Идёт набор NCT07100613

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

Фаза II С лечением Oral Lichen Planus Oral Lichen Planus Related Stress Oral Mucosal Disease Oral Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Clobetasol Patch, Clobetasol + Resveratrol Patch, Clobetasol in Orabase.
Кому может быть актуально: Состояния в реестре: Oral Lichen Planus, Oral Lichen Planus Related Stress, Oral Mucosal Disease, Oral Pain. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Италия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Efficacy of a Microparticulate Muco-adhesive Patch Containing Drug-nutraceutical Association in paTIents Affected by Oral Mucosa Alterations (EMPATIA)

Обзор

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

Подробное описание

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.

Вмешательства

Препарат Clobetasol Patch
A mucoadhesive patch containing clobetasol propionate 0.05%. Applied once daily for 30 days to the oral lesion.
Препарат Clobetasol + Resveratrol Patch
A mucoadhesive patch containing clobetasol propionate 0.05% and resveratrol. Applied once daily for 30 days to the oral lesion.
Препарат Clobetasol in Orabase
Clobetasol propionate 0.05% in orabase-type adhesive paste. Applied once daily for 30 days to the oral lesion.

Первичные конечные точки

Change in Symptom Intensity (Pain/Burning) [Срок оценки: Baseline and Day 30]
Change in Clinical Severity of Lesions [Срок оценки: Baseline and Day 30]

Вторичные конечные точки (3)

Change in Oral Health-Related Quality of Life [Срок оценки: Baseline and Day 30]
Compliance with Treatment [Срок оценки: Day 15 and Day 30]
Epithelial Structural Improvement (OCT Imaging) [Срок оценки: Baseline and Day 30]

Критерии участия

Критерии включения

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.