Search Results for "Dermatoses"
Roselyn E. Epps MD| |
Topical Corticosteroid Treatment Choice: A Clinical and Practical Discussion of Clocortolone Pivalate Cream
Whitney Valins MD and Bobby Y. Reddy MD| |
Jennifer Rivard MD, Henry W. Lim MD| |
Nikoo Cheraghi MD and Olubukola T. Babalola MD| |
Stephanie K. Fabbro MD and Benjamin H. Kaffenberger MD| |
Adam J. Friedman MD FAAD,a Erika C. von Grote PhD,b Matthew H. Meckfessel PhDb| |
J Drugs Dermatol. 2016;15(5):633-639.
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.
The Treatment of Inflammatory Facial Dermatoses With Topical Corticosteroids:Focus on Clocortolone Pivalate 0.1% Cream
Methods: Clocortolone pivalate 0.01% cream was applied to affected facial skin in subjects presenting with seborrheic dermatitis, contact dermatitis, atopic dermatitis, or psoriasis. Application was completed three times daily for 21 days. Assessments of erythema, edema, transudation, lichenification, scaling, pruritus and/or pain were completed at baseline and Days 4, 7, 14, and 21. Overall therapeutic response was assessed at all follow-up visits. Forty-nine subjects were entered, ranging in age from 1 month to 88 years of age. Thirty-eight subjects completed the studies, with 11 subjects lost to follow-up after the first visit. Individuals between the ages of 13 and 19 years were pre-emptively excluded to avoid potential application of a corticosteroid to acne-affected or acne-prone skin.
Results: Treatment with clocortolone pivalate 0.1% cream resulted in decreases in erythema, edema, transudation, lichenification, scaling, and pruritus/pain in 76% of treated study subjects. The overall therapeutic response in approximately two-thirds of the subjects (68%) was rated as good to excellent. There were 7 adverse events noted over the course of the study that were judged to be related to treatment, all of which were cutaneous and localized to the site of application (acneiform eruptions, burning, and folliculitis).
Conclusion: Clocortolone pivalate 0.1% cream was effective in relieving the signs and symptoms of corticosteroid-responsive inflammatory dermatoses involving facial skin, including seborrheic dermatitis, contact dermatitis, atopic dermatitis, and psoriasis. Overall, the safety profile was favorable and devoid of any treatment-related serious adverse events.
J Drugs Dermatol. 2012;11(10):1194-1198.
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.
Introduction: Acitretin is a systemic retinoid drug used in the treatment of severe psoriasis. It has also been used for a spectrum of
other difficult-to-treat dermatoses, including hyperkeratotic and inflammatory dermatoses and non-melanoma skin cancers. Here we
review the available data regarding both FDA-approved and off-label uses of acitretin, clinically relevant adverse events, precautions
Methods: A PubMed literature search was conducted utilizing the search term "acitretin," which yielded 714 hits. Results were further limited to English language clinical trials in human subjects. Of 78 articles evaluated for relevance, 60 were included for review.
Results: Acitretin is effective as monotherapy and in multidrug therapeutic regimens for the treatment of psoriasis and other hyperkeratotic and inflammatory disorders, as well as for malignancy chemoprevention. Its use is limited by its teratogenic potential and other adverse effects, including mucocutaneous effects and hepatotoxicity. Potential adverse effects may be reduced or avoided by using lower doses of acitretin or in combination with other therapies.
Limitations: The reviewed studies include many small trials and case reports of the use of acitretin for psoriasis. Studies of acitretin therapy for the treatment of other cutaneous disorders are limited.
Conclusion: Acitretin is a beneficial treatment for psoriasis, and should be considered when not contraindicated. Particularly when used in combination with ultraviolet (UV) phototherapy, is a safe and cost effective therapeutic strategy.
J Drugs Dermatol.2011;10(7):772-782.
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.
Matthew E. Byran, MD; Kristen Lienart, BS; Bruce R. Smoller, MD and Sandra Marchese Johnson, MD| |
Logan W. Thomas MS4, Ashley Elsensohn MD MPH, Terese Bergheim MD, Jessica Shiu MD PhD, and Anand Ganesan MD PhD| |
J Drugs Dermatol. 2018;17(3):323-329.
Fred Laufer MD| |
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 Role of a Novel Daily Cleansing and Moisturizing Regimen in the Management of Atopic Dermatitis: A Clinical Review
The efficacy of Galderma’s Cetaphil® and Restoraderm® support the emerging and available data that epidermal barrier function and its repair are a crucial element in treating patients with atopic dermatitis and several other common dermatoses. The Galderma Restoraderm products are novel formulations that support the epidermal barrier by enhancing filaggrin expression, which restores natural moisturizing factors in the skin and helps to rebuild a healthy skin barrier. The Restoraderm products are over-the-counter, widely available, and competitively priced, making them accessible to a large majority of the patient population.
Efficacy of Extended-Release 45 mg Oral Minocycline and Extended-Release 45 mg Oral Minocycline Plus 15% Azelaic Acid in the Treatment of Acne Rosacea
J. Mark Jackson MD,a Douglas J. Lorenz PhD,b and Leon H. Kircik MDc-e| |
J Drugs Dermatol. 2013;12(3):292-298.
Aanand N. Geria MD, Christina N. Lawson MD, Rebat M. Halder MD| |
J Drugs Dermatol. 2011;10(5):483-489.
New Insights Into Ideal Skin Care for the Acne Patient: Addressing Skin Barrier Disruption, Oil Control, and Ultraviolet Protection Through Advanced Formulations
Cetaphil® DermaControl™ Moisturizer SPF 30 (Galderma Laboratories, L.P., Fort Worth, Texas) is a new widely available and affordable skin care therapy specifically designed for use by patients with acne-prone skin and acne-affected skin. Its state-of-the-art psuedoceramide technology helps maintain barrier function without adding excessive surface greasiness, which leads to better compliance and fewer side effects; and it also provides protection against ultraviolet radiation.
Rachel Seidel,b.c Nicolette Lavi,c and Lisa Chipps MD MSa,c| |
CASE: A woman in her second trimester presented with an intensely pruritic vesiculobullous rash diagnosed as PG. She was started on prednisone and gradually tapered to an appropriate maintenance dose until her uncomplicated delivery of a full-term healthy newborn.
CONCLUSION: Proper management of PG requires a suitable pharmacotherapy regimen, close observation, and collaboration with a multi-disciplinary treatment team. These steps are crucial to reduce maternal morbidity, lessen fetal risk, and adequately prepare for the possibility of unfavorable obstetric outcomes.
J Drugs Dermatol. 2015;14(8):904-907.
Joseph Bikowski MD| |
Successful Treatment of a Lichenoid-Like Granulomatous Reaction to Purple Tattoo Pigment With Intralesional Kenalog
Stephanie Feldstein MDa and Jared Jagdeo MD MSb,c,d| |
J Drugs Dermatol. 2015;14(6):638-640.
Nicholas Ross, Michele Farber MD, and Joya Sahu MD| |
Of the many tattoo reactions the most common are allergic, granulomatous, lichenoid, photosensitive, pseudolymphomatous, and infectious. Eruptive milia are a rare complication with only three prior reports in the English literature. A 19-year-old African American female presented with tiny, white papules confined within the margins of a tattoo. She denied trauma or associated symptoms at the site. Biopsy demonstrated deposits of black granular material within the dermis and a small infundibular cyst; a diagnosis of eruptive milia within tattoo was made. The milia responded to treatment with urea 40% cream and tretinoin 0.1% cream. Given its rarity, it is important to recognize the presentation of this disorder as other tattoo reactions require more aggressive management. While further research is necessary to determine the exact pathogenesis of this condition, the authors propose a mechanism along with a review of the literature to discuss management.
J Drugs Dermatol. 2017;16(6):621-624.
Vicky Kwan Wong BA, Brian Fuchs MD, Mark Lebwohl MD| |
Yulia K. Khan, Amer N. Kalaaji MD, Bart L. Clarke MD| |
Rino Cerio MD, Magdalene Dohil MD, Jeanine Downie MD FAAD, Sofia Magina MD, Emmanuel Mahé MD, Alexander J. Stratigos MD| |
Nikoo Cheraghi MD,a Armand Cognetta Jr. MD,b and David Goldberg MDc| |
Background: Dermatologists were historically well versed in the use of radiation therapy for the management of non-melanoma skin cancers and various inflammatory dermatologic conditions. With the advent of Mohs micrographic surgery and therapeutic discoveries for treating inflammatory dermatoses, radiotherapy assumed loss of a role in the clinical repertoire of the dermatologist. In recent years, its importance has again been realized for the management of non-melanoma skin cancers not amenable to surgical treatment or as adjuvant or palliative therapy.
Objective: To review the evolving use of radiation therapy in the treatment of non-melanoma skin cancer.
Methods and Materials: All published literature regarding the applications of radiotherapy for the treatment of non-melanoma skin cancer were analyzed and collated.
Results: A comprehensive review of radiotherapy for the treatment of non-melanoma skin cancer was outlined.
Conclusion: Dermatologists should be well versed in radiation therapy in order to deliver the best possible care for patients, as radiotherapy is an important adjuvant tool for the treatment of non-melanoma skin cancer.
J Drugs Dermatol. 2017;16(5):464-469.
