EFFICACY AND SAFETY OF A NOVEL MUCOADHESIVE CLOBETASOL PATCH FOR TREATMENT OF ORAL LICHEN PLANUS

Abstract

<h3>Objectives</h3> Oral lichen planus (OLP) is a chronic inflammatory disorder of the oral mucosa with no approved treatment. This was the first and largest global randomized, double-blind, placebo-controlled efficacy and safety OLP trial of a novel mucoadhesive clobetasol propionate patch (Rivelin-CLO). <h3>Study Design</h3> One hundred and thirty-eight adults with symptomatic OLP and ≥1 measurable ulcer were randomized to 1, 5, 20 µg/patch doses or placebo in 1:1:1:1 ratio. Up to 6 patches were applied BID for 4 weeks. The primary endpoint was total ulcer area reduction. Secondary endpoints included patient- and clinician-reported outcome measures. <h3>Results</h3> One hundred and twenty-two patients completed the study. All 138 patients were included in the efficacy and safety analyses. The 20-μg/patch treatment resulted in significant reduction in total ulcer area (−45.0 mm²; <i>P</i> < .05), symptom severity score (−2.967; <i>P</i> < .001; 28-point scale), clinician's severity assessment (−4.453; <i>P</i> < .05; 106-point scale), and oral mucosal disease-specific quality of life (−9.022; <i>P</i> < .05; 104-point scale). One- and 5 ug/patch treatments showed a positive impact but did not broadly reach significance. Patches were universally reported as easy to apply and remove, well tolerated, and associated with high compliance. Most adverse events deemed to be related to treatment were mild and localized and did not result in study discontinuation. <h3>Conclusions</h3> Rivelin-CLO 20 μg/patch treatment for 4 weeks resulted in clinically significant improvement in OLP ulcer size, symptoms, and quality of life, with a favorable safety profile, demonstrating its potential to address a significant unmet need in OLP. (Funded by Afyx Therapeutics A/S; EudraCT 2017-002193-40; ClinicalTrials.gov NCT03592342.)