Mucoadhesive Modified-Release Formulations for the Topical Treatment of Symptomatic Oral Lichen Planus
Efficacy of a Microparticulate Muco-adhesive Patch Containing Drug-nutraceutical Association in paTIents Affected by Oral Mucosa Alterations (EMPATIA)
University of Palermo
45 participants
Sep 4, 2024
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria5
- 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 Criteria8
- 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.
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Interventions
A mucoadhesive patch containing clobetasol propionate 0.05%. Applied once daily for 30 days to the oral lesion.
A mucoadhesive patch containing clobetasol propionate 0.05% and resveratrol. Applied once daily for 30 days to the oral lesion.
Clobetasol propionate 0.05% in orabase-type adhesive paste. Applied once daily for 30 days to the oral lesion.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07100613