The Multifunctionality of 10% Sodium Sulfacetamide, 5% Sulfur Emollient Foamin the Treatment of Inflammatory Facial Dermatoses
Zoe Diana Draelos MD| |
Ellen S. Kurtz PhD, Warren Wallo| |
Stanislav N. Tolkachjov MD,a Philip Y. Sun MS,b and Alina G. Bridges DOa| |
Pyoderma gangrenosum (PG) is a neutrophilic, ulcerative dermatosis that can develop at sites of cutaneous trauma, including surgical incisions, a phenomenon known as pathergy. The characteristic lesion is a painful, rapidly expanding ulceration with a violaceous undermined border.1 A biopsy taken from the expanding violaceous border shows predominantly neutrophilic dermal inflammation with neutrophilic abscess formation.
The etiology of PG appears to be variable among patients, as about a half of the reported cases are associated with systemic disease such as inflammatory bowel disease, rheumatoid arthritis, or myeloproliferative disorders, while the other half seem to be idiopathic.2 PG is difficult to diagnose as other etiologies, including infectious, vasculitic, and other inflammatory dermatoses, must be excluded.1 Histopathologic and biochemical markers of PG, such as dermal neutrophilic infiltrate or overexpression of interleukin-8,3 respectively, are not pathognomonic. Given that several drugs, such as hydralazine, mesalamine, and sunitinib, are reportedly associated with PG, failure to recognize this association and stop these medications may delay diagnosis and therapy. We report a case of idiopathic postoperative PG following video-assisted thoracic surgery (VATS).
J Drugs Dermatol. 2017;16(7):711-713.
Martha P. Arroyo, MD, PhD; Patricia Heller, MD and Miriam Keltz Pomeranz, MD| |
Drug reactions are an uncommon and unpredictable complication of medical therapy. Cutaneous drug reaction rates occur with a frequency of 1% to 8% and can be higher for certain classes of drugs1. They can range from mild morbilliform eruptions to more severe forms such as drug-hypersensitivity syndrome, toxic epidermal necrolysis or anaphylaxis. Acute generalized exanthematous pustulosis (AGEP) is a rare presentation of a drug reaction and can be difficult to distinguish from other pustular dermatoses. Herein we review a case of AGEP and include a discussion of salient clinical and histological features of AGEP.
Leon Kircik MD| |
Tuyet A. Nguyen BA BS and Adam J. Friedman MD| |
J Drugs Dermatol. 2013;12(10):1131-1137.
Clinically Relevant Reduction in Persistent Facial Erythema of Rosacea on the First Day of Treatment With Oxymetazoline Cream 1.0%
Emil A. Tanghetti MD,a Jeffrey S. Dover MD FRCPC,b David J. Goldberg MD,c Sunil S. Dhawan MD,d Lei Luo MPH,e David R. Berk MD,e Gurpreet Ahluwalia PhD,e and Nancy Alvandi PhDe| |
J Drugs Dermatol. 2012;11(7):804-807.
Novel Antibacterial Activity of Monolaurin Compared with Conventional Antibiotics against Organisms from Skin Infections: An in Vitro Study
Beatriz G. Carpo MD, Vermén M. Verallo-Rowell MD, Jon Kabara MS PhD| |
A Randomized, Double-Blind Phase 4 Study of the Efficacy and Safety of Ethanol-Free Clobetasol Propionate Foam, 0.05%, vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis
Leon H. Kircik MD,a-c William J. Eastman MD,d and Jennifer Gwazdauskas MBAe| |
OBJECTIVES: To demonstrate superior efficacy, similar safety, and superior QOL outcomes in subjects with moderate to severe chronic hand dermatitis following treatment with clobetasol propionate foam, 0.05%, compared with vehicle foam.
METHODS: In this randomized, double-blind, vehicle-controlled, parallel-group, multicenter study (ClinicalTrials.gov identifier NCT01323673), subjects aged 12 years and older with moderate to severe chronic hand dermatitis and an Investigator's Static Global Assessment (ISGA) score of 3 or 4 at baseline were randomized 1:1 to receive clobetasol propionate foam, 0.05%, or vehicle foam, twice daily over 15 days. The primary end point was the proportion of subjects who achieved treatment success, defined as improvement from baseline of ≥2 ISGA grades for the target hand at day 15.
RESULTS: In total, 125 subjects were enrolled: 62 subjects were randomized to the clobetasol propionate foam group and 63 subjects were randomized to the vehicle foam group. The proportion of subjects with treatment success at day 15 did not differ significantly between treatment groups. Adverse events (AEs) were reported in 18% of subjects in the clobetasol propionate foam group and 8% of subjects in the vehicle foam group. No serious AEs, AEs resulting in discontinuation of study product, or severe AEs were reported in the clobetasol propionate foam group.
CONCLUSIONS: Clobetasol propionate foam, 0.05%, was not significantly more efficacious than vehicle foam at improving chronic hand dermatitis on investigator-assessed end points. Emollient properties of the study product vehicle may be a confounder in the study.
J Drugs Dermatol. 2013;12(3):328-334.
Taurine Chloramine Inhibits NO and TNF-α Production in Zymosan Plus Interferon-γ Activated RAW 264.7 Cells
Bo Sook Kim,a In Soo Cho,b Seung Yong Park,c Georgia Schuller-Levis,d William Levis,e Eunkyue Parkd| |
Taurine is present abundantly in various tissues, especially in leukocytes embattled to foreign invaders such as microorganisms or oxidants. Taurine-chloramine (Tau-Cl) is produced from taurine at the site of inflammation via the myeoloperoxidase-halide pathway in leukocytes induced by oxidants and/or infectious materials. Previously, our data demonstrated that Tau-Cl inhibited nitric oxide (NO) production and TNF-α secretion induced by lipopolysaccharide (LPS), a Toll-like receptor 4 (TLR-4) ligand or lipoarabinomannan (LAM), a TLR-2 ligand plus interferon-γ (IFN-γ) in peritoneal macrophages or RAW 264.7 cells. Zymosan, a β-glucan of yeast cell wall, is a ligand for TLR-2 and dectin-1 and stimulates macrophages to produce proinflammatory mediators such as NO and TNF-α. Based on our previous data, we examined the effect of zymosan and IFN-γ induced production of NO and TNF-α in the absence or presence of Tau-Cl or taurine using RAW 264.7 cells. Production of NO and secretion of TNF-α is increased when zymosan is combined with IFN-γ. Tau-Cl inhibited production of NO and secretion of TNF-α in zymosan plus IFN-γ activated RAW 264.7 cells in a dose-dependent manner (99% vs. 48% using 0.8mM Tau-Cl). Taurine was without effect. Nitric oxide synthase protein (iNOS), induced by zymosan plus IFN-γ, was inhibited by Tau-Cl (0.8mM) as measured using western blot analysis. NOS mRNA was inhibited by Tau-Cl at four, eight and 16 hours post activation, but not at 24 hours. TNF-α mRNA was inhibited at four hours and eight hours, but not at 16 and 24 hours. These data suggest that expression of both iNOS and TNF-α mRNAs are inhibited by treatment with Tau-Cl within four and eight hours, but not at later time points. Transient suppression of activation of RAW 264.7 cells induced by zymosan may play a critical physiological role for taurine in protecting against tissue injury from initial overt inflammation. This study indicates that tropical treatment of taurine may ameliorate inflammatory dermatoses caused by an environmental yeast or abnormal immune function.
J Drugs Dermatol. 2011;10(6):659-665.
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.
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| |
Why Is Rosacea Considered to Be an Inflammatory Disorder?
The Primary Role, Clinical Relevance, and Therapeutic Correlations of Abnormal Innate Immune Response in Rosacea-Prone Skin
The pathophysiology of rosacea has undergone renewed interest over the past decade, with a large body of evidence supporting the role of an abnormal innate immune response in rosacea. Many mechanisms interact with the cutaneous innate immune system that may be operative. A variety of potential triggers stimulate this immune detection system which is upregulated and hyper-responsive in facial skin of patients with rosacea as compared to normal skin. Based on the most current data, two conclusions have been reached. First, the major presentations of rosacea appear to be inflammatory dermatoses. Second, the presence of a microbial organism is not a primary or mandatory component of the pathogenesis of rosacea. Available therapies for rosacea exhibit reported modes of action that appear to correlate with the inhibition of inflammatory processes involved in the pathophysiology of at least some presentations of rosacea.
J Drugs Dermatol.2012;11(6):694-700.
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.
Pilot Evaluation of a Novel Topical Formulation Containing High Level, Cholesterol-Dominant, Physiological Lipids for Specific Targeting of Skin Barrier Deficits in Aging Skin
Hema Sundaram MD,a Ana Du BS,b Margarita Yatskayer MS,b Stephen Lynch PhD,b Yevgeniy Krol,c and Christian Oresajo PhDb| |
Leon H. Kircik MD| |
Deborah S. Sarnoff MD| |
Leon H. Kircik MD| |
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.
