Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Acne: Pooled Analysis by Age and Sex
August 2026 | Volume 25 | Issue 8 | 708 | Copyright © August 2026
Published online July 31, 2026
Julie C. Harper MDa, Heather C. Woolery-Lloyd MDb, Linda Stein Gold MDc, Hilary Baldwin MDd,e, Valerie D. Callender MDf,g, Michael Gold MDh, Adelaide A. Hebert MDi, Eric Guenin PharmD PhD MPHj, Leon H. Kircik MDk,l,m
aDermatology & Skin Care Center of Birmingham, Birmingham, AL
bUniversity of Miami Miller School of Medicine, Miami, FL
cHenry Ford Hospital, Detroit, MI
dThe Acne Treatment and Research Center, Brooklyn, NY
eRobert Wood Johnson University Hospital, New Brunswick, NJ
fCallender Dermatology and Cosmetic Center, Glenn Dale, MD
gHoward University College of Medicine, Washington, DC
hTennessee Clinical Research Center, Nashville, TN
iUTHealth McGovern Medical School Houston, Houston, TX
jOrtho Dermatologics,* Bridgewater, NJ
kIcahn School of Medicine at Mount Sinai, New York, NY
lIndiana University School of Medicine, Indianapolis, IN
mPhysicians Skin Care, PLLC, DermResearch, PLLC, and Skin Sciences, PLLC, Louisville, KY
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.
J Drugs Dermatol. 2026;25(8):708-716. doi:10.36849/JDD.9878
INTRODUCTION
With an estimated global prevalence of >9% across all ages, acne vulgaris is one of the most common skin disorders.1 However, acne prevalence among adults may be increasing, particularly for females.2,3 Skin physiology, acne clinical presentation, or treatment tolerability may differ between males and females or between younger and older patients.3-6 Further, older females (aged >27 years) reported a greater negative impact of acne on quality of life (QoL) than younger females (11–26 years).7 Thus, there is an ongoing need for treatments that are well tolerated and effective for patients, regardless of sex or age.
Successful acne resolution is hampered by poor treatment adherence, which can be exacerbated by treatment-related side effects and perceived or actual lack of effectiveness.8-10 Combination therapies that address multiple pathophysiological mechanisms of acne (ie, increased inflammation and sebum production, abnormal keratinization, and follicular proliferation of Cutibacterium acnes) are recommended for treatment and may be more efficacious than monotherapies.11,12 Moreover, simplifying a combination treatment regimen by delivering its active ingredients in a single fixed-dose formulation may improve both adherence and treatment outcomes.13
