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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-12

Study Completion Date

2023-08-10

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).

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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%.

Conditions

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Oral Lichen Planus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Sealed envelopes

Study Groups

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Clobetasol propionate 0,05% gel

Patients were treated with a topic gel of clobetasol propionate 0,05%

Group Type ACTIVE_COMPARATOR

Clobetasol Topical Gel

Intervention Type DRUG

Topic Clobetasol gel applied locally on OLP lesions.

Placebo

Patients were treated with a topic placebo gel control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo oral gel applied locally on OLP lesions.

Interventions

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Clobetasol Topical Gel

Topic Clobetasol gel applied locally on OLP lesions.

Intervention Type DRUG

Placebo

Placebo oral gel applied locally on OLP lesions.

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes