{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T11:15:03Z","timestamp":1791976503528,"version":"4.4.0"},"reference-count":41,"publisher":"American Medical Association (AMA)","issue":"11","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Dermatol"],"published-print":{"date-parts":[[2024,11,1]]},"abstract":"\n Importance<\/jats:title>\n Safe, effective, and well-tolerated topical treatment options available for long-term use in patients with atopic dermatitis (AD) are limited and associated with low adherence rates.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To evaluate efficacy and safety of once-daily roflumilast cream, 0.15%, vs vehicle cream in patients with AD.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n Two phase 3, randomized, double-blind, vehicle-controlled trials (Interventional Trial Evaluating Roflumilast Cream for the Treatment of Atopic Dermatitis 1 and 2 [INTEGUMENT-1 and INTEGUMENT-2]), included patients from sites in the US, Canada, and Poland. Participants were 6 years or older with mild to moderate AD based on Validated Global Assessment for Atopic Dermatitis (assessed on a 5-point scale ranging from 0 [clear] to 4 [severe]).<\/jats:p>\n <\/jats:sec>\n \n Intervention<\/jats:title>\n Patients were randomized 2:1 to receive roflumilast cream, 0.15%, or vehicle cream once daily for 4 weeks.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n The primary efficacy end point was Validated Investigator Global Assessment for Atopic Dermatitis success at week 4, defined as a score of 0 or 1 plus at least a 2-grade improvement from baseline. Secondary end points included Eczema Area and Severity Index and Worst Itch Numeric Rating Scale. Safety and local tolerability were also evaluated.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Among 1337 patients (654 patients in INTEGUMENT-1 and 683 patients in INTEGUMENT-2), the mean (SD) age was 27.7 (19.2) years, and 761 participants (56.9%) were female. The mean body surface area involved was 13.6% (SD\u2009=\u200911.6%; range, 3.0% to 88.0%). Significantly more patients treated with roflumilast than vehicle achieved the primary end point (INTEGUMENT-1: 32.0% vs 15.2%, respectively;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001; INTEGUMENT-2: 28.9% vs 12.0%, respectively;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001). At week 4, statistically significant differences favoring roflumilast also occurred for the achievement of at least 75% reduction in the Eczema Area and Severity Index (INTEGUMENT-1: 43.2% vs 22.0%, respectively;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001; INTEGUMENT-2: 42.0% vs 19.7%, respectively;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001). Roflumilast was well tolerated with low rates of treatment-emergent adverse events. At each time point, investigators noted no signs of irritation at the application site in 885 patients who were treated with roflumilast (\u226595%), and 885 patients who were treated with roflumilast (90%) reported no or mild sensation at the application site.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n In 2 phase 3 trials enrolling adults and children, once-daily roflumilast cream, 0.15%, improved AD relative to vehicle cream, based on multiple efficacy end points, with favorable safety and tolerability.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifiers:\n NCT04773587<\/jats:ext-link>\n ,\n NCT04773600<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamadermatol.2024.3121","type":"journal-article","created":{"date-parts":[[2024,9,18]],"date-time":"2024-09-18T11:02:49Z","timestamp":1726657369000},"page":"1161","source":"Crossref","is-referenced-by-count":70,"title":["Roflumilast Cream, 0.15%, 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