Brennan, MT;
Madsen, LS;
Saunders, DP;
Napenas, JJ;
McCreary, C;
Ni Riordain, R;
Pedersen, AML;
... Ruzicka, T; + view all
(2022)
Efficacy and Safety of a Novel Mucoadhesive Clobetasol Patch for Treatment of Erosive Oral Lichen Planus.
Journal of Oral Pathology & Medicine
, 51
(1)
pp. 86-97.
10.1111/jop.13270.
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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.
| Type: | Article |
|---|---|
| Title: | Efficacy and Safety of a Novel Mucoadhesive Clobetasol Patch for Treatment of Erosive Oral Lichen Planus |
| Location: | Denmark |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1111/jop.13270 |
| Publisher version: | https://doi.org/10.1111/jop.13270 |
| Language: | English |
| Additional information: | This version is the author accepted manuscript. For information on re-use, please refer to the publisher's terms and conditions. |
| Keywords: | Clobetasol, Erosive, Mucoadhesive Patch, Oral Lichen Planus, Treatment |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Eastman Dental Institute |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10140923 |
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