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Efficacy and safety of a novel mucoadhesive clobetasol patch for treatment of erosive oral lichen planus: A phase 2 randomized clinical trial.
Brennan, Michael T; Madsen, Lars Siim; Saunders, Deborah P; Napenas, Joel J; McCreary, Christine; Ni Riordain, Richeal; Pedersen, Anne Marie Lynge; Fedele, Stefano; Cook, Richard J; Abdelsayed, Rafik; Llopiz, Maria T; Sankar, Vidya; Ryan, Kevin; Culton, Donna A; Akhlef, Yousra; Castillo, Fausto; Fernandez, Inti; Jurge, Sabine; Kerr, Alexander R; McDuffie, Chad; McGaw, Tim; Mighell, Alan; Sollecito, Thomas P; Schlieve, Thomas; Carrozzo, Marco; Papas, Athena; Bengtsson, Thomas; Al-Hashimi, Ibtisam; Burke, Laurie; Burkhart, Nancy W; Culshaw, Shauna; Desai, Bhavik; Hansen, Jens; Jensen, Pia; Menné, Torkil; Patel, Paras B; Thornhill, Martin; Treister, Nathaniel; Ruzicka, Thomas.
Afiliación
  • Brennan MT; Department of Oral Medicine, Atrium Health Carolinas Medical Center, Charlotte, North Carolina, USA.
  • Madsen LS; Afyx Therapeutics A/S, Copenhagen, Denmark.
  • Saunders DP; Health Sciences North, Northeast Cancer Centre, Sudbury, Ontario, Canada.
  • Napenas JJ; Northern Ontario School of Medicine, Sudbury, Ontario, Canada.
  • McCreary C; Department of Oral Medicine, Atrium Health Carolinas Medical Center, Charlotte, North Carolina, USA.
  • Ni Riordain R; College of Medicine and Health, Cork University Dental School and Hospital, University College Cork, Cork, Ireland.
  • Pedersen AML; College of Medicine and Health, Cork University Dental School and Hospital, University College Cork, Cork, Ireland.
  • Fedele S; University of Copenhagen Department of Odontology, Copenhagen, Denmark.
  • Cook RJ; UCL Eastman Dental Institute and UCLH NIHR Biomedical Research Centre, University College London, London, UK.
  • Abdelsayed R; Faculty of Dentistry Oral & Craniofacial Sciences, Oral Medicine & Oral Clinical Research Unit, Guy's Hospital Campus, King's College London, London, UK.
  • Llopiz MT; The Dental College of Georgia, Augusta University, Augusta, Georgia, USA.
  • Sankar V; Vitae Research Center, LLC Miami, Miami, Florida, USA.
  • Ryan K; Division of Oral Medicine and Dentistry, Brigham and Women's Hospital, Boston, Massachusetts, USA.
  • Culton DA; Tufts University School of Dental Medicine, Boston, Massachusetts, USA.
  • Akhlef Y; University of Glasgow Hospital & Dental School, Glasgow, UK.
  • Castillo F; Department of Dermatology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
  • Fernandez I; Department of Oral & Maxillofacial Surgery, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark.
  • Jurge S; QWay Research, Hialeah, Florida, USA.
  • Kerr AR; Valencia Medical & Research Center, Miami, Florida, USA.
  • McDuffie C; University of Sheffield School of Clinical Dentistry, Sheffield, UK.
  • McGaw T; NYU College of Dentistry, New York, New York, USA.
  • Mighell A; ENT Associates of Texas, Frisco, Texas, USA.
  • Sollecito TP; Kaye Edmonton Clinic, Edmonton, Alberta, Canada.
  • Schlieve T; School of Dentistry, The University of Leeds, Leeds, UK.
  • Carrozzo M; School of Dental Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
  • Papas A; UT Southwestern Medical Center, Dallas, Texas, USA.
  • Bengtsson T; School of Dental Sciences, Newcastle University, Newcastle, UK.
  • Al-Hashimi I; Tufts University School of Dental Medicine, Boston, Massachusetts, USA.
  • Burke L; Statmind AB, Lund, Sweden.
  • Burkhart NW; UT Southwestern Medical Center, Dallas, Texas, USA.
  • Culshaw S; Scientific Consultant, Dallas, Texas, USA.
  • Desai B; LORA Group, Royal Oak, Maryland, USA.
  • Hansen J; The International Oral Lichen Planus Support Group, Texas A&M University College of Dentistry, Dallas, Texas, USA.
  • Jensen P; University of Glasgow Hospital & Dental School, Glasgow, UK.
  • Menné T; The Dental College of Georgia, Augusta University, Augusta, Georgia, USA.
  • Patel PB; Afyx Therapeutics A/S, Copenhagen, Denmark.
  • Thornhill M; Afyx Therapeutics A/S, Copenhagen, Denmark.
  • Treister N; Scientific Consultant, Copenhagen, Denmark.
  • Ruzicka T; Texas A&M University College of Dentistry, Dallas, USA.
J Oral Pathol Med ; 51(1): 86-97, 2022 Jan.
Article en En | MEDLINE | ID: mdl-34907617
BACKGROUND: 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® -CLO) for the treatment of OLP. METHODS: Patients with confirmed OLP and measurable symptomatic ulcer(s) participated in a randomized, double-blind, placebo-controlled, multicenter clinical trial testing a novel mucoadhesive clobetasol patch (Rivelin® -CLO) in OLP across Europe, Canada, and the United States. Patients were randomized to placebo (nonmedicated), 1, 5, 20 µg Clobetasol/patch, twice daily, for 4 weeks. 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. RESULTS: Data were analyzed and expressed as mean [SD]. One hundred thirty-eight patients were included in the study; 99 females and 39 males, mean age was 61.1 [11.6] years. Statistical analyses revealed that treatment with 20-µg Rivelin® -CLO patches demonstrated significant improvement with ulcer area (p = 0.047), symptom severity (p = 0.001), disease activity (p = 0.022), pain (p = 0.012), and quality of life (p = 0.003) 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-µg group (25/32) patients compared to the placebo group (11/30), (p = 0.012). Adverse events were mild/moderate. Candidiasis incidence was low (2%). CONCLUSIONS: Rivelin® -CLO patches were superior to placebo demonstrating statistically significant, clinically relevant efficacy in objective and subjective improvement and, with a favorable safety profile.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Clobetasol / Liquen Plano Oral Tipo de estudio: Clinical_trials Aspecto: Patient_preference Límite: Female / Humans / Male / Middle aged Idioma: En Revista: J Oral Pathol Med Asunto de la revista: ODONTOLOGIA / PATOLOGIA Año: 2022 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Dinamarca
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Clobetasol / Liquen Plano Oral Tipo de estudio: Clinical_trials Aspecto: Patient_preference Límite: Female / Humans / Male / Middle aged Idioma: En Revista: J Oral Pathol Med Asunto de la revista: ODONTOLOGIA / PATOLOGIA Año: 2022 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Dinamarca