Aclaris Therapeutics, Inc. announced positive results from a Phase II clinical trial of the its lead drug, A-101. In the trial, A-101 demonstrated clinically and statistically significant improvements in clearing seborrheic keratoses (SK).

The double-blind, placebo-controlled Phase II clinical trial was designed to evaluate the safety, tolerability, and efficacy of A-101 in removing SKs. The trial used a within-subject design to compare three concentrations of A-101 and vehicle (placebo) in 35 patients with SKs. A-101 achieved statistical significance in clearing SK lesions on the back in a dose-related fashion. A-101 was well tolerated at all concentrations.

“These results are an important step forward in validating the potential of A-101 to successfully remove SK lesions non-invasively and without the unwanted side-effects of current treatments such as scarring or skin pigment changes,” said Dr. Neal Walker, president and CEO of Aclaris. “We recently initiated a Phase IIb study as we continue to advance the clinical development program for A-101.”

SK lesions have a waxy, scaly, slightly elevated appearance and often multiple growths are present. Currently, SK lesions are treated using modalities such as cryosurgery, electrosurgery, curettage, or surgical removal, which often result in pigmentary changes and/or scarring at the treatment site.

“The most common complaint from patients with seborrheic keratosis is the appearance of the lesions, which can lead to social stigma,” said James Leyden, M.D., professor emeritus at the University of Pennsylvania. “There are currently no FDA-approved treatments to address SK. If approved, A-101 could offer patients and physicians an important new option to treat this unmet medical need.”