Impact of Fluocinonide 0,05% in Oral Lichen Planus

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Oral Lichen Planus

Intervention / Treatment
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* Drug: Fluocinonide 0,05% oral gel
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Comparator: Fluocinonide 0,,05% oral gel<br>Patients were treated with a topical gel of Fluocinonide 0.05%, applied to oral lesions twice daily for 1 month. | Drug: Fluocinonide 0,05% oral gel<br>* Application of Fluocinonide oral gel on oral syntomatic lesions<br>|
| Placebo Comparator: Placebo Comparator: Placebo<br>Patients were treated with a topical gel of placebo, applied to oral lesions twice daily for 1 month. | Drug: Placebo<br>* Application of placebo oral gel on oral lesions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of sings | Assessment of sings using the Thongprasom scoring system at baseline and after 2 months | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of symptoms | Assessment of symptoms using the VAS scale at baseline and after 2 months | 3 months |