Triple-Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Acne in Adult and Pediatric Participants
June 2024 | Volume 23 | Issue 6 | 394 | Copyright © June 2024
Published online May 29, 2024
Hilary Baldwin MDa,b, Linda Stein Gold MDc, Julie C Harper MDd, Andrew F Alexis MD MPHe, Valerie D. Callender MDf,g, Leon Kircik MDh,i,j, Eric Guenin PharmD PhD MPHk, Lawrence F. Eichenfield MDl,m
aThe Acne Treatment and Research Center, Brooklyn, NY
bRobert Wood Johnson University Hospital, New Brunswick, NJ
cHenry Ford Hospital, Detroit, MI
dDermatology and Skin Care Center of Birmingham, Birmingham, AL
eWeill Cornell Medicine, New York, NY
fCallender Dermatology and Cosmetic Center, Glenn Dale, MD
gHoward University College of Medicine, Washington, DC
hIcahn School of Medicine at Mount Sinai, New York, NY
iIndiana University School of Medicine, Indianapolis, IN
jPhysicians Skin Care, PLLC, DermResearch, PLLC, and Skin Sciences, PLLC, Louisville, KY
kOrtho Dermatologics, Bridgewater, NJ
lUniversity of California San Diego School of Medicine, La Jolla, CA
mRady Children's Hospital, San Diego, CA
*Ortho Dermatologics is a division of Bausch Health US, LLC
Abstract
Background: Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel (CAB) is the first fixed-dose triple-combination approved for the treatment of acne. This post hoc analysis investigated the efficacy and safety of CAB in pediatric (<18 years) and adult (greater than or equal to 18 years) participants.
Methods: In two multicenter, double-blind, phase 3 studies (NCT04214639 and NCT04214652), participants greater than or equal to 9 years of age with moderate-to-severe acne were randomized (2:1) to 12 weeks of once-daily treatment with CAB or vehicle gel. Pooled data were analyzed for pediatric and adult subpopulations. Assessments included treatment success (greater than or equal to 2-grade reduction from baseline in Evaluator's Global Severity Score and a score of 0 [clear] or 1 [almost clear], inflammatory/noninflammatory lesion counts, Acne-Specific Quality of Life (Acne-QoL) questionnaire, treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability.
Results: At week 12, treatment success rates for both pediatric and adult participants were significantly greater with CAB (52.7%; 45.9%) than with vehicle (24.0%; 23.5%; P<0.01, both). CAB-treated participants in both subgroups experienced greater reductions from baseline versus vehicle in inflammatory (pediatric: 78.6% vs 50.4%; adult: 76.6% vs 62.8%; P<0.001, both) and noninflammatory lesions (pediatric: 73.8% vs 41.1%; adult: 70.7% vs 52.2%; P<0.001, both). Acne-QoL improvements from baseline to week 12 were significantly greater with CAB than with a vehicle. Most TEAEs were of mild-to-moderate severity; no age-related trends for safety/tolerability were observed.
Conclusions: CAB gel demonstrated comparable efficacy, quality of life improvements, and safety in pediatric and adult participants with moderate-to-severe acne. As the first fixed-dose, triple-combination topical formulation, CAB represents an important new treatment option for patients with acne.
J Drugs Dermatol. 2024;23(6):394-402. doi:10.36849/JDD.8357
INTRODUCTION
Although acne affects patients of all ages, there are age-related differences in clinical presentation as well as patients' experience with acne and acne treatments.1 Acne onset typically corresponds to hormonal changes during puberty, and shifts toward earlier puberty are associated with increasing acne prevalence among preteen children.2,3 There are numerous topical and systemic treatment options available for acne, though not all are approved for patients under 12 years of age.4 Even with approved treatments, effectiveness among preadolescent (aged 7-12 years or menarche in girls3) and teenaged patients may be hampered by poor treatment adherence as well as a greater likelihood of severe acne and treatment-related irritation than adults.1,5,6 Adult acne may be a continuation of adolescent acne or may appear de novo, particularly among women in response to hormonal changes associated with menstruation, pregnancy, and perimenopause.7,8 Although adults may experience a greater impact of acne on quality of life (QoL),9 they are less likely to receive a prescription treatment for acne than patients
