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

Document Type

Article

Publication Date

8-1-2026

Publication Title

Journal of drugs in dermatology

Keywords

Adolescent, Adult, Child, Female, Humans, Male, Young Adult, Acne Vulgaris, Adapalene, Benzoyl Peroxide Drug Combination, Administration, Cutaneous, Age Factors, Benzoyl Peroxide, Clindamycin, Dermatologic Agents, Double-Blind Method, Drug Combinations, Gels, Severity of Illness Index, Sex Factors, Treatment Outcome

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.

Medical Subject Headings

Adolescent; Adult; Child; Female; Humans; Male; Young Adult; Acne Vulgaris; Adapalene, Benzoyl Peroxide Drug Combination; Administration, Cutaneous; Age Factors; Benzoyl Peroxide; Clindamycin; Dermatologic Agents; Double-Blind Method; Drug Combinations; Gels; Severity of Illness Index; Sex Factors; Treatment Outcome

PubMed ID

42555077

Volume

25

Issue

8

First Page

708

Last Page

716

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