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.

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 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.