Over-the-Counter Product Role in the Daily Management of Atopic Dermatitis: Achieving Success With Advanced Technology
Leon H. Kircik MD| |
Leon H. Kircik MD| |
Resident Rounds is a section of the JDD dedicated to highlighting various dermatology departments with residency training programs. Resident Rounds includes three sections: (1) a program spotlight, highlighting pertinent information about the department and residency training program; (2) a section presenting study materials used by residents at the program; and (3) a section designed to highlight recent interesting cases seen at the institution. This issue of Resident Rounds features the Henry Ford Hospital Department of Dermatology Residency Training Program. The editor of Resident Rounds is Omar A. Ibrahimi MD PhD. He is currently the Director of Cutaneous Laser and Cosmetic Surgery and a Mohs surgeon at the University of Connecticut. Dr. Ibrahimi is also a Visiting Scientist at the Wellman Center for Photomedicine at Massachusetts General Hospital/Harvard Medical School. If you are interested in highlighting your training program in a future issue, please contact Dr. Ibrahimi at OIbrahimi@jddonline.com.
Fran E. Cook-Bolden MD| |
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.
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| |
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.
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.
Halobetasol Propionate Lotion, 0.05% Provides Superior Hydration Compared to Halobetasol Propionate Cream, 0.05% in a Double-Blinded Study of Occlusivity and Hydration
Gary Grove PhD,a Charles Zerweck PhD,a Tim Houser MS,a Anthony Andrasfay BS,b Bob Gauthier MS,b Charles Holland PhD,b and Daniel Piacquadio MDb| |
J Drugs Dermatol. 2017;16(2):140-144.
Resident Rounds. Part III: Neutrophilic Eccrine Hidradenitis in the Setting of Acute Myelogenous Leukemia Treated With Cytarabine
Darya Shlapak MBA, Kathyrn Kerisit MD, Christine Lin MD, Alun Wang MD PhD, and Brittany Stumpf MD| |
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.
DFD-01, a Novel Medium Potency Betamethasone Dipropionate 0.05% Emollient Spray, Demonstrates Similar Efficacy to Augmented Betamethasone Dipropionate 0.05% Lotion for the Treatment of Moderate Plaque Psoriasis
Joseph F. Fowler Jr. MD,a Adelaide A. Hebert MD,b Jeffrey Sugarman MD PhDc| |
OBJECTIVE: To compare the efficacy and safety of medium potency DFD-01 with super potent augmented betamethasone dipropionate 0.05% lotion (Diprolene) for the topical treatment of moderate plaque psoriasis.
METHODS: Adults with moderate plaque psoriasis (Investigator Global Assessment [IGA]=3; 10–20% BSA) were randomized 2:1:1 to DFD-01, Diprolene, or Vehicle. Products were applied twice daily to affected areas for 14 days. Treatment success was defined as IGA=0 or 1 and ≥2-grade improvement from baseline. IGA and target lesion Total Sign Score (TSS; sum of erythema, scaling, and plaque elevation scores) were assessed at baseline and at days 4, 8, and 15. Adverse events (AEs) were recorded.
RESULTS: 351 subjects with moderate psoriasis were randomized to DFD-01 (n=174), Diprolene (n=90), or Vehicle (n=87). Mean BSA was 13–14%. Treatment success was achieved in 19.0% DFD-01, 18.9% Diprolene, and 2.3% Vehicle (P<0.001 DFD-01 vs Vehicle) at day 15. Treatment success at day 8 was 10% DFD-01, 6.7% Diprolene, and 1.2% Vehicle (P=0.003 DFD-01 vs Vehicle). TSS was significantly reduced with DFD-01 compared with Vehicle at days 4, 8, and 15 (P≤0.006) and compared with Diprolene at day 4 (P=0.010). DFD-01 relieved signs of erythema and scaling earlier than Diprolene or Vehicle, showing significant improvements on day 4 (P≤0.048). All products were well tolerated. Significantly more burning/stinging was reported with Diprolene than DFD-01 (13.6% vs 4.1%, P=0.006).
CONCLUSION: Medium potency DFD-01 was efficacious for the treatment of moderate psoriasis. DFD-01 demonstrated similar efficacy to super potent Diprolene lotion. Results at 4 and 8 days indicate that DFD-01 shows early improvement in some subjects. DFD-01 was well tolerated and had an excellent safety profile.
J Drugs Dermatol. 2016;15(2):154-162.
Treatment of Mild-to-Moderate Chronic Hand Dermatitis With Clobetasol Propionate 0.05% EF Foam: Results From an Open-Label Study
Leon H. Kircik MDa,b and Cathy Tropmann RPhc| |
Objective: To assess the safety and efficacy of clobetasol propionate 0.05% emulsion formulation (EF) foam in subjects with mild-to-moderate chronic hand dermatitis.
Methods: This was a single-center, open-label pilot study of 30 adults with chronic hand dermatitis. Subjects were treated with clobetasol propionate 0.05% EF foam twice-daily and returned for assessment at day 8 and day 15. The primary efficacy endpoint was the proportion of subjects who achieved treatment success, defined as improvement of ≥1 grade in their chronic hand dermatitis as per the Investigator's Static Global Assessment (ISGA) from baseline to day 15. Safety and quality-of-life measures were also assessed.
Results: A minimum 1-grade improvement in the ISGA was achieved by 96.7 percent (29/30) of subjects at day 15, with 80 percent (24/30) of subjects achieving a score of 0 (clear) or 1 (almost clear). Clobetasol propionate 0.05% EF foam appeared to be safe and well-tolerated, with only four subjects experiencing treatment-related adverse events. No pattern of adverse event occurrence or predisposition could be delineated from this study.
Conclusion: Clobetasol propionate 0.05% EF foam appeared to be safe and effective for the treatment of chronic hand dermatitis.
J Drugs Dermatol. 2011;10(12):1398-1402.
J Drugs Dermatol. 2012;11(4):528-529.
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.
Thomas Lee MD, Julia Schwartz MD| |
Brandon L. Adler BA and Adam J. Friedman MD| |
Helena A. Jenkinson MD,a Alan E. Siroy MD MPH,b Adrienne Choksi MDc| |
J Drugs Dermatol. 2017;16(10):1050-1052.
Charlene Lam MD MPH, Jeffery J. Miller MD MBA, and Joslyn S. Kirby MD| |
Del Rosso, J.Q.| |
Gunilla Carlsson Thorn MD, Shatil Amin MD, and Jonathan Cotliar MD| |
Leon Kircik MD,a,b,c Mark G. Lebwohl MD,c James Q. Del Rosso DO,d
Jerry Bagel MD,eLinda Stein Gold MD,f Jonathan S. Weiss MDg
In both Phase 3 studies, a statistically significantly greater percentage of subjects in the desoximetasone spray 0.25% compared to vehicle group achieved both Clinical Success and Treatment Success at Day 28. These results, which were the primary efficacy variables, demonstrated superior efficacy in the active study group for both overall improvement of plaque psoriasis (by PGA) and in the individual psoriasis lesion (by TLSS) designated at baseline as the most severely involved plaque (target lesion). Assessment of secondary efficacy variables in both Phase 3 studies showed that subjects receiving desoximetasone Spray 0.25% twice daily exhibited statistically significantly mean changes from Baseline to Day 28 in PGA, TLSS, and % BSA affected when compared to subjects receiving vehicle spray twice daily.
Tolerability and safety were assessed at all study visits. No statistically significant differences were observed between study arms and no major safety signals related to AEs were noted. No stinging and burning were reported with the spray formulation. This Class I topical corticosteroid has shown to be safe and efficacious in moderate to severe plaque psoriasis.
J Drugs Dermatol. 2013;12(12):1404-1410.
Elizabeth Lazaridou MD PhD, Christina Fotiadou MD, Christina Giannopoulou MD, Demetrios Ioannides MD PhD| |
The painful, erythematous and eroded vulva often proves to be a diagnostic problem both clinically and histologically. Its differential diagnosis includes both non-neoplastic and neoplastic diseases like Bowen's disease and squamous cell carcinoma (SCC). We report the case of a 62-year-old woman diagnosed, after considerable delay, with Bowen's disease of the vulva that eventually progressed to invasive SCC, despite the treatment with imiquimod 5% cream. Our case indicates, on one hand, that dermoscopy could contribute to the accuracy of the pre-operative clinical diagnosis. On the other hand it confirms the fact that treatment of Bowen's disease of the vulva could be rather intriguing. Although imiquimod 5% cream is an effective, non-invasive treatment option for large lesions or poor healing sites, it should be administered with great consideration in carefully selected cases.
J Drugs Dermatol. 2012;11(1):110-112.
Paola Machado Gomes Esteves MD, Marcella Gramigna Magalhaes Barbalho MD, Julia Gomes Cortes MD, Tullia Cuzzi MD PhD, Celso Tavares Sodré MD, and Marcia Ramos-e-Silva MD PhD| |
J Drugs Dermatol. 2015;14(10):1152-1154.
Long-Term Etanercept Use for Severe Generalized Psoriasis in an HIV-Infected Individual: A Case Study
J Drugs Dermatol. 2012;11(3):413-414.
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
News, Views, and Reviews. Cutaneous Hyperandrogenism: Role of AntiandrogenTherapy in Acne, Hirsutism, and Androgenetic Alopecia
Aimee Krausz BA and Adam J. Friedman MD| |
Olha Ilnytska PhD, Simarna Kaur PhD, Suhyoun Chon PhD, Kurt A. Reynertson PhD, Judith Nebus MBA,
Michelle Garay MS, Khalid Mahmood PhD, and Michael D. Southall PhD
J Drugs Dermatol. 2016;15(6):684-690.
