RecruitingPhase 2

Mucoadhesive Modified-Release Formulations for the Topical Treatment of Symptomatic Oral Lichen Planus

Italy45 participantsStarted 2024-09-04

Plain-language 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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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.

What they're measuring

Change in Symptom Intensity (Pain/Burning)

Timeframe: Baseline and Day 30

Change in Clinical Severity of Lesions

Timeframe: Baseline and Day 30

Trial details

NCT IDNCT07100613

SponsorUniversity of Palermo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10-01

Contact for this trial

Vera Panzarella

091 6554612 vera.panzarella@unipa.it