MD| |
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.
Application of a Topical Biomimetic Electrical Signaling Technology to Photo-Aging: A Randomized, Double-Blind, Placebo-Controlled Trial of a Galvanic Zinc-Copper Complex
Jeannette Chantalat MS MBA, Elizabeth Bruning BSC LLB, Ying Sun PhD, Jue-Chen Liu PhD| |
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.
Michael Romanowicz DMD RPh, Judith J Stephenson SM, James Q. Del Rosso DO, Greg Lenhart MS| |
Manal Salah MD, Nevien Sami PhD, Maha Fadel PhD| |
One-year Topical Stabilized Retinol Treatment Improves Photodamaged Skin in a Double-blind, Vehicle-controlled Trial
Manpreeet Randhawa PhD,a Dianne Rossetti BSc,a James J. Leyden MD,b Jared Fantasia MSc,a
Joshua Zeichner MD,c Gabriela Oana Cula PhD,a Michael Southall PhD,a and Samantha Tucker-Samaras PhDa
OBJECTIVE: This study aimed to assess the efficacy and safety of 0.1% stabilized retinol on photodamaged skin during a one-year treatment.
METHODS: The investigation included two 52-week, double-blind, vehicle-controlled studies. In the main study, 62 subjects applied either a stabilized retinol formulation or its vehicle to the full face. A second exploratory study evaluated histological/histochemical markers in 12 subjects after 52 weeks of either retinol or vehicle use on contralateral dorsal forearms.
RESULTS: The retinol group showed significant photodamage improvement over vehicle at all timepoints during the study. After 52 weeks, retinol had improved crow’s feet fine lines by 44%, and mottled pigmentation by 84%, with over 50% of subjects showing +2 grades of improvement in many parameters. Additionally, at week 52, histochemical data confirmed the clinical results, showing increased expression of type I procollagen, hyaluronan, and Ki67 as compared to vehicle
CONCLUSION: This study confirms that a stabilized retinol (0.1%) formulation can significantly improve the signs of photoaging, and improvements in photodamage continue with prolonged use.
J Drugs Dermatol. 2015;14(3):271-276.
Comparative Evaluation of Topical Calcipotriol Versus Coal Tar and Salicylic Acid Ointment in Chronic Plaque Psoriasis
Preeti Singh MD,a Surabhi Gupta MD,a Afroz Abidi MD,a and Arvind Krishna MDb| |
AIMS: To evaluate and compare the differences in terms of efficacy, safety and relapse with Calcipotriol 0.005% (50 mcg/gm) and 6% coal tar and 3% salicylic ointment in patients with Plaque psoriasis.
SETTING and DESIGNS: Study conducted on 60 patients of plaque psoriasis, who attended the skin OPD in our hospital.
METHODS: The patients with mild to moderate plaque psoriasis were selected. 60 patients were enrolled for the study after obtaining informed consent. Subjects were asked to apply Calcipotriol 0.005% (50 mcg/gm) (Heximar Win care) twice a day on the right side plaques and on left side plaques, Petroleum jelly (Vaseline) in the morning and 6% coal tar and 3% salicylic ointment (Protar® Percos) at nighttime. PASI score was used to assess the reponse to therapy at 2nd, 4th, 6th and 8th week. After treatment subjects were observed for 6 weeks for any relapse.
STATISTICAL ANALYSIS: It was done by paired t-test and independent sample t-test.
CONCLUSIONS: The results showed that statistically significant difference was seen in the mean percentage reduction of PASI score between both the groups, at all the assessment visits, 2, 4, 6, and 8 weeks, the mean percentage reduction at 2 weeks for calcipotriol being 21±12.06 and for coal tar being 13.44±11.19 (P=0.000), at 4 weeks for calcipotriol was 40±16.71 and for coal tar 25±99 (P=0.000), at 6 weeks for calcipotriol was 53.99+-22.43 and for coal tar 41±21.23 (P=0.002), at 8 weeks for calcipotriol was 62.73±24.04 and for coal tar was 51.53±23.27 (P=0.11). Relapse was seen in 5/60 (8.3%) of patients on calcipotriol treated side and 9/60 (15%) of patients with coal tar treated side. Thus it can be concluded that calcipotriol cream is more efficacious when compared with coal tar and does have a quick response. It is well tolerated and acceptable cosmetically.
J Drugs Dermatol. 2013;12(8):868-873.
The Effect of Combined Calcipotriol and Betamethasone Dipropionate Ointment in the Treatment of Vitiligo: An Open, Uncontrolled Trial
Objective: To evaluate the efficacy and safety of calcipotriol 0.005%/betamethasone dipropionate 0.05% ointment in the treatment of vitiligo.
