Impact of Fluocinonide 0,05% in Oral Lichen Planus
- Conditions
- Oral Lichen Planus
- Interventions
- Drug: Placebo
- Registration Number
- NCT06135805
- Lead Sponsor
- University of Catania
- 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 is a chronic inflammatory condition affecting the mucosa of the oral cavity , which significantly reduces the quality of life of affected individuals.
- 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 with Oral Lichen Planus were divided by a randomization system, into two groups: case group treated with Fluocinonide 0.05% oral gel and applied to oral lesions 2 times a day for 1 month and a placebo group as a control group; with 2 months of follow-up.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active Comparator: Fluocinonide 0,,05% oral gel Fluocinonide 0,05% oral gel Patients were treated with a topical gel of Fluocinonide 0.05%, applied to oral lesions twice daily for 1 month. Placebo Comparator: Placebo Placebo Patients were treated with a topical gel of placebo, applied to oral lesions twice daily for 1 month.
- Primary Outcome Measures
Name Time Method Assessment of sings 3 months Assessment of sings using the Thongprasom scoring system at baseline and after 2 months
- Secondary Outcome Measures
Name Time Method Assessment of symptoms 3 months Assessment of symptoms using the VAS scale at baseline and after 2 months
Trial Locations
- Locations (1)
AOU Policlinico G. Rodolico
🇮🇹Catania, Italy