{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,30]],"date-time":"2026-03-30T17:06:47Z","timestamp":1774890407221,"version":"3.50.1"},"reference-count":27,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2023,6,5]],"date-time":"2023-06-05T00:00:00Z","timestamp":1685923200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,9,15]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Scalp psoriasis affects most patients with psoriasis, but it can be difficult to treat.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>To evaluate the efficacy and safety of once-daily roflumilast foam 0.3% on scalp and body psoriasis.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In a phase IIb randomized controlled trial, adults and adolescents aged \u2265 12\u2005years with scalp and body psoriasis were randomized (2 : 1) to roflumilast foam 0.3% or vehicle for 8 weeks. The primary efficacy endpoint was scalp Investigator Global Assessment (S-IGA) success (score of \u2018clear\u2019 or \u2018almost clear\u2019 plus \u2265 2-grade improvement from baseline) at week 8. Safety and tolerability were also evaluated.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Significantly more roflumilast-treated patients (59.1%) than vehicle-treated patients (11.4%) achieved S-IGA success at week 8 (P &amp;lt; 0.001); differences favoured roflumilast as early as the first postbaseline visit at week 2 (P &amp;lt; 0.001). Significant improvements were also seen for secondary endpoints, including body IGA success, Scalp Itch Numeric Rating Scale and the Psoriasis Scalp Severity Index. The safety of roflumilast was generally similar to vehicle. Patients treated with roflumilast experienced low rates of treatment-emergent adverse events (AEs), with few discontinuations due to an AE. Few patients with skin of colour (11%) and few adolescents (0.7%) were included.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The results support the further development of roflumilast foam for treating scalp and body psoriasis.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/bjd\/ljad182","type":"journal-article","created":{"date-parts":[[2023,6,9]],"date-time":"2023-06-09T13:44:18Z","timestamp":1686318258000},"page":"392-399","source":"Crossref","is-referenced-by-count":20,"title":["Once-daily roflumilast foam 0.3% for scalp and body psoriasis: a randomized, double-blind, vehicle-controlled phase IIb study"],"prefix":"10.1093","volume":"189","author":[{"given":"Leon H","family":"Kircik","sequence":"first","affiliation":[{"name":"Icahn School of Medicine at Mount Sinai , New York, NY , USA"},{"name":"Indiana Medical Center , Indianapolis, IN , USA"},{"name":"Physicians Skin Care PLLC , Louisville, KY , USA"},{"name":"Skin Sciences PLLC , Louisville, KY , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Javier","family":"Alonso-Llamazares","sequence":"additional","affiliation":[{"name":"Driven Research LLC , Coral Gables, FL , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Neal","family":"Bhatia","sequence":"additional","affiliation":[{"name":"Therapeutics Clinical Research , San Diego, CA , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Bukhalo","sequence":"additional","affiliation":[{"name":"Arlington Dermatology , Rolling Meadows, IL , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alim R","family":"Devani","sequence":"additional","affiliation":[{"name":"Dermatology Research Institute , Calgary, AB , Canada"},{"name":"Skin Health and Wellness Centre , Calgary, AB , Canada"},{"name":"Probity Medical Research , Calgary, AB , Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zoe D","family":"Draelos","sequence":"additional","affiliation":[{"name":"Dermatology Consulting Services, High Point , NC , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Janet","family":"DuBois","sequence":"additional","affiliation":[{"name":"DermResearch Inc. , Austin, TX , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Melinda J","family":"Gooderham","sequence":"additional","affiliation":[{"name":"SkiN Centre for Dermatology , Peterborough, ON , Canada"},{"name":"Probity Medical Research , Peterborough, ON , Canada"},{"name":"Queen\u2019s University , Peterborough, ON , Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steven E","family":"Kempers","sequence":"additional","affiliation":[{"name":"Minnesota Clinical Study Center , Fridley, MN , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Edward\u00a0","family":"Lain","sequence":"additional","affiliation":[{"name":"Sanova Dermatology , Austin, TX , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"Lee","sequence":"additional","affiliation":[{"name":"Progressive Clinical Research , San Antonio, TX , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Angela","family":"Moore","sequence":"additional","affiliation":[{"name":"Arlington Research Center , Arlington, TX , USA"},{"name":"Baylor University Medical Center , Dallas, TX , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2971-0199","authenticated-orcid":false,"given":"Dedee