Treatment Response With Once-Daily Topical Dapsone Gel, 7.5% for Acne Vulgaris: Subgroup Analysis of Pooled Data from Two Randomized, Double-Blind Stu
June 2017 | Volume 16 | Issue 6 | Original Article | 591 | Copyright © 2017
Zoe Diana Draelos MD,a David A. Rodriguez MD,b Steven E. Kempers MD,c Suzanne Bruce MD,d Marina I. Peredo MD PC,e Jeanine Downie MD,f Joan-En Chang-Lin PhD,g David R. Berk MD,g Shiling Ruan PhD,g and Alexandre Kaoukhov MDg
aDermatology Consulting Services, High Point, NC bDermatology Associates and Research, Coral Gables, FL cAssociated Skin Care Specialists, Fridley, MN dSuzanne Bruce and Associates, PA, Houston, TX ePrivate Practice, Smithtown, NY fImage Dermatology, Montclair, NJ gAllergan plc, Irvine, CA
BACKGROUND: Acne vulgaris has varying physical and psychological effects in men and women of different ages, races, and ethnicities.
OBJECTIVE: This analysis assessed the relationship of age, sex, and race to treatment response with once-daily topical dapsone gel, 7.5%.
METHODS: We conducted a pooled subgroup analysis of 2 randomized, double-blind, vehicle-controlled clinical trials conducted in the US and Canada. The studies included patients with 20 to 50 inflammatory and 30 to 100 noninflammatory facial lesions, and a Global Acne Assessment Score (GAAS) of 3 (moderate). Pooled data (N=4340) were analyzed by age (12–17 and ≥18 years), sex, and race (Caucasian and non-Caucasian) for GAAS success (score of 0 [none] or 1 [minimal]) and mean percent change from baseline in inflammatory, noninflammatory, and total lesion counts. The impact of age and sex on treatment response was examined using multivariate analysis. Adverse events were analyzed by subgroups.
RESULTS: Treatment responses with dapsone gel, 7.5% were greater overall and for all subgroups versus vehicle. GAAS success rates and mean decrease in all lesion counts with dapsone gel, 7.5% were greater in older (aged ≥18 years) versus younger patients, and for females versus males. Treatment response with dapsone gel, 7.5% in racial subgroups was similar. Multivariate analysis showed statistical significance for age group and sex as predictors of GAAS success (P less than equal to .005) and reduction in lesion counts (P less than equal to .025). Adverse events were similar across subgroups.
CONCLUSIONS: Older age (≥18 years) and female sex were predictors of treatment response. These subgroups tended to have greater acne improvement in subgroup comparisons. Caucasian and non-Caucasian patients had similar responses. The safety profile of dapsone gel, 7.5% was similar across subgroups.
J Drugs Dermatol. 2017;16(6):591-598.
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Acne vulgaris is a common condition across racial and ethnic groups.1-4 Although the prevalence is highest in adolescents,4,5 it also affects many adults.4-6 Following adolescence, acne affects substantially more women than men.4,6-8 Acne can have negative effects on self-esteem, quality of life (QOL), and psychological well-being in adolescents and adults, and in Caucasian and non-Caucasian individuals.9-14 Recent studies have focused on specific problems associated with acne in adult females. Women across various races and ethnicities may experience anxiety, depression, and a negative impact on their QOL because of acne.13,14Dapsone gel, 5% (Aczone Gel, 5%; Allergan plc, Dublin, Ireland) is an anti-inflammatory sulfone compound approved for treatment of acne vulgaris.15 Its efficacy has varied in some patient subgroups. A pooled subgroup analysis of two randomized, double-blind, vehicle-controlled trials reported greater improvement in acne with dapsone gel, 5% in females than males.16 A separate subgroup analysis observed that females aged 18 years and older achieved a significantly greater rate (P=.022) of Global Acne Assessment Score (GAAS) success with dapsone gel, 5% than younger females (aged 12–17 years).17 The US Food and Drug Administration approved a reformulated, once-daily dapsone gel (Aczone Gel, 7.5%; Allergan plc).18 which may promote adherence more than twice-daily dosing.15 Two identically designed, pivotal studies of dapsone gel, 7.5%