Gender as a Clinically Relevant Outcome Variable in Acne: Benefits of a Fixed Combination Clindamycin Phosphate (1.2%) and Benzoyl Peroxide (2.5%) Aqueous Gel

Objective: There is an increasing interest in gender differences both in the pathogenesis and treatment of skin diseases. We investigate whether there were any treatment differences in male and female subjects treated with clindamycin phosphate 1.2%/benzoyl peroxide (BPO) 2.5% gel as monotherapy for moderate to severe acne. Methods: We performed a post hoc analysis of the efficacy and cutaneous tolerability in 797 subjects receiving clindamycin phosphate 1.2%/BPO 2.5% gel from two 12-week, multicenter studies that enrolled 2,813 subjects with moderate to severe acne. Efficacy and tolerability were compared with both male and female subjects, overall and stratified by age (12-18 years and >= 18 years). Results: Absolute mean reductions in lesion counts with clindamycin phosphate 1.2%/BPO 2.5% gel were comparable and not significantly different across gender and age groups. Net reductions were greater in the adolescent groups. Treatment success in the older males was significantly greater (P=.046) compared with the adolescent males, and the difference between the male and female adolescent groups was significant in favor of the female subjects (P=.046). Cutaneous tolerability was comparable across all groups and between clindamycin phosphate 1.2%/BPO 2.5% gel and vehicle. Conclusions: Clindamycin phosphate 1.2%/BPO 2.5% gel provided comparable reductions in lesion counts across all 4 groups; however, the impact was greater in those subjects with more severe acne (the older males and adolescent females), and net benefit was greater in the adolescent subjects. J Drugs Dermatol. 2012;11(12):1440-1445.