F","family":"Murrell","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, University of NSW , Sydney , Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9557-3642","authenticated-orcid":false,"given":"Kim A","family":"Papp","sequence":"additional","affiliation":[{"name":"Probity Medical Research , Waterloo, ON , Canada"},{"name":"K. Papp Clinical Research , Waterloo, ON , Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David M","family":"Pariser","sequence":"additional","affiliation":[{"name":"Eastern Virginia Medical School , Norfolk, VA , USA"},{"name":"Virginia Clinical Research Inc. , Norfolk, VA , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rodney\u00a0","family":"Sinclair","sequence":"additional","affiliation":[{"name":"Sinclair Dermatology , East Melbourne , Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew","family":"Zirwas","sequence":"additional","affiliation":[{"name":"Dermatologists of the Central States, Probity Medical Research , Bexley, OH , USA"},{"name":"Ohio University , Bexley, OH , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patrick","family":"Burnett","sequence":"additional","affiliation":[{"name":"Arcutis Biotherapeutics Inc. , Westlake Village, CA , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert C","family":"Higham","sequence":"additional","affiliation":[{"name":"Arcutis Biotherapeutics Inc. , Westlake Village, CA , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Krupa","sequence":"additional","affiliation":[{"name":"Arcutis Biotherapeutics Inc. , Westlake Village, CA , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David R","family":"Berk","sequence":"additional","affiliation":[{"name":"Arcutis Biotherapeutics Inc. , Westlake Village, CA , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2023,6,5]]},"reference":[{"key":"2023091515303998100_ljad182-B1","doi-asserted-by":"crossref","first-page":"46","DOI":"10.1159\/000504841","article-title":"Characterization of patients with psoriasis in challenging-to-treat body areas in the Corrona Psoriasis Registry","volume":"237","author":"Callis Duffin","year":"2021","journal-title":"Dermatology"},{"key":"2023091515303998100_ljad182-B2","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1186\/s12895-020-00099-7","article-title":"Epidemiology of psoriasis in hard-to-treat body locations: data from the Danish skin cohort","volume":"20","author":"Egeberg","year":"2020","journal-title":"BMC Dermatol"},{"key":"2023091515303998100_ljad182-B3","doi-asserted-by":"crossref","first-page":"31","DOI":"10.1159\/000017972","article-title":"Evaluation of topical drug treatment in psoriasis","volume":"197","author":"van de Kerkhof","year":"1998","journal-title":"Dermatology"},{"key":"2023091515303998100_ljad182-B4","first-page":"33","article-title":"Management of scalp psoriasis: current perspectives","volume":"6","author":"Blakely","year":"2016","journal-title":"Psoriasis (Auckl)"},{"key":"2023091515303998100_ljad182-B5","doi-asserted-by":"crossref","first-page":"769","DOI":"10.1007\/s13555-021-00521-z","article-title":"Scalp psoriasis: a literature review of effective therapies and updated recommendations for practical management","volume":"11","author":"Mosca","year":"2021","journal-title":"Dermatol Ther (Heidelb)"},{"key":"2023091515303998100_ljad182-B6","first-page":"327","article-title":"Patients with psoriasis prefer solution and foam vehicles: a quantitative assessment of vehicle preference","volume":"70","author":"Housman","year":"2002","journal-title":"Cutis"},{"key":"2023091515303998100_ljad182-B7","doi-asserted-by":"crossref","first-page":"561","DOI":"10.1080\/14656566.2018.1448788","article-title":"Pharmacotherapeutic approaches for treating psoriasis in difficult-to-treat areas","volume":"19","author":"Kivelevitch","year":"2018","journal-title":"Expert Opin Pharmacother"},{"key":"2023091515303998100_ljad182-B8","first-page":"309","article-title":"Quality of life in patients with scalp psoriasis","volume":"150","author":"Zampieron","year":"2015","journal-title":"G Ital Dermatol Venereol"},{"key":"2023091515303998100_ljad182-B9","doi-asserted-by":"crossref","first-page":"962","DOI":"10.1016\/j.jaad.2008.11.890","article-title":"Treatment of severe scalp psoriasis: from the Medical Board of the National Psoriasis Foundation","volume":"60","author":"Chan","year":"2009","journal-title":"J Am Acad Dermatol"},{"key":"2023091515303998100_ljad182-B10","doi-asserted-by":"crossref","first-page":"1465","DOI":"10.1111\/jdv.15450","article-title":"Itch: an under-\u00adrecognized problem in psoriasis","volume":"33","author":"Elewski","year":"2019","journal-title":"J Eur Acad Dermatol Venereol"},{"key":"2023091515303998100_ljad182-B11","first-page":"21","article-title":"Phosphodiesterase-4 inhibition in psoriasis","volume":"11","author":"Milakovic","year":"2021","journal-title":"Psoriasis (Auckl)"},{"key":"2023091515303998100_ljad182-B12","doi-asserted-by":"crossref","first-page":"229","DOI":"10.1056\/NEJMoa2000073","article-title":"Trial of roflumilast cream for chronic plaque