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

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.