Methods: Thirty-one patients with vitiligo were enrolled in our study. The mean age of the patients was 32.6±11 years (range 18-56 years) and the mean duration of vitiligo was 3.7±5.8 years (range 0.07-30 years). Patients were treated with topical calcipotriol 0.005%/betamethasone dipropionate 0.05% ointment twice a day for at least 12 weeks, and the degree of repigmentation was analyzed using digital photography at baseline and at weeks 4, 8, and 12. The response was evaluated as excellent (76%-100%), moderate (51%-75%), mild (26%-50%), minimal (1%-25%), or no response. Possible adverse effects during the treatment period were also noted.
Results: Three patients (9.7%) had an excellent response, six patients (19.4%) had a moderate response, eight patients (25.8%) had a mild response, seven patients (22.6%) had a minimal response, and seven patients (22.6%) had no response. Patients at a progressive phase responded better to this ointment than patients at a stable phase (P=.005). The correlations between response rate and the duration of the disease were not significant (P=.791). Four adverse events related to the ointment were reported (pruritus, n=2; acne, n=2).
Conclusion: Calcipotriene 0.005%/betamethasone dipropionate 0.05% ointment is effective and well tolerated in the treatment of patients with vitiligo.
J Drugs Dermatol. 2012;11(10):e52-e54.
Current Understanding of Seborrheic Keratosis: Prevalence, Etiology, Clinical Presentation, Diagnosis, and Management
J. Mark Jackson MD FAAD,a Andrew Alexis FAAD MPH FAAD,b Brian Berman MD PhD FAAD,c Diane S. Berson MD FAAD,d Susan Taylor MD FAAD,e Jonathan S. Weiss MD FAADf| |
J Drugs Dermatol. 2015;14(10):1119-1125.
Linda Stein Gold MD,a William P. Werschler MD,b Jennifer Mohawk PhDc| |
BACKGROUND: Acne vulgaris affects a diverse group of people, and there is an increasingly wide variety of acne treatments. Because of the many options, clinicians have a better ability to individualize treatment; however, achieving optimal results relies on understanding how various agents perform in specific population segments. Fixed-combination adapalene plus benzoyl peroxide (A/BPO) is a first-line recommended acne therapy and is available in two adapalene concentrations (0.1% and 0.3%) combined with BPO 2.5%. This analysis investigated whether gender and age have an impact on either the efficacy or safety of topical A/BPO 0.3%.
METHODS: A post-hoc subanalysis was performed on data from a multicenter, randomized, double-blind, parallelgroup, 12-week study of A/BPO gel 0.3%/2.5% or vehicle gel in subjects ≥ 12 years old with moderate to severe acne vulgaris (Investigator global assessment [IGA] of 3 or 4). Efficacy measurements included achievement of an IGA of clear (0) or almost clear (1), and change in lesion counts from baseline to week 12. Safety measures included adverse events and cutaneous tolerability. The intent to treat (ITT) and safety populations were analyzed.
RESULTS: The A/BPO gel 0.3%/2.5% treatment group included 217 subjects. Among the subjects, 111 were 12-17 years old and 106 were ≥ 18 years old; 104 were male and 113 were female. A/BPO 0.3%/2.5% was safe, tolerable, and significantly superior to vehicle in success rates (IGA 0 or 1) and reduction of inflammatory/noninflammatory lesions (P≤0.05) across both age groups and genders.
CONCLUSIONS: A/BPO 0.3%/2.5% treatment achieved success and was equally effective and safe in younger vs older subjects and in males vs females. These results support the use of A/BPO 0.3%/2.5% in all subjects 12 and older.
Clinicaltrials.gov registry: (NCT01880320)
J Drugs Dermatol. 2017;16(6):582-589.
A Controlled Comparison Study of Topical Fluourouracil 5% Cream Pre-Treatment of Aminolevulinic Acid/Photodynamic Therapy for Actinic Keratosis
Emil A. Tanghetti MD, Carolyn Hamann MBA, and Margo Tanghetti BS| |
METHODS: This was an investigator-blinded randomized study in which 30 patients were randomized 1:1:1 into the following groups: Group 1 patients pretreated for 6-7 days with 5-FU, ALA applied with incubation of 2 hours, ALA removed with wet gauze, illuminated treated areas with 10 J/cm2 with Blu-U device; Group 2 patients treated with 5-FU BID for 6-7 days and no ALA/PDT; Group 3 patients received no pretreatment, ALA applied with incubation of 2 hours, ALA removed with wet gauze, illuminated treated areas with 10 J.cm2 with Blu-U device. Patients were seen at screening/baseline, treatment for ALA/PDT, 24 hours post treatment, 1 week post treatment and 3 months post treatment. All subjects were then given a re-challenge course of 5-FU for 6 days and reassessed.
