FDA Clears Eskata for Treatment of SKs


The FDA has approved Aclaris Therapeutics’ Eskata for the treatment of raised seborrheic keratoses (SKs). The formula is a proprietary high-concentration hydrogen peroxide-based topical solution for application using a targeted pen-like applicator.

“We are proud to offer Eskata to dermatologists and their patients as a treatment that can clear raised SKs without cutting, burning or freezing the skin,” said Stuart D. Shanler, M.D., chief scientific officer of Aclaris. “We believe Eskata may appeal to patients who are bothered by the appearance of their raised SKs—especially in highly visible areas such as the face and neck—and that patients are looking for a treatment that is safe and effective.”

Eskata will be available in spring 2018 as a self-pay aesthetic treatment. While treatment was generally well-tolerated in trials, common side effects include itching, stinging, crusting, swelling, redness and scaling at the site of application.


Eskata received approval based on two pivotal Phase 3 trials wherein patients received up to two treatments of Eskata with one at the start of treatment and a second at week three. Patients treated with Eskata were more likely to have all four treated SKs completely cleared after two treatments than patients who received placebo. 

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