Aclaris completes enrollment for phase 3 studies of seborrheic keratosis treatment
Aclaris Therapeutics announced that patient enrollment has been completed in two phase 3 clinical trials and a phase 3 open-label safety trial of its candidate A-101 Topical Solution for treating seborrheic keratosis.
A-101, a proprietary high-concentration hydrogen peroxide topical solution, could become the first FDA-approved treatment for seborrheic keratosis, according to the release. Initial results from the three trials are expected in the fourth quarter of 2016, Aclaris reported.
“We are excited to have reached this important milestone for A-101, as it brings us closer to our goal of developing the first non-invasive treatment for [seborrheic keratosis], a condition in which there are currently no FDA-approved treatments,” Stuart Shanler, MD, chief scientific officer of Aclaris, stated in the release. “We look forward to completing the clinical trials for both [seborrheic keratosis] and common warts in the coming months.”
In the two clinical trials, Aclaris will measure the safety and efficacy of A-101(40% concentration) in patients with seborrheic keratosis on the trunk, extremities and face, according to the release. The randomized, double-blind trials will be conducted at 34 investigational centers in the United States.
Aclaris also announced it has completed enrollment of a phase 2 clinical trial measuring safety, tolerability and dose-response to two concentrations of A-101 (40% and 45%) for treating verruca vulgaris, or common warts.
Seborrheic keratosis lesions affect more than 83 million people in the United States, and are one of the most common skin tumors, according to the release.