Comparative efficacy and tolerability of dapsone 5% gel in adult versus adolescent females with acne vulgaris.

Objective: To determine whether the response to dapsone 5% gel was similar in adolescent girls and adult women with facial acne vulgaris.

Design And Setting: Subgroup analysis of female subjects with acne vulgaris receiving active treatment enrolled in two randomized, double-blind Phase 3 clinical trials.

Treatment: Twice-daily applications of dapsone 5% gel over 12 weeks.

Participants: Adolescent (12-17 years of age) and adult (≥18 years of age) females.

Measurements: At baseline and at Weeks 2,4,6,8, and 12, subjects were evaluated using the global acne assessment score and by counts of inflammatory, noninflammatory, and total acne vulgaris lesions. Adverse events were monitored.

Results: A total of 347 adolescent and 434 adult women were included in the subgroup analysis. At Week 12, dapsone 5% gel significantly reduced mean global acne assessment score in both subgroups (p<0.001); however, the proportion of subjects with clinical success (no or minimal acne based on global acne assessment score) at Week 12 was greater in adult women (53.5%) versus adolescent females (45.3%, p=0.022). Significantly greater percentage reductions in both noninflammatory (p<0.0001) and total lesion counts (p=0.0008) were observed in the adult group as compared to the adolescent group. Percentage reductions from baseline in inflammatory lesions were similar in both groups. No major safety issues and no previously unrecognized safety signals were noted.

Conclusion: This subgroup analysis of female patients indicates that dapsone 5% gel twice daily is effective in reducing inflammatory and noninflammatory acne vulgaris lesions in both adolescent and adult women, and is safe in these subgroups. Overall, these data suggest that efficacy of dapsone 5% gel twice daily for facial acne vulgaris may be greater in the adult female population.