The Therapeutic Effect of Curcumin in Nanogels Compared to 0.1% Fluocinolone Acetonide Oral Paste in the Management of Atrophic-Erosive Oral Lichen Planus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in OLP-DAS Score
研究概览
简要总结
This randomized, double-blind clinical trial evaluates the therapeutic effects of curcumin in nanogels compared to 0.1% fluocinolone acetonide oral paste in the management of atrophic-erosive oral lichen planus (OLP). The study aims to determine whether curcumin nanogels, a natural treatment with enhanced bioavailability, are as effective and better tolerated than standard corticosteroid therapy.
详细描述
Oral lichen planus (OLP) is a chronic, immune-mediated inflammatory condition that causes painful mucosal lesions and significantly impairs patients' quality of life. Although topical corticosteroids are the standard treatment, their long-term use is associated with adverse effects. Curcumin, a natural compound with anti-inflammatory and antioxidant properties, has shown promise as an alternative treatment. However, its clinical application is limited by poor bioavailability.
This randomized, double-blind, controlled clinical trial aims to compare the therapeutic effects of curcumin in nanogels and 0.1% fluocinolone acetonide oral paste in patients with atrophic-erosive OLP. Thirty eligible participants will be randomly assigned to either the curcumin nanogel or fluocinolone group, and treatment outcomes will be evaluated using the Oral Lichen Planus Disease Activity Scale (OLP-DAS) and a patient satisfaction questionnaire over a 4-week period.
The study is conducted at the Faculty of Dentistry, Chulalongkorn University, and seeks to evaluate whether curcumin nanogels offer comparable therapeutic efficacy to corticosteroids, with potentially fewer side effects.
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
- Double (Participant, Investigator)
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
- •Age 18 years or older
- •Ability to provide written informed consent
- •Clinically and histopathologically confirmed diagnosis of erosive or atrophic oral lichen planus (OLP)
- •Presence of symptoms (NRS pain score > 0 at baseline)
- •Ability to communicate and follow instructions
- •Willingness to apply oral paste treatment and comply with study protocol
排除标准
- •Pregnancy or lactation
- •Current orthodontic treatment
- •Uncontrolled diabetes mellitus (HbA1c > 7% or FPG > 130 mg/dL)
- •Use of anticoagulants or antiplatelet agents
- •Severe dry mouth (Challacombe score > 7)
- •History of gastric ulcers, duodenal ulcers, or gallstones
- •Presence of any active malignancy or infection
- •Use of topical/systemic treatment for OLP in the past 2 weeks
- •Current use of immunosuppressants
- •Known allergy to corticosteroids or herbal agents such as turmeric
- •Diagnosis of oral lichenoid contact lesion or graft-versus-host disease (GVHD)
- •History of allogeneic bone marrow transplantation
- •Current smokers
研究组 & 干预措施
Curcumin Group
Curcumin nanogels applied 3 times daily for 4 weeks
干预措施: Curcumin in Nanogels (Drug)
Fluocinolone Paste Group
0.1% Fluocinolone acetonide oral paste applied 3 times daily for 4 weeks
干预措施: 0.1% Fluocinolone Acetonide Oral Paste (Drug)
结局指标
主要结局
Change in OLP-DAS Score
时间窗: Baseline, 2 weeks, and 4 weeks
Evaluation of change in Oral Lichen Planus-Disease Activity Scale (OLP-DAS) score, which includes lesion severity, lesion extent, and pain score, from baseline to follow-up The Oral Lichen Planus-Disease Activity Scale (OLP-DAS) includes 3 components: * OLP Sign Score (0-65) * OLP Severity Index (0-20) * Numerical Rating Scale for pain (0-10) The total OLP-DAS score ranges from 0 to 95. Higher scores indicate worse disease activity.
次要结局
- Product Satisfaction Questionnaire(At 4 weeks after treatment start)