Mucoadhesive patch treatment for symptomatic oral lichen planus
Efficacy of a Microparticulate Muco-adhesive Patch Containing Drug-nutraceutical Association in paTIents Affected by Oral Mucosa Alterations (EMPATIA)
This trial will test whether a mucoadhesive patch with clobetasol, with or without resveratrol, reduces pain and improves symptoms in adults with oral lichen planus.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Palermo Academic / other |
| Locations | 1 site (Palermo, Italy) |
| Trial ID | NCT07100613 on ClinicalTrials.gov |
What this trial studies
This is a triple-blind, randomized Phase 2 trial comparing three topical approaches for symptomatic oral lichen planus: a mucoadhesive patch with clobetasol, a patch with clobetasol plus resveratrol, and a standard clobetasol 0.05% orabase paste. Participants apply their assigned treatment daily for 30 days and attend clinical visits at baseline, day 15, and day 30 for photographic documentation, symptom scoring, and questionnaires on pain and quality of life. The patch formulations are designed to adhere to the oral mucosa and release medication in a controlled manner to improve retention and local drug exposure. Outcomes focus on changes in oral pain/burning, lesion appearance, and patient-reported daily well-being.
Who should consider this trial
Good fit: Adults 18 and older with histologically confirmed symptomatic oral lichen planus who are not on recent corticosteroids or immunosuppressants and can attend study visits are ideal candidates.
Not a fit: Patients with epithelial dysplasia, recent topical or systemic steroid use, medication-induced lichenoid reactions, pregnancy or breastfeeding, immunodeficiency, or inability to comply with visits are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the mucoadhesive patch could provide longer local drug contact, better symptom relief, and improved convenience compared with conventional ointment formulations.
How similar studies have performed: High-potency topical clobetasol is an established therapy for OLP, but delivering it via a mucoadhesive patch and adding resveratrol is relatively novel with only limited preclinical or small clinical data supporting the approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Palermo, Italy
- University of Palermo — Palermo, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Vera Panzarella
- Email: vera.panzarella@unipa.it
- Phone: 091 6554612
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.