Clinical Trials in Italy / NCT07100613
Recruiting Phase 2

Mucoadhesive Modified-Release Formulations for the Topical Treatment of Symptomatic Oral Lichen Planus

NCT07100613 · tracked via the Priya Life Science Italy tracker
Phase
Phase 2
Started
2024-09-04
Last updated
2025-08-03

Condition(s) studied

Oral Lichen PlanusOral Lichen Planus Related StressOral Mucosal DiseaseOral Pain

Investigational drug(s) / intervention(s)

Clobetasol Patch →Clobetasol + Resveratrol PatchAll Clobetasol trials (4) →All Resveratrol trials (2) →Clobetasol in Orabase

Clobetasol Patch: A mucoadhesive patch containing clobetasol propionate 0.05%. Applied once daily for 30 days to the oral lesion.

Clobetasol + Resveratrol Patch: A mucoadhesive patch containing clobetasol propionate 0.05% and resveratrol. Applied once daily for 30 days to the oral lesion.

Clobetasol in Orabase: Clobetasol propionate 0.05% in orabase-type adhesive paste. Applied once daily for 30 days to the oral lesion.

Study summary

The goal of this clinical trial is to learn if a mucoadhesive patch containing clobetasol alone or in combination with resveratrol can reduce symptoms and improve quality of life in adults with Oral Lichen Planus (OLP). The main questions it aims to answer are:

Does the patch reduce oral pain and burning sensations? Does it improve the appearance of oral lesions and patients' daily well-being?

Researchers will compare:

A patch containing clobetasol A patch containing clobetasol and resveratrol A standard clobetasol 0.05% ointment in an adhesive base

Participants will:

Apply their assigned treatment to the oral lesion daily for 30 days Attend three clinical visits for evaluations and imaging Complete questionnaires about pain, symptoms, and treatment experience

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adults aged 18 years or older. * Clinical suspicion of Oral Lichen Planus (OLP). * Histological confirmation of OLP based on World Health Organization (WHO) criteria (presence of hyperkeratosis, acanthosis, basal cell degeneration, and a band-like lymphocytic infiltrate in the lamina propria). * Absence of epithelial dysplasia. * Ability to understand and sign informed consent. Exclusion Criteria: * Previous diagnosis or treatment for OLP. * Use of topical or systemic corticosteroids in the last 4 weeks. * Use of medications known to cause lichenoid reactions. * History of allergic reactions to dental materials (e.g., amalgam). * Hematological disorders or immunodeficiencies. * Pregnancy or breastfeeding. * Current use of immunosuppressive therapies. * Inability or unwillingness to comply with study procedures.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University of Palermo Palermo Italy Recruiting

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07100613 on ClinicalTrials.gov ↗ ← All trials in Italy