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

Administration, Topical Clobetasol / adverse effects Female Glucocorticoids Humans Lichen Planus, Oral / drug therapy Male Middle Aged Quality of Life
clobetasol erosive mucoadhesive patch oral lichen planus treatment

Journal

Journal of oral pathology & medicine : official publication of the International Association of Oral Pathologists and the American Academy of Oral Pathology
ISSN: 1600-0714
Titre abrégé: J Oral Pathol Med
Pays: Denmark
ID NLM: 8911934

Informations de publication

Date de publication:
Jan 2022
Historique:
revised: 29 11 2021
received: 10 11 2021
accepted: 07 12 2021
pubmed: 16 12 2021
medline: 22 1 2022
entrez: 15 12 2021
Statut: ppublish

Résumé

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 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 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 Rivelin

Sections du résumé

BACKGROUND 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
METHODS 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
RESULTS 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
CONCLUSIONS CONCLUSIONS
Rivelin

Identifiants

DOI: 10.1111/jop.13270 PMID: 34907617
pubmed: 34907617
doi: 10.1111/jop.13270
doi:

Substances chimiques

Glucocorticoids 0
Clobetasol ADN79D536H

Types de publication

Clinical Trial, Phase II Journal Article Multicenter Study Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

86-97

Subventions

Organisme : Innovation Fund Denmark
ID : 5180-00005B

Informations de copyright

© 2022 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Références

Goldsmith LA, Katz SI, Gilchrest BA, et al. Fitzpatrick’s Dermatology in General Medicine, 8th ed. McGraw-Hill; 2012.
Le Cleach L, Chosidow O. Clinical practice. Lichen Planus. N Engl J Med. 2012;366:723-732. doi:10.1056/NEJMcp1103641
Li C, Tang X, Zheng X, et al. Global prevalence and incidence estimates of oral lichen planus: a systematic review and meta-analysis. JAMA Dermatol. 2020;156:172-181. doi:10.1001/jamadermatol.2019.3797
Radwan-Oczko M. Topical application of drugs used in treatment of oral lichen planus lesions. Adv Clin Exp Med. 2013;22:893-898.
Gupta S, Jawanda MK. Oral lichen planus: an update on etiology, pathogenesis, clinical presentation, diagnosis and management. Indian J Dermatol. 2015;60:222-229. doi:10.4103/0019-5154.156315
Carrozzo M, Porter S, Mercadante V, Fedele S. Oral lichen planus: a disease or a spectrum of tissue reactions? Types, causes, diagnostic algorhythms, prognosis, management strategies. Periodontol 2000. 2019;80:105-125. doi:10.1111/prd.12260
Mortazavi H, Safi Y, Baharvand M, Jafari S, Anbari F, Rahmani S. Oral white lesions: an updated clinical diagnostic decision tree. Dent J. 2019;7(1):15. doi:10.3390/dj7010015
Burke LB, Brennan MT, Ni Riordain R, Madsen LS. Novel oral lichen planus symptom severity measure for assessing patients’ daily symptom experience. Oral Dis. 2019;25(6):1564-1572. doi:10.1111/odi.13109
Radwan-Oczko M, Zwyrtek E, Owczarek JE, Szczesniak D. Psychopathological profile and quality of life of patients with oral lichen planus. J Appl Oral Sci. 2018;26:e20170146. doi:10.1590/1678-7757-2017-0146
Oberti L, Alberta L, Massimo P, Francesco C, Dorina L. Clinical management of oral lichen planus: a systematic review. Mini Rev Med Chem. 2019;19:1049-1059. doi:10.2174/1389557519666190301144157
Lodi G, Manfredi M, Mercadante V, Murphy R, Carrozzo M. Interventions for treating oral lichen planus: corticosteroid therapies. Cochrane Database Syst Rev. 2020;2:CD001168. doi: 10.1002/14651858.CD001168.pub3
Al-Hashimi I, Schifter M, Lockhart PB, et al. Oral lichen planus and oral lichenoid lesions: diagnostic and therapeutic considerations. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007;103(Suppl):S25-S12. doi:10.1016/j.tripleo.2006.11.001
Gonzalez-Moles MA, Scully C. HPA-suppressive effects of aqueous clobetasol propionate in the treatment of patients with oral lichen planus. J Eur Acad Dermatol Venereol. 2010;24:1055-1059. doi:10.1111/j.1468-3083.2010.03591.x
Colley HE, Said Z, Santocildes-Romero ME, et al. Pre-clinical evaluation of novel mucoadhesive bilayer patches for local delivery of clobetasol-17-propionate to the oral mucosa. Biomaterials. 2018;178:134-146. doi:10.1016/j.biomaterials.2018.06.009
Escudier M, Ahmed N, Shirlaw P, et al. A scoring system for mucosal disease severity with special reference to oral lichen planus. Br J Dermatol. 2007;157:765-770. doi:10.1111/j.1365-2133.2007.08106.x
Ni Riordain R, McCreary C. Validity and reliability of a newly developed quality of life questionnaire for patients with chronic oral mucosal diseases. J Oral Pathol Med. 2011;40:604-609. doi:10.1111/j.1600-0714.2011.01021.x
Giuliani M, Troiano G, Cordaro M, et al. Rate of malignant transformation of oral lichen planus: a systematic review. Oral Dis. 2019;25:693-709. doi:10.1111/odi.12885
Marable DR, Bowers LM, Stout TL, et al. Oral candidiasis following steroid therapy for oral lichen planus. Oral Dis. 2016;22:140-147. doi:10.1111/odi.12399
Osipoff A, Carpenter MD, Noll JL, Valdez JA, Gormsen M, Brennan MT. Predictors of symptomatic oral lichen planus. Oral Surg Oral Med Oral Pathol Oral Radiol. 2020;129:468-477. doi:10.1016/j.oooo.2019.12.019

Auteurs

Michael T Brennan (MT)

Department of Oral Medicine, Atrium Health Carolinas Medical Center, Charlotte, North Carolina, USA.
ORCID: 0000-0003-0638-4335

Lars Siim Madsen (LS)

Afyx Therapeutics A/S, Copenhagen, Denmark.

