SYNOPSIS z Seborrheic keratoses (SKs) are among the most common benign cutaneous lesions, affecting approximately 84 million individuals in the United States.1 Removal of SKs by dermatologists often requires invasive cryosurgery, shave excision, electrosurgery, curettage, or laser- or light-based treatment2; an unmet treatment need exists for the safe, noninvasive, and effective removal of SKs3 z Key reasons that individuals with SKs prefer to have them treated or removed include concern with the seriousness of the lesion, physical irritation or pruritus, embarrassment from the visual appearance of the lesion, or the desire to look younger4 z Eskata (hydrogen peroxide topical solution, 40% [w/w]; HP40; Aclaris Therapeutics, Inc., Wayne, PA) is a proprietary, stabilized, noninvasive treatment with demonstrated safety and efficacy in the removal of SKs of the face, trunk, and extremities, and low risk of skin pigmentation changes or scarring3,5,6 — HP40 is the first US Food and Drug Administration (FDA)-approved topical treatment for individuals with raised SKs3,6 OBJECTIVE z To describe segments of consumers with raised facial SKs, identify specific concerns regarding treatment to remove SKs and gain an understanding of barriers to treatment for facial/hairline SKs METHODS Study Design z An online survey was conducted between September 28 and October 13, 2017 among 702 eligible participants aged 35–65 years — The sponsor was not identified to survey participants Inclusion Criteria z Eligible participants were diagnosed with SKs by a health care provider (HCP) or self-confirmed the presence of SKs using the definition and example images provided for the survey z In addition, participants were required to meet the following criteria — Bothered by appearance of SKs located on the face or hairline (score ≥3 on a 5-point Likert scale [1 = not at all bothered; 2 = slightly bothered; 3 = somewhat bothered; 4 = moderately bothered; 5 = extremely bothered]) — At least somewhat interested in an FDA-approved topical treatment to remove SKs on the face or hairline — Annual income ≥$75,000 and residing in an urban or suburban area Exclusion Criteria z Survey participant or immediate family member was an employee or consultant for any pharmaceutical, advertising, marketing, market research, or public relations company at the time of survey completion Sample Recruitment Quotas z The sample population was estimated to include 140 males (20%) and 560 females (80%); ≥210 subjects (30%) had visited a dermatologist in the past 2 years z The estimated population by age was categorized as 35–39 years (10%), 40–49 years (40%), 50–59 years (40%), and 60–65 years (10%) z The population recruited for the survey was selected to mirror US Census demographics for race and ethnicity z ≥210 subjects (30%) must have been to a dermatologist in the past 2 years Survey Questions z A summary of survey questions is provided in Table 1 Table 1. Number of Survey Questions Included by Categorya 1. Screening 17 questions 2. Demographics and media habits 4 questions 3. Lifestyle, personality, skin care attitudes and behaviors, and relationship with a dermatologist 24 questions 4. Experience with SKs 26 questions 5. Profile of a product for treatment of SKs 14 questions SKs, seborrheic keratoses. aThe inclusion of some questions was conditional based on previous participant responses. Statistics z Categorical data were presented as frequency and percentage; continuous variables were presented as mean (standard deviation [SD]) RESULTS Demographics z A total of 702 survey participants were enrolled and were consistent with the sample recruitment quotas (Table 2) Table 2. Demographics and Characteristics of Survey Participants Male 142 (20) Age category 35–39 70 (10) 40–49 281 (40) 50–59 281 (40) 60–65 70 (10) Visited dermatologist in previous 2 years 290 (41) Mean (SD) household income, US dollars 120,566 (24,252) Residing in a suburban area 547 (78) Values are n (%) unless indicated otherwise. z The racial and ethnic demographics of enrolled survey participants are summarized in Figure 1 Figure 1. Racial and Ethnic Background of Population Samplea Black, Afro-Caribbean, African American 10% (n=69) Non-Hispanic white or Euro-American 62% (n=436) Hispanic/Latin American 12% (n=81) East Asian/Asian American 13% (n=91) South Asian/Indian American 1% (n=6) Multi-ethnic/racial 3% (n=19) aThe sum of the percentages is greater than 100% due to rounding. z Survey participants reported a Fitzpatrick skin type of I or II (33%), III (42%), IV (16%), and V or VI (9%) z Among survey participants who had visited a dermatologist, the most common reasons for doing so were routine skin cancer check (66%); removal of noncancerous skin growths, marks, or spots (52%); and to have a suspicious mole or spot checked (47%) z A total of 39% of participants reported that they were previously diagnosed with SKs by an HCP — A total of 99% of participants confirmed the presence of spots, growths, or marks similar to the SKs in the images provided Concerns About SKs z Among the 468 participants (67%) with SKs on multiple body locations, SKs on the face or hairline were of greatest concern (86%) z A total of 314 participants (45%) had consulted a professional (eg, HCP, aesthetician) about the SKs on their face or hairline; when asked why, among 208 responders the most common reasons given were concern that the lesion could be cancerous (60%) and dislike of how the spots looked or felt (56%) (Figure 2) Figure 2. Question: Why did you first ask about your facial