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

Not Applicable

Completed

• Conditions: Oral Lichen Planus
• Interventions: Drug: Clobetasol Topical Gel; Drug: Placebo

• Registration Number: NCT05818618
• Lead Sponsor: University of Catania

Brief Summary

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

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%.

Study Timeline

• Study Start: 2020-03-12
• Study First Submitted: 2023-04-05
• Study First Submitted QC: 2023-04-05
• Study First Posted: 2023-04-19
• Primary Completion: 2023-07-05
• Status Verified: 2023-08
• Study Completion: 2023-08-10
• Last Update Submitted: 2023-08-24
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clobetasol propionate 0,05% gel	Clobetasol Topical Gel	Patients were treated with a topic gel of clobetasol propionate 0,05%
Placebo	Placebo	Patients were treated with a topic placebo gel control

Primary Outcome Measures

Name	Time	Method
miRNAs GCF levels	8 weeks	The level of expression of different miRNAs in the GCF before and after treatment in the two groups. (Scale 0-4)

Secondary Outcome Measures

Name	Time	Method
OLP disease severity scores	8 weeks	The eventual improvement in OLP symptoms, signs and disease severity scores after treatment in the two groups. (Scale 0-4)

Trial Locations

Locations (1)

AOU Policlinico G. Rodolico; 🇮🇹 Catania, Italy