Efficacy, Safety, and Tolerability of Topical Dapsone Gel, 7.5% for Treatment of Acne Vulgaris by Fitzpatrick Skin Phototype

February 2018 | Volume 17 | Issue 2 | Original Article | 160 | Copyright © 2018

Susan C. Taylor MD,a Fran E. Cook-Bolden MD,b Amy McMichael MD,c Jeanine B. Downie MD,d David A. Rodriguez MD,e Andrew F. Alexis MD MPH,f Valerie D. Callender MD,g and Nancy Alvandi PhDh

aPerelman School of Medicine, University of Pennsylvania, Philadelphia, PA bSkin Specialty Dermatology, New York, NY cWake Forest Baptist Health, Winston-Salem, NC dImage Dermatology, Montclair, NJ eDermatology Associates and Research, Coral Gables, FL fSkin of Color Center, Mount Sinai St. Luke's and Mount Sinai West, Icahn School of Medicine at Mount Sinai, New York, NY gCallender Dermatology and Cosmetic Center, Glenn Dale, MD hAllergan plc, Irvine, CA

Abstract

BACKGROUND: Acne vulgaris (acne) is prevalent in individuals with skin of color, often with more frequent sequelae than in patients with lighter skin color. It is important to determine if there are also differences in response to medications. OBJECTIVE: This study evaluated the efficacy and tolerability of once-daily dapsone gel, 7.5% in patients with acne, stratified by Fitzpatrick skin phototype. METHODS: Data were pooled from 2 identically designed, phase 3, randomized, double-blind, vehicle-controlled studies in patients aged 12 years and older with moderate acne. Patients applied dapsone gel, 7.5% or vehicle once daily for 12 weeks. Efficacy was evaluated using the Global Acne Assessment Score (GAAS), lesion counts, and Acne Symptom and Impact Scale (ASIS); adverse events (AEs) and tolerability were also assessed. RESULTS: This analysis included 2216 patients with skin phototypes I-III and 2111 with types IV-VI. Dapsone gel, 7.5% significantly improved acne severity versus vehicle in both skin phototype subgroups, as determined by the percentage of patients with at least a 1-grade improvement in GAAS and mean change from baseline in GAAS (both, P less than .0001) at week 12 versus baseline. Dapsone gel, 7.5% significantly reduced inflammatory, comedonal, and total lesions in skin phototypes I-III (P less than .001) and IV-VI (P less than equal to .01) versus vehicle. Improvements in inflammatory lesions occurred first, with generally similar patterns of improvement seen over time in GAAS, comedonal lesions, and ASIS domains. The incidence of AEs was similar in both skin phototype subgroups and between study medications. Local scaling, erythema, stinging/burning, and dryness were rated "none" by most patients in both treatment groups and skin phototype subgroups. CONCLUSION: Once-daily dapsone gel, 7.5% was effective, safe, and well tolerated in patients with all skin phototypes who were treated for moderate acne. J Drugs Dermatol. 2018;17(2):160-167.

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INTRODUCTION

Acne vulgaris (acne) is the most common dermatologic diagnosis in the United States from childhood through the age of 44 years, reaching its highest prevalence during adolescence and early adulthood.1 Acne is associated with more frequent sequelae in subjects with skin of color (SOC). In a community-based epidemiologic study,2 acne was prevalent in 37%, 32%, 30%, 24%, and 23% of black, Hispanic, Asian, Caucasian, and Indian women, respectively, and post-inflammatory hyperpigmentation and atrophic scarring was seen more frequently in black and Hispanic women than in those of other races/ethnicities. Racial/ethnic differences regarding the clinical presentation of acne and its impact have also been reported. The same study reported that inflammatory and comedonal lesions were equally prevalent in black, Hispanic, and Indian women; however, in Asian women, inflammatory lesions were more prevalent, and in Caucasian women, comedonal lesions more prevalent. In a separate cross-sectional survey, all racial/ethnic groups reported that acne adversely affected quality of life (QOL) and self-perception, with most participants reporting some anxiety and depression symptoms.3 In general, greater impairments in QOL are associated with greater levels of anxiety and depression in patients with acne.4 The key to improving patients’ QOL, including anxiety and depression, is the effective treatment of their acne.5,6Dapsone, which has anti-inflammatory properties, has been available since 2005 as a topical 5% gel formulation that is applied twice daily for the treatment of acne vulgaris (Aczone 

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