Efficacy and Safety of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel: Post Hoc Analysis by Baseline Disease Severity

INTRODUCTION: Clindamycin phosphate (CLIN) 1.2%/adapalene (ADAP) 0.15%/benzoyl peroxide (BPO) 3.1% gel (CAB) is the only triple-combination topical approved for acne. These post hoc analyses assessed efficacy and safety of CAB gel compared with component dyads and branded ADAP 0.3%/BPO 2.5% gel in participants stratified by baseline acne severity. METHODS: Data were pooled from two phase 2 and two phase 3 12-week studies. Participants were randomized to once-daily CAB or vehicle; one phase 2 study included dyad combinations of CAB active ingredients (ADAP/BPO, CLIN/BPO, and CLIN/ADAP) and the other included a head-to-head comparison with branded ADAP 0.3%/BPO 2.5%. Assessments included percent changes from baseline in inflammatory/noninflammatory lesions (IL/NIL) and treatment success (≥ 2-grade reduction from baseline in Evaluator's Global Severity Score [EGSS] and clear/almost clear skin). Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were assessed. RESULTS: At week 12, IL reductions in moderate participants (EGSS = 3; n = 1557) were significantly greater with CAB vs vehicle, dyads, and branded ADAP/BPO (77.1% vs 54.1%, 64.4-69.4%, and 72.8%, respectively; P < 0.05, all). IL reductions in severe participants (EGSS = 4; n = 230) were significantly greater with CAB vs vehicle, ADAP/BPO, and CLIN/BPO (74.5% vs 44.4%, 63.9%, and 61.3%; P < 0.05, all), and similar to CLIN/ADAP and branded ADAP/BPO (73.7%/75.4%). IL reductions were greater than NIL. Moderate participants achieved greater treatment success rates with CAB vs vehicle, dyads, or branded ADAP/BPO (53.9% vs 19.5%, 31.5-35.3%, and 38.1%; P ≤ 0.001, all); only CAB- and CLIN/ADAP-treated severe participants had significantly greater rates vs vehicle (30.9% and 34.0% vs 9.0%; P < 0.05). Most TEAEs were of mild to moderate severity. All mean cutaneous safety/tolerability scores were ≤ 1 (1 = mild). CONCLUSIONS: CAB demonstrated superior efficacy to three dyads and branded ADAP 0.3%/BPO 2.5% in moderate acne participants, and generally numerically greater efficacy in severe acne participants. To our knowledge, these analyses include data from the only double-blind, vehicle-controlled, head-to-head study. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03170388, NCT04892706, NCT04214639, and NCT04214652.

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