Clindamycin Phosphate 1.2%/Adapalene 0.15%/ Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne: A Pooled Analysis by Age
December 2025 | Volume 24 | Issue 12 | 9407 | Copyright © December 2025
Published online November 26, 2025
Leon H. Kircik MDa-c, Julie C. Harper MDd, Hilary Baldwin MDe, f, Lawrence F. Eichenfield MDg, h, Emil A. Tanghetti MDi, Emmy Graber MD MBAj, k, Heather C. Woolery-Lloyd Mdl, Eric Guenin PharmD PhD MPHm, Zoe D. Draelos MDn
aIcahn School of Medicine at Mount Sinai, New York, NY
bIndiana University School of Medicine, Indianapolis, IN
cPhysicians Skin Care, PLLC, DermResearch, PLLC, and Skin Sciences, PLLC, Louisville, KY; dDermatology & Skin Care Center
of Birmingham, Birmingham, AL; eThe Acne Treatment and Research Center, Brooklyn, NY; fRobert Wood Johnson University Hospital, New Brunswick, NJ; gUniversity of California, San Diego School of Medicine, La Jolla, CA; hRady Children's Hospital, San Diego, CA;
iCenter for Dermatology and Laser Surgery, Sacramento, CA; jThe Dermatology Institute of Boston, Boston, MA;
kNortheastern University, Boston, MA; lUniversity of Miami Miller School of Medicine, Miami, FL; mOrtho Dermatologics*,
Bridgewater, NJ; nDermatology Consulting Services, PLLC, High Point, NC
*Ortho Dermatologics is a division of Bausch Health US, LLC
Abstract
Background: Acne pathophysiology and presentation may differ between pediatric/adolescent/young adult (9-24 years) and adult (≥25 years) patients. Fixed-dose clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel demonstrated superior efficacy to vehicle and component dyads with good safety/tolerability in 3 clinical trials of acne. This post hoc analysis evaluated the efficacy/safety of CAB in pediatric/adolescent/young adult ("younger") vs adult participants.
Methods: In one phase 2 (NCT03170388) and two phase 3 (NCT04214652, NCT04214639) trials, participants aged greater than or equal to 9 years with moderate-to-severe acne were randomized to once-daily CAB or vehicle gel. Pooled data were analyzed for participants grouped by age: younger (9-24 years; n=515) and adult (greater than or equal to 25 years; n=142). Endpoints included the percentage of participants achieving treatment success (greater than or equal to 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 inflammatory/noninflammatory lesions at week 12. Treatment-emergent adverse events (TEAEs) were evaluated throughout.
Results: At week 12, approximately half of CAB-treated participants in both age groups achieved treatment success (9-24: 50.6%; greater than or equal to 25: 49.0%) vs less than one-fourth with vehicle (15.7%; 20.6%; P<0.01, both). Across groups, CAB yielded >70% reductions in inflammatory/noninflammatory lesions vs 45% to 62% with vehicle (P≤0.001, all). For all endpoints, CAB efficacy was similar across age groups. Most TEAEs with CAB were of mild-to-moderate severity, and there were no age-related trends in safety/tolerability.
Conclusions: Fixed-dose, triple-combination CAB gel was efficacious and well tolerated in participants with moderate-to-severe acne, regardless of age. Approximately half of the participants achieved clear/almost clear skin, with >70% reductions in lesion counts.
