Efficacy and safety of a novel mucoadhesive clobetasol patch for treatment of erosive oral lichen planus: A phase 2 randomized clinical trial

Michael T. Brennan, Lars Siim Madsen, Deborah P. Saunders, Joel J. Napenas, Christine McCreary, Richeal Ni Riordain, Anne Marie Lynge Pedersen, Stefano Fedele, Richard J. Cook, Rafik Abdelsayed, Maria T. Llopiz, Vidya Sankar, Kevin Ryan, Donna A. Culton, Yousra Akhlef, Fausto Castillo, Inti Fernandez, Sabine Jurge, Alexander R. Kerr, Chad McDuffieTim McGaw, Alan Mighell, Thomas P. Sollecito, Thomas Schlieve, Marco Carrozzo, Athena Papas, Thomas Bengtsson, Ibtisam Al-Hashimi, Laurie Burke, Nancy W. Burkhart, Shauna Culshaw, Bhavik Desai, Jens Hansen, Pia Jensen, Torkil Menné, Paras B. Patel, Martin Thornhill, Nathaniel Treister, Thomas Ruzicka

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)86-97
Number of pages12
JournalJournal of Oral Pathology and Medicine
Volume51
Issue number1
DOIs
StatePublished - Jan 2022

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Oral Surgery
  • Otorhinolaryngology
  • Cancer Research
  • Periodontics

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