Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Impact of the Efficacy of Fluocinonide 0.05% Oral Gel in the Treatment of Oral Lichen Planus

ID
Name
121-30
Description
A double-blind placebo-controlled trial is conducted in order to evaluate the efficacy of Fluocinonide 0,05% and determinate the statistical significance of the outcome variables. Oral cavity lichen is a chronic inflammatory condition affecting the mucosa of the oral cavity , which significantly reduces the quality of life of affected individuals.
Trial arms
Trial start
2020-10-27
Estimated PCD
2023-12-19
Trial end
2024-01-03
Status
Recruiting
Treatment
Fluocinonide 0,05% oral gel
Application of Fluocinonide oral gel on oral syntomatic lesions
Arms:
Active Comparator: Fluocinonide 0,,05% oral gel
Placebo
Application of placebo oral gel on oral lesions
Arms:
Placebo Comparator: Placebo
Size
20
Primary endpoint
Assessment of sings
3 months
Eligibility criteria
Inclusion Criteria: * Clinical and histologic diagnosis of Lichen Planus Orale; * Presence of symptoms related to Lichen Planus Orale; * Clinical follow-up period of at least 12 weeks; * Acceptance of informed consent Exclusion Criteria: * State of pregnancy or lactation; h * Histologic signs of dysplasia; * Medications that induce a lichenoid response (ACE inhibitors, β-blockers, etc.); * Presence of amalgam fillings in the vicinity of lesions; * Treatment of oral lichen in the previous 6 months from the start of the program; * Presence of extraoral lesions (genital, skin, etc.); * Diabetes being treated with oral hypoglycemic drugs; * History of previous immunodeficiency; * HIV seropositivity; * Previous allogeneic bone marrow transplantation; * Diagnosis of LES or other autoimmune disease
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}
Updated at
2023-11-18

1 organization

1 product

1 drug

1 indication

Organization
University of Catania
Product
Fluocinonide
Indication
Oral Lichen Planus
Drug
Varlilumab