Journal of Clinical and Aesthetic Dermatology

MauiDerm 2017

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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S9 JCAD journal of clinical and aesthetic dermatology May 2017 • Volume 10 • Number 5 (Supplement 1) A ffiliations: Department of D ermatology, Icahn School of Medicine at Mount Sinai, New York, NY Objective: Treatment of actinic keratosis (AK) on the face with ingenol mebutate gel is associated with a high clearance rate, but also with transient localized skin responses (LSRs) that r esolve quickly, without sequelae. The primary objective of this study was to compare the degree of irritation, as measured by LSRs, during ingenol mebutate gel treatment used with or without dimethicone lotion. The secondary objective was AK clearance with both regimens. Additional measures assessed were pruritus and irritation and patient-reported satisfaction. Methods: Eligible adults had two separate, relatively symmetrical 25cm 2 areas on the face containing 3 to 8 nonhypertrophic AKs. They were treated with one cycle of ingenol mebutate gel, 0.015%, on each area. Dimethicone was applied to one of the areas (randomized) once daily, starting on Day 2 and continuing until at least Day 8. LSRs were assessed on Days 2, 4, 8, 15, 29, and 57. Severity of LSRs was assessed on a scale from 0 to 4; the sum of the six scores was the total LSR score (range, 0–24). Pruritus and irritation were assessed at these visits with a visual analog scale (VAS) (range, 0–10). AK counts were assessed at baseline and at Day 57 to determine lesion count reduction. Paired t-test was used to compare responses between the two treatment arms. Patients reported the level of overall satisfaction at Day 59. Incidence of adverse events was also assessed. Results: In total, 20 patients were treated. Mean scores for individual LSRs increased from Day 2 to Day 4 and decreased at all subsequent time points in both arms. Scores were s omewhat lower at Days 8 and 15 in t he ingenol + dimethicone arm versus the ingenol-only arm. This weak trend became stronger for the total composite LSR score. Irritation VAS scores were comparable in both treatment arms, but numerically lower at Day 15 in the ingenol + dimethicone a rm. Pruritus scores were consistent and similar in both arms, with a numerically lower score on Day 15 in the ingenol + dimethicone arm. Patient satisfaction score (mean, 8.0) suggested a high level of satisfaction. AK clearance was comparable in both treatment arms: the mean (SD) number of AKs at baseline for the ingenol-only and the ingenol + dimethicone arms was 6.8 (2.86) and 6.7 (3.25), respectively, and at Day 57 the numbers were 0.5 (0.61) and 0.4 (0.60). All adverse events were mild and related to study drug. Conclusion: In the treatment of AKs of the face, the addition of dimethicone lotion to ingenol mebutate gel slightly lowered the severity of LSRs, although the difference was not statistically significant, likely because of the limited sample size. The reduction in AK lesions over time was consistent and similar in both treatment arms. ATOPIC DERMATITIS The Use of Real-World Data to Evaluate the Association Between Atopic Dermatitis and Cardiovascular Disease: A Retrospective Claims Analysis Presenters: Wu JJ, 1 Armand C, 2 No DJ, 3 Mahajan P, 2 Gadkari A, 4 Andria M, 4 Ghorayeb E, 2 Eckert L 5 Affiliations: 1 Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA; 2 Sanofi, Bridgewater, NJ, USA; 3 Loma Linda University School of Medicine, Loma Linda, CA; 4 Regeneron P harmaceuticals, Inc, Tarrytown, NJ; 5 S anofi, Chilly-Mazarin, France Introduction: Atopic dermatitis (AD) is a chronic, relapsing, inflammatory skin disease clinically characterized by intense pruritus. While a growing body of evidence suggests that AD can be accompanied by a v ariety of systemic diseases, the association between AD and cardiovascular (CV) disease remains unclear. Objective: To determine the incidence of CV disease and major adverse CV events (MACE) in adults with AD and matched non-AD controls, and to evaluate the association of AD with these outcomes. Methods: Data for this retrospective cohort study were from the Truven Health Marketscan ® Claims database from January 1, 2008 to December 31, 2014. Adults (≥18 years) with AD based on ≥2 AD diagnosis codes (ICD-9 691.8; first code=index date) and continuous enrollment ≥12 months pre-index were matched to non-AD controls on age, sex, index date, and follow-up duration. Outcomes were CV disease (coronary heart disease, peripheral artery disease, congestive heart failure, atherosclerosis, peripheral vascular disease, cerebrovascular disease) and major adverse CV events (MACE; myocardial infarction, stroke, angina with hospitalization, coronary revascularization procedure). Patients with CV disease or MACE during the 12-month pre-index period were excluded from the respective analysis. To account for variables that may contribute to CV disease, cohorts were stratified by presence of "metabolic disorders" during pre-index and/or follow-up periods, defined as diabetes, hypoglycemia, hyperlipidemia, hypertension, obesity, and calcium metabolism disorders, and including

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