Status:
COMPLETED
Impact of Fluocinonide 0,05% in Oral Lichen Planus
Lead Sponsor:
University of Catania
Conditions:
Oral Lichen Planus
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 i...
Detailed Description
A double-blind placebo-controlled study was conducted to evaluate the clinical efficacy of Fluocinonide 0.05% oral gel and determine the statistical significance of outcome variables. 20 patients wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2024
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT06135805
Start Date
August 20 2023
End Date
February 28 2024
Last Update
September 19 2024
Active Locations (1)
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1
AOU Policlinico G. Rodolico
Catania, Italy, 95124