Aclaris Therapeutics, Inc. announced positive results from a Phase 2b clinical trial of the Company's lead drug, A-101. In the trial, A-101 demonstrated clinically and statistically significant improvements in clearing multiple seborrheic keratoses (SK), one of the most common types of skin tumors. Though the lesions are benign, many patients elect to have SK treated, either because the lesions are irritated or are cosmetically concerning.

The double-blind, vehicle-controlled Phase 2b clinical trial was designed to evaluate the safety, tolerability and efficacy of A-101 in removing multiple SK lesions on the trunk and extremities. The trial used a parallel-group design to compare two concentrations of A-101 and vehicle (placebo) in 172 subjects with SK lesions. Results from the study showed A-101 achieved statistical significance in clearing SK lesions in a dose-related fashion.

A-101 was well tolerated at both concentrations studied. This positive outcome represents an important milestone for A-101 and further demonstrates its potential as a non-invasive treatment for SK, a condition for which there are currently no FDA-approved therapies. These study results are promising and suggest that A-101 may have the potential to address an unmet medical need and an investigator on multiple A-101 clinical trials.

While cryotherapy is the most commonly used treatment for the removal of SK lesions, it is painful for patients and sometimes results in permanent hypopigmentation. A well-tolerated, FDA-approved, non-invasive treatment option for SK would be a welcome advance for patients and physicians.