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 Sailesh
AU - Hansen, Jens
AU - Jensen, Pia
AU - Menné, Torkil
AU - Patel, Paras B.
AU - Thornhill, Martin
AU - Treister, Nathaniel
AU - Ruzicka, Thomas
N1 - Funding Information:
Afyx Therapeutics A/S sponsored this research and funded drafting of the manuscript and creation of the figures. Afyx received support from the Innovation Fund Denmark (grant number 5180-00005B). Medical writing and editorial assistance were provided by Anne McDonough. Stefano Fedele received salary support from the UCLH NIHR Biomedical Research Centre. The sponsor participated in the conception and design of the study, analysis and interpretation of the data, statistical analysis, drafting and critical revision of the report, and gave approval to submit the manuscript for publication. The authors thank the late Dr. Morten Schiødt (Rigshospitalet, Copenhagen, Denmark) for his substantial contribution to the enrollment of patients and collection of data at the Department of Oral and Maxillofacial Surgery, Rigshospitalet (Copenhagen, Denmark); Helen Colley, Craig Murdoch, Paul Hatton, and University of Sheffield School of Clinical Dentistry, (Sheffield, UK) for their previous work and advice on product development; the Oral Lichen Planus Support Group for providing insight to patient perspective on OLP and treatment complications and participating in outcome development; Jonathan Silverberg, Jacob Pontoppidan, Christian Vestergaard, and Oskar Hagberg for their service on the Data Monitoring Committee; Leslie Long-Simpson, Malene Bay, and Jenene Noll for key operational support of clinical trials; Kathleen Sullivan for editing the manuscript; and Anne McDonough, who provided medical writing services for Afyx Therapeutics A/S. They also thank the OLP patients who agreed to be interviewed as part of the symptom measurement development process and the patients and healthy volunteers who participated in the clinical trials of Rivelin® patches to date, and staff at the investigational sites and Afyx Therapeutics A/S.
Funding Information:
Afyx Therapeutics A/S sponsored this research and funded drafting of the manuscript and creation of the figures. Afyx received support from the Innovation Fund Denmark (grant number 5180‐00005B). Medical writing and editorial assistance were provided by Anne McDonough. Stefano Fedele received salary support from the UCLH NIHR Biomedical Research Centre. The sponsor participated in the conception and design of the study, analysis and interpretation of the data, statistical analysis, drafting and critical revision of the report, and gave approval to submit the manuscript for publication.
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
VL - 51
SP - 86
EP - 97
JO - Journal of Oral Pathology and Medicine
JF - Journal of Oral Pathology and Medicine
SN - 0904-2512
IS - 1
ER -