Brennan, M., Madsen, L.S., Saunders, D. et al. (36 more authors) (2022) Efficacy and safety of a novel mucoadhesive Clobetasol patch for treatment of erosive oral lichen planus. Journal of Oral Pathology and Medicine, 51 (1). pp. 86-97. ISSN 0904-2512
Abstract
Background
Oral lichen planus (OLP) is a chronic inflammatory disorder of the oral mucosa. Currently there is no approved treatment for oral lichen planus (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 USA. Patients were randomized to placebo (non-medicated), 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 (138) 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.
Metadata
Item Type: | Article |
---|---|
Authors/Creators: |
|
Copyright, Publisher and Additional Information: | © 2021 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd. This is an author-produced version of a paper subsequently published in Journal of Oral Pathology and Medicine. Uploaded in accordance with the publisher's self-archiving policy. |
Keywords: | Clobetasol; Erosive; Mucoadhesive Patch; Oral Lichen Planus; Treatment |
Dates: |
|
Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Clinical Dentistry (Sheffield) |
Funding Information: | Funder Grant number UNIVERSITY OF SHEFFIELD NONE |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 16 Dec 2021 14:02 |
Last Modified: | 13 Jan 2023 01:13 |
Status: | Published |
Publisher: | Wiley |
Refereed: | Yes |
Identification Number: | 10.1111/jop.13270 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:181406 |