The Efficacy and Safety of Topical Dapsone Gel, 5% for the Treatment of Acne Vulgaris in Adult Females With Skin of Color

February 2016 | Volume 15 | Issue 2 | Original Article | 197 | Copyright © February 2016

Andrew F. Alexis MD MPH,a Cheryl Burgess MD,b Valerie D. Callender MD,c Jo L. Herzog MD,d Wendy E. Roberts MD,e Eric S. Schweiger MD,f Toni C. Stockton MD,g and Conor J. Gallagher PhDh

aMount Sinai St. Luke’s and Roosevelt Hospitals, Icahn School of Medicine at Mount Sinai, New York, NY
bCenter for Dermatology and Dermatologic Surgery, Washington, DC
cCallender Dermatology and Cosmetic Center, Glenn Dale, MD
dBrookwood Dermatology, Vestavia Hills, AL
eRancho Mirage, CA
fSchweiger Dermatology, New York, NY
gStockton Dermatology, Phoenix, AZ
hAllergan plc, Irvine, CA

BACKGROUND: Topical dapsone gel, 5% is approved for treatment of acne vulgaris but has not been studied specifically in women with skin of color (SOC; Fitzpatrick skin types IV, V, or VI).
OBJECTIVE: Evaluate safety and efficacy of dapsone gel, 5% applied topically twice daily for 12 weeks in women with SOC.
METHODS: Females with SOC aged 18 years and older with facial acne participated in a multicenter, open-label, single-group, 12-week pilot study of twice-daily monotherapy with dapsone gel, 5%. The investigator-rated 5-point Global Acne Assessment Score (GAAS) was used to assess efficacy. The impact of acne on subjects was assessed using the validated Acne Symptom and Impact Scale (ASIS).
RESULTS: The study enrolled and treated 68 women with SOC and facial acne. GAAS decreased significantly from baseline to week 12 (mean, -1.2 [95% CI, -1.4, -1.0]; P<.001), a 39.0% improvement. Overall, 42.9% of subjects were responders based on a GAAS of 0 or 1 at week 12. Subjects also experienced significant reductions in mean total lesions (52% decrease), inflammatory lesions (65%), and comedo counts (41%; all P<.001). Dapsone gel, 5% monotherapy was associated with significant improvement in subject-assessed acne signs (P<.001) and impact on quality of life (QOL; P<.001), based on ASIS. Dapsone gel, 5% used twice daily was well tolerated, with no treatment-related adverse events. The local dermal tolerability scores tended to remain stable or decrease from baseline to week 12.
CONCLUSIONS: Monotherapy with dapsone gel, 5% administered twice daily was safe and effective for treatment of facial acne in women with SOC. Significant improvement in overall acne severity and both inflammatory lesions and comedones was observed. Further, study subjects reported considerable improvement in both acne signs and impact on QOL.

J Drugs Dermatol. 2016;15(2):197-204.


Acne vulgaris is prevalent in women with skin of color (SOC) and is the most common diagnosis made during dermatologic visits for patients with SOC.1,2 In a community-based epidemiologic study of women in four cities, the prevalence of acne was 37%, 30%, 33%, and 23% in black, Asian, Hispanic, and continental Indian women, respectively.3 Racial differences also exist in the clinical presentation of acne, the symptoms and signs that patients find most bothersome, and the quality of life impact of acne. In a recent cross-sectional study, women with SOC reported a substantially greater impact of acne on perception of appearance, negative emotions, and social functioning compared with white women.4 Facial acne was found to be more frequent on the cheek area of women with SOC in contrast to the chin and cheek areas of white women. 4 Nodulocystic acne has been reported to be less prevalent in blacks compared with whites and Hispanics.5,6 Women with SOC also present with a higher prevalence of keloids and hypertrophic scars related to acne versus those with lighter skin.7
Inflammatory skin disorders such as acne in patients with SOC are often complicated by postinflammatory hyperpigmentation (PIH).7 A consequence of acne, PIH arises from inflammatory lesions or comedones and may last for weeks to months.4,6,7 Inflammatory papules may develop an overlying hyperpigmentation in patients with SOC that may mimic PIH.8
Dapsone is a sulfone compound with potent anti-inflammatory properties9 acting through several potential molecular mechanisms.10-14 In 2005, a topical formulation of dapsone gel, 5% (Aczone®; Allergan plc, Dublin, Ireland) was approved by