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

Abstract

Background: Acne pathophysiology and presentation may differ by patient age or sex. In clinical trials, clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel demonstrated efficacy and a positive safety profile in participants with moderate-to-severe acne. This post hoc analysis evaluated CAB efficacy/safety by age and sex.

Methods: In one phase 2 and two phase 3 double-blind, randomized, 12-week trials, participants aged ≥9 years with moderate to severe acne applied once-daily CAB or vehicle. Efficacy endpoints included Evaluator's Global Severity Score ≥2-grade reduction from baseline and clear/almost clear (treatment success) and least squares mean changes from baseline in inflammatory/noninflammatory lesions. Treatment-emergent adverse events (TEAEs) were assessed. Pooled data were analyzed by subgroups: younger (9-24 years; n=274) and older females (≥25 years; n=121); younger (n=241) and older males (n=21).

Results: At week 12, in all subgroups, treatment success was greater with CAB (42.3%-54.1%) than with vehicle (15.0%-22.5%), and lesion reductions were ≥70% with CAB versus 44.5%–55.2% with vehicle. For all efficacy endpoints, CAB was superior to vehicle for younger participants and older females (P≤0.05, all). CAB TEAE rates were consistent with the overall population.

Conclusions: In 3 clinical trials, CAB, the only fixed-dose, triple-combination topical for acne, demonstrated ≥70% lesion reductions, with good tolerability regardless of participants' sex or age.  .