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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Clobetasol Patch
DrugA mucoadhesive patch containing clobetasol propionate 0.05%. Applied once daily for 30 days to the oral lesion.
Clobetasol + Resveratrol Patch
DrugA mucoadhesive patch containing clobetasol propionate 0.05% and resveratrol. Applied once daily for 30 days to the oral lesion.
Clobetasol in Orabase
DrugClobetasol propionate 0.05% in orabase-type adhesive paste. Applied once daily for 30 days to the oral lesion.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Clobetasol PatchExperimental treatment 1 intervention
Group B: Clobetasol + Resveratrol PatchExperimental treatment 1 intervention
Group C: Clobetasol in OrabaseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Symptom Intensity (Pain/Burning)
Patient-reported pain and burning intensity will be measured using the 10-point Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse symptoms.
Time frame
Baseline and Day 302
Change in Clinical Severity of Lesions
Clinical improvement will be assessed using the Thongprasom clinical scoring system (score range 0-5, where 0 = no lesion and 5 = severe erosive lesion). Higher scores indicate worse lesion severity. The outcome will measure the change from baseline to day 30.
Time frame
Baseline and Day 30Secondary outcomes
1
Change in Oral Health-Related Quality of Life
Evaluated using the Oral Health Impact Profile-14 (OHIP-14) questionnaire (range 0-56, with higher scores indicating worse quality of life).
Time frame
Baseline and Day 302
Compliance with Treatment
Adherence to the patch protocol, measured as the number of daily applications recorded in participant diaries.
Time frame
Day 15 and Day 303
Epithelial Structural Improvement (OCT Imaging)
Changes in mucosal architecture will be assessed using Optical Coherence Tomography (OCT). Improvement is defined as reduction in epithelial discontinuities and inflammatory patterns.
Time frame
Baseline and Day 30Sponsors and contacts
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Source ClinicalTrials.gov