RESULTS: AK counts in all groups were dramatically decreased and similar at 1 and 3 months post treatment. The re-challenge brought a significant difference with many subclinical lesions in the area of activity in the ALA and 5-FU alone groups.
CONCLUSIONS: All three arms appeared equal in treating visible AKs. These data strongly suggests a synergistic role of 5-FU with ALA/PDT over ALA/PDT or 5-FU alone in treating the subclinical lesions demonstrated on a 5-FU re-challenge. Treatment of these subclinical lesions should result in a longer remission. The data also suggests that a 5-FU re-challenge could be a clinical tool to judge the efficacy of treatment for AK if these subclinical lesions are proven to be an AK precursor.
J Drugs Dermatol. 2015;14(11):1241-1244.
Michael H. Gold MD,a,b Leon H. Kircik MD,c-e Vivian W. Bucay MD,f,g
Monika G. Kiripolsky MD,h,i and Julie A. Biron BSca
OBJECTIVE: To determine the efficacy of a new topical formulation of 1% retinol and the effects of this same formulation using a 0.5% retinol concentration to minimize irritation.
METHODS: Patients at 2 sites (n=6, n=5) with photodamaged skin applied a novel suspension of retinol (1%) daily to their faces for 8 to 12 weeks. Clinicians graded improvement in ultraviolet-induced features at 4 to 6 weeks and at 8 to 12 weeks. Positive results of the observational pilot study warranted a follow-up study on the low concentration. At a third site, females (n=30) with facial photodamage applied the same formulation with or without retinol (0.5%) daily for 8 weeks. Twenty-two subjects applied the test product and 8 applied vehicle according to a randomized, double-blinded, institutional review board–approved protocol. Improvements in photodamage features were graded at 4 and 8 weeks.
RESULTS: In the observational pilot study, most participants showed improvement in overall photodamage, crow’s feet, elasticity,wrinkles, brightness, and hyperpigmentation at 60 to 80 days. Improvements at 60 to 80 days were greater than at 30 to 46 days. In the low-concentration study with 0.5% retinol, improvements were modest, most likely due to the lower retinol concentration. Burning, pruritus, dryness, and erythema were minimal with the 0.5% retinol concentration.
CONCLUSIONS: The topical formulation of 1% retinol improves photodamaged skin for at least 8 to 12 weeks. Although improvements with the 0.5% retinol were more modest, side effects such as burning, dryness, pruritus, and erythema during the 8-week study period were minimal. These encouraging results justify a longer-term study to determine whether topically applied 0.5% retinol can provide benefits comparable with those seen with topically applied 1% retinol.
J Drugs Dermatol. 2013;12(5):533-541.
Results of a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Botulinum Toxin Type A Topical Gel for the Treatment of Moderate-to-Severe Lateral Canthal Lines
Richard Glogau MD,a,b Andrew Blitzer MD DDS,c Fredric Brandt MD,d Michael Kane MD,e Gary D. Monheit MD,f Jacob M. Waugh MDG| |
Objectives: To assess the safety and efficacy of RT001 for the treatment of lateral canthal lines in a randomized, double-blind, placebo-controlled study.
Materials & Methods: Adult subjects were enrolled to receive a single treatment of RT001 (n=45) or placebo (n=45) applied topically in the lateral canthal area. The primary endpoint was the composite of the Investigator Global Assessment of Lateral Canthal Line Severity (IGA-LCL) and the Patient Severity Assessment of lateral canthal line severity (PSA) defined as a 2-point or greater improvement on both scales.
Results: At four weeks, 44.4 percent of subjects treated with RT001 achieved a 2-point or greater improvement on a rigorous composite of both the IGA-LCL and PSA scales compared to 0.0% for the placebo subjects (P<0.0001). At four weeks, 88.9 percent of subjects achieved clinically relevant improvement by investigator assessment. Adverse events were mild in severity and unrelated to study treatment.
Conclusions: RT001 appears to be a safe and well-tolerated treatment for improvement of lateral canthal lines.
J Drugs Dermatol. 2012;11(1):38-45.
