Comparison of Tacrolimus 0.1% and Clobetasol 0.05% in the Management of Symptomatic Oral Lichen Planus- A Double-blinded Randomized Clinical Trial in Sri Lanka
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 68
- 主要终点
- The intensity of Pain
研究概览
简要总结
This clinical study is carried out to assess the efficacy of Tacrolimus and Clobetasol in symptomatic Oral Lichen Planus.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically and Histologically proven Oral Lichen Planus
- •Symptomatic
排除标准
- •topical/ systemic medication for OLP in the previous three months
- •contraindication for medications use such as a history of allergy to either corticosteroids/ tacrolimus
- •immunosuppression, or pregnant / lactating females
- •lichenoid reactions either drug induced or due to dental amalgam
- •diabetes mellitus and on oral hypoglycemic drugs
- •systemic involvement such as concurrent skin/genital lesions
研究组 & 干预措施
Clobetasol Group
clobetasol propionate (0.05%) cream
干预措施: Clobetasol 0.05% (Drug)
Tacrolimus Group
tacrolimus (0.1%) cream
干预措施: Tacrolimus 0.1% (Drug)
结局指标
主要结局
The intensity of Pain
时间窗: Three weeks after the application of drugs
The intensity of pain was assessed using visual analog scale (VAS) - The patients were asked to score their intensity of pain using a VAS where the pain scores ranged from 0 (no pain) to 10 (extreme pain) Four VAS was recorded one for spicy food and the other one for without spicy food for right side and left sides separately. The mean VAS was calculated for each side and the severity of pain was evaluated according to the following scales: Scale 0: no pain: VAS=0, Scale 1: mild pain: 0\< VAS≤3.5, Scale 2: moderate pain: 3.5 \<VAS≤7, Scale 3: severe pain: 7\< VAS≤10.
The clinical response
时间窗: Three weeks after the application of drugs
The clinical response of the lesion was scored according to the grading system formulated by Thongprasom et al.,in 1992 for the mucosal lesions: Score 5 = white striae with erosive area more than 1 cm, Score 4 = white striae with erosive area less than 1 cm, Score 3 = white striae with atrophic area more than 1 cm, Score 2 = white striae with atrophic area less than 1 cm, Score 1 =mild white striae, no erythematous area Score 0 = no lesion, normal mucosa. This scorings were performed for both right and left sides separately.
次要结局
未报告次要终点
研究者
Dr. P.V.K.S Hettiarachchi
Dr
University of Peradeniya