Efficacy of a Microparticulate Muco-adhesive Patch Containing Drug-nutraceutical Association in paTIents Affected by Oral Mucosa Alterations (EMPATIA)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in Symptom Intensity (Pain/Burning)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Clobetasol Patch
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.
干预措施: Clobetasol Patch (Drug)
Clobetasol + Resveratrol Patch
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.
干预措施: Clobetasol + Resveratrol Patch (Drug)
Clobetasol in Orabase
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.
干预措施: Clobetasol in Orabase (Drug)
结局指标
主要结局
Change in Symptom Intensity (Pain/Burning)
时间窗: Baseline and Day 30
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.
Change in Clinical Severity of Lesions
时间窗: Baseline and Day 30
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.
次要结局
- Change in Oral Health-Related Quality of Life(Baseline and Day 30)
- Compliance with Treatment(Day 15 and Day 30)
- Epithelial Structural Improvement (OCT Imaging)(Baseline and Day 30)
研究者
Vera Panzarella
Associate Professor
University of Palermo