Inflammatory Mediators are Inhibited by a Taurine Metabolite in CpG Oligodeoxynucleotide and IFN-r Activated Macrophage Cell Line
Bo Sook Kim DVM PhD,a Daryl S. Spinner PhD,b Richard J. Kascsak PhD,b Seung Yong Park DVM PhD,c In Soo Cho DVM PhD,d Georgia Schuller-Levis PhD,e and Eunkyue Park PhDe| |
J Drugs Dermatol. 2013;12(5):551-557.
Khalid Al Aboud, MD; V. Ramesh, MD; and Khalid Al Hawasawi, MD| |
David R. Berk MD, Arthur Z. Eisen MD| |
A Retrospective Review of Treatment Results for Patients With Central Centrifugal Cicatrical Alopecia
Ariana Eginli BA, Emily Dothard MD, Courtney W. Bagayoko MD, Karen Huang MS, Alyssa Daniel MD, and Amy J. McMichael MD| |
INTRODUCTION: Central centrifugal cicatricial alopecia (CCCA) is a form of scarring alopecia primarily affecting women of African descent on the crown of the scalp. Limited data exists regarding evidence-based treatment for CCCA.
OBJECTIVE: To examine photos of subjects with CCCA before and after treatment in order to evaluate results of treatment and compare results of different treatment regimens.
METHODS: Photographs of 15 subjects with CCCA before and after treatment were evaluated by two blinded investigators who assigned disease severity scores to photographs based on a published scale: Central Scalp Alopecia Photographic Scale in African American Women.
RESULTS: Median change in severity score (post-treatment severity score – pre-treatment severity score) was 0.5 (P = 0.58) for all 15 subjects receiving a series of 7 to 8 intralesional steroid injections along with topical steroids (Class I/II) +/- minoxidil and +/- anti-dandruff shampoo, indicating worsening of disease after treatment. Subjects receiving minoxidil versus those who did not (0.25 vs 0.5; P = 0.38) and subjects receiving anti-dandruff shampoo versus those who did not (0.0 vs 0.5; P = 0.42) demonstrated no statistically significant difference in pre- and post-treatment severity scores. Of 15 subjects, 5/15 (33.3%) had decreased severity scores, 8/15 (53.3%) had increased severity scores, and 2/15 (13.3%) had no change in severity scores.
CONCLUSIONS: Although no statistically significant difference was found in pre- versus post-treatment disease severity, this may indicate intralesional steroid injections and topical steroids +/- minoxidil and +/- anti-dandruff shampoo halt disease progression.
J Drugs Dermatol. 2017;16(4):317-320.
A Randomized, Double-Blind, Controlled Comparative Trial of the Anti-Aging Properties of Non-Prescription Tri-Retinol 1.1% vs. Prescription Tretinoin 0.025%
Elizabeth T. Ho BS,a Nathan S. Trookman MD,b Brian R. Sperber MD PhD,b Ronald L. Rizer PhD,c Ralph Spindler PhD,d Sujatha Sonti PhD,a Vincent Gotz MS Pharm,e Rahul Mehta PhDa| |
J Drugs Dermatol. 2012;11(1):64-69.
Shannon Famenini MD and Carolyn Goh MD| |
J Drugs Dermatol. 2014;13(7):809-812.
Diane Thiboutot MD, Andrew F. Alexis MD MPH, Leon H. Kircik MD| |
This is a CME supplement; visit the JDD Medical Education Library to participate in this activity and earn 1 category 1 CME Credit.
Hobart W. Walling MD PhD, Brian L Swick MD, Pedram Gerami MD, Richard K. Scupham MD PhD| |
Topical Human Epidermal Growth Factor in the Treatment of Senile Purpura and the Prevention of Dermatoporosis
Braden McKnight BS,a Rachel Seidel BA,b and Ron Moy MDa| |
OBJECTIVE: To examine the effects of topically human epidermal growth factor on the clinical presence of senile purpura and its effect on skin thickness as measured via cutaneous ultrasound.
METHODS: Six subjects applied human epidermal growth factor morning and night for six weeks. Clinical outcomes were evaluated by comparing initial clinical photos to 6-week photos and performing a blinded investigator’s global assessment (IGA). Skin thickness was evaluated via cutaneous ultrasound measurement.
RESULTS: Ultrasound measurements indicated a mean skin thickening of 195.2 ± 35.7um (SEM) over 6 weeks. The average number of purpuric lesions decreased from 15 ± 4.6 (SEM) to 2.3 ± 0.7 (SEM) over that same period.
