TY - JOUR
T1 - Efficacy and safety of a novel mucoadhesive clobetasol patch for treatment of erosive oral lichen planus
T2 - A phase 2 randomized clinical trial
AU - Brennan, Michael T.
AU - Madsen, Lars Siim
AU - Saunders, Deborah P.
AU - Napenas, Joel J.
AU - McCreary, Christine
AU - Ni Riordain, Richeal
AU - Pedersen, Anne Marie Lynge
AU - Fedele, Stefano
AU - Cook, Richard J.
AU - Abdelsayed, Rafik
AU - Llopiz, Maria T.
AU - Sankar, Vidya
AU - Ryan, Kevin
AU - Culton, Donna A.
AU - Akhlef, Yousra
AU - Castillo, Fausto
AU - Fernandez, Inti
AU - Jurge, Sabine
AU - Kerr, Alexander R.
AU - McDuffie, Chad
AU - McGaw, Tim
AU - Mighell, Alan
AU - Sollecito, Thomas P.
AU - Schlieve, Thomas
AU - Carrozzo, Marco
AU - Papas, Athena
AU - Bengtsson, Thomas
AU - Al-Hashimi, Ibtisam
AU - Burke, Laurie
AU - Burkhart, Nancy W.
AU - Culshaw, Shauna
AU - Desai, Bhavik
AU - Hansen, Jens
AU - Jensen, Pia
AU - Menné, Torkil
AU - Patel, Paras B.
AU - Thornhill, Martin
AU - Treister, Nathaniel
AU - Ruzicka, Thomas
N1 - Publisher Copyright:
© 2022 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
PY - 2022/1
Y1 - 2022/1
N2 - 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.
AB - 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.
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U2 - 10.1111/jop.13270
DO - 10.1111/jop.13270
M3 - Article
C2 - 34907617
AN - SCOPUS:85122731110
SN - 0904-2512
VL - 51
SP - 86
EP - 97
JO - Journal of Oral Pathology and Medicine
JF - Journal of Oral Pathology and Medicine
IS - 1
ER -