Clinical Trial

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

Study acronym: EMPATIA
Recruiting Phase 2
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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
Trial Details
NCT Number NCT07100613
Lead Sponsor University of Palermo
Conditions Oral Lichen Planus, Oral Lichen Planus Related Stress, Oral Mucosal Disease, Oral Pain
Enrollment 45 participants
Start Date 2024-09-04
Primary Completion 2027-10-01 (estimated)
Study Completion 2027-10-01 (estimated)
Updated on ClinicalTrials.gov 2025-08-03