CONCLUSION: Senile purpura presents itself as a cosmetic disturbance posing significant psychological distress and serves as a marker of the severity of skin thinning. In this study, we demonstrate that topical h-EGF diminishes the appearance of senile purpura by thickening skin and may help prevent the development of late stage dermatoporosis.
J Drugs Dermatol. 2015;14(10):1147-1150.
Kircik, L. et al.| |
The limitations of photoprotection modalities have been the inability to arrest the progression of photodamage. Chemoprevention strategies involving a sunscreen has been incomplete because of the need to induce sustained repair of mutations and slow carcinogenesis. Photolyases, or photoreactivation enzymes, serve the role of repairing mutations and damage to DNA induced by ultraviolet (UV) radiation and therefore influence the initiation phases of carcinogenesis. As these enzymes are absent in humans, exogenous forms have been manufactured and are now utilized in topical agents to supplement and augment the innate repair mechanisms that are mostly inefficient.
J Drugs Dermatol. 2017;16(5 Suppl):61-66.
Pearl E. Grimes MD| |
OBJECTIVE: To assess the efficacy and safety of bimatoprost 0.03% alone and in combination with a topical steroid (mometasone) compared with mometasone alone in patients with nonsegmental vitiligo on nonfacial areas in a proof-of-concept study.
METHODS: This randomized, double-blind, controlled study was conducted over a 20-week treatment period. Patients were randomized to 1 of 3 treatment groups: bimatoprost monotherapy (n=11), bimatoprost plus mometasone (n=10), and mometasone plus placebo (n=11). The primary outcome was global response at week 20, based on an investigator’s assessment of improvement score of at least 5 (at least 50%–75% improvement from baseline) on an 8-point scale (0=worse; 7=cleared). Other outcomes included global response at other visits, response by anatomic site, change from baseline lesion severity (overall and by site), and safety.
RESULTS: Because of a lack of response observed for the primary end point, a post hoc analysis with a less stringent definition of response (score of ≥4 [25%–50% improvement]) was conducted. In this analysis, 46% of the bimatoprost plus mometasone group responded overall compared with 18% in the bimatoprost monotherapy group, and no patients in the mometasone plus placebo group. Greater response rates were observed in both bimatoprost groups compared with the mometasone plus placebo group starting at week 12. There were no differences among groups in signs and symptoms of irritation.
CONCLUSIONS: Bimatoprost alone or with mometasone provided greater repigmentation than treatment with mometasone alone. Larger studies that also assess facial lesions are warranted.
J Drugs Dermatol. 2016;15(6):703-710.
Efficacy and Tolerability of Retapamulin 1% Ointment for the Treatment of Infected Atopic Dermatitis: A Pilot Study
Study Design: A single-center, open-label pilot study was conducted to investigate the efficacy and safety of retapamulin 1% (Altabax, Stiefel/ GlaxoSmithKline) ointment for the treatment of secondarily infected atopic dermatitis in subjects aged 9 months to 98 years old (n=29).
Results: Twice-daily application of retapamulin 1% produced a mean 8.1-point reduction from baseline in the mean Skin Infection Rating Scale score. The majority of subjects achieved clinical cure with topical retapamulin therapy. Retapamulin 1% ointment was effective against S aureus isolates, including methicillin-resistant Staphylococcus aureus (MRSA). Treatment was well tolerated.
Conclusion: Retapamulin 1% is effective for the treatment of atopic dermatitis infected with S aureus, and demonstrates efficacy against both methicillin-susceptible and methicillin-resistant strains. Given its efficacy and good tolerability in this pilot study, retapamulin 1% ointment should be further evaluated as a treatment for infected atopic dermatitis. It may provide convenience and efficacy with a low risk for development of bacterial resistance.
J Drugs Dermatol. 2012;11(7):858-860.
Isoconazole Nitrate vs Isoconazole Nitrate and Diflucortolone Valerate in the Treatment of Tinea Inguinalis: Results of a Multicenter Retrospective Study
Patients and Methods: Treatment duration was three weeks. The efficacy of the treatment was based on the assessment of several signs and symptoms, which were collected on a 4-point scale. All patients were examined clinically before the beginning of the treatment, one week later, two weeks later, and at the end of the treatment. Mycological examinations were performed before the beginning of the treatment and at the end of the study.
Results: Treatment results with the combination of isoconazole nitrate and diflucortolone valerate were superior regarding erythema and pruritus. Both erythema and pruritus resolved in a larger percentage of patients and more quickly. Both regimens were well tolerated. Mycological cure rates were similar in both groups of patients.
