Aclaris Therapeutics, Inc. initiated two Phase 3 clinical trials to evaluate A-101 Topical Solution for the treatment of seborrheic keratosis (SK). 

The two Phase 3 clinical trials will evaluate the safety and efficacy of A-101 Topical Solution compared with a vehicle solution (placebo).  Approximately 800 subjects will be randomized in these multi-center, double-blinded, vehicle-controlled, clinical trials, which are being conducted at 34 investigational centers within the United States.

“The initiation of the Phase 3 program for A-101 Topical Solution is an important milestone in our development program and follows the positive Phase 2 clinical results and an End-of-Phase 2 meeting with the FDA,” said Christopher Powala, Chief Operating Officer of Aclaris. “Our goal is to offer a new treatment option for patients and physicians to treat SK lesions, a condition for which there are currently no FDA-approved drugs.”