Efficacy and safety of fixed-dose clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel in hispanic participants with moderate-to-severe acne

Document Type

Conference Proceeding

Publication Date

11-12-2025

Publication Title

J Clin Aesthet Dermatol

Abstract

Introduction: Acne vulgaris is a common dermatologic condition and a leading dermatologic diagnosis in Black and Hispanic patients. Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose, triple-combination formulation approved for the treatment of acne. In three published clinical studies of participants with moderate-to-severe acne, CAB gel demonstrated superior efficacy to vehicle and component dyads, with good safety/tolerability. The objective of these analyses was to determine the efficacy, safety, and tolerability of CAB in Hispanic participants of these studies. Methods: In one Phase 2 (NCT03170388) and two Phase 3 (NCT04214652, NCT04214639) randomized, double-blind, 12-week studies, participants aged nine years or older with moderate-to-severe acne were randomized to once-daily CAB or vehicle gel. Endpoints included percentage of participants achieving treatment success (≥2-grade reduction from baseline in Evaluator's Global Severity Score [EGSS] and clear/almost clear skin) and least-squares mean percent change from baseline in inflammatory/noninflammatory lesion counts at Week 12. Treatment-emergent adverse events (TEAEs) and cutaneous safety and tolerability were also assessed. Pooled data across all three studies were analyzed for participants who self-identified as Hispanic/Latino (herein referred to as Hispanic; n=90 CAB; n=57 vehicle gel). Results: At Week 12, over half of Hispanic participants achieved treatment success with CAB versus less than one-quarter with vehicle gel (56.2% vs. 18.4%; p<0.001). CAB treatment provided more than 75-percent reductions in inflammatory/noninflammatory lesion counts at Week 12 vs 56.4 percent and 45.0 percent, respectively, with vehicle (p<0.001, both). TEAE rates with CAB in the Hispanic population were similar to those in the overall study populations (27% vs. 24.6–36.2%). Most TEAEs were of mild-to-moderate severity, and discontinuations due to AEs were low (<4%). Mean cutaneous safety and tolerability scores (0=none to 3=severe) with CAB at all visits were less than one (mild), similar to the overall study populations. Hyperpigmentation scores decreased from baseline (0.6) to Week 12 (0.3) following CAB treatment. Conclusion: In Hispanic participants with moderate-to-severe acne treated with CAB, over half achieved treatment success and acne lesion reductions were reduced by more than 75 percent by Week 12, without any additional safety signals. These results, combined with those of previous post-hoc analyses in Black study participants, demonstrate that CAB is an efficacious, safe, and tolerable acne treatment for patients of different racial and ethnic groups.

Volume

18

Issue

Suppl 1

First Page

S36

Last Page

S37

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