Impact of Topical Clobetasol on Gingival Crevicular Fluid miRNAs in Subjects Affected by Oral Lichen Planus

Study Overview
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Brief Summary
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According to recent research, microRNAs (miRNAs) may function as early disease indicators and contribute to the severity of a number of precancerous and malignant oral disorders. The aim of the present study, through a double-blind randomized controlled trial design, is to analyze in the gingival crevicular fluid (GCF) as a non-invasive approach the impact of topical clobetasol on miRNAs expression in subjects affected by oral lichen planus (OLP).

Detailed Description
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A double-blind randomized controlled clinical trial is conducted in order to evaluate the impact of topical clobetasol on GCF miRNAs expression in subjects with OLP and determine the statistical significance of the outcome variables. At least 60 patients with OLP, randomly allocated in two groups: placebo group with a 4% hydroxyethyl cellulose adhesive gel and the clobetasol group with the same gel containing clobetasol propionate 0,05%.

Official Title
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Impact of Topical Clobetasol on Gingival Crevicular Fluid miRNAs in Subjects Affected by Oral Lichen Planus: a Randomized Clinical Trial

Conditions
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Oral Lichen Planus

Intervention / Treatment
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* Drug: Clobetasol Topical Gel
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The complete correspondence of the most recent WHO clinical and histopathological criteria (2020) for OLP diagnosis. Exclusion Criteria: 1) Previous therapies for OLP during the last six months preceding the study; 2) State of pregnancy or breastfeeding; 3) Contact or drug oral lichenoid lesions; 4) Allergies to the molecules used in the study; 5) HIV seropositivity.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Interventional Model Description: The main aim of the study is to analyze the impact of topical clobetasol on gingival crevicular fluid miRNAs expression in subjects affected by oral lichen planus.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clobetasol propionate 0,05% gel<br>Patients were treated with a topic gel of clobetasol propionate 0,05% | Drug: Clobetasol Topical Gel<br>* Topic Clobetasol gel applied locally on OLP lesions.<br>|
| Placebo Comparator: Placebo<br>Patients were treated with a topic placebo gel control | Drug: Placebo<br>* Placebo oral gel applied locally on OLP lesions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| miRNAs GCF levels | The level of expression of different miRNAs in the GCF before and after treatment in the two groups. (Scale 0-4) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OLP disease severity scores | The eventual improvement in OLP symptoms, signs and disease severity scores after treatment in the two groups. (Scale 0-4) | 8 weeks |