Sol-Gel Technologies achieves 50% enrollment in Phase 3 Twin program
Sol-Gel Technologies announced that it has completed enrollment of half of the patients in its pivotal Phase 3 clinical trials of Twin in subjects with acne vulgaris. Twin is a once daily topical cream containing a fixed-dose combination of encapsulated benzoyl peroxide and encapsulated tretinoin 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 nine 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 benzoyl peroxide and encapsulated tretinoin, compared to a 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 reflects FDA's agreement that the protocol design, primary endpoints and statistical analysis approach for Sol-Gel's Phase III program evaluating Twin for the treatment of patients with acne vulgaris are acceptable to support a future new drug application filing for marketing approval.