Mouth patches with clobetasol, with or without resveratrol, for oral lichen planus
Tests clobetasol patches, with or without resveratrol, in adults with oral lichen planus.
Key facts
- Who runs it
- University of Palermo
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Registry title
- Mucoadhesive Modified-Release Formulations for the Topical Treatment of Symptomatic Oral Lichen Planus
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 45 people, planned
- Started
- 4 Sept 2024
- Expected to end
- 1 Oct 2027
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Clobetasol Patch
- Clobetasol + Resveratrol Patch
- Clobetasol in Orabase
- Record updated
- 3 August 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with oral lichen planus, an inflammatory condition inside the mouth, confirmed by a tissue sample. They must not have been diagnosed or treated for it before.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Oral lichen planus confirmed by tissue sample (biopsy) using WHO criteria, with no abnormal precancerous cells (no epithelial dysplasia).
- Earlier treatment
- No earlier diagnosis or treatment for oral lichen planus. No topical or systemic corticosteroids in the last 4 weeks. No current immunosuppressive therapy.
Main reasons for not taking part
- Earlier diagnosis or treatment for oral lichen planus
- Corticosteroid use in the last 4 weeks, or current immunosuppressive therapy
- Use of medicines known to cause lichen-like reactions, or allergy to dental materials such as amalgam
- Blood disorders or a weak immune system
- Pregnancy or breastfeeding
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Current use of immunosuppressive therapies
- History of allergic reactions to dental materials (e.g., amalgam)
- Hematological disorders or immunodeficiencies
- Pregnancy or breastfeeding
- Inability or unwillingness to comply with study procedures
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
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
The 3 groups in the trial
- Clobetasol PatchTreatment being tested
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.
- Clobetasol + Resveratrol PatchTreatment being tested
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.
- Clobetasol in OrabaseExisting treatment, for comparison
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Efficacy of a Microparticulate Muco-adhesive Patch Containing Drug-nutraceutical Association in paTIents Affected by Oral Mucosa Alterations (EMPATIA)
- Plain-language title
- Mouth patches with clobetasol, with or without resveratrol, for oral lichen planusGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 15 November 2026.
- Record updated
- 3 August 2025