Actively Recruiting
Mucoadhesive Modified-Release Formulations for the Topical Treatment of Symptomatic Oral Lichen Planus
Led by University of Palermo · Updated on 2025-08-03
45
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Mucoadhesive Modified-Release Formulations for the Topical Treatment of Symptomatic Oral Lichen Planus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Clinical suspicion of Oral Lichen Planus (OLP)
- Histological confirmation of OLP according to WHO criteria (including hyperkeratosis, acanthosis, basal cell degeneration, and lymphocytic infiltrate)
- No epithelial dysplasia present
- Ability to understand and sign informed consent
You will not qualify if you...
- Previous diagnosis or treatment for Oral Lichen Planus
- Use of topical or systemic corticosteroids within the last 4 weeks
- Use of medications that can cause lichenoid reactions
- History of allergic reactions to dental materials like amalgam
- Hematological disorders or immunodeficiencies
- Pregnancy or breastfeeding
- Current use of immunosuppressive therapies
- Inability or unwillingness to follow study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Palermo
Palermo, Italy, Italy
Actively Recruiting
Research Team
V
Vera Panzarella
CONTACT
V
Viviana De Caro
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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