Efficacy of a Microparticulate Muco-adhesive Patch Containing Drug-nutraceutical Association in paTIents Affected by Oral Mucosa Alterations (EMPATIA)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Italy
University of Palermo
RECRUITING
Palermo
Contact Information
Primary
Vera Panzarella
vera.panzarella@unipa.it
091 6554612
Backup
Viviana De Caro
viviana.decaro@unipa.it
09123891926
Time Frame
Start Date:2024-09-04
Estimated Completion Date:2027-10-01
Participants
Target number of participants:45
Treatments
Experimental: Clobetasol Patch
Participants will receive a mucoadhesive patch containing clobetasol propionate 0.05%. The patch is applied directly to the symptomatic oral lesion once daily for 30 days, following oral hygiene. No food or drink is allowed for 30 minutes after application. The patch is self-dissolving.
Experimental: Clobetasol + Resveratrol Patch
Participants will receive a mucoadhesive patch containing clobetasol propionate 0.05% and resveratrol. The patch is applied once daily for 30 days on the symptomatic oral lesion. It is self-adhering and dissolves without removal. No food or drink is allowed for 30 minutes after application.
Active_comparator: Clobetasol in Orabase
Participants will receive clobetasol propionate 0.05% in an orabase-type adhesive paste, applied once daily for 30 days after oral hygiene. Application is made directly to the lesion. No food or drink is allowed for 30 minutes after application.