NCT05818618

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: University of Catania · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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%.

Conditions

• Oral Lichen Planus

Interventions

Type	Name	Description
DRUG	Clobetasol Topical Gel	Topic Clobetasol gel applied locally on OLP lesions.
DRUG	Placebo	Placebo oral gel applied locally on OLP lesions.

Timeline

• Start date: 2020-03-12
• Primary completion: 2023-07-05
• Completion: 2023-08-10
• First posted: 2023-04-19
• Last updated: 2023-08-25

Locations

1 site across 1 country: Italy