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New Observational Study Demonstrates Patient Impact of Seborrheic Keratosis, A Common, Undertreated Skin Condition Affecting 83.8 Million Americans

Results Underscore Desire for Effective, Non-Scarring Treatment Option

MALVERN, Pa., Oct. 19, 2016 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS) today announced results from an observational  study that found patients with asymptomatic seborrheic keratosis (SK) are bothered by their highly visible skin lesions and very interested in treatment options to improve their appearance, even if a cost were associated with treatment. The study was conducted in dermatology practices by Burke, Inc. on behalf of Aclaris.

Often undertreated, SKs impact more than 83 million people in the U.S., and though benign, SKs can have a significant physical and emotional impact on patients. SK lesions frequently appear in highly visible locations; 80% of SK patients have lesions on the face or neck. SK lesions are typically characterized by a waxy, scaly, elevated appearance and vary in color from light tan to dark brown or black.

Results from the prospective observational study will be presented at the annual Fall Clinical Dermatology Conference in Las Vegas on October 20-23, 2016. This is the first study to evaluate the burden on patients with asymptomatic SK lesions, or those that are not irritated or bleeding. The study included 406 patients aged 40-69 with asymptomatic SK lesions in 10 regionally-diverse community dermatology practices who completed questionnaires in their dermatologists’ offices.  

“As a physician, I see the negative effects that SKs cause in many patients every day in practice as they are so common and multiple.  Many patients find SKs to be unsightly and a reminder that they are ‘getting older’.  From their perspective, the SKs should not be there,” said Dr. James Del Rosso, lead study investigator and dermatologist in Las Vegas, Nevada. “This study highlights how patients feel about their condition and what they will do to hide or get rid of their lesions.”

Findings from the study include:

  • The majority of patients (61 percent) took action to hide, disguise, or deal with their SK lesions (e.g., hiding them with clothes, makeup or hair or picking at lesions so they fall off).
  • Approximately one-third (34 percent) of patients had previously asked their dermatologist about treatment for SK, motivated by concerns about appearance as well as health.
  • A vast majority of patients (86 percent) indicated they were somewhat or extremely interested in treatment provided in a dermatologist’s office and were willing to pay a reasonable out-of-pocket fee.
  • Factors that correlated with higher interest in treatment were the presence of lesions on the face or neck.

While no SK treatment has been approved by the U.S. Food and Drug Administration (FDA), invasive procedural treatment options include cryosurgery (freezing), electrodesiccation (burning), curettage and surgery.

“This study confirms there is a strong desire for SK treatment among dermatology patients.  Current treatments are often painful or have undesirable outcomes like scarring or dyspigmentation which leave physicians and patients frustrated with the gap in treatment options,” said Dr. Neal Walker, President and Chief Executive Officer of Aclaris. “There is a significant need for an effective, non-scarring treatment for the millions of people suffering with SKs. To meet this need, we are focused on developing a first-in-class, non-invasive treatment for SK.”

About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a clinical-stage specialty pharmaceutical company focused on identifying, developing, and commercializing innovative and differentiated drugs to address significant unmet needs in dermatology. Aclaris is based in Malvern, Pennsylvania and more information can be found by visiting Aclaris’ website at www.aclaristx.com.

About Seborrheic Keratosis
SK lesions are among the most common non-cancerous skin lesions, affecting over 83 million people in the U.S.i One of the most frequent diagnoses made by dermatologists, SK lesions typically have a waxy, scaly, slightly elevated appearance. They can vary in color from light tan to dark brown or black, and appear on the face, trunk, and extremities. Patients may be affected with just one lesion or dozens of SK lesions. SK does not pose a health risk, though the lesions can become itchy, irritated, and painful. SK lesions usually are treated by cryosurgery, electrodesiccation, curettage or excision. Each of these methods may be painful or can result in pigmentary changes or scarring at the treatment site.

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 clinical development of Aclaris’ A-101 drug candidate for the treatment of SKs. 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 for the year ended December 31, 2015, Aclaris’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the "Financial Information" section of the Investors page of Aclaris' website at http://www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

Aclaris Contact:
Michael Tung, M.D.
Vice President/Investor Relations
484-329-2140
mtung@aclaristx.com

Media Contact: 
Mariann Caprino
TogoRun
917-242-1087
m.caprino@togorun.com 

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