SKs?a 2 6 10 11 14 20 29 56 60 0 10 20 30 40 50 60 70 Other Friend or family member didn't like the way it looked/felt Friend/family member concerned it could be cancer Made me look like I didn't take care of myself Made me look unhealthy Irritated or itchy and were bothering me Made me look older I didn't like the way it looked/felt Concerned it was skin cancer Survey Responders (n=208), % SKs, seborrheic keratoses. aParticipants could choose more than one response. Coping Strategies for SKs z A majority of survey participants (n=591; 84%) reported attempts to mask or modify their SKs — Makeup application was the most common strategy (53%; 65% of females and 8% of males), followed by use of over-the-counter products, such as wart removers or anti- aging products (44%), and avoidance of sun exposure (27%) (Figure 3) Figure 3. Question: Which of the following things have you ever done to hide, disguise, or deal with the SKs on your face or hairline?a 16 4 6 6 13 13 15 27 44 53 28 3 8 7 20 9 23 25 28 8 13 4 5 6 11 14 17 27 48 65 0 10 20 30 40 50 60 70 Never done any of these Other Wear clothing designed to hide Hide with eyeglasses Avoid looking at or touching them Wear hair in a certain style to cover Pick at them and let them fall o� Stay out of the sun Use OTC products (eg, anti-aging moisturizers) Use make-up to cover up Survey Participants, % Female (n=560) Male (n=142) All (N=702) OTC, over-the-counter; SKs, seborrheic keratoses. aParticipants could choose more than one response. z A majority of survey participants (n=569; 81%) were extremely interested or very interested in receiving treatment for their face/hairline SKs (mean [SD] score = 4.3 [0.8]; Figure 4) Figure 4. Question: Suppose that there was a new FDA-approved topical treatment to remove SKs on the face and hairline. The treatment would be applied in the dermatologist’s office, but your insurance considers this a cosmetic treatment and you’d have to pay for the treatment on your own. Assuming the cost of treatment was reasonable to you, how interested would you be in getting this treatment to remove the SKs on your face/hairline? (N=702) 0 4 15 33 48 0 10 20 30 40 50 1 - Not at all interested 2 - Slightly interested 3 - Somewhat interested 4 - Very interested 5 - Extremely interested Su rv ey P ar ti ci p an ts , % n=28 n=105 n=229 n=340 SKs, seborrheic keratoses. z Despite expressing high levels of interest in treatment, the majority of survey participants (n=502; 72%) elected not to have their facial or hairline SKs removed (Figure 5) z A total of 112 participants (24%) who had SKs on the rest of the body had had them removed or treated Figure 5. Question: Earlier you said you had not had any of the SKs on your face or hairline removed or treated. Please indicate if the factors presented here were a major reason you have not had them treated or removed.a 3 7 10 11 14 14 19 20 21 23 29 38 46 0 5 10 15 20 25 30 35 40 45 50 Couldn't get an appointment with a dermatologist Told need to return for multiple treatments Removing SKs would resolve only one of many other skin concerns Wanted to avoid pain or discomfort of procedure It is easy to cover SKs up Didn't know where to go to have them removed The HCP did not o�er treatment Appearance of SKs do not bother enough Didn't want to risk getting a scar Learned there was not a medical reason Wasn't aware of any treatment options or that they could be removed Out-of-pocket costs too high There are other priorities in my life Survey Responders (n=502), % SKs, seborrheic keratoses. aParticipants could choose more than one response. References 1. Bickers DR, et al. J Am Acad Dermatol. 2006;55:490-500. 2. Jackson JM, et al. J Drugs Dermatol. 2015;14:1119-25. 3. Baumann LS, et al. J Am Acad Dermatol. 2018 Jun 1 [Epub ahead of print]. 4. Del Rosso JQ. J Clin Aesthet Dermatol. 2017;10:16-25. 5. DuBois JC, et al. Dermatol Surg. 2018;44:330-40. 6. Eskata [package insert]. Wayne, PA: Aclaris Therapeutics, Inc.; 2017. Acknowledgments This study was sponsored by Aclaris Therapeutics, Inc., Wayne, PA. Medical writing support was provided by Peloton Advantage, Parsippany, NJ, and funded by Aclaris Therapeutics, Inc. Disclosures Shuai Xu, MD, MSc, reports consulting for Aclaris Therapeutics. He also reports grant support from Pfizer Inc, Leo Pharma, and Novartis. Stacy Wang, PharmD, is an employee of Aclaris Therapeutics, Inc., and Esther Estes, MD, MPH, is a former employee of Aclaris Therapeutics, Inc. Email address for questions or comments: stevexumd@gmail.com CONCLUSIONS 1 Individuals with SKs on the face or hairline have concerns about potential skin cancer and/or appearance 2 Over two-thirds of patients reported interest in removal of SKs but did not have them removed; reasons cited included lack of awareness that removal treatment options exist (29%) and never being offered the option by their HCPs (19%) 3 Findings from this survey highlight the negative impact that benign SKs could have on patients. In addition, the findings inform dermatologists and other HCPs on missed opportunities to improve communications with patients on SK treatment options The Hidden Impact of Seborrheic Keratoses: Analysis of a Psychometric Survey of an Ethnically Diverse Cohort of U.S. Adults Shuai Xu, MD, MSc,1 Stacy Wang, PharmD,2 Esther Estes, MD, MPH3 1Northwestern University Feinberg School of Medicine, Chicago, IL; 2Aclaris Therapeutics, Inc., Wayne, PA; 3Formerly of Aclaris Therapeutics, Inc., Wayne, PA Presented at the Fall Clinical Dermatology Conference, October 18–21, 2018, Las Vegas, Nevada