FDA approves ESKATA (hydrogen peroxide) topical solution

 

Aclaris Therapeutics, Inc., announced the FDA approved ESKATA™ (hydrogen peroxide) topical solution, 40% (w/w) for the treatment of seborrheic keratoses (SKs). SKs are non-cancerous skin growths that affect more than 83 million American adults. They may frequently appear in highly visible areas such as the face and neck, and can increase in size and number with age.

With ESKATA, healthcare providers and patients now have a topical, non-invasive treatment option that can clear raised SKs with a low risk of scarring. Until now, there has not been an FDA-approved topical treatment for SKs, a condition that is more prevalent than acne, psoriasis and rosacea combined. Please see ESKATA Full Prescribing Information and Patient Information at www.ESKATA.com.

Stuart Shanler, M.D., co-founder and Chief Scientific Officer at Aclaris, is available to discuss the clinical history of ESKATA and why ESKATA may appeal to patients with raised SKs in aesthetically sensitive areas. Anne M. Chapas, M.D., FAAD, Founder and Medical Director of Union Square Dermatology; Clinical Instructor of Dermatology, Mount Sinai Medical Center, New York; and a consultant for Aclaris is also available to discuss her clinical perspective.

Important Safety Information

ESKATA (hydrogen peroxide) topical solution, 40% (w/w) is for use as an in-office treatment. ESKATA is applied by your healthcare provider and is not for use at home.

Serious eye problems can happen if ESKATAgets into your eyes. If ESKATA accidentally gets into your eyes, your healthcare provider will tell you to flush them well with water for 15 to 30 minutes.

Skin reactions occurred in and around the treatment area after application of ESKATA. Some were severe, including breakdown of the outer layer of the skin (erosion), ulcers, blisters and scarring.

The most common side effects of ESKATA include itching, stinging, crusting, swelling, redness and scaling.

Tell your healthcare provider about any side effects that bother you or do not go away. Tell your healthcare provider right away if ESKATA gets into your eyes, mouth or nose during application.

Approved Use for ESKATA

ESKATA is a prescription medicine used to treat seborrheic keratoses that are raised.

You are encouraged to report negative side effects of prescription drugs to the FDA. Contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 Please see ESKATA Full Prescribing Information and Patient Information at www.ESKATA.com.

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