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

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).

Study Overview

• Status: Completed
• Conditions: Oral Lichen Planus
• Intervention / Treatment: Drug: Clobetasol Topical Gel; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rosalia Leonardi; Email: rleonard@unict.it
• Study Contact Backup: Name: Gaetano Isola; Phone Number: 0953785652; Email: gaetano.isola@unict.it

Study Locations

• Italy
  • Catania, Italy, 95124
    • AOU Policlinico G. Rodolico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Catania
• Investigators: Principal Investigator: Gaetano Isola, University of Catania

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2020
• Primary Completion (Actual): July 5, 2023
• Study Completion (Actual): August 10, 2023

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Stomatognathic Diseases; Mouth Diseases; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Lichen Planus, Oral; Lichen Planus; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Clobetasol
• Other Study ID Numbers: 121-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study protocol
• IPD Sharing Time Frame: 5 months
• IPD Sharing Access Criteria: Pubmed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No