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

University of Palermo

Status and phase: Enrolling; Phase 2

Conditions: Oral Mucosal Disease; Oral Lichen Planus; Oral Lichen Planus Related Stress; Oral Pain

Treatments: Drug: Clobetasol in Orabase; Drug: Clobetasol + Resveratrol Patch; Drug: Clobetasol Patch

Study type: Interventional

Funder types: Other

Identifiers

NCT07100613

EMPATIA

Details and patient eligibility

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

Full description

Oral Lichen Planus (OLP) is a chronic inflammatory condition affecting the oral mucosa, often causing painful lesions, burning sensations, and impaired quality of life. Current treatments primarily rely on high-potency topical corticosteroids, such as clobetasol propionate. However, conventional formulations like ointments or pastes may be difficult to apply, poorly retained in the oral cavity, and associated with limited bioavailability or side effects.

This clinical trial investigates the efficacy of a novel mucoadhesive drug delivery system in the form of a patch. The patch is designed to adhere to the oral mucosa, releasing the active compounds in a controlled and prolonged manner. Two types of patches are tested: one containing clobetasol propionate alone and one containing a combination of clobetasol and resveratrol, a natural polyphenol known for its anti-inflammatory and immunomodulatory properties.

The study is a triple-blind, randomized, controlled clinical trial conducted on adult patients with a confirmed histological diagnosis of symptomatic OLP. Participants are randomly assigned to one of three arms:

Arm 1: Patch with clobetasol propionate Arm 2: Patch with clobetasol propionate and resveratrol Arm 3 (Control): Clobetasol 0.05% in an orabase-type adhesive paste Treatments are applied over a 30-day period following a standardized schedule. Clinical evaluations take place at baseline, 15 days, and 30 days, and include photographic documentation, symptom scoring with the Visual Analog Scale (VAS), and clinical severity assessment using the Thongprasom score. In addition, participants complete the Oral Health Impact Profile-14 (OHIP-14) questionnaire to evaluate changes in oral-health-related quality of life.

Structural changes in the mucosa are monitored using Optical Coherence Tomography (OCT), a non-invasive imaging technique that allows real-time visualization of tissue layers, providing objective information on epithelial healing and inflammation.

The primary outcomes are reduction in pain and burning symptoms, improvement of lesion severity, and increased quality of life. Secondary outcomes include patient compliance and OCT-based structural improvement. This study aims to offer a more effective, better tolerated, and innovative therapeutic approach for managing oral lichen planus.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 3 patient groups

Clobetasol Patch

Experimental group

Description:

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.

Treatment:

Drug: Clobetasol Patch

Clobetasol + Resveratrol Patch

Experimental group

Description:

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.

Treatment:

Drug: Clobetasol + Resveratrol Patch

Clobetasol in Orabase

Active Comparator group

Description:

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.

Treatment:

Drug: Clobetasol in Orabase