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Completed

NCT Number: NCT05818618

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

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).

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOU Policlinico G. Rodolico

Catania, 95124, Italy

About this study

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%.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clobetasol Topical Gel

Drug

Topic Clobetasol gel applied locally on OLP lesions.

Placebo

Drug

Placebo oral gel applied locally on OLP lesions.

Primary outcomes

  1. miRNAs GCF levels

    Time frame: 8 weeks

    The level of expression of different miRNAs in the GCF before and after treatment in the two groups. (Scale 0-4)

Secondary outcomes

  1. OLP disease severity scores

    Time frame: 8 weeks

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

Sponsors and collaborators

Lead sponsor

University of Catania

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 19, 2023
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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