Once-Daily Topical Dapsone Gel, 7.5%: Effective for Acne Vulgaris Regardless of Baseline Lesion Count, With Superior Efficacy in Females

November 2018 | Volume 17 | Issue 11 | Original Article | 1192 | Copyright © November 2018

Emil A. Tanghetti MD,a Julie Harper MD,b Hilary E. Baldwin MD,c Leon H. Kircik MD,d Zhanying Bai MS,e Nancy Alvandi PhDe

aCenter for Dermatology & Laser Surgery, Sacramento, CA bDermatology and Skin Care Center of Birmingham, Birmingham, AL cThe Acne Treatment and Research Center, Morristown, NJ dDermResearch, PLLC, Louisville, KY eAllergan plc, Irvine, CA

INTRODUCTION: Acne vulgaris is more common in females than males and is challenging to treat. A post hoc analysis of 2 clinical trials evaluated the effect of dapsone gel, 7.5% based on sex and baseline acne lesion count. METHODS: Two identically designed, randomized, double-blind, vehicle-controlled, multicenter, 12-week, phase 3 trials enrolled patients aged ≥12 years with facial acne and 20 to 50 inflammatory and 30 to 100 comedonal lesions. Patients applied dapsone gel, 7.5% or vehicle topically once daily for 12 weeks. Baseline to week 12 reductions were evaluated for total, inflammatory, and comedonal lesions in the pooled dapsone population by sex and total baseline acne lesion count (low: 50–74, medium: 75–99, and high: ≥100). RESULTS: The analysis included 2160 patients (56% female, 44% male). Males and females had similar average baseline total, inflammatory, and comedonal lesion counts. Low, medium, and high subgroups experienced efficacy with dapsone gel, 7.5%. Females in each subgroup experienced superior efficacy to males. In females, total lesion counts in the low, medium, and high subgroups decreased by 56.07%, 50.22%, and 47.63%, respectively, compared with 47.95%, 42.30%, and 34.68% in males (P less than 0.001 for each male-female comparison). Females’ respective inflammatory lesion count percentage reductions were 60.96%, 57.91%, and 55.83%, versus 52.75% (P less than 0.001), 46.85% (P less than 0.001), and 44.70% (P=0.008) in males. Females’ respective comedonal lesion count percentage reductions were 52.96%, 45.40%, and 44.22%, versus 44.67% (P less than 0.001), 39.38% (P=0.030), and 29.89% (P=0.001) in males. The TEAE rate was low for the overall population (18.3%) and similar for females (19.0%) and males (17.4%). Males and females had similarly favorable dermal tolerability. CONCLUSION: Once-daily dapsone gel, 7.5% was efficacious for acne regardless of baseline total lesion count, with superior efficacy in females and similar tolerability in males and females. REGISTRATION IDENTIFIER: Clinicaltrials.gov: NCT01974141 and NCT01974323 J Drugs Dermatol. 2018;17(11):1192-1198.


Acne vulgaris is a common dermatologic disease in adolescents and adults.1-4 Acne affects considerable proportions of both males and females but it is more common in females.2,4-7 Studies have revealed that sex, along with the severity of baseline disease and the complexity of the prescribed treatment regimen, may influence acne treatment outcomes.8-13 In a recent study, we reported better results in females with acne than in males with twice daily dapsone gel, 5%; this was the first study to highlight the importance of the sex of a patient with acne and the observed outcome.14 A subgroup analysis of pooled data from two large, phase 3, pivotal trials15,16 of dapsone gel, 7.5% (Aczone® Gel, 7.5%, Allergan plc, Dublin, Ireland),17 a once-daily topical medication approved for acne vulgaris in patients aged 12 years and older, showed that females who received the treatment had a higher mean decrease in acne lesion counts than males, as well as a greater proportion of patients who achieved success on the Global Acne Assessment Score (GAAS) scale.18There is a need for increased attention to the treatment of female acne.19,20 Females with acne may encounter a variety of treatment challenges, including a high incidence of persistent acne and a need for multimodal treatment approaches.6-8,20,21 Females may also experience acne that evolves in sever