Prospective Pilot Evaluation of the Safety, Tolerability, and Efficacy of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel plus Clascoterone 1% Cream in Adult Patients with Acne.

Abstract

Background: Acne vulgaris (acne) is a common disorder with a complex, multi-faceted pathophysiology. To date, there has not been a single topical treatment that targets all aspects of acne pathophysiology (ie, increased sebum production, presence of Cutibacterium acnes, inflammation, and follicular hyperkeratinization). As such, topical treatments need to be utilized in combination to target all four of the major recognized pathophysiologic components in acne lesion formation.

Objective: This single-center prospective evaluation assessed the safety, tolerability, and efficacy of clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% gel used concurrently with clascoterone 1% cream for treatment of acne in an eight-week, open-label pilot evaluation.

Methods: Six subjects (N=6), aged 21 to 27, were enrolled and evaluated at Week 0, Week 2, Week 4, and Week 8 with respect to erythema, dryness, and inflammatory lesion count (ILC).

Results: ILC decreased from 23.50 +/- 8.17 at baseline to 9.50 +/- 7.53 at Week 8 from baseline to Week 12. Average subject-reported adherence rate was 93.81%, and the most commonly reported side effects were burning/stinging and erythema; all were rated as mild.

Conclusion: This pilot evaluation, albeit small and open-label, demonstrates promising results for the first studied combination of topical agents to target all four aspects of acne pathophysiology. Further large-scale studies are needed to further elucidate the additive efficacy and side effect profile when these two topical medications are used concomitantly.