Mucoadhesive Modified-Release Formulations for the Topical Treatment of Symptomatic Oral Lichen Planus
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Palermo
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Clobetasol Patch
- Clobetasol + Resveratrol Patch
- Clobetasol in Orabase
Treatment groups
45 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov