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

NCT05818618 | Completed

• 1 other identifier: 121-21
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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).

Conditions

Oral Lichen Planus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• OLP disease severity scores

  8 weeks

Study Arms (2)

Clobetasol propionate 0,05% gel

ACTIVE COMPARATOR

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

Drug: Clobetasol Topical Gel

Placebo

PLACEBO COMPARATOR

Patients were treated with a topic placebo gel control

Drug: Placebo

Interventions

Clobetasol Topical Gel DRUG

Topic Clobetasol gel applied locally on OLP lesions.

Clobetasol propionate 0,05% gel

Placebo DRUG

Placebo oral gel applied locally on OLP lesions.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The complete correspondence of the most recent WHO clinical and histopathological criteria (2020) for OLP diagnosis.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• University of Catania: lead

Study Sites (1)

AOU Policlinico G. Rodolico

Catania, 95124, Italy

Location

MeSH Terms

Conditions

Lichen Planus, Oral

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gaetano Isola

  University of Catania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Sealed envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: 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.

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 19, 2023
• Study Start: March 12, 2020
• Primary Completion: July 5, 2023
• Study Completion: August 10, 2023
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: 5 months
• Access Criteria: Pubmed

Locations

IT (1)