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.
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.
Two Multicenter, Randomized, Double-Blind, Parallel Group Comparison Studies of a Novel Enhanced Lotion Formulation of Halobetasol Propionate, 0.05% Versus Its Vehicle in Adult Subjects With Plaque Psoriasis
David Pariser MD,a Michael Bukhalo MD,b Scott Guenthner MD,c Steven Kempers MD,d Stephen Shideler MD,e Linda Stein Gold MD,f Eduardo Tschen MD MBA,g Jim Berg,h Mary Beth Ferdon PhD,h and Syd Dromgoole PhDh| |
BACKGROUND: A novel lotion formulation of halobetasol propionate, 0.05% (HBP Lotion) with enhanced vehicle characteristics of a cream while preserving the ease of use and cosmetic elegance of a lotion has been developed to treat plaque psoriasis. OBJECTIVE: Determine the safety and effectiveness of HBP Lotion in patients with plaque psoriasis. METHODS: Two prospective, randomized, vehicle-controlled clinical studies were conducted in 443 adult subjects with moderate-severe plaque psoriasis. Subjects applied the test article to psoriatic plaques within the treatment area twice daily for 14 days. Efficacy data are based upon treatment “success” defined as those subjects that achieved scores of 0=clear or 1=almost clear with at least a two-grade improvement relative to baseline for an Investigator’s Global Assessment (IGA) and clinical signs (plaque elevation, erythema, scaling). Safety data are presented as adverse events and local skin reactions. RESULTS: After two weeks of treatment with HBP Lotion, 44.5% of the HBP Lotion treated subjects in each study achieved (a) treatment “success” (ie, an IGA score of 0=clear or 1=almost clear and >2 grade improvement compared to baseline) and (b) a notable reduction in plaque elevation, erythema, scaling, and pruritus. In contrast, only 6.3% and 7.1% of VEH subjects in Studies 1 and 2, respectively, achieved treatment success and the reduction of disease related signs was materially lower. Statistically, at day 15 in both Phase 3 studies, treatment success with HBP Lotion was superior to VEH (P less than 0.001). From a safety perspective the outcomes were in general unremarkable with similar findings in the HBP Lotion and VEH treatment groups. CONCLUSIONS: The results demonstrate the safety and effectiveness of HBP Lotion in the treatment of plaque psoriasis. Furthermore, this novel HBP lotion formulation is also distinguished by its moisturization qualities and ease of use.
J Drugs Dermatol. 2017;16(3):234-240.
Rosacea Fulminans With Extrafacial Lesions in an Elderly Man: Successful Treatment With Subantimicrobial-Dose Doxycycline
Lauren A. Smith MD, Shane A. Meehan MD, and David E. Cohen MD MPH| |
J Drugs Dermatol. 2014;13(6):763-765.
Lichenoid Drug Reaction Following Influenza Vaccination in an HIV-Positive Patient: A Case Report and Literature Review
Emily W. de Golian MD,a Christina B. Brennan MD,b and Loretta S. Davis MDb| |
J Drugs Dermatol. 2014;13(7):873-875.
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.
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.
Magdalene A. Dohil MD| |
J Drugs Dermatol. 2013;12(suppl 9):s128-s132.
Rapid Onset of Action in Patients With Moderate-to-Severe Plaque Psoriasis With Halobetasol 0.01%/Tazarotene 0.045% Fixed Combination
Linda Stein Gold MD,a Leon H. Kircik MD,b David Pariser MD,c Jeffrey L. Sugarman MD PhD,d Tina Lin PharmD,e Robert Kang MS,f Radhakrishnan Pillai PhDg| |
Pollution as a Risk Factor for the Development of Melasma and Other Skin Disorders of Facial Hyperpigmentation ‑ Is There a Case to Be Made?
Wendy E. Roberts MD FAAD| |
J Drugs Dermatol. 2015;14(4):337-341.
Reproducible Novel Transcriptional Differences Between Psoriatic Lesional and Non-Lesional Skin Show Increased Inflammation and Metabolism
Daniel J. Aires MD JD,a Graham Rockwell PhD,b Alan Menter MD,c Colton Nielson,d Jo Wick PhD,e Stephanie Sedivy MD,f Ossamma Tawfik MD PhD,g Anne Bowcock PhD,h and Animesh A. Sinha MD PhDi| |
OBJECTIVE: To reproducibly assess single-gene transcriptional changes in psoriatic skin.
METHODS: We evaluated 210 top candidate genes from a first psoriasis study group (population 1), and then confirmed differential expression in a second independent psoriasis study group (population 2).
RESULTS: One hundred and thirty-eight differentially expressed genes were replicated in the 2 studies, of which 57 have not previously been reported as associated with psoriasis. This is significantly greater than the 10 expected false positives. Lesional skin vs uninvolved areas showed inflammatory and cell regulation changes.
CONCLUSION: Previously undescribed psoriasis-associated genes revealed in this study may provide potential future targets for development and assessment of novel therapeutic agents for psoriasis.
J Drugs Dermatol. 2015;14(8):794-800.
Kendra Gail Bergstrom MD| |
James Q. Del Rosso DO FAOCD| |
Background: South Asians represent a rapidly growing part of the U.S. population, increasing 188 percent from 1990 to 2000 (0.27% to 0.78%). Studies investigating the epidemiology of skin disorders in South Asian Americans are lacking.
Objective: We sought to determine common skin conditions and concerns among this population.
Methods: This was a community-based survey study. The IRB-approved survey tool was distributed to South Asians adults in the New York City area. All data was self-reported.
Results: 190 surveys were completed. 54 percent of responders were female and 46 percent were male. The age of participants ranged from 18-74 years. The respondents were predominantly foreign born (76%), but a large minority (32%) reported living in the U.S. for over 20 years. Nearly half (49%) of the study population reported having visited a dermatologist in the past. The five most common dermatologic diagnoses included: acne (37%), eczema (22%), fungal infection (11%), warts (8%) and moles (8%). The five most common concerns included: dry skin (25%), hair loss (22%), uneven tone (21%), dark spots (18%) and acne (17%).
Conclusions: Our results suggest that the leading skin conditions and concerns in South Asian Americans are similar to those reported in other populations with skin of color.
J Drugs Dermatol. 2011;10(5):524-528.
Salicylic Acid 6% in an Ammonium Lactate Emollient Foam Vehicle in the Treatment of Mild-to-Moderate Scalp Psoriasis
Leon Kircik MD| |
J Drugs Dermatol. 2011;10(3):270-273.
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.
Whitney P. Bowe MD| |
J Drugs Dermatol. 2014;13(suppl 6):s66-s70.
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.
A Method for Maintaining the Clinical Results of 4% Hydroquinone and 0.025% Tretinoin With a Cosmeceutical Formulation
Zoe Diana Draelos MD,a Susana Raab BS,b Margarita Yatskayer MS,b Nannan Chen PhD,b
Yevgeniy Krol BS,c and Christian Oresajo PhDb
J Drugs Dermatol. 2015;14(4):386-390.
Psoriasis and Cardiometabolic Disease: A Brief, Focused, Educational Intervention on Cardiometabolic Risks
Courtney J. Burnett BS, Dennis P. West PhD, Alfred W. Rademaker PhD, and Roopal V. Kundu MD| |
J Drugs Dermatol. 2016;15(10):1176-1180.
Tina Bhutani MD, Kristine B. Zitelli MD, John Koo MD| |
Psoriasis is a chronic disease that exists in two phases: (1) the acute, flaring phase when psoriasis is highly inflamed, erythematous and pruritic and (2) the chronic, indolent phase after the acute manifestations are brought under control. Ideal therapies for psoriasis must focus on both of these phases. Therefore, a rapid and effective agent must be utilized to treat the acute phase, followed by safe long-term therapy for maintenance. This article proposes a new, effective sequential topical therapy for psoriasis using ongoing treatment with clobetasol (Clobex®) spray for one month followed by calcitriol (Vectical®) ointment for the next month. This strategy provides a highly effective, reliable and safe treatment option with minimal local and systemic adverse risks.
J Drugs Dermatol. 2011;10(8):831-834.
J Drugs Dermatol. 2012;11(3):385-389.
J Drugs Dermatol. 2012;11(2):252-255.
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.
Minocycline Pigmentation Following Carbon Dioxide Laser Resurfacing: Treatment With the Q-switched Nd:YAG Laser
Eric F. Bernstein MD MSE,a Caroline Koblenzer MD,b and Rosalie Elenitsas MDc| |
J Drugs Dermatol. 2015;14(4):411-414.
Pimecrolimus Cream and Tacrolimus Ointment in the Treatment of Atopic Dermatitis: A Pilot Study on Patient Preference
Neh Onumah MDa and Leon Kircik MDb,c| |
J Drugs Dermatol. 2013;12(10):1145-1148.
A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy of a Citrus Bioflavanoid Blend in the Treatment of Senile Purpura
Background: Senile purpura is a common, chronic skin condition affecting more than 10 percent of individuals over the age of 50.
Despite being a benign condition, the continual development of purpura lesions in afflicted patients is frequently a source of significant
visual and social concern. To date, there are no known effective treatments for this condition.
Objectives: To evaluate the efficacy of a novel nutraceutical citrus bioflavonoid blend in improving the skin's appearance in patients with senile purpura.
