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

• Published in: Journal of oral pathology & medicine 2022-01, Vol.51 (1), p.86-97
• Main 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
• Format: Article
• Language: English
• Subjects: Administration, Topical; Candidiasis; Clinical trials; clobetasol; Clobetasol - adverse effects; erosive; Female; Glucocorticoids; Humans; Inflammatory diseases; Lichen planus; Lichen Planus, Oral - drug therapy; Male; Middle Aged; mucoadhesive patch; Mucosa; oral lichen planus; Pain; Patients; Placebos; Quality of Life; Safety; Statistical analysis; treatment; Ulcers
• ISSN: 0904-2512; 1600-0714
• DOI: 10.1111/jop.13270

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.