{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T14:07:24Z","timestamp":1786975644916,"version":"build-2736575974"},"reference-count":29,"publisher":"American Medical Association (AMA)","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Dermatol"],"published-print":{"date-parts":[[2023,6,1]]},"abstract":"\n Importance<\/jats:title>\n Current topical treatment options for seborrheic dermatitis are limited by efficacy and\/or safety.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To assess safety and efficacy of roflumilast foam, 0.3%, in adult patients with seborrheic dermatitis affecting the scalp, face, and\/or trunk.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n This multicenter (24 sites in the US and Canada) phase 2a, parallel group, double-blind, vehicle-controlled clinical trial was conducted between November 12, 2019, and August 21, 2020. Participants were adult (aged \u226518 years) patients with a clinical diagnosis of seborrheic dermatitis for a 3-month or longer duration and Investigator Global Assessment (IGA) score of 3 or greater (at least moderate), affecting 20% or less body surface area, including scalp, face, trunk, and\/or intertriginous areas. Data analysis was performed from September to October 2020.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Once-daily roflumilast foam, 0.3% (n\u2009=\u2009154), or vehicle foam (n\u2009=\u200972) for 8 weeks.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n The main outcome was IGA success, defined as achievement of IGA score of clear or almost clear plus 2-grade improvement from baseline, at week 8. Secondary outcomes included IGA success at weeks 2 and 4; achievement of erythema score of 0 or 1 plus 2-grade improvement from baseline at weeks 2, 4, and 8; achievement of scaling score of 0 or 1 plus 2-grade improvement from baseline at weeks 2, 4, and 8; change in Worst Itch Numeric Rating Scale (WI-NRS) score from baseline; and WI-NRS success, defined as achievement of 4-point or greater WI-NRS score improvement in patients with baseline WI-NRS score of 4 or greater. Safety and tolerability were also assessed.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n A total of 226 patients (mean [SD] age, 44.9 [16.8] years; 116 men, 110 women) were randomized to roflumilast foam (n\u2009=\u2009154) or vehicle foam (n\u2009=\u200972). At week 8, 104 (73.8%) roflumilast-treated patients achieved IGA success compared with 27 (40.9%) in the vehicle group (\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001). Roflumilast-treated patients had statistically significantly higher rates of IGA success vs vehicle at week 2, the first time point assessed. Mean (SD) reductions (improvements) on the WI-NRS at week 8 were 59.3% (52.5%) vs 36.6% (42.2%) in the roflumilast and vehicle groups, respectively (\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001). Roflumilast was well tolerated, with the rate of adverse events similar to that of the vehicle foam.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n The results from this phase 2a randomized clinical trial of once-daily roflumilast foam, 0.3%, demonstrated favorable efficacy, safety, and local tolerability in the treatment of erythema, scaling, and itch caused by seborrheic dermatitis, supporting further investigation as a nonsteroidal topical treatment.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT04091646<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamadermatol.2023.0846","type":"journal-article","created":{"date-parts":[[2023,5,3]],"date-time":"2023-05-03T11:06:50Z","timestamp":1683112010000},"page":"613","source":"Crossref","is-referenced-by-count":37,"title":["Efficacy of Roflumilast Foam, 0.3%, in Patients With Seborrheic Dermatitis"],"prefix":"10.1001","volume":"159","author":[{"given":"Matthew J.","family":"Zirwas","sequence":"first","affiliation":[{"name":"Dermatologists of the Central States, Bexley, Ohio"},{"name":"Probity Medical Research, Bexley, Ohio"},{"name":"Ohio University, Bexley"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zoe D.","family":"Draelos","sequence":"additional","affiliation":[{"name":"Dermatology Consulting Services, High Point, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janet","family":"DuBois","sequence":"additional","affiliation":[{"name":"DermResearch, Inc, Austin, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leon H.","family":"Kircik","sequence":"additional","affiliation":[{"name":"Icahn School of Medicine at Mount Sinai, New York, New York"},{"name":"Physicians Skin Care, PLLC, Louisville, Kentucky"},{"name":"Indiana Medical Center, Indianapolis"},{"name":"Skin Sciences, PLLC, Louisville, Kentucky"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angela Y.","family":"Moore","sequence":"additional","affiliation":[{"name":"Arlington Center for Dermatology, Arlington Research Center, Arlington, Texas"},{"name":"Baylor University Medical Center, Dallas, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linda","family":"Stein Gold","sequence":"additional","affiliation":[{"name":"Henry Ford Medical Center, Detroit, Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"Alonso-Llamazares","sequence":"additional","affiliation":[{"name":"Driven Research LLC, Coral Gables, Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Bukhalo","sequence":"additional","affiliation":[{"name":"Arlington Dermatology, Rolling Meadows, Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suzanne","family":"Bruce","sequence":"additional","affiliation":[{"name":"SBA Dermatology, Houston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimmie","family":"Eads","sequence":"additional","affiliation":[{"name":"The Indiana Clinical Trials Center, PC, Plainfield"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence J.","family":"Green","sequence":"additional","affiliation":[{"name":"George Washington University School of Medicine, Rockville, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott T.","family":"Guenthner","sequence":"additional","affiliation":[{"name":"The Dermatology Center of Indiana, PC, Plainfield"},{"name":"The Indiana Clinical Trials Center, PC, Plainfield"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura K.","family":"Ferris","sequence":"additional","affiliation":[{"name":"University of Pittsburgh, Department of Dermatology, Pittsburgh, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seth B.","family":"Forman","sequence":"additional","affiliation":[{"name":"ForCare Medical Center, Tampa, Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven E.","family":"Kempers","sequence":"additional","affiliation":[{"name":"Minnesota Clinical Study Center, Fridley"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward","family":"Lain","sequence":"additional","affiliation":[{"name":"Sanova Dermatology, Austin, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles W.","family":"Lynde","sequence":"additional","affiliation":[{"name":"University of Toronto, Toronto, Ontario, Canada"},{"name":"Lynde Centre for Dermatology, Markham, Ontario, Canada"},{"name":"Probity Medical Research, Markham, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David M.","family":"Pariser","sequence":"additional","affiliation":[{"name":"Eastern Virginia Medical School, Norfolk"},{"name":"Virginia Clinical Research, Inc, Norfolk"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Darryl P.","family":"Toth","sequence":"additional","affiliation":[{"name":"XLR8 Medical Research, Windsor, Ontario, Canada"},{"name":"Probity Medical Research, Windsor, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul S.","family":"Yamauchi","sequence":"additional","affiliation":[{"name":"David Geffen School of Medicine at UCLA, Los Angeles, California"},{"name":"Dermatology Institute & Skin Care Center, Inc, Santa Monica, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert C.","family":"Higham","sequence":"additional","affiliation":[{"name":"Arcutis Biotherapeutics, Inc, Westlake Village, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Krupa","sequence":"additional","affiliation":[{"name":"Arcutis Biotherapeutics, Inc, Westlake Village, 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