Clinical trial

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

Name

121-21

Description

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).

Trial arms

Trial start

2020-03-12

Estimated PCD

2023-07-05

Trial end

2023-08-10

Status

Completed

Treatment

Clobetasol Topical Gel

Topic Clobetasol gel applied locally on OLP lesions.

Arms:

Clobetasol propionate 0,05% gel

Placebo

Placebo oral gel applied locally on OLP lesions.

Arms:

Placebo

Size

Primary endpoint

miRNAs GCF levels

8 weeks

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Sealed envelopes', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 64, 'type': 'ACTUAL'}}

Updated at

2023-08-25

1 organization

1 product

1 drug

1 indication

Organization

University of Catania

Product

Clobetasol

Indication

Oral Lichen Planus

Drug

Varlilumab