NCT01544842终止不适用
Comparison of Topical Tacrolimus, Triamcinolone and Placebo in the Treatment of Symptomatic Oral Lichen Planus
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change in clinical score for OLP
研究概览
简要总结
The purpose of this study is to compare the effectiveness of topical tacrolimus, triamcinolone and placebo in alleviating signs and symptoms of oral lichen planus (OLP).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of OLP made by a specialist in oral pathology based on clinical and histopathological features
- •Clinical score for OLP ≥ 20 at baseline
- •Symptomatic OLP at baseline
- •Washout period of 2 weeks
- •Age over 18
排除标准
- •Pregnant or lactating women
- •Allergy to tacrolimus or other macrolides
- •Allergy to other drugs or substances used in the study
- •Abnormal liver function
- •Netherton's syndrome
- •Cyclosporin medication
- •Other regular medication that could have significant interactions with tacrolimus
研究组 & 干预措施
Tacrolimus
Active Comparator
Tacrolimus ointment 0.1%, three times a day for 6-9 weeks.
干预措施: 0.1 % tacrolimus ointment (Drug)
Triamcinolone
Active Comparator
Triamcinolone paste 0.1%, three times a day for 3-6 weeks.
干预措施: 0.1 % triamcinolone paste (Drug)
Placebo
Placebo Comparator
Orabase paste, three times a day for 3-6 weeks.
干预措施: Orabase paste (Drug)
结局指标
主要结局
Change in clinical score for OLP
时间窗: 1,2,3,4,5,6,7,8 and 9 weeks, 6 months
The clinical score for OLP is a measure designed by the investigators for assessing the clinical extent and type of OLP, and the symptoms experienced by the patient. The value of the score is between 0-120.
次要结局
未报告次要终点
研究者
研究点 (2)
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