Hilary Baldwin, Julie C Harper, Joshua A Zeichner, Zoe D Draelos, Lawrence F Eichenfield, Michael Gold, Linda Stein Gold, Leon H Kircik
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引用次数: 0
Abstract
Introduction: Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose, triple-combination formulation approved for acne treatment. In 3 clinical studies of participants with moderate-to-severe acne, CAB demonstrated superior efficacy to vehicle and component dyads, with good safety and tolerability. Detailed efficacy/safety data from individual clinical study participants are presented.
Methods: In two phase 3 (NCT04214652, NCT04214639) randomized, double-blind, 12-week studies, participants aged at least 9 years with moderate-to-severe acne were randomized to once-daily CAB or vehicle gel. Descriptive data - including lesion count changes, treatment success (at least 2-grade reduction from baseline in Evaluator's Global Severity Score and clear/almost clear skin), compliance, treatment-emergent adverse events (AEs), and cutaneous safety/tolerance assessments - were summarized from 6 CAB-treated cases.
Results: By week 12, all cases achieved >70% lesion reductions, 4/6 achieved treatment success, and 1/6 achieved a 2-grade reduction in severity. All cases were compliant with CAB treatment. No cases reported serious AEs. Transient increases occurred on cutaneous safety and tolerability assessments, with scores generally decreasing back to/below baseline levels by week 12.
Conclusions: In two phase 3 clinical trials, fixed-dose, triple-combination CAB demonstrated good efficacy/safety. All 6 CAB-treated cases achieved substantial (>70%) lesion reductions, with 5/6 achieving treatment success or 2-grade reduction in severity by week 12. Transient cutaneous safety/tolerability severity increases generally resolved to baseline values by week 12. These clinical study cases reinforce the importance of patient education regarding adherence, expectations, and AEs. J Drugs Dermatol. 2024;23(11):1017-1024. doi:10.36849/JDD.8639.
期刊介绍:
The Journal of Drugs in Dermatology (JDD) is a peer-reviewed publication indexed with MEDLINE®/PubMed® that was founded by the renowned Dr. Perry Robins MD. Founded in 2002, it offers one of the fastest routes to disseminate dermatologic information and is considered the fastest growing publication in dermatology.
We present original articles, award-winning case reports, and timely features pertaining to new methods, techniques, drug therapy, and devices in dermatology that provide readers with peer reviewed content of the utmost quality.
Our high standards of content are maintained through a balanced, peer-review process. Articles are reviewed by an International Editorial Board of over 160 renowned experts.