{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T01:14:10Z","timestamp":1787015650294,"version":"build-2736575974"},"reference-count":19,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2022,1,13]],"date-time":"2022-01-13T00:00:00Z","timestamp":1642032000000},"content-version":"vor","delay-in-days":12,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100012774","name":"Innovationsfonden","doi-asserted-by":"publisher","award":["5180\u201000005B"],"award-info":[{"award-number":["5180\u201000005B"]}],"id":[{"id":"10.13039\/100012774","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Oral Pathology Medicine"],"published-print":{"date-parts":[[2022,1]]},"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n \n Oral lichen planus (OLP) is a chronic inflammatory disorder of the oral mucosa. Currently there is no approved treatment for OLP. We report on the efficacy and safety of a novel mucoadhesive clobetasol patch (Rivelin\n \u00ae<\/jats:sup>\n \u2010CLO) for the treatment of OLP.\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n Patients with confirmed OLP and measurable symptomatic ulcer(s) participated in a randomized, double\u2010blind, placebo\u2010controlled, multicenter clinical trial testing a novel mucoadhesive clobetasol patch (Rivelin\n \u00ae<\/jats:sup>\n \u2010CLO) in OLP across Europe, Canada, and the United States. Patients were randomized to placebo (nonmedicated), 1, 5, 20\u00a0\u00b5g Clobetasol\/patch, twice daily, for 4\u00a0weeks. The primary endpoint was change in total ulcer area compared to baseline. Secondary endpoints included improvement from baseline in pain, disease activity, and quality of life.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Data were analyzed and expressed as mean [SD]. One hundred thirty\u2010eight patients were included in the study; 99 females and 39\u00a0males, mean age was 61.1 [11.6] years. Statistical analyses revealed that treatment with 20\u2010\u03bcg Rivelin\n \u00ae<\/jats:sup>\n \u2010CLO patches demonstrated significant improvement with ulcer area (\n p<\/jats:italic>\n \u00a0=\u00a00.047), symptom severity (\n p<\/jats:italic>\n \u00a0=\u00a00.001), disease activity (\n p<\/jats:italic>\n \u00a0=\u00a00.022), pain (\n p<\/jats:italic>\n \u00a0=\u00a00.012), and quality of life (\n p<\/jats:italic>\n \u00a0=\u00a00.003) as compared with placebo. Improvement in OLP symptoms from beginning to the end of the study was reported as very much better (best rating) in the 20\u2010\u00b5g group (25\/32) patients compared to the placebo group (11\/30), (\n p<\/jats:italic>\n \u00a0=\u00a00.012). Adverse events were mild\/moderate. Candidiasis incidence was low (2%).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n Rivelin\n \u00ae<\/jats:sup>\n \u2010CLO patches were superior to placebo demonstrating statistically significant, clinically relevant efficacy in objective and subjective improvement and, with a favorable safety profile.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/jop.13270","type":"journal-article","created":{"date-parts":[[2021,12,15]],"date-time":"2021-12-15T01:54:34Z","timestamp":1639533274000},"page":"86-97","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":41,"title":["Efficacy and safety of a novel mucoadhesive clobetasol patch for treatment of erosive oral lichen planus: A phase 2 randomized clinical trial"],"prefix":"10.1111","volume":"51","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0638-4335","authenticated-orcid":false,"given":"Michael T.","family":"Brennan","sequence":"first","affiliation":[{"name":"Department of Oral Medicine Atrium Health Carolinas Medical Center Charlotte North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lars Siim","family":"Madsen","sequence":"additional","affiliation":[{"name":"Afyx Therapeutics A\/S Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deborah P.","family":"Saunders","sequence":"additional","affiliation":[{"name":"Health Sciences North Northeast Cancer Centre Sudbury Ontario Canada"},{"name":"Northern Ontario School of Medicine Sudbury Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joel J.","family":"Napenas","sequence":"additional","affiliation":[{"name":"Department of Oral Medicine Atrium Health Carolinas Medical Center Charlotte North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"McCreary","sequence":"additional","affiliation":[{"name":"College of Medicine and Health Cork University Dental School and Hospital University College Cork Cork Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richeal","family":"Ni Riordain","sequence":"additional","affiliation":[{"name":"College of Medicine and Health Cork University Dental School and Hospital University College Cork Cork Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6424-5803","authenticated-orcid":false,"given":"Anne Marie Lynge","family":"Pedersen","sequence":"additional","affiliation":[{"name":"University of Copenhagen Department of Odontology Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9006-9412","authenticated-orcid":false,"given":"Stefano","family":"Fedele","sequence":"additional","affiliation":[{"name":"UCL Eastman Dental Institute and UCLH NIHR Biomedical Research Centre University College London London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard J.","family":"Cook","sequence":"additional","affiliation":[{"name":"Faculty of Dentistry Oral & Craniofacial Sciences Oral Medicine & Oral Clinical Research Unit Guy\u2019s Hospital Campus King's College London London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rafik","family":"Abdelsayed","sequence":"additional","affiliation":[{"name":"The Dental College of Georgia Augusta University Augusta Georgia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria T.","family":"Llopiz","sequence":"additional","affiliation":[{"name":"Vitae Research Center LLC Miami Miami Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vidya","family":"Sankar","sequence":"additional","affiliation":[{"name":"Division of Oral Medicine and Dentistry Brigham and Women's Hospital Boston Massachusetts USA"},{"name":"Tufts University School of Dental Medicine Boston Massachusetts 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