Conclusions: Combination therapy with isoconazole nitrate and diflucortolone valerate is an effective and well-tolerated regimen in adult patients with tinea inguinalis.
J Drugs Dermatol. 2012;11(11)e70-e73.
Hair Removal with the 3-msec Alexandrite Laser in Patients with Skin Types IV-VI: Efficacy, Safety, and the Role of Topical Corticosteroids in Preventing Side Effects
Mohammed S. Aldraibi MD PhD, Dany J. Touma MD, Amor Khachemoune MD CWS| |
A Comparison of Physicochemical Properties of a Selection of Modern Moisturizers: Hydrophilic Index and pH
Material and Methods: The pH and hydrophilic fraction of 31 skin moisturizers sold in the US were measured. Hydrophilic Index (HI) was calculated using the "HI equation." The two parameters were charted using a scatter plot with quadrant divisions. Products with lower hydrophilicity were considered "more greasy" and assigned a lower HI as compared to their counterparts with a higher hydrophilicity.
Results: Our findings are in good accordance with common clinical impressions: lotions generally have higher HI, while ointments have lower HI. The majority of the products tested fall into low HI, suggesting that a large percentage of the products may be rich in overall lipid content. The pH values range widely, from 3.7 to 8.2, with the majority of the products close to the physiologic skin pH of 4 to 6.
Conclusion: This study introduces HI as a novel method of quantifying the aqueous content of topical emollients. When considered together with pH, the two indices can guide providers in choosing the most suitable emollients for patients with skin diseases involving altered acid mantle and barrier disruption, such as atopic dermatitis, irritant contact dermatitis, and ichthyosis vulgaris.
J Drugs Dermatol. 2012;11(5):633-636.
Anthony F. Santoro, MD; Mark A. Rezac, MD and Jason B. Lee, MD| |
David Rosmarin MD, Anne LaRaia MD, Scott Schlauder MD, Alice B. Gottlieb MD PhD| |
Joel Lee Cohen MD FAAD and Ashish C. Bhatia MD FAAD| |
Methods: In this randomized, double-blinded, placebo-controlled split-face study, 20 subjects with bilateral facial telangiectasia were treated with a pulsed dye laser (PDL) device at purpuric settings. The test articles, a gel containing vitamin K oxide and placebo (vehicle), were each randomly assigned to one side of the subject’s face. Subjects applied the test articles twice a day for the following 9 ± 1 days. Improvement in both focal and general field purpura on each side of the face was assessed by the investigator using photographs. A scale of -100% (worsening) to 100% (improving) was used to rate photos against a baseline photograph obtained 15–30 minutes after treatment with the PDL device.
Results: Resolution of the field of purpura was consistently greater with the vitamin K oxide gel after the second day of treatment. The greatest difference between the vitamin K oxide gel and placebo scores occurred on the fourth day after treatment. Although differences in active versus placebo scores did not reach statistical significance during the nine-day study period, a trend toward faster resolution of purpura with the active product was seen. Treatment-related adverse effects were not observed in any subject.
Conclusion: Vitamin K oxide gel appears to hasten the resolution of pulsed dye laser-induced purpura in subjects being treated for bilateral facial telangiectasia, and may well be useful in accelerating resolution of facial bruising from other cosmetic procedures such as fillers used for soft-tissue augmentation as well as other types of cutaneous surgical procedures.
Ethan T. Routt MD,a Shelbi C. Jim On MD,a Joshua A. Zeichner MD,a and Leon H. Kircik MDb,c,d| |
J Drugs Dermatol. 2014;13(4):391-395.
Patricia Farris MD,a,b Jean Krutmann MD,h Yuan-Hong Li MD PhD,i
David McDaniel MD,c,d,e,f,g and Yevgeniy Krolj
J Drugs Dermatol. 2013;12(12):1389-1394.
