Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Acne: Pooled Analysis by Age and Sex

Background: Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel demonstrated efficacy in the treatment of acne, with a good safety/tolerability profile, in participants with moderate to severe acne. Acne clinical presentation and response to treatment may differ between males and females as well as between pediatric-postadolescent (<24 years) and adult (≥25 years) patients. The objective of this post hoc analysis was to evaluate the impact of age and sex on the efficacy and safety of CAB gel. Methods: In one phase 2 and two phase 3 double-blind, 12-week studies, participants with moderate-to-severe acne were randomized to once-daily CAB or vehicle (Veh). Data were analyzed post hoc for participants categorized by age and sex: females 9-24 or ≥25 years (ns=274 and 121) and males 9-24 or ≥25 years (ns=241 and 21). Efficacy endpoints included treatment success (percentage of participants achieving ≥2-grade reduction from baseline in Evaluator’s Global Severity Score and a score of 0 or 1 [clear/almost clear]) and reductions from baseline in inflammatory and noninflammatory lesions (IL/NIL). Treatment-emergent adverse events (TEAEs) were also assessed. Results: At week 12, a greater percentage of participants in all sex/age subgroups achieved treatment success with CAB (42.3-54.1%) than Veh (15.0-22.5%). Similarly, lesion reductions were larger with CAB than Veh (IL: CAB, 75.9-77.8%; Veh, 50.8-65.2%; NIL: CAB, 69.7-73.7%; Veh, 44.5-55.2%). For all efficacy endpoints, CAB was statistically superior to Veh among males and females 9-24 years and females ≥25 years (P≤0.05, all). For males ≥25 years, only NIL reductions were significantly greater with CAB (P≤0.05), likely due to the small population. For all CAB-treated groups, most TEAEs were of mild-moderate severity. Rates of TEAEs deemed related to CAB treatment were similar for males and females 9-24 years (19.7% and 18.6%, respectively) and somewhat higher for females ≥25 years (24.4%). Considerably lower treatment-related TEAE rates in males ≥25 years (8.3%) may reflect the low number of participants in this group (n=12 treated with CAB). Conclusions: In 3 clinical trials, participants treated with CAB gel—the only fixed-dose, triple-combination topical for acne—experienced ≥70% lesion reductions, and approximately half achieved clear or almost clear skin. CAB gel demonstrated good efficacy and tolerability regardless of participants’ sex or age. Funding: Ortho Dermatologics