|The following article is part of conference coverage from the 2018 Fall Clinical Dermatology Conference in Las Vegas, Nevada. Dermatology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in dermatology. Check back for the latest news from Fall Clinical Derm 2018.|
A-101 40 (Eskata™, Aclaris Therapeutics), a stabilized topical solution of 40% hydrogen peroxide, became the first and only FDA-approved topical drug for raised seborrheic keratoses on December 14, 2017. This therapy is safe, effective, and well-tolerated by patients, according to research presented at the 2018 Fall Clinical Dermatology Conference, held October 18-21 in Las Vegas, Nevada.
The proprietary topical solution of stabilized 40% hydrogen peroxide known as A-101 40 was approved to meet the treatment need for a well-tolerated, non-invasive, topical agent for the removal of raised seborrheic keratoses. Researchers in the current open-label, multicenter study (NCT02667288) evaluated the safety and efficacy of A-101 40 for 4 target lesions receiving up to 4 treatments per lesion over the course of 64 days. Eligible seborrheic keratoses could not be pedunculated or in an intertriginous area and had to be stable, typical, less than 0-2 mm thick, between 5 mm and 15 mm long/wide, and located on the extremities, trunk, or face, but not inside or within 5 mm of the orbital rim.
Target seborrheic keratoses were treated on day 1 of the study, then reevaluated on days 22, 43, and 64, and retreated if they had a Physician Lesion Assessment score greater than 0 (0=clear with no visible lesion, 1=near clear with different but not elevated surface appearance, 2= visible but ≤1 mm, 3=visible and >1 mm) After the fourth visit, patients were followed for another 84 days, for a total of 148 study days, at which time study investigators assessed lesions for the final time. Safety was assessed at every visit, including day 148, with the following endpoints: vital signs, local skin reactions, treatment-emergent adverse events (TEAEs), and laboratory evaluations.
Of the 147 patients who began the study, 94.6% (n=139) completed the study. On days 22, 43, and 64, all participants had at least 1 target seborrheic keratosis to be retreated. Mild or moderate TEAEs were reported in 17% (n=25) of patients, and no patient discontinued treatment due to TEAEs or serious adverse events. Only 1 patient experienced a TEAE that was treatment-related (contact/skin irritation). Local skin reactions were predominantly mild, and usually consisted of stinging, crusting, transient pruritus, edema, scaling, and erythema that would most often resolve by the following visit.
Study investigators concluded that “[u]p to 4 treatment sessions with hydrogen peroxide topical solution, 40% (w/w) were safe and well tolerated for patients with seborrheic keratoses.”
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Disclosure: Study funding was provided by Aclaris Therapeutics.
Callender VD, Frankel EH, Weiss JS, et al. Open-label study of a-101, a 40% hydrogen peroxide topical solution, in patients with seborrheic keratosis. Presented at: 2018 Fall Clinical Dermatology Conference. October 18-21, 2018; Las Vegas, NV.