Efficacy and safety of a novel mucoadhesive clobetasol patch for treatment of erosive oral lichen planus: A phase 2 randomized clinical trial. (13th January 2022)

• Record Type: Journal Article
• Authors: 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;
• Is Part Of: Journal of oral pathology & medicine. Volume 51:Number 1(2022)
• Page Start: 86
• Page End: 97
• Publication Date: 2022-01-13
• Subjects: clobetasol -- erosive -- mucoadhesive patch -- oral lichen planus -- treatment; Dentistry -- Periodicals; Teeth -- Diseases -- Periodicals; 617
• DOI: 10.1111/jop.13270
• Languages: English
• ISSNs: 0904-2512

Abstract

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.