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

NCT07100613 | Recruiting Phase 2

• 1 other identifier: EMPATIA
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Oral Lichen Planus; Oral Lichen Planus Related Stress; Oral Mucosal Disease; Oral Pain

Keywords

mucoadhesive patch; oral lichen planus; clobetasol; resveratrol; drug delivery system; Optical coherence tomography; Ora pain

Outcome Measures

Primary Outcomes (2)

• Change in Symptom Intensity (Pain/Burning)

  Patient-reported pain and burning intensity will be measured using the 10-point Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse symptoms.

  Baseline and Day 30

• Change in Clinical Severity of Lesions

  Clinical improvement will be assessed using the Thongprasom clinical scoring system (score range 0-5, where 0 = no lesion and 5 = severe erosive lesion). Higher scores indicate worse lesion severity. The outcome will measure the change from baseline to day 30.

  Baseline and Day 30

Secondary Outcomes (3)

• Change in Oral Health-Related Quality of Life

  Baseline and Day 30

• Compliance with Treatment

  Day 15 and Day 30

• Epithelial Structural Improvement (OCT Imaging)

  Baseline and Day 30

Study Arms (3)

Clobetasol Patch

EXPERIMENTAL

Participants will receive a mucoadhesive patch containing clobetasol propionate 0.05%. The patch is applied directly to the symptomatic oral lesion once daily for 30 days, following oral hygiene. No food or drink is allowed for 30 minutes after application. The patch is self-dissolving.

Drug: Clobetasol Patch

Clobetasol + Resveratrol Patch

EXPERIMENTAL

Participants will receive a mucoadhesive patch containing clobetasol propionate 0.05% and resveratrol. The patch is applied once daily for 30 days on the symptomatic oral lesion. It is self-adhering and dissolves without removal. No food or drink is allowed for 30 minutes after application.

Drug: Clobetasol + Resveratrol Patch

Clobetasol in Orabase

ACTIVE COMPARATOR

Participants will receive clobetasol propionate 0.05% in an orabase-type adhesive paste, applied once daily for 30 days after oral hygiene. Application is made directly to the lesion. No food or drink is allowed for 30 minutes after application.

Drug: Clobetasol in Orabase

Interventions

Clobetasol Patch DRUG

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

Also known as: Mucoadhesive Clobetasol Patch

Clobetasol Patch

Clobetasol + Resveratrol Patch DRUG

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

Also known as: Mucoadhesive Patch with Clobetasol and Resveratrol

Clobetasol + Resveratrol Patch

Clobetasol in Orabase DRUG

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

Also known as: Clobetasol 0.05% Orabase Paste

Clobetasol in Orabase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

University of Palermo

Palermo, Italy, Italy

RECRUITING

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Clobetasol; Resveratrol; Orabase

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Central Study Contacts

Vera Panzarella

CONTACT

091 6554612; vera.panzarella@unipa.it

Viviana De Caro

CONTACT

09123891926; viviana.decaro@unipa.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Model Description: Triple-arm, parallel assignment model with 1:1:1 randomization. Each participant is randomly assigned to one of three intervention groups receiving either: (1) a mucoadhesive patch with clobetasol, (2) a mucoadhesive patch with clobetasol and resveratrol, or (3) clobetasol 0.05% in an orabase-type paste.

Study Record Dates

• First Submitted: July 19, 2025
• First Posted: August 3, 2025
• Study Start: September 4, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 3, 2025

Record last verified: 2025-07

Locations

IT (1)