Oral Lichen Planus
Conditions
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).
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%.
Interventions
DRUGClobetasol Topical Gel
Topic Clobetasol gel applied locally on OLP lesions.
DRUGPlacebo
Placebo oral gel applied locally on OLP lesions.
Sponsors
University of Catania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Sealed envelopes
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| miRNAs GCF levels | 6 months | The level of expression of different miRNAs in the GCF before and after treatment in the two groups. (Scale 0-4) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OLP disease severity scores | 6 months | The eventual improvement in OLP symptoms, signs and disease severity scores after treatment in the two groups. (Scale 0-4) |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORGaetano Isola
University of Catania
Outcome results
None listed