Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Participants With Moderate-to-Severe Acne: The Patient Journey

November 2024 | Volume 23 | Issue 11 | 1017 | Copyright © November 2024


Published online October 29, 2024

doi:10.36849/JDD.8639

Hilary Baldwin MDa,b, Julie C. Harper MDc, Joshua A. Zeichner MDd, Zoe D. Draelos MDe, Lawrence F. Eichenfield MDf,g, Michael Gold MDh, Linda Stein Gold MDi, Leon H. Kircik MDd,j,k

aThe Acne Treatment and Research Center, Brooklyn, NY
bRobert Wood Johnson University Hospital, New Brunswick, NJ
cDermatology & Skin Care Center of Birmingham, Birmingham, AL
dIcahn School of Medicine at Mount Sinai, New York, NY
eDermatology Consulting Services, PLLC, High Point, NC
fUniversity of California, San Diego School of Medicine, La Jolla, CA
gRady Children's Hospital, San Diego, CA
hTennessee Clinical Research Center, Nashville, TN
iHenry Ford Hospital, Detroit, MI
jIndiana University School of Medicine, Indianapolis, IN
kPhysicians Skin Care, PLLC, DermResearch, PLLC, and Skin Sciences, PLLC, Louisville, KY

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

INTRODUCTION

Treatment of acne vulgaris is difficult due to its chronicity, long treatment time course, and low patient adherence.1,2 The main treatment goal is to clear lesions quickly to manage and/or mitigate persistent sequelae such as scarring and/or dyspigmentation.3

Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB; Cabtreo®; Ortho Dermatologics) 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.4,5 As clinical data may provide a limited perspective on individual participant experiences, detailed efficacy and safety data from 6 clinical study participants with moderate-to-severe acne are presented here to document their treatment journey with CAB.

METHODS

Study Design and Participants
Details of the two phase 3 randomized, double-blind, vehicle-controlled, 12-week studies (NCT04214639; NCT04214652) have been published previously.5 In brief, eligible participants aged greater than or equal to 9 years with moderate-to-severe acne were randomized (2:1) to once-daily treatment with CAB or vehicle gel. These studies were conducted in accordance with the principles of Good Clinical Practice and the Declaration of Helsinki and were approved by institutional review board/ethics committees at all sites. All participants or their legal guardians provided written informed consent.

Study Assessments
Endpoints included percentage of participants achieving treatment success (greater than or equal to 2-grade reduction from baseline in Evaluator's Global Severity Score [EGSS] and clear/almost clear skin) and percent change from baseline in inflammatory/noninflamma-
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