Psoriasis and Psoriatic Arthritis in a Patient with HIV: Response to Mycophenolate Mofetil Treatment
Seth B. Forman MD, Robert Higginson PA-C, Algin B. Garrett MD| |
Clinical Assessment of Immediate and Long-Term Effects of a Two-Step Topical Hyaluronic Acid Lip Treatment
Elizabeth T. Makino BS CCRA MBA,a Priscilla Tan BA,a Kun Qian MD,b Michael Babcock MD FAAD,b and Rahul C. Mehta PhDa| |
Key features of lip aging include loss of volume, color, and definition as well as increases in lines/wrinkles and uneven skin texture. A single-center, open-label clinical study was conducted to assess the efficacy and tolerability of a novel, topical two-step lip treatment (HA5 LS) in female subjects presenting with mild to moderate lip dryness and mild to severe lip condition. Subjects were instructed to apply HA5 LS at least three times a day to ensure coverage 8 hours a day for four weeks. Clinical assessments for efficacy and tolerability were conducted at baseline, baseline post-application, week 2, and week 4. Standardized digital photography, subject self-assessment questionnaires, and instrumentation measurements for skin hydration (corneometer) and lip plumpness (digital caliper) were also conducted. Thirty-six female subjects aged 22-40 years enrolled in the study. HA5 LS provided instant and long term effects, achieving significant improvements in all clinical grading parameters including lip texture, color, definition/contour, scaling, cupping, lines/wrinkles, lip plumpness, and overall lip condition from baseline post-application to week 4 (all P less than equal to .001; Wilcoxon signed-rank test). Instrumentation measurements for hydration and digital caliper at weeks 2 and 4 were also significant (all P less than equal to .032; paired t-test). HA5 LS was also well-tolerated and highly-rated by subjects throughout the study duration. Results from this study suggest that HA5 LS addresses the key features of lip aging, providing both instant and long-term benefits.
J Drugs Dermatol. 2017;16(4):366-371.
An Evaluation of the Benefits of a Topical Treatment in the Improvement of Photodamaged Hands With Age Spots, Freckles, and/or Discolorations
Michael H. Gold MDa,b and Conor Gallagher PhDc| |
OBJECTIVE: To evaluate the efficacy of a topically applied cream formulated with an alpha-hydroxy acid, depigmenting agents, and antioxidants to improve the appearance of characteristics associated with photodamaged hands.
METHODS: This was a single-site, open-label study of a proprietary topical treatment (Vivité Vibrance Décolleté, Allergan, Inc.) in adult female subjects with moderate-to-severe photoaging of the hands. The treatment was administered to the hands twice daily over an 8-week period. Treatment efficacy was assessed at baseline and weeks 4 and 8 using the Investigator Global Assessment (IGA) score based on the percentage coverage and color depth of photodamaged areas. The severity of age spots, freckles, and hand skin discoloration were also assessed; digital and ultraviolet photography of the hands was performed. Subject-reported assessments of treatment efficacy were evaluated using a questionnaire administered at week 8. Statistical significance was defined with an α set at P≤.05.
RESULTS: Thirty-five subjects were enrolled with a mean age of 55.6 years; 33 subjects completed the study. The IGA of the appearance of hand photodamage improved from a mean (standard deviation) score of 5.0 (0.8) at baseline to 3.1 (1.5) and 2.6 (1.3) at weeks 4 and 8, respectively (1=mild; 9=severe). Based on expert-grader evaluation, subjects demonstrated statistically significant improvements from baseline in IGA at weeks 4 and 8 in age spots and freckling at weeks 4 and 8, (P<.0003) and in skin discolorations at week 8 (P<.05). The majority of subjects reported that they perceived improvements in each of the 9 parameters associated with skin appearance. No adverse events were reported.
CONCLUSIONS: The appearance of age-related hand pigmentation characteristics were significantly improved at 4 and 8 weeks of treatment. Subjects reported post-treatment improvements in other characteristics associated with healthy skin.
J Drugs Dermatol. 2013;12(12):1468-1472.
Efinaconazole 10% and Tavaborole 5% Penetrate Across Poly-ureaurethane 16%: Results of In Vitro Release Testing and Clinical Implications of Onychodystrophy in Onychomycosis
Chris G. Adigun MD,a Tracey C. Vlahovic DPM,b Michael B. McClellan MS,c Kailas D. Thakker PhD,c Ryan R. Klein PhD,c Tuan A. Elstrom BS,d and Daniel B. Ward Jr. MD FAADd| |
OBJECTIVE: The purpose of this work was to determine through in vitro release testing (IVRT) whether poly-ureaurethane 16% allows for penetration of efinaconazole 10% or tavaborole 5%. Results could spur subsequent clinical studies which would have implications for the addition of an antifungal based on fungal confirmation, after addresssing the underlying nail dystrophy primarily.
METHODS: A vertical diffusion cell system was used to evaluate the ability of efinaconazole 10% and tavaborole 5% to penetrate across poly-ureaurethane 16%. The diffusion cells had a 1.0 cm2 surface area and approximately 8 mL receptor volume. Poly-ureaurethane 16% was applied to a 0.45 μm nylon membrane and allowed to dry before use. Efinaconazole 10% or tavaborole 5% was then applied to the poly-ureaurethane 16% coated membrane, and samples were pulled from the receptor chamber at various times. Reverse phase chromatography was then used to assess the penetration of each active ingredient across the membrane.
