drugset / Trial / NCT07100613

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

NCT07100613

Phase 2 Recruiting 45 enrolled University of Palermo
RandomizedParallel-groupTriple-blindTreatment

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

Timeline

Start
2024-09-04
Primary completion
2027-10-01
Completion
2027-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Resveratrol Small molecule Topical
Subject clobetasol propionate Small molecule 0.05 % Topical