Methods: A six-week, randomized, multicenter, placebo-controlled, double-blind study was conducted to determine whether a uniquely formulated, oral citrus bioflavonoid supplement could treat active lesions of senile purpura while preventing new lesions from arising. Seventy patients with senile purpura were enrolled and 67 completed the study. Subjects were randomized into two groups receiving either a citrus bioflavonoid blend or placebo medication, which was taken orally twice daily for six weeks. Clinical evaluations were performed by blinded investigators at two locations.
Results: A statistically significant reduction in the number of new purpura lesions in the skin area undergoing clinical study was documented. At the end of six weeks, the citrus bioflavonoid blend treated group showed a 50 percent reduction in purpura lesions from baseline. Patient self-assessment of the effectiveness of the medication echoed the results of an investigator global assessment with a statistically significant improvement in the skin's appearance noted by the patients receiving the active medication. No adverse effects were noted by either the patients or investigators.
Conclusion: This new treatment appears to both safely and effectively diminish skin bruising in patients with senile purpura.
J Drugs Dermatol.2011;10(7):718-722.
Adam J. Luber BA, Shaheen H. Ensanyat BS, and Joshua A. Zeichner MD| |
J Drugs Dermatol. 2014;13(2):130-134.
Brian Robert Keegan MD PhD| |
To qualify for inclusion, subjects were required to have a clinical diagnosis of stable plaque psoriasis involving ≥10% of the body surface area (BSA), a combined target lesion severity score (TLSS) of ≥7 for the target lesion, a plaque elevation score of ≥3 (moderate) for the target lesion, and a Physician Global Assessment (PGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity.
At the baseline visit, the mean proportions of BSA affected by psoriasis were 17% (range 10% to 86%) in the desoximetasone 0.25% spray group and 16% (range 10% to 70%) in the vehicle spray group. Approximately 90% of the patients in each group had moderate to very severe scaling at baseline. Desoximetasone 0.25% spray was effective with significant improvements in overall severity and was well tolerated, with dryness, irritation, and pruritus at the application site being the only reported adverse events occurring in >1% of patients, each of which occurred in less than 3% of patients.
As a large proportion of psoriasis patients (94%) have reported being bothered by scaling, the relief of scaling was examined in these studies. At week 1, 69.7% of patients on desoximetasone 0.25% spray had scaling that was considered clear / almost clear / mild compared with 48.3% for those on vehicle spray (P= .0027). By week 4, the proportion of patients with clear / almost clear / mild scaling had risen to 83.9% in the desoximetasone 0.25% spray group (P < .0001). After four weeks of treatment, 66.4% of patients in the topical corticosteroid group had an overall improvement of at least two grades of disease severity. This demonstrates that desoximetasone 0.25% spray provided fast and effective relief of scaling in patients with plaque psoriasis affecting 10% to 86% of their BSA.
J Drugs Dermatol. 2015;14(8):835-840.
Joshua Zeichner MDa and Sophie Seite PhDb| |
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A Double-Blind, Placebo-Controlled Pilot Study to Estimate the Efficacy and Tolerability of a Nonsteroidal Cream for the Treatment of Cradle Cap (Seborrheic Dermatitis)
Elmer David MD,a Hanan Tanuos MD,a Timothy Sullivan MD,b Albert Yan MD,c and Leon H. Kircik MDd-f| |
J Drugs Dermatol. 2013;12(4):448-452.
Jessica El-Kehdy MD,a Eckart Haneke MD,b and Paula G. Karam MDc| |
J Drugs Dermatol. 2013;12(2):228-230.
An Open-label Study of the Safety and Efficacy of Sertaconazole Nitrate in the Treatment of Seborrheic Dermatitis
Boni E. Elewski MD and Wendy C. Cantrell CRNP| |
Design: Single-center, open-label study.
Setting: One academic medical center.
Participants: Twenty adult male and female subjects aged 22 to 85 years (average, 56 years) with mild-to-severe seborrheic dermatitis of the face.
Measurements: The primary efficacy evaluation was the proportion of subjects with a score of 0 or 1 at the end of treatment (week 4) on the Investigator's Static Global Assessment scale. Secondary end points included percent change from baseline to week 4 in sum individual scores of erythema, scaling, induration, and pruritus at a preselected target lesion. Other end points included change in scores on Subject's Global Assessment scale and the Dermatology Life Quality Index.
Results: Success on the primary end point was achieved by 10 of 17 evaluable subjects (58.8%). Improvements in Investigator's Static Global Assessment score from baseline were statistically significant at each week. Significant improvements were also demonstrated in erythema, scaling, induration, and pruritus at week 4 compared to baseline. Improvement in Subject's Global Assessment scores compared to baseline were significant only at week 1 (P=0.031). Change in total mean SD Dermatology Life Quality Index scores from baseline to week 4 was 0.34 (± 0.62, P=0.039).
Conclusion: The results of this preliminary study support the efficacy and safety of sertaconazole nitrate cream, 2%, for the treatment of seborrheic dermatitis.
J Drugs Dermatol. 2011;10(8):898-902.
Ralph C. Daniel MD| |
J Drugs Dermatol. 2013;12(11):1263-1266.
Assessment of Efficacy and Irritation of Ingenol Mebutate Gel 0.015% Used With or Without Dimethicone Lotion for Treatment of Actinic Keratosis on the Face
Shelbi C. Jim On MD, Peter W. Hashim MD, John K. Nia MD, and Mark G. Lebwohl MD| |
Background: Ingenol mebutate gel 0.015% provides high clearance rates for actinic keratosis (AK) on the face and scalp but causes transient local skin responses (LSRs).
Objective: This study sought to determine whether the application of 1% dimethicone would decrease ingenol mebutate–associated LSRs and/or affect efficacy during the treatment of multiple AKs on the face.
Methods: Ingenol mebutate gel 0.015% was applied for 3 days to two 25 cm2 areas, each containing 3 to 8 AKs on the face of each subject, followed by application of 1% dimethicone lotion in an investigator-blinded manner to one randomly selected AK-containing area until LSRs were no longer present.
Results: In total, 20 subjects were enrolled and completed the study. Topical 1% dimethicone lotion applied during and after treatment of facial AK with ingenol mebutate gel 0.015% reduced mean total LSR scores at days 8 and 15 compared with ingenol mebutate gel only, although the difference was not statistically significant. Efficacy was equivalent between the two treatment arms.
Limitations: The study evaluated a relatively small number of subjects, all of whom were white.
Conclusions: The application of 1% dimethicone following ingenol mebutate gel 0.015% produced a trend toward lower severity of some LSRs, with no difference in efficacy.
J Drugs Dermatol. 2017;16(5):432-436.
Fitzpatrick Skin Types and Clindamycin Phosphate 1.2%/Benzoyl Peroxide Gel: Efficacy and Tolerability of Treatment in Moderate to Severe Acne
Background: Acne in skin of color is an increasing problem, presenting unique challenges. Although combination therapy is now standard of care in acne, concerns exist with the increased potential irritation and dryness in skin of color. Although individual medications
can be titrated or applied at different times of the day to minimize irritation, this is not always practical or desirable. There is a paucity of
clinical studies that evaluate the safety and efficacy of acne medications in skin of color.
Methods: A post-hoc analysis of efficacy and cutaneous tolerability in 797 subjects receiving clindamycin phosphate 1.2% benzoyl peroxide (BPO) 2.5% gel from two 12-week, multi-center, double-blind studies that enrolled 2,813 subjects with moderate to severe acne. Efficacy, tolerability, and subject satisfaction in Fitzpatrick skin types I-III subjects were compared to subjects with Fitzpatrick skin types IV-VI.
Results: Median reductions in inflammatory lesions were comparable between the two groups. There was a small difference in non - inflammatory and total lesions in favor of those patients with Fitzpatrick skin types I-III (P=0.013 and P=0.024, respectively). Median reductions in inflammatory, noninflammatory, and total lesions at week 12 were 63%, 50%, and 52.4%, respectively for Fitzpatrick skin types I-III and 65%, 47%, and 51.4%, respectively for Fitzpatrick skin types IV-VI. Treatment success was comparable between the two groups and both groups had a high level of subject satisfaction at week 12. Cutaneous tolerability was excellent, with all mean scores less than or equal to 0.2 at week 12 (where 1=mild). Results in the two groups were comparable, although there was slightly more erythema reported in the Fitzpatrick skin types I-III subjects (0.2 versus 0.1). This could be due to the difficulty in vis ualizing erythema in subjects with darker skin.
Conclusions: Acne subjects with Fitzpatrick skin types IV-VI were not found to be more susceptible to cutaneous irritation from treatment with clindamycin phosphate 1.2%/BPO 2.5% gel and both efficacy and tolerability was comparable across the two treatment groups.
J Drugs Dermatol. 2012;11(5):643-648.
