Actively Recruiting
Efficacy of a Mucoadhesive Patch with Clobetasol and Resveratrol for Treating Oral Lichen Planus Symptoms
Led by University of Palermo · Updated on 2025-08-03
45
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating new mucoadhesive patches containing clobetasol, alone or combined with resveratrol, to reduce symptoms and improve quality of life in adults with symptomatic Oral Lichen Planus (OLP). This chronic inflammatory oral condition causes painful lesions and burning sensations, negatively affecting daily well-being. The trial aims to see if these patches can better manage pain, lesion appearance, and overall oral health compared to a standard clobetasol ointment. Participants are randomly assigned to one of three groups: a patch with clobetasol propionate 0.05%, a patch with clobetasol plus resveratrol, or a clobetasol 0.05% adhesive paste. Each treatment is applied once daily for 30 days directly to the oral lesion after oral hygiene, with no food or drink for 30 minutes afterward. The patches are self-adhering and dissolve on their own. During the study, participants attend three visits at the start, day 15, and day 30 for clinical evaluations, symptom scoring, and imaging with Optical Coherence Tomography (OCT) to monitor tissue healing. They complete questionnaires about pain, symptoms, and oral health-related quality of life. Researchers measure changes in pain, lesion severity, quality of life, treatment compliance, and mucosal structure over the 30-day period to assess the treatments' effects.
CONDITIONS
Brief 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 based on WHO criteria
- Absence of epithelial dysplasia
- 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 in the last 4 weeks
- Use of medications known to cause lichenoid reactions
- History of allergic reactions to dental materials such as amalgam
- Hematological disorders or immunodeficiencies
- Pregnancy or breastfeeding
- Current use of immunosuppressive therapies
- Inability or unwillingness to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 30 days
Participants apply a mucoadhesive patch or an adhesive paste containing clobetasol, with or without resveratrol, once daily for 30 days to the symptomatic oral lesion. No food or drink is allowed for 30 minutes after application.
3 visits (baseline, Day 15, and Day 30)
Trial Site Locations
Total: 1 location
1
University of Palermo
Palermo, Italy, Italy
Actively Recruiting
Research Team
V
Vera Panzarella
V
Viviana De Caro
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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