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

Brennan, M. T. et al. (2022) Efficacy and safety of a novel mucoadhesive clobetasol patch for treatment of erosive oral lichen planus: A phase 2 randomized clinical trial. Journal of Oral Pathology and Medicine, 51(1), pp. 86-97. (doi: 10.1111/jop.13270) (PMID:34907617)

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.

• Item Type: Articles
• Additional Information: Research Funding: Innovation Fund Denmark. Grant Number: 5180-00005B.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Culshaw, Professor Shauna
• Authors: Brennan, M. T., Madsen, L. S., Saunders, D. P., Napenas, J. J., McCreary, C., Ni Riordain, R., Pedersen, A. M. L., Fedele, S., Cook, R. J., Abdelsayed, R., Llopiz, M. T., Sankar, V., Ryan, K., Culton, D. A., Akhlef, Y., Castillo, F., Fernandez, I., Jurge, S., Kerr, A. R., McDuffie, C., McGaw, T., Mighell, A., Sollecito, T. P., Schlieve, T., Carrozzo, M., Papas, A., Bengtsson, T., Al‐Hashimi, I., Burke, L., Burkhart, N. W., Culshaw, S., Desai, B., Hansen, J., Jensen, P., Menné, T., Patel, P. B., Thornhill, M., Treister, N., and Ruzicka, T.
• College/School: College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing > Dental School
• Journal Name: Journal of Oral Pathology and Medicine
• Publisher: Wiley
• ISSN: 0904-2512
• ISSN (Online): 1600-0714
• Published Online: 14 December 2021