Sol-Gel Technologies initiates Phase 3 TWIN clinical program

Sol-Gel Technologies announced dosing of the first subject in the pivotal Phase III clinical program evaluating the safety and efficacy of TWIN in subjects with acne vulgaris. TWIN is a cream containing a fixed-dose combination of encapsulated tretinoin and encapsulated benzoyl peroxide using Sol-Gel’s proprietary microencapsulation platform. The program consists of two randomized, double-blind, vehicle-controlled Phase III clinical trials. Each pivotal trial is planned to enroll approximately 420 subjects aged 9 and above at a 2:1 ratio, with a power of 99%. The objective of the study is to evaluate the efficacy and safety of TWIN, a topical cream containing encapsulated tretinoin and encapsulated benzoyl peroxide, compared to vehicle when applied once daily for 12 weeks in patients with moderate-to-severe acne vulgaris. The pivotal TWIN clinical program is being executed under a special protocol assessment, or SPA, agreement with the FDA. The SPA provides agreement that the study design, clinical endpoints and statistical analysis approach for Sol-Gel’s Phase III program evaluating TWIN for the treatment of patients with acne vulgaris will be deemed adequate to support an NDA filing for marketing approval.

https://thefly.com/landingPageNews.php?id=2837771