Efficacy and Safety of Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Asian Participants with Moderate to Severe Acne

Document Type

Conference Proceeding

Publication Date

4-6-2026

Publication Title

J Drugs Dermatol

Keywords

adapalene, benzoyl peroxide, clindamycin phosphate, acne, acne vulgaris, adult, adverse drug reaction, Asian, conference abstract, controlled study, double blind procedure, drug therapy, drug withdrawal, female, gel, Global Severity Index, human, hyperpigmentation, major clinical study, male, multicenter study, phase 3 clinical trial, randomized controlled trial, side effect, topical drug administration

Abstract

Background: Acne vulgaris is a common skin condition with significant clinical impact in Asian patients, for whom treatment may involve unique considerations. Clinical presentation and sequelae of acne can vary by race; for instance, Asian individuals with darker skin phototypes may be at increased risk of postinflammatory hyperpigmentation.1 Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose, triple-combination formulation approved for acne. In phase 2 and 3 clinical trials of participants with moderate to severe acne, CAB gel was more efficacious than vehicle (treatment success: ~50% vs 8-25%; IL/NL reductions: 71-80% vs 46-60%) with good safety/tolerability.2,3 Objective: To determine the efficacy, safety, and tolerability of CAB gel in Asian participants. Methods: In two phase 2 (NCT03170388, NCT0 4892706) and two phase 3 (NCT04214652, NCT0 4214639) double-blind, 12-week trials, 1115 enrolled participants aged ≥9 years (≥12 in NCT04892706) with moderate to severe acne were randomized to once-daily CAB or vehicle gel; additional randomization arms are not included here. Efficacy endpoints included treatment success (≥2-grade reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin) and least-squares mean percent change from baseline in IL/NL counts at week 12. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were also assessed. Data were pooled and analyzed post hoc in participants who self-identified as Asian. Results: The analysis included 96 Asian participants (n=47 CAB; n=49 vehicle gel). At week 12, significantly more Asian participants treated with CAB gel achieved treatment success than vehicle (66.5% vs 23.4%; P<0.001). CAB-treated participants experienced >80% reductions in IL/NL counts (87.7% and 80.3%, respectively), significantly greater compared with vehicle (58.3% and 55.7%; P≤0.001, both). TEAEs in CAB-treated Asian participants occurred at a rate similar to those in the overall study populations (27.7% vs 24.6%-36.2%), with the majority categorized as mild or moderate. There were no reports of serious AEs and only 1 discontinuation due to AEs in the CAB-treatment group. Hyperpigmentation mean scores stayed below baseline value (0.7; 1=mild) at all time points. Conclusions: In Asian participants with moderate to severe acne treated with CAB gel, 66.5% achieved treatment success and acne lesion counts were reduced by >80% by week 12, with favorable safety and tolerability. These improvements are even greater than the substantial results seen in the overall study populations. Given its high efficacy and favorable tolerability, triple-combination CAB gel is well suited for the treatment of acne in Asian patients.

Volume

25

Issue

4

First Page

S7

Find It @ Sladen

Share

COinS