Safety and Tolerability of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Truncal Acne

Abstract

Introduction: Truncal acne—lesions on the shoulders, chest, upper extremities, and/or back—is underdiagnosed and undertreated. Untreated truncal acne can lead to scarring and postinflammatory hyperpigmentation. Applying topical treatments to a larger skin surface area than the face 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 good efficacy and safety in participants with moderate to severe 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 study) 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. Treatment-emergent adverse events (TEAEs; truncal or truncal and facial) and truncal cutaneous safety (investigator-assessed) and tolerability (participant-assessed) 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: Approximately half of the participants were female, and most of the participants were White and non-Hispanic. Most had moderate facial and mild to moderate truncal acne at baseline. Through week 12, TEAE rates on the trunk were higher in the CAB vs vehicle group (5.9% vs 1.0%). Most TEAEs were mild, none were serious, and only 1 participant (CAB-treated) discontinued due to TEAEs. Mean scores on truncal cutaneous safety and tolerability evaluations with CAB were <0.5 (1=mild) at all visits. More than 92% of CAB-treated participants had a score of 0 (none) on scaling, hypopigmentation, itching, burning, and stinging at any visit. Severe (grade 3) ratings postbaseline occurred in <1% of CAB-treated participants for erythema, hyperpigmentation, and burning (n=1 each).  

Conclusions: Fixed-dose, triple-combination CAB gel demonstrated good safety and tolerability over 12 weeks in a subset of participants with truncal acne and moderate to severe facial acne. The lack of safety signals combined with the favorable safety and tolerability profile of CAB shows that it is a safe treatment option for both truncal and facial acne.

Funding: Ortho Dermatologics