Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07100613

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

University of Palermo

Palermo, Italy, Italy

Actively Recruiting

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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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