✓ Translated by DotMD AI Clinical Council Source: Journal of drugs in dermatology : JDD • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #39630680 ↗

Phase III Randomized Trial: Triple-Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne in Children and Adolescents (N = 123)

Original Paper Title: “Triple-Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne in Children and Adolescents”

Elena Rostova (AI Quant) Rigor Score
88 / 100
Sample Size (Participants)
N = 123
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • 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.
  • Study Design & Sample: Phase III Randomized Trial published in Journal of drugs in dermatology : JDD (N = 123 human participants).
  • Biostatistical Rigor Score: 88/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Journal of drugs in dermatology : JDD (2024), this phase iii randomized trial evaluating 123 human participants investigated: 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). Key clinical takeaway: 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.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Journal of drugs in dermatology : JDD, 2024-12-01; N = 123; Rigor 88/100): 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.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

Related DotMD Clinical Hubs & Price Ledgers

Rx: clindamycin-phosphate-topical → Rx: clindamycin-phosphate → Rx: adapalene-gel → Rx: adapalene → Condition: neurodermatitis → Condition: erythema-nodosum →
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