psoriasis","volume":"383","author":"Lebwohl","year":"2020","journal-title":"N Engl J Med"},{"key":"2023091515303998100_ljad182-B13","doi-asserted-by":"crossref","first-page":"1073","DOI":"10.1001\/jama.2022.15632","article-title":"Effect of roflumilast cream vs vehicle cream on chronic plaque psoriasis: the DERMIS-1 and DERMIS-2 randomized clinical trials","volume":"20","author":"Lebwohl","year":"2022","journal-title":"JAMA"},{"key":"2023091515303998100_ljad182-B14","author":"ClinicalTrials.gov"},{"key":"2023091515303998100_ljad182-B15","doi-asserted-by":"crossref","first-page":"775","DOI":"10.1080\/09546634.2019.1577546","article-title":"Qualitative analysis and reproducibility assessment of the Scalp Itch Numeric Rating Scale among patients with moderate to severe plaque psoriasis of the scalp","volume":"30","author":"Wang","year":"2019","journal-title":"J Dermatolog Treat"},{"key":"2023091515303998100_ljad182-B16","doi-asserted-by":"crossref","first-page":"1014","DOI":"10.1016\/j.jval.2013.07.002","article-title":"Item-level psychometric properties for a new patient-reported psoriasis symptom diary","volume":"16","author":"Strober","year":"2013","journal-title":"Value Health"},{"key":"2023091515303998100_ljad182-B17","doi-asserted-by":"crossref","first-page":"157","DOI":"10.1111\/bjd.14464","article-title":"Psychometric properties of the Itch Numeric Rating Scale in patients with moderate-to-severe plaque psoriasis","volume":"175","author":"Kimball","year":"2016","journal-title":"Br J Dermatol"},{"key":"2023091515303998100_ljad182-B18","doi-asserted-by":"crossref","first-page":"210","DOI":"10.1111\/j.1365-2230.1994.tb01167.x","article-title":"Dermatology Life Quality Index (DLQI) \u2013 a simple practical measure for routine clinical use","volume":"19","author":"Finlay","year":"1994","journal-title":"Clin Exp Dermatol"},{"key":"2023091515303998100_ljad182-B19","doi-asserted-by":"crossref","first-page":"392","DOI":"10.5114\/reum.2018.80718","article-title":"Psoriasis in special localizations","volume":"56","author":"Dopytalska","year":"2018","journal-title":"Reumatologia"},{"key":"2023091515303998100_ljad182-B20","doi-asserted-by":"crossref","first-page":"607","DOI":"10.1016\/j.jaad.2005.12.021","article-title":"Determining the relative importance of patient motivations for nonadherence to topical corticosteroid therapy in psoriasis","volume":"55","author":"Brown","year":"2006","journal-title":"J Am Acad Dermatol"},{"key":"2023091515303998100_ljad182-B21","first-page":"s100","article-title":"The clinical relevance and therapeutic benefit of established active ingredients incorporated into advanced foam vehicles: vehicle characteristics can influence and improve patient outcomes","volume":"18","author":"Del Rosso","year":"2019","journal-title":"J Drugs Dermatol"},{"key":"2023091515303998100_ljad182-B22","article-title":"Anionic surfactants and skin tolerability: a pharmaceutical application of Krafft temperature","author":"Berk"},{"key":"2023091515303998100_ljad182-B23","doi-asserted-by":"crossref","first-page":"187","DOI":"10.1159\/000484354","article-title":"Scalp itch: a systematic review","volume":"4","author":"V\u00e1zquez-Herrera","year":"2018","journal-title":"Skin Appendage Disord"},{"key":"2023091515303998100_ljad182-B24","author":"Otezla\u00ae (apremilast) [prescribing information]","year":"2020"},{"key":"2023091515303998100_ljad182-B25","author":"Daliresp\u00ae (roflumilast) [package insert]","year":"2020"},{"key":"2023091515303998100_ljad182-B26","doi-asserted-by":"crossref","first-page":"633","DOI":"10.1111\/j.1365-2133.2009.09593.x","article-title":"Epidemiology and comorbidity of psoriasis in children","volume":"162","author":"Augustin","journal-title":"Br J Dermatol"},{"key":"2023091515303998100_ljad182-B27","first-page":"187","article-title":"Prevalence of psoriasis in children and adolescents in the United States: a claims-based analysis","volume":"17","author":"Paller","year":"2018","journal-title":"J Drugs Dermatol"}],"container-title":["British Journal of Dermatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/bjd\/advance-article-pdf\/doi\/10.1093\/bjd\/ljad182\/51043842\/ljad182.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/bjd\/article-pdf\/189\/4\/392\/51604991\/ljad182.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/bjd\/article-pdf\/189\/4\/392\/51604991\/ljad182.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,15]],"date-time":"2023-09-15T17:13:39Z","timestamp":1694798019000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/bjd\/article\/189\/4\/392\/7190556"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,6,5]]},"references-count":27,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2023,6,5]]},"published-print":{"date-parts":[[2023,9,15]]}},"URL":"https:\/\/doi.org\/10.1093\/bjd\/ljad182","relation":{},"ISSN":["0007-0963","1365-2133"],"issn-type":[{"value":"0007-0963","type":"print"},{"value":"1365-2133","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2023,10]]},"published":{"date-parts":[[2023,6,5]]}}}