Christina C. Patrone BAa and Larisa J. Geskin MD FAADb| |
Mycosis Fungoides and Sézary Syndrome, the two most common types of Cutaneous T-Cell Lymphoma (CTCL), present many management challenges for dermatologists. Here, we provide a comprehensive review of up-to-date literature, guidelines, and expert clinical insights. We highlight the updates in the World Health Organization Classification of Cutaneous Lymphomas; we summarize the epidemiology, including a recently observed stabilization of increasing incidence of CTCL in the past decade and increased incidence in males, blacks, and veterans; we also provide the most recent updates on prognostic factors for CTCL. Utilization of Next-Generation Sequencing and other novel technologies has shed light on pathogenic mechanisms of CTCL, including immune dysregulation, antigen stimulation, and genomic alterations. CTCL management still remains a significant challenge due to lack of standardization of therapies for every stage of the disease. We provide a straightforward approach to clinical evaluation, diagnostic workup via immunophenotyping and molecular studies, staging guidelines, and select treatment strategies in Mycosis Fungoides and Sézary Syndrome. CTCL patients require individualized, holistic, and multidisciplinary care, for whom addressing management in different skin types and prioritizing quality of life issues are essential.
J Drugs Dermatol. 2017;16(5):405-412.
A Retrospective Study to Investigate Racial and Ethnic Variations in the Treatment of Psoriasis With Etanercept
Objectives: Psoriasis is a chronic inflammatory condition that occurs worldwide; however, few studies have examined this condition in non-Caucasian populations. The purpose of this study was to investigate racial/ethnic differences in demographics, psoriasis severity,
efficacy, safety, and health-related quality of life in patients treated with etanercept using data from the Etanercept Assessment of Safety and Effectiveness (EASE) in Psoriasis trial.
Patients and Methods: This is an investigator-initiated evaluation of data from the EASE study.
Results:The study included 2511 patients (Caucasian n=2164; Hispanic/Latino n=173; African American n=98; Asian n=76). Although baseline Physicians' Global Assessment (PGA) scores were similar, we found significant baseline differences in patient characteristics, prior therapy, percentage of body surface area (%BSA) affected and Dermatology Life Quality Index (DLQI) scores between the groups. At baseline, the Caucasian group had the longest disease duration (19 years), but the lowest percentage of BSA involvement (28%). The Asian group had the highest percentage of BSA involvement (41%). Baseline DLQI score was lowest for Caucasians (12.0) and highest for Hispanic/Latinos (14.6).
At week 12, response to therapy was similar in all ethnic/racial groups. The BSA involvement was reduced by more than 50 percent for all groups, but remained significantly higher for the Asian group (17%) than for the Caucasian (13%; P=0.0105) and African American groups (13%; P=0.0461).
At week 12, the mean Asian DLQI score of 5.2 was significantly higher (worse) than scores for the Caucasian (3.5; P=0.0001) and Hispanic/Latino groups (3.8; P=0.028). For both percentage of BSA and DLQI, differences among racial/ethnic groups in the percentage improvement from baseline were not statistically significant. Adverse event rates were similar for the groups.
Conclusions:Patient characteristics at enrollment differed among ethnic groups, but no significant racial/ethnic differences were found in safety or efficacy of etanercept. However, racial/ethnic differences in the impact of psoriasis on quality of life were observed.
J Drugs Dermatol. 2011;10(8):862-868.
Joy Makdisi BS and Adam Friedman MD FAAD| |
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.
Janna M. Vassantachart MD,a Teo Soleymani MD,b and Jashin J. Wu MD FAADc| |
J Drugs Dermatol. 2016;15(8):995-1000.
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.
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.
Stratum Corneum Abnormalities and Disease-Affected Skin: Strategies for Successful Outcomes in Inflammatory Acne
Laura Jordan DO MS and Hilary E. Baldwin MD b| |
J Drugs Dermatol. 2016;15(10):1170-1173.
Gita Faghihi MD,a Parastoo Khosravani MD,a Mohammad Ali Nilforoushzadeh MD,a,b Sayyed Mohsen
Hosseini PhD,a Fatemeh Assaf MD,a Naser Zeinali MD,a and Abbas Smiley MD MScc
METHODS: In a double-blind randomized clinical trial, 56 adult patients with papulopustular rosacea were enrolled. The severity of disorder was determined by the patient according to visual analogue score (VAS). Investigator’s global assessment (IGA) scores and number of inflammatory lesions were recorded. 5% dapsone gel was administered for group D and 0.75% metronidazole gel was administered for group M. Systemic doxycycline was administered for all patients. Follow-up assessments were done at 4, 8, and 12 weeks. Changes in VAS, IGA scores and number of lesions were evaluated. Intention to treat analysis was carried out using SPSS version 17 (Chicago, IL).
RESULTS: There was no significant difference in sex and age distribution between the two groups. Mean (SD) IGA score before and after intervention in group D was 3.9 (0.9) and 3.3 (0.9), respectively (P<0.0001). Mean (SD) IGA score before and after intervention in group M was 4.2 (1.2) and 3.6 (1.3), respectively (P<0.0001). Mean (SD) number of lesions before and after intervention in group D was 15 (7.4) and 11.1 (6), respectively (P<0.0001). Mean (SD) number of lesions before and after intervention in group M was 17.6 (7.7) and 12.5 (7.4), respectively (P<0.0001). Mean (SD) VAS score before and after intervention in group D was 6.6 (1.8) and 5.7 (1.9), respectively (P<0.0001). Mean (SD) VAS score before and after intervention in group M was 6.9 (2.0) and 5.3 (2.1), respectively (P<0.0001). Mean IGA score, mean number of lesions and mean VAS score were not significantly different between the two groups, whether before, during or after intervention.
CONCLUSION: Dapsone gel was as effective as metronidazole gel in the treatment of papulopustular rosacea.
J Drugs Dermatol. 2015;14(6):602-606.
Stephanie J. Kang DO,a Scott A. Davis MA,a Steven R. Feldman MD PhD,a,b,c and Amy J. McMichael MDa| |
OBJECTIVE: To determine whether racial or ethnic groups are treated differently for dyschromia. The secondary objective is to discover the main treatments used and determine trends over time in demographics.
METHODS: We searched the 1993-2010 National Ambulatory Medical Care Survey (NAMCS) for visits associated with a diagnosis of dyschromia (ICD-9 codes 709.00 or 709.09). The demographics and leading treatments were tabulated, and trends over time were assessed by linear regression.
RESULTS: There were about 24.7 million visits for dyschromia over the 18-year period. Among 5,531,000 patients with the sole diagnosis of dyschromia, there were 2,800 visits from females and 1,200 visits from males per 100,000 population. Females were more likely to receive prescription combination therapy for dyschromia than males by a ratio of 10 to 1. Leading treatments overall prescribed by dermatologists included hydroquinone, topical corticosteroids, and retinoids. Asians were 27% more likely to receive a combination therapy than non-Asians. African Americans and Hispanics were less likely to have a procedure performed for dyschromia.
LIMITATIONS: Data are based on a number of ambulatory care visits, which does not allow direct estimation of prevalence.
CONCLUSIONS: Dyschromia is a significant concern for many patients, and this is especially true among patients of color. Treatment for dyschromia is influenced by skin type, and thus ethnic or racial groups are treated differently. Studies have shown that combination therapy may offer better results than a single medication for hyperpigmentation disorders. Combination agents may be underutilized in African Americans and Hispanics for dyschromia.
J Drugs Dermatol. 2014;13(4):401-406.
Investigator-Blinded, Single-Center Study to Evaluate the Efficacy and Tolerability of a 4% Hydroquinone Skin Care System Plus 0.02% Tretinoin Cream in Mild-to-Moderate Melasma and Photodamage
Marta Rendon MD FAADa and Laurence Dryer PhDb| |
METHODS: Single-center, investigator-blinded study in 39 adult females with mild-to-moderate epidermal melasma, mild-to-marked pigmentation intensity, and Fitzpatrick skin type III to VI treated for 24 weeks. Improvements in melasma severity, pigmentation intensity, photodamage, and patient satisfaction were assessed at weeks 4, 8, 12, 18, and 24. Cutaneous tolerability was assessed by investigator (erythema, dryness, peeling) and patients (burning and stinging). Adverse events (AEs) were monitored throughout.
RESULTS: Melasma severity, pigmentation intensity, and melasma area and severity index (MASI) scores relative to baseline were all significantly reduced from week 4 onward (P<.001). In addition, signs of facial photodamage were significantly improved. At week 24, 87.9% of patients were “satisfied” or “very satisfied” with the overall treatment effectiveness and Quality of Life (QoL) was much improved. No patient discontinued due to lack of efficacy or treatment-related AEs. One patient (2.8%) reported severe cutaneous intolerability (erythema at week 4).
CONCLUSION: Treating mild-to-moderate melasma using a 4% hydroquinone skin care system plus 0.02% tretinoin cream can significantly reduce the severity and intensity of melasma and associated pigmentation, and improve signs of photodamage within four weeks. Treatment was generally well tolerated and associated with high levels of patient satisfaction.
J Drugs Dermatol. 2016;15(4):466-475.
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| |
Leon H. Kircik, MD| |
J Drugs Dermatol. 2012;11(10):1158-1165.
J Drugs Dermatol. 2012;11(8):979-987.
