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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

Lookup NU author(s): Professor Marco Carrozzo


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© 2021 John Wiley & Sons A/S. Published by John Wiley & Sons LtdBackground: 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.

Publication metadata

Author(s): Brennan MT, Madsen LS, Saunders DP, Napenas JJ, McCreary C, Ni Riordain R, Pedersen AML, Fedele S, Cook RJ, Abdelsayed R, Llopiz MT, Sankar V, Ryan K, Culton DA, Akhlef Y, Castillo F, Fernandez I, Jurge S, Kerr AR, McDuffie C, McGaw T, Mighell A, Sollecito TP, Schlieve T, Carrozzo M, Papas A, Bengtsson T, Al-Hashimi I, Burke L, Burkhart NW, Culshaw S, Desai B, Hansen J, Jensen P, Menne T, Patel PB, Thornhill M, Treister N, Ruzicka T

Publication type: Article

Publication status: Published

Journal: Journal of Oral Pathology and Medicine

Year: 2022

Volume: 51

Issue: 1

Pages: 86-97

Print publication date: 01/01/2022

Online publication date: 14/12/2021

Acceptance date: 07/12/2021

ISSN (print): 0904-2512

ISSN (electronic): 1600-0714

Publisher: John Wiley and Sons Inc


DOI: 10.1111/jop.13270

PubMed id: 34907617


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