Safety and Tolerability of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Truncal Acne
August 2025 | Volume 24 | Issue 8 | 803 | Copyright © August 2025
Published online July 31, 2025
Leon H. Kircik MDa, Julie C. Harper MDb, Michael Gold MDc, Linda Stein Gold MDd, Zoe D. Draelos MDe, Eric Guenin PharmD PhD MPHf, Su Yong Choi PharmDf, Karol Wroblewski PharmDg, Hilary Baldwin MDh, Valerie D. Callender MDi, Adelaide A. Hebert MDj, Jonathan S. Weiss MDk
aIcahn School of Medicine at Mount Sinai, New York, NY; Indiana University School of Medicine, Indianapolis, IN; Physicians Skin Care, PLLC, DermResearch, PLLC, and Skin Sciences, PLLC, Louisville, KY
bDermatology & Skin Care Center of Birmingham, Birmingham, AL
cTennessee Clinical Research Center, Nashville, TN
dHenry Ford Hospital, Detroit, MI
eDermatology Consulting Services, PLLC, High Point, NC
fOrtho Dermatologics*, Bridgewater, NJ
gRutgers University, New Brunswick NJ
hThe Acne Treatment and Research Center, Brooklyn, NY; Robert Wood Johnson University Hospital, New Brunswick, NJ
iCallender Dermatology and Cosmetic Center, Glenn Dale, MD; Howard University College of Medicine, Washington, DC
jUTHealth McGovern Medical School Houston, Houston, TX
kGeorgia Dermatology Partners, Snellville, GA; Gwinnett Clinical Research Center, Inc., Snellville, GA
Abstract
Background: Truncal acne is underdiagnosed and undertreated, and it can lead to scarring and postinflammatory hyperpigmentation. However, applying topical treatments to larger skin surface areas introduces additional safety/tolerability concerns. Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose, triple-combination topical for acne and has demonstrated favorable efficacy/safety in participants with facial acne.
Methods: Data were pooled from one phase 2 (NCT04892706) and two phase 3 (NCT04214639, NCT04214652), double-blind, 12-week studies. Participants aged ≥9 years (≥12 years, phase 2) with moderate to severe facial acne were randomized to once daily CAB or vehicle gel. Truncal acne treatment was optional, and efficacy was not the main outcome. Truncal treatment-emergent adverse events (TEAEs) and truncal cutaneous safety/tolerability were evaluated through week 12. Only participants treating both face and trunk were included in this post hoc analysis (CAB, n=118; vehicle, n=101).
Results: Through week 12, TEAE rates on the trunk were higher with CAB vs vehicle (5.9% vs 1.0%). Most TEAEs were mild, none were serious, and only 1 participant (CAB-treated) discontinued due to TEAEs. Mean truncal cutaneous safety/tolerability scores with CAB were <0.5 (1=mild) at all visits. Severe (grade 3) ratings postbaseline occurred in <1% of CAB-treated participants for erythema, hyperpigmentation, and burning (n=1 each).
Conclusions: In this pooled analysis, fixed-dose CAB gel was well tolerated over 12 weeks in participants treating their truncal acne. The lack of safety signals combined with the favorable safety/tolerability profile of CAB shows that it is a safe treatment option for truncal and facial acne.
INTRODUCTION
Acne vulgaris is one of the most common dermatologic conditions, with an estimated global prevalence of 20% in patients aged ≥16 years1; prevalence may be higher among adolescents/young adults (aged 12–25 years).2 Approximately half of patients with facial acne also have truncal acne.3,4 Truncal acne – lesions on the shoulders, chest, upper extremities, and/or back – is underdiagnosed and undertreated as patients often seek treatment only for facial acne.3,5,6 Additionally, truncal acne may not be discussed with clinicians due to time constraints.5 Untreated truncal acne can lead to scarring and postinflammatory hyperpigmentation (PIH).3,7 This form of acne can also negatively impact quality of life (QoL), leading to feelings of anger and embarrassment and a loss of confidence.8 Patients with both facial and truncal acne may have worse QoL than those with only facial acne.5
