Evaluation of Lycopene in the Treatment of Erosive Oral Lichen Planus (A Randomized Clinical Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain assessment was conducted using Visual Analogue Scale (VAS)
研究概览
简要总结
The aim of this study was to evaluate the effect of oral lycopene and systemic steroids in the treatment of erosive oral lichen planus and compare between the two therapeutic modalities.
详细描述
Twenty erosive lichen planus patients were recruited and randomly assigned in one of two groups, the test (lycopene) and control (corticosteroids) group.
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
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Erosive oral lichen planus patients with severe and extensive painful erythematous, erosive and/ or ulcerative lesions who are in need for systemic corticosteroid therapy
排除标准
- •Pregnant females and smokers.
- •Patients suggestive of having lichenoid contact/drug reactions.
- •Patients suffering from any systemic disease as diabetes, liver disease, renal disease, any other autoimmune or collagen disease.
- •Lesions showing histological features of dysplasia.
- •Patients with skin lichen planus lesions.
研究组 & 干预措施
Lycopene
干预措施: Lycopene Softgel, 10 Mg (Drug)
Corticosteroids
干预措施: Prednisolone (Drug)
结局指标
主要结局
Pain assessment was conducted using Visual Analogue Scale (VAS)
时间窗: up to 5 months
Patients were instructed to mark a 10 cm line at a point equivalent to their present pain. The score was determined by measuring the distance in mm on the line from the "no pain" anchor to the patient's mark, providing a range of scores from 0-100. A Pain-free experience was scored zero, while the worst pain was scored 100.
Lesion size assessment
时间窗: up to 5 months
Assessment of OLP lesions was performed using the Thongprasom et al. scoring index where: * Score 0: No lesion/Normal mucosa. * Score 1: Mild white striae only. * Score 2: White striae with erythematous area \<1cm². * Score 3: White striae with erythematous area \>1cm². * Score 4: White striae with erosive area \<1cm². * Score 5: White striae with erosive area \>1cm². * Scores from different oral sites were added to give a final score for every patient from 0-50.
次要结局
未报告次要终点
研究者
Nourhan M.Aly
Assistant Lecturer of Dental Public Health
University of Alexandria