VANCOUVER – Dapsone gel 5% proved effective and well tolerated for facial acne in women with skin of color in a multicenter pilot study.
The study was conducted because even though dapsone gel 5% (Aczone) is approved for the treatment of acne on the strength of two pivotal randomized, double-blind clinical trials totaling more than 3,000 patients, scant data exist on the topical agent’s performance in women with skin of color, Dr. Andrew F. Alexis explained at the World Congress of Dermatology.
Dr. Andrew F. Alexis
He presented an open-label, seven-center, 12-week, single-arm study involving 68 women of color – three-quarters of whom were black – who treated their facial acne with dapsone gel 5% twice daily as monotherapy.
Participants averaged a mean baseline score of 2.6 on the 0-4 Global Acne Assessment Score (GAAS), with a mean total of 50 inflammatory and noninflammatory acne lesions on the face.
The primary endpoint was change in GAAS at 12 weeks, although patients also were formally assessed at 2 and 6 weeks. The average reduction in GAAS was 8.8% at 2 weeks, 20% at 6 weeks, and 39% at 12 weeks. At week 12, 43% of the women were categorized as responders, meaning they had a GAAS of 0 (meaning no acne lesions) or 1 (indicating mild disease), reported Dr. Alexis of Mt. Sinai Hospital in New York.
Total lesion counts dropped steadily throughout the 12-week trial: by 16% from baseline to week 2, 30% at week 6, and 52% at week 12. Inflammatory lesions responded best, with a 65% reduction in number at week 12.
Patient-reported outcomes on the validated, 17-item Acne Symptom and Impact Scale were favorable: Reductions of roughly 50% were documented over 12 weeks on the scale’s two domains, acne signs and quality of life impact.
No clinically meaningful treatment-related adverse events were reported in the study, although a handful of women reported trace levels of redness, burning, dryness, and/or oiliness.
Acne is more common among African American than white women. In a large epidemiologic study of adolescent and adult women, the prevalence of acne vulgaris was 37% in African Americans, compared with 24% in whites (J. Eur. Acad. Dermatol. Venereol. 2011;25:1054-60).
Dr. Alexis’ study was sponsored by Allergan. He reported serving as a consultant to and receiving research grants from the company.