Triple-Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne in Children and Adolescents
December 2024 | Volume 23 | Issue 12 | 1049 | Copyright © December 2024
Published online November 30, 2024
Lawrence F. Eichenfield MDa, Adelaide A. Hebert MDb, Julie C. Harper MDc, Hilary Baldwin MDd, Neal Bhatia MDe, Linda Stein Gold MDf, Leon H. Kircik MDg, Emmy Graber MD MBAh, Emil A. Tanghetti MDi, Andrew F. Alexis MD MPHj, James Q. Del Rosso DOk
aUniversity of California, San Diego School of Medicine, La Jolla, CA; Rady Children's Hospital, San Diego, CA
bUTHealth McGovern Medical School Houston, Houston, TX
cDermatology & Skin Care Center of Birmingham, Birmingham, AL
dThe Acne Treatment and Research Center, Brooklyn, NY; Robert Wood Johnson University Hospital, New Brunswick, NJ
e Therapeutics Clinical Research, San Diego, CA
fHenry Ford Hospital, Detroit, MI
gIcahn School of Medicine at Mount Sinai, New York, NY; Indiana University School of Medicine, Indianapolis, IN; Physicians Skin Care, PLLC, DermResearch, PLLC, and Skin Sciences, PLLC, Louisville, KY
hThe Dermatology Institute of Boston, Boston, MA; Northeastern University, Boston, MA
iCenter for Dermatology and Laser Surgery, Sacramento, CA
jWeill Cornell Medical College, New York, NY
kJDR Dermatology Research/Thomas Dermatology, Las Vegas, NV; Advanced Dermatology and Cosmetic Surgery, Maitland, FL; Touro University Nevada, Henderson, NV
Abstract
Background: Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose triple-combination approved for acne (indicated in patients 12 years and older). As topical acne treatment in pediatric patients may be complicated by tolerability and/or a perceived lack of efficacy, post hoc analyses were used to investigate efficacy/safety of CAB in children and adolescents.
Methods: Data were pooled from 2 phase 3, double-blind, 12-week studies (NCT04214639; NCT04214652). Participants aged 9 years and older with moderate-to-severe acne were randomized (2:1) to once-daily CAB or vehicle gel. Endpoints included treatment success (at least 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. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were evaluated. Post hoc analyses were conducted in adolescents aged 12 to 17 years (CAB, n=123; vehicle, n=50) with descriptive data shown for children aged 10 to 11 (CAB, n=3; vehicle, n=2).
Results: At week 12, 51.5% of CAB-treated adolescents achieved treatment success vs 24.9% with vehicle (P<0.01). CAB also provided inflammatory/noninflammatory lesion reductions of 78.3%/73.7% vs 50.5%/42.9% with vehicle (P<0.001, both). Most TEAEs were of mild-to-moderate severity, and <2.5% of participants discontinued due to adverse events. Only the 3 children treated with CAB achieved treatment success, with lesion reductions ranging from 76% to 100%. One CAB-treated child experienced TEAEs and none discontinued.
Conclusions: In 2 pooled phase 3 studies, once-daily CAB gel was well tolerated and efficacious in pediatric participants with acne, with over half achieving treatment success at week 12.
J Drugs Dermatol. 2024;23(12):1049-1057. doi:10.36849/JDD.8643
INTRODUCTION
Acne vulgaris is one of the most common dermatologic disorders worldwide.1 This inflammatory condition most frequently affects adolescents, where it can develop rapidly and present as more severe disease compared with adults.2,3 Treatment of acne can be difficult owing to chronicity, long treatment time course (≥12 weeks), and poor patient adherence from perceived lack of efficacy, adverse effects, or complicated regimens.4-8 There are additional efficacy, safety (eg, impact on growth/development, systemic side effects), and tolerability concerns (eg, irritation) when treating pediatric and adolescent patients.7 Additionally, not all of the many therapeutic options available have been tested or approved for use in patients under the age of 12 years.7
Acne pathophysiology is a multifactorial process involving multiple inflammatory pathways, increased sebum production, and abnormal keratinization.6 Combining treatments that target multiple pathogenic factors may improve efficacy. Current United States guidelines recommend treating mild to severe acne with topical