Efficacy of Low-Fluence Nd:YAG 1064 nm Laser for the Treatment of Post-Inflammatory Hyperpigmentation in the Axillary Area
Sahar Ghannam MD PhD,a,b Fatemah K. Al Otabi,c Konstantin Frank,d and Sebastian Cotofana MD PhDe| |
OBJECTIVE: Post-inflammatory hyperpigmentation results in aesthetically unpleasant discoloration of the skin in the affected area. The efficacy of low-fluence Q-switched 1064-nm Nd:YAG laser has so far not been evaluated for the treatment of the axilla. This observational study was designed to evaluate whether the application of the laser treatment can satisfactorily reduce axillary hyperpigmentation. MATERIAL AND METHODS: 17 females (mean age, 34.27 ± 9.24; range, 19–48) were treated in a single center between 2014 and 2016 for post-inflammatory hyperpigmentation of the axillary area. One treatment session was done every 2 weeks. Pairwise pre- / post-treatment assessment was graded by the practitioner, the patient, and an independent non-medical observer for consistency using a standardized grading scale. RESULTS: Post-treatment evaluation revealed an improvement score of 4 ± 0.44; range, 4–5 (good improvement) with a variance of 0.19 after the treatment. The scoring of the practitioner rs= 0.31 correlated higher with the patient-related outcome than with the scoring of the independent non-medical observer rs= 0.17. The minimum number of sessions needed for an excellent patient-evaluated improvement was 3, but an increased number of sessions was not significantly correlated with the outcome. The results of the treatment lasted for at least 6 months after the last session. CONCLUSION: A low-fluence Q-switched 1064-nm Nd:YAG laser provided safe and effective treatment for post-inflammatory hyperpigmentation in the axillary area, with good-to-excellent improvement after a minimum of 3 sessions.
J Drugs Dermatol. 2017;16(11):1118-1123.
Moderate to Severe Acne in Adolescents With Skin of Color: Benefits of a Fixed Combination Clindamycin Phosphate 1.2% and Benzoyl Peroxide 2.5% Aqueous Gel
Objective: Acne is common in adolescents and especially difficult to manage in people with color. A fixed combination of clindamycin
phosphate and benzoyl peroxide (BPO) (clindamycin phosphate 1.2%/BPO 2.5% gel) was evaluated to determine its utility in treating
moderate to severe acne in adolescents with skin of color.
Methods: Three hundred thirty-seven adolescent acne subjects (aged 12 to <18 years) with skin of color were evaluated from 2 multicenter, double-blind studies. Subjects were randomized to receive clindamycin phosphate 1.2%/BPO 2.5% gel or vehicle, once daily for 12 weeks. Efficacy and tolerability were evaluated. Data were compared with an adolescent (A) and skin of color (B) cohort from the same pivotal study enrolling 2,813 subjects.
Results: Superior mean percent reductions in inflammatory, noninflammatory, and total lesion counts were observed in subjects receiving clindamycin phosphate 1.2%/BPO 2.5% gel compared to vehicle. At week 12, clindamycin phosphate 1.2%/BPO 2.5% gel showed similar lesion reduction compared to groups A and B (P<0.001). Treatment success with clindamycin phosphate 1.2%/BPO 2.5% gel, assessed by investigator and subject, was superior to vehicle and comparable to that seen in groups A and B (P<0.001). Clindamycin phosphate 1.2%/ BPO 2.5% gel was associated with a low incidence of treatment-related AEs and a favorable cutaneous tolerability profile.
Conclusions: Clindamycin phosphate 1.2%/BPO 2.5% gel has been shown to be effective, safe, and well tolerated in moderate to severe acne in adolescents with skin of color.
J Drugs Dermatol. 2012;11(7):818-824.
Jeffrey M. Weinberg MDa and Evelyn K. Koestenblatt MS MTa| |
The treatment of cutaneous fungal infections has been shown to be directly affected by the extent of patients' adherence to therapy regimens that are often cumbersome and last for several weeks. One useful alternative approach is once-daily dosing of topical antifungal agents rather than the traditional twice-daily regimen, an example of what has been called a “forgiving” regimen, designed to promote patient adherence. Sertaconazole, an imidazole antifungal agent, is known to be safe and effective when used twice daily in the treatment of tinea pedis. This report discusses a small (n=32) clinical trial designed to determine whether sertaconazole nitrate 2% cream, used once daily, is as effective as the traditional regimen. Results demonstrated that sertaconazole is as effective when used once daily for four weeks. Patients showed rapid improvement in pruritus as early as week 2, and at six weeks' follow up, all patients were free of erythema while 93.8 percent were free of pruritus; no relapses had occurred. These encouraging findings suggest that sertaconazole nitrate may be useful in a once-daily regimen and also may result in better patient adherence to therapy.
J Drugs Dermatol. 2011;10(10):1135-1140.
Andrew F. Alexis MD MPH,a Fran E. Cook-Bolden MD,b and J.P. York PhDc| |
BACKGROUND: Acne affects individuals of all races and ethnicities; however, lighter and darker skin phototypes face different treatment challenges that may affect treatment response and tolerability. This analysis investigated possible differences in the efficacy and safety of the fixed dose combination of 0.3% adapalene with 2.5% benzoyl peroxide (A/BPO gel 0.3%/2.5%) in subjects with Fitzpatrick Skin Types (FST) I–VI.
METHODS: This was a post-hoc analysis of a Phase 3, multicenter, randomized, double-blind, parallel-group study of moderate to severe acne in subjects with FST I-VI. Subjects received A/BPO gel 0.3%/2.5%, A/BPO gel 0.1%/2.5% (benchmark), or vehicle, once daily for 12 weeks. Efficacy measurements included success rate (IGA of Clear or Almost Clear), change in inflammatory and noninflammatory lesions from baseline to week 12, safety, and tolerability. The intent to treat (ITT) and safety populations were analyzed. Demographics and disposition were analyzed with descriptive statistics; categorical variables by frequency and percentage; and continuous variables with means, medians, minimum, maximum, and standard deviations.
RESULTS: The A/BPO gel 0.3%/2.5% treatment group included 128 subjects with FST I-III, and 89 subjects with FST IV-VI. At week 12, A/BPO gel 0.3%/2.5% was safe, tolerable, and significantly superior to vehicle for all FST and severity groups in inflammatory and noninflammatory lesion reduction (P less than equal to .05). Compared to baseline, 32% of subjects with FST I-III were clear or almost clear, compared to 7% in the vehicle group (P=.001). In FST IV–VI, 28% of subjects were clear or almost clear, compared to 15% for vehicle (P=NS). In all treatment groups and skin phototypes, week 12 tolerability scores were similar to baseline scores, and tolerability scores for most subjects of all skin phototypes were “none” or “mild” for all measures.
SUMMARY: We report that the fixed dose combination of A/BPO gel 0.3%/2.5% is efficacious and safe in patients with FST I-VI with moderate and severe inflammatory acne.
Clinicaltrials.gov registry: NCT01880320
J Drugs Dermatol. 2017;16(6):574-581.
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.
Wallace Nozile MS, Cheri N. Adgerson MD, and George F. Cohen MD| |
J Drugs Dermatol. 2015;14(4):343-349.
Anti-Inflammatory Activities of Colloidal Oatmeal (Avena sativa) Contribute to the Effectiveness of Oats in Treatment of Itch Associated With Dry, Irritated Skin
Kurt A. Reynertson PhD, Michelle Garay MS, Judith Nebus MBA, Suhyoun Chon PhD, Simarna Kaur PhD,
Khalid Mahmood PhD, Menas Kizoulis BA, Michael D. Southall PhD
METHODS: Four extracts of colloidal oatmeal were made with various solvents and tested in anti-inflammatory and antioxidant assays. In addition, an investigator blind study was performed with twenty-nine healthy female subjects who exhibited bilateral mild to moderate itch with moderate to severe dry skin on their lower legs. Subjects were treated with a colloidal oatmeal skin protectant lotion.
RESULTS: Extracts of colloidal oatmeal diminished pro-inflammatory cytokines in vitro and the colloidal oat skin protectant lotion showed significant clinical improvements in skin dryness, scaling, roughness, and itch intensity.
CONCLUSIONS: These results demonstrate that colloidal oat extracts exhibit direct anti-oxidant and anti-inflammatory activities, which may provide the mechanisms for observed dermatological benefits while using the colloidal oatmeal skin protectant lotion.
J Drugs Dermatol. 2015;14(1):43-48.
Comparative Trial of 5% Dexpanthenol in Water-in-Oil Formulation With 1% Hydrocortisone Ointment in the Treatment of Childhood Atopic Dermatitis: A Pilot Study
Objective: To compare the effectiveness of 5% dexpanthenol (DT) ointment with 1% hydrocortisone (HC) ointment in childhood AD therapy.
Method: Patients were treated topically with 5% DT ointment on the right side of the body and 1% HC ointment on the other side twice daily for 4 weeks. The clinical responses were evaluated by SCORAD (Scoring Atopic Dermatitis index) with statistical analysis using paired t-test.
Result: Of the 30 children enrolled, 26 completed the protocol; mean age was 7.19 years. The average baseline SCORAD score of the DT-treated side and the HC-treated side was 30.95 and 30.54, respectively. There was no statistically significant difference in SCORAD score reduction between the 2 agents. The edematous score of the HC-treated side exhibited faster resolution than that of the DT-treated side, with a statistically significant difference at week 1 and without a statistically significant difference at weeks 2 to 4. The lichenification response rate of HC treatment was more rapid than that of DT treatment; however, there was no statistical group difference. No adverse events were observed with either agent.
