The article entitled, “Safety and efficacy of hydrogen peroxide topical solution, 40% (w/w) in patients with seborrheic keratoses: results from two identical, randomized, double-blind, placebo-controlled, Phase 3 studies (A-101-SEBK-301/302),”1 summarized the pivotal results demonstrating the safety and efficacy of ESKATA in treating raised seborrheic keratoses after one to two treatments.
ESKATA is the first and only
“We are extremely pleased to have the results of these two pivotal Phase 3 SK trials published in such a prestigious medical journal,” noted
This study was funded by
Important Safety Information and Approved Use
ESKATA can cause serious side effects, including:
- Eye problems. Eye problems can happen if ESKATA™ (hydrogen peroxide) topical solution, 40% (w/w) gets into your eyes, including: ulcers or small holes in your eyes, scarring, redness, irritation, eyelid swelling, severe eye pain, and permanent eye injury, including blindness.
- If ESKATA accidentally gets into your eyes, your healthcare provider will tell you to flush them well with water for 15 to 30 minutes. Your healthcare provider may send you to another healthcare provider if needed.
- Local skin reactions. Skin reactions have happened in and around the treatment area after application of ESKATA. Severe skin reactions can include: breakdown of the outer layer of the skin (erosion), ulcers, blisters and scarring. Tell your healthcare provider if you have any skin reactions during treatment with ESKATA.
The most common side effects of ESKATA include: itching, stinging, crusting, swelling, redness and scaling.
Your healthcare provider will not apply another treatment of ESKATA if your treated area is still irritated from the previous treatment.
Tell your healthcare provider right away if ESKATA gets into your eyes, mouth or nose during application. ESKATA is for topical use on the skin only, and is not for use in your eyes, mouth or vagina.
These are not all the possible side effects of ESKATA.
Approved Use for ESKATA
ESKATA is a prescription medicine used to treat seborrheic keratoses that are raised.
ESKATA is for use as an in-office treatment. ESKATA is applied by your healthcare provider and is not for use at home.
You are encouraged to report negative side effects of prescription drugs to the FDA. Contact Aclaris Therapeutics, Inc. at 1-833-ACLARIS or 1-833-225-2747 or FDA at 1-800-
Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan," "potential," "will," and similar expressions, and are based on Aclaris' current beliefs and expectations. These forward-looking statements include expectations regarding the commercial use of ESKATA and the expansion of our intellectual property portfolio covering ESKATA. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris' reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of Aclaris' Annual Report on Form 10-K filed for the year ended
Senior Vice President
Corporate Strategy/Investor Relations
1 Baumann LS, Blauvelt A, Draelos ZD, Kempers SE, Lupo MP, Schlessinger J, Smith SR, Wilson DC, Bradshaw M, Estes E, Shanler SD, Safety and efficacy of hydrogen peroxide topical solution, 40% (w/w) in patients with seborrheic keratoses: results from two identical, randomized, double-blind, placebo-controlled, phase 3 studies (A-101-SEBK-301/302),
Source: Aclaris Therapeutics, Inc.