Triple-Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne in Children and Adolescents
Recommended Citation
Eichenfield LF, Hebert AA, Harper JC, Baldwin H, Bhatia N, Gold LS, Kircik LH, Graber E, Tanghetti EA, Alexis AF, and Del Rosso JQ. Triple-Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne in Children and Adolescents. J Drugs Dermatol 2024; 23(12):1049-1057.
Document Type
Article
Publication Date
12-1-2024
Publication Title
Journal of drugs in dermatology
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.
Medical Subject Headings
Humans; Acne Vulgaris; Clindamycin; Adolescent; Child; Female; Male; Gels; Double-Blind Method; Drug Combinations; Benzoyl Peroxide; Treatment Outcome; Severity of Illness Index; Dermatologic Agents; Administration, Cutaneous
PubMed ID
39630680
Volume
23
Issue
12
First Page
1049
Last Page
1057