Conclusion: The effectiveness of 5% DT ointment is equal to that of 1% HC ointment. DT ointment may be used as alternative treatment in mild to moderate childhood AD therapy.
J Drugs Dermatol. 2012;11(3):366-374.
Robert A. Swerlick MD aand Caren F. Campbell MD b| |
J Drugs Dermatol. 2013;12(1):99-102.
Effect of Systemic Isotretinoin Therapy on Mucociliary Clearance and Nasal Surface Mucosa in Acne Patients
Zennure Takci MD,a Gulcin Guler Simsek MD,b Hayriye Karabulut MD,c
Yunus Buran MD,c and Ayse Serap Karadag MDd
METHODS: A total of 30 patients with severe or moderate acne were enrolled in this study. The median prescribed dose of isotretinoin was 0.75 mg per kg per day. Clinical and biochemical examinations were carried out periodically. The ST and nasal cytology were performed before treatment and during the third month of therapy.
RESULTS: Of the 30 patients who initially agreed to participate in the research, 21 completed the study (18 female and 3 male, mean ± standard deviation (SD) aged 20.9 ± 4.7 years, range 15-32 years). There was a significant difference between the mucociliary clearance time for subjects in the pre- and post-treatment periods (173.8 ± 89.2 seconds vs 245.2 ± 191.6 seconds, respectively; P=.009). Cytological examination revealed that the squamous cell ratio was significantly lower and the reactive changes of the respiratory epithelium were significantly higher 3 months after isotretinoin therapy than before therapy (P=.010, P=.002, respectively). There were mild signs of inflammation according to the number of neutrophilic leukocytes (8.3% vs 26.6%, P=.06) after 3 months of isotretinoin therapy.
CONCLUSION: Systemic isotretinoin alters the mucociliary transport, decreases the squamous cell ratio, increases the reactive changes in the respiratory epithelium significantly, and increases neutrophils in the nasal surface mucosa in the third month of treatment.
J Drugs Dermatol. 2013;12(8):e124-e128.
Objective: The objective of this study was to determine the role of immunity and inflammation in androgenetic alopecia in women and modulate therapy according to inflammatory and immunoreactant profiles.
Materials and Methods: 52 women with androgenetic alopecia (AA) underwent scalp biopsies for routine light microscopic assessment and direct immunofluroescent studies. In 18 patients, serologic assessment for antibodies to androgen receptor, estrogen receptor and cytokeratin 15 was conducted.
Results: A lymphocytic folliculitis targeting the bulge epithelium was observed in many cases. Thirty-three of 52 female patients had significant deposits of IgM within the epidermal basement membrane zone typically accompanied by components of complement activation. The severity of changes light microscopically were more apparent in the positive immunoreactant group. Biopsies from men with androgenetic alopecia showed a similar pattern of inflammation and immunoreactant deposition. Serologic assessment for antibodies to androgen receptor, estrogen receptor or cytokeratin 15 were negative. Combined modality therapy with minocycline and topical steroids along with red light produced consistent good results in the positive immunoreactant group compared to the negative immunoreactant group.
Conclusion: A lymphocytic microfolliculitis targeting the bulge epithelium along with deposits of epithelial basement membrane zone immunoreactants are frequent findings in androgenetic alopecia and could point toward an immunologically driven trigger. Cases showing a positive immunoreactant profile respond well to combined modality therapy compared to those with a negative result.
J Drugs Dermatol. 2011;10(12):1404-1411.
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.
Mark A. Strom BS,a Girish C. Mohan MD,b and Peter A. Lio MDa| |
Background: Some dermatologic disorders are known to be much more common in patients of color, but the leading dermatologic
disorders in patients of color have not yet been described on the basis of nationally representative data.
Purpose: To determine the leading dermatologic disorders for each major racial and ethnic group in the United States.
Methods: We queried the National Ambulatory Medical Care Survey (NAMCS) for the leading diagnoses in patient visits to U.S. dermatologists from 1993 to 2009. The leading diagnoses were tabulated for each racial and ethnic group, and the top conditions were compared between groups. In a separate analysis, visits for skin conditions regardless of physician specialty were analyzed for leading diagnoses in each racial and ethnic group.
Results: The top five diagnoses for African-American patients in dermatology clinics were acne, unspecified dermatitis or eczema, seborrheic dermatitis, atopic dermatitis, and dyschromia. For Asian or Pacific Islander patients, the top five were acne, unspecified dermatitis or eczema, benign neoplasm of skin, psoriasis, and seborrheic keratosis. By contrast, in Caucasian patients, the top five were actinic keratosis, acne, benign neoplasm of skin, unspecified dermatitis or eczema, and nonmelanoma skin cancer. In Hispanic patients of any race, the leading diagnoses were acne, unspecified dermatitis or eczema, psoriasis, benign neoplasm of skin, and viral warts. When the leading dermatologic diagnoses across all physician specialties were assessed, the top diagnoses for African-Americans were unspecified dermatitis or eczema, acne, dermatophytosis of scalp and beard, sebaceous cyst, and cellulitis or abscess; for Asians or Pacific Islanders were unspecified dermatitis or eczema, acne, atopic dermatitis, urticaria, and psoriasis; and for Caucasians were acne, unspecified dermatitis or eczema, actinic keratosis, viral warts, and sebaceous cyst. For Hispanics of any race, they were unspecified dermatitis or eczema, acne, sebaceous cyst, viral warts, and cellulitis or abscess. For a sole diagnosis of a dermatologic condition, only 28.5% of African-Americans' visits and 23.9% of Hispanics' visits were to dermatologists, as compared to 36.7% for Asians and Pacific Islanders and 43.2% for Caucasians.
Limitations: The data are based on numbers of ambulatory care visits rather than numbers of patients. Data on race or ethnicity were not collected for some patients.
Conclusions: Several dermatologic disorders are much more commonly seen in patients of color. Acne and unspecified dermatitis or eczema are in the top five for all major U.S. racial and ethnic groups. There may be an opportunity to improve the care of patients of color by ensuring they have equal access to dermatologists.
J Drugs Dermatol. 2012;11(4):466-473.
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.
Andrew F. Alexis MD MPH| |
J Drugs Dermatol. 2014;13(suppl 6):s61-s65.
Shawn Shetty MD and A. Razzaque Ahmed MD DSc| |
J Drugs Dermatol. 2013;12(6):672-677.
The Integration of Physiologically-Targeted Skin Care in the Management of Atopic Dermatitis: Focus on the Use of a Cleanser and Moisturizer System Incorporating a Ceramide Precursor, Filaggrin Degradation Products, and Specific “Skin-Barrier–Friendly” Excipients
James Q. Del Rosso DO FAOCDa and Leon H. Kircik MDb| |
J Drugs Dermatol. 2013;12(7 suppl 1):s85-s91
Andrew C. Krakowski MD,a Lawrence F. Eichenfield, MDb| |
James R. Schwartz PhD| |
J Drugs Dermatol. 2016;15(2):140-144.
Efficacy and Safety of Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel Plus Oral Doxycycline in Subjects With Severe Inflammatory Acne Who Are Candidates for Oral Isotretinoin
James Q. Del Rosso DO,a Linda Stein Gold MD,b Sandra Marchese Johnson MD FAAD,c Maria Jose Rueda MD,d Hilary Baldwin MD,e Edward L. Lain MD,f Megan Landis MD,g Marta Rendon MD,8 Emil Tanghetti MD,9 and Jonathan Weiss MD10| |
J Drugs Dermatol. 2018;17(3):264-273.
Julia Schwartz MDa and Adam J. Friedman MDa,b| |
Is Chronic Cutaneous Discoid Lupus Protective Against Severe Renal Disease in Patients With Systemic Lupus Erythematosus?
Joseph F. Merola MD,a Caroline A. Chang MD,b Miguel R. Sanchez MD,c Stephen D. Prystowsky MDc| |
Methods: Over three years, sixteen patients met the diagnostic criteria of discoid lupus, positive anti-nuclear-antibody, and at least one extracutaneous manifestation.
Results: Most patients (14/16) were female, between 26 to 66 years old. Arthritis was the most common extracutaneous manifestation followed by Raynaud's phenomenon. The anti-nuclear-antibody was speckled in ten patients with titers ranging from 1:40 to 1:1280 IU/mL. Elevated levels of double-stranded-DNA in low titers were found in four patients, anti-Smith-antibody in four; anti-Sjogren-syndrome-A-antibody in seven, and anti-ribonucleoprotein-antibody in seven. Renal function markers were transiently high in some patients but normalized over time. Hematuria and/or proteinuria were present at some time in seven patients. The highest BUN and creatinine levels were 42 mg/dL and 1.5 mg/dL, respectively. One patient had membranous glomerulonephropathy class 5; however, discoid lupus developed well after the onset of renal disease during a time when renal function had returned to normal.
Conclusion: Our observational data supports previous reports suggesting that patients with active discoid lupus rarely have progressive renal insufficiency. The mechanism for the development of discoid lupus may involve an immunologic mechanism that differs from that which produces severe organ involvement, especially advanced immune-complex-mediated renal disease. Patients with discoid lupus rarely have sustained high levels of antibodies to double-stranded-DNA. Discoid lupus appears to be a marker for a more benign lupus course. This clinical observation lays the groundwork for a larger prospective, longitudinal cohort study for further validation.
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