RESULTS: The flux and permeability of efinaconazole or tavaborole across poly-ureaurethane 16% were determined from efinaconazole 10% or tavaborole 5%, respectively. The flux and permeability of efinaconazole were determined to be 503.9 +/- 31.9 μg/cm2/hr and 14.0 +/- 0.9 nm/sec. The flux and permeability of tavaborole were determined to be 755.5 +/- 290.4 μg/cm2/hr and 42.0 +/- 16.1 nm/sec.
CONCLUSION: In addition to the treatment of onychoschizia, onychorrhexis, and other signs of severe dessication of the nail plate, a barrier that regulates TOWL should be considered in the management onychomycosis to address barrier dysfunction and to promote stabilization of the damaged nail. Previously published flux values across the nail are reported to be 1.4 μg/cm2/day for efinaconazole and 204 μg/cm2/day for tavaborole. These values are substantially lower than the herein determined flux for both molecules across poly-ureaurethane 16%. A comparison of the data suggests that poly-ureaurethane 16%, if used prior to efinaconazole or tavaborole, would not limit the ability of either active ingredient to access the nail, and therefore, would be unlikely to reduce their antifungal effect. Onychodystrophy is inherent in, and often precedes onychomycosis, and consideration should be given for initiation of treatment in the same sequence: stabilizing and protecting the nail plate barrier primarily, and subsequently adding oral or topical antifungals after laboratory confirmation. Future clinical studies will be needed to determine combination efficacy for in vivo use.
J Drugs Dermatol. 2016;15(9):1116-1120.
Photodynamic Therapy With Low-Strength ALA,Repeated Applications and Short Contact Periods(40-60 Minutes) in Acne, Photoaging and Vitiligo
Gabriel Serrano MD, Matilde Lorente MD, Madga Reyes MD, Fernando Millan MD, Adrian Lloret MD, Joaquin Melendez, Maria Navarro, Miguel Navarro MD| |
Efinaconazole Solution in the Treatment of Toenail Onychomycosis: A Phase 2, Multicenter, Randomized, Double-Blind Study
Eduardo H. Tschen MD,a Alicia D. Bucko DO,a Norihide Oizumi MS, Hideki Kawabata MS,Jason T. Olin PhD, and Radhakrishnan Pillai PhD| |
Objective: We investigated the efficacy and safety of a solution using a novel topical triazole antifungal, efinaconazole, in distal lateral subungual onychomycosis (DLSO). Methods: Multicenter, randomized, double-blind, vehicle-controlled phase 2 study in mild to moderate toenail DLSO (n=135). Subjects randomized (2:2:2:1 ratio) to receive efinaconazole 10% solution (with or without semiocclusion), efinaconazole 5% solution, or vehicle, once daily for 36 weeks, with one 4-week posttreatment follow-up (week 40). Efficacy assessments included complete cure, mycologic cure, clinical efficacy, and other assessments of overall treatment effectiveness. No efficacy variables were designated as primary.
Results: At follow-up, complete cure was numerically higher in all active groups (16%-26%) compared with vehicle (9%). Mycologic cure rates with efinaconazole 10% semiocclusion, efinaconazole 10%, and efinaconazole 5% were 83%, 87%, and 87%, respectively. Efinaconazole 10% (with or without semiocclusion) demonstrated significantly greater clinical efficacy and treatment effectiveness when compared with vehicle (P=.0088 and .0064; .0056 and .0085, respectively, for both efinaconazole 10% groups). Adverse events were generally similar and mild. Local-site reactions were restricted to few subjects and did not differ meaningfully from those produced by vehicle.
Conclusions: This study provided evidence that once-daily efinaconazole 10% solution (with or without semiocclusion) applied topically for 36 weeks was more effective than vehicle in treating DLSO and was well tolerated. Based on these results, efinaconazole 10% solution was chosen for the phase 3 development program.
J Drugs Dermatol. 2013;12(2):186-192.
Grace K. Kim DO and James Q. Del Rosso DO FAOCD| |
Brooke E. Rothstein BA,a,b Brianna McQuade PharmD,a Jacqueline E. Greb BA,a,b Ari M. Goldminz MD,a
and Alice B. Gottlieb MD PhDa,b
J Drugs Dermatol. 2016;15(5):648-649.
Shannon Famenini BSa and Jashin J. Wu MDb| |
J Drugs Dermatol. 2013;12(3):317-320.