Deborah P Saunders (DP)

Health Sciences North, Northeast Cancer Centre, Sudbury, Ontario, Canada.
Northern Ontario School of Medicine, Sudbury, Ontario, Canada.

Joel J Napenas (JJ)

Department of Oral Medicine, Atrium Health Carolinas Medical Center, Charlotte, North Carolina, USA.

Christine McCreary (C)

College of Medicine and Health, Cork University Dental School and Hospital, University College Cork, Cork, Ireland.

Richeal Ni Riordain (R)

College of Medicine and Health, Cork University Dental School and Hospital, University College Cork, Cork, Ireland.

Anne Marie Lynge Pedersen (AML)

University of Copenhagen Department of Odontology, Copenhagen, Denmark.
ORCID: 0000-0002-6424-5803

Stefano Fedele (S)

UCL Eastman Dental Institute and UCLH NIHR Biomedical Research Centre, University College London, London, UK.
ORCID: 0000-0001-9006-9412

Richard J Cook (RJ)

Faculty of Dentistry Oral & Craniofacial Sciences, Oral Medicine & Oral Clinical Research Unit, Guy's Hospital Campus, King's College London, London, UK.

Rafik Abdelsayed (R)

The Dental College of Georgia, Augusta University, Augusta, Georgia, USA.

Maria T Llopiz (MT)

Vitae Research Center, LLC Miami, Miami, Florida, USA.

Vidya Sankar (V)

Division of Oral Medicine and Dentistry, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Tufts University School of Dental Medicine, Boston, Massachusetts, USA.

Kevin Ryan (K)

University of Glasgow Hospital & Dental School, Glasgow, UK.

Donna A Culton (DA)

Department of Dermatology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

Yousra Akhlef (Y)

Department of Oral & Maxillofacial Surgery, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark.

Fausto Castillo (F)

QWay Research, Hialeah, Florida, USA.

Inti Fernandez (I)

Valencia Medical & Research Center, Miami, Florida, USA.

Sabine Jurge (S)

University of Sheffield School of Clinical Dentistry, Sheffield, UK.

Alexander R Kerr (AR)

NYU College of Dentistry, New York, New York, USA.

Chad McDuffie (C)

ENT Associates of Texas, Frisco, Texas, USA.

Tim McGaw (T)

Kaye Edmonton Clinic, Edmonton, Alberta, Canada.

Alan Mighell (A)

School of Dentistry, The University of Leeds, Leeds, UK.

Thomas P Sollecito (TP)

School of Dental Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.

Thomas Schlieve (T)

UT Southwestern Medical Center, Dallas, Texas, USA.
ORCID: 0000-0002-9978-4225

Marco Carrozzo (M)

School of Dental Sciences, Newcastle University, Newcastle, UK.

Athena Papas (A)

Tufts University School of Dental Medicine, Boston, Massachusetts, USA.

Thomas Bengtsson (T)

Statmind AB, Lund, Sweden.

Ibtisam Al-Hashimi (I)

UT Southwestern Medical Center, Dallas, Texas, USA.
Scientific Consultant, Dallas, Texas, USA.

Laurie Burke (L)

LORA Group, Royal Oak, Maryland, USA.

Nancy W Burkhart (NW)

The International Oral Lichen Planus Support Group, Texas A&M University College of Dentistry, Dallas, Texas, USA.

Shauna Culshaw (S)

University of Glasgow Hospital & Dental School, Glasgow, UK.

Bhavik Desai (B)

The Dental College of Georgia, Augusta University, Augusta, Georgia, USA.

Jens Hansen (J)

Afyx Therapeutics A/S, Copenhagen, Denmark.

Pia Jensen (P)

Afyx Therapeutics A/S, Copenhagen, Denmark.

Torkil Menné (T)

Scientific Consultant, Copenhagen, Denmark.

Paras B Patel (PB)

Texas A&M University College of Dentistry, Dallas, USA.

Martin Thornhill (M)

University of Sheffield School of Clinical Dentistry, Sheffield, UK.

Nathaniel Treister (N)

Division of Oral Medicine and Dentistry, Brigham and Women's Hospital, Boston, Massachusetts, USA.

Thomas Ruzicka (T)

Ludwig-Maximilian University, Munich, Germany.

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Classifications MeSH

questionsmedicales.fr › Thérapeutique › Traitement médicamenteux › Voies d'administration de substances chimiques et des médicaments › Administration par voie topique › Efficacy and safety of a novel mucoadhesive...
questionsmedicales.fr › Composés polycycliques › Composés à cycles fusionnés › Stéroïdes › Stéroïdes fluorés › Bétaméthasone › Clobétasol › Efficacy and safety of a novel mucoadhesive...
questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Effets physiologiques des médicaments › Hormones, substituts d'hormones et antagonistes d'hormones › Hormones › Glucocorticoïdes › Efficacy and safety of a novel mucoadhesive...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Efficacy and safety of a novel mucoadhesive...
questionsmedicales.fr › Maladies de la peau et du tissu conjonctif › Maladies de la peau › Dermatoses papulosquameuses › Éruption lichénoïde › Lichen plan › Lichen plan buccal › Efficacy and safety of a novel mucoadhesive...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Adulte d'âge moyen › Efficacy and safety of a novel mucoadhesive...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Mesures épidémiologiques › Démographie › État de santé › Qualité de vie › Efficacy and safety of a novel mucoadhesive...