Mucoadhesive patch treatment for symptomatic oral lichen planus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Palermo
  Palermo, Italy, Italy Recruiting

Study contacts

• Study coordinator: Vera Panzarella
• Email: vera.panzarella@unipa.it
• Phone: 091 6554612

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.