Good news for Aclaris. New data suggest that their drug candidate A-101 40 percent may be an appealing option to remove seborrheic keratosis (SK) lesions in highly visible areas, such as the face, with minimal risk of scarring or hypopigmentation.
The new findings appear in the journal Dermatologic Surgery.
A-101 is an investigational, proprietary, high-concentration hydrogen peroxide-based topical solution that Aclaris is developing as a potential treatment for SK. The FDA’s Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) is December 24, 2017.
If approved, A-101 40 percent would be the first FDA-approved medication for SK.
In the randomized, double-blind, vehicle-controlled Phase 2 trial, the 40 percent and 32.5 percent concentrations were each compared to vehicle in a total of 119 patients.
Greater magnitude of effect was observed with the A-101 40 percent concentration than the 32.5 percent concentration when each was compared to vehicle.
At day 106, the target lesion was clear or near clear in 68 percent of patients in the A-101 40 percent group, 62 percent of patients in the A-101 32.5 percent group, and 5 percent of patients in the vehicle group.
Improvements compared to vehicle were seen after just one treatment, but most patients received a second treatment in accordance with the study protocol.
A-101 solution had a favorable safety and tolerability profile at both concentrations. There were no treatment-related adverse events among patients treated with A-101.
Local skin reactions were predominantly classified as mild and transient. No patients had scarring or hypopigmentation at the end of the trial.
“Sometimes dermatologists determine that the risk of a poor cosmetic outcome is too great in the risk-benefit equation for treatment of SK,” says Neal Walker, MD, President and Chief Executive Officer of Aclaris, in a news release. “We are pleased with the results from this study, which highlight the potential of A-101 40 percent to meet a significant unmet need for a topical, non-invasive treatment for SK.”Next Story