NCT01061853终止3 期
Efficacy of Topical Rapamycin in Treatment of Chronic Erosive Oral Lichen Planus. Double Blind Randomised Controlled Trial Rapamycin vs Topical Steroids
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 76
- 试验地点
- 9
- 主要终点
- COMPLETE CLEARING OF ORAL EROSIVE LESIONS
研究概览
简要总结
The purpose of this study is to determine wether topical rapamycin is more efficient than topical steroids in the treatment of chronic erosive 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Oral Lichen Planus
- •Oral Erosive Area More Than 1cm²
- •Lichen Planus Pathologically Proven
排除标准
- •No Previous Treatment by Rapamycin
- •Non Child Bearing Or Breast Feeding Woman
- •Patient Who Cannot Be Treated By Rapamycin Or Betamethasone
- •Chronic Renal Insufficiency (Creatinin Clearance < 40ml/Mn)
- •Ongoing Treatment By Topical Calcineurin Inhibitors Or Systemic Steroids Or Retinoids Or Systemic Immunosuppressors Or Thalidomide Or Griseofulvin Or Antimalarials
- •Cholesterolemia >7.8 Mmol/L Or Hypertriglyceridemia >3.95mmol/L Non Responsive To Medical Treatments
- •Leucopenia (<3000/Mm3)
- •Thrombopenia (<100 000/Mm3)
- •Hypertransaminasemia (>3n)
- •Hypersensitivity To Macrolides
研究组 & 干预措施
T
Experimental
TOPICAL SIROLIMUS AND PETROLATUM IN ORABASE
干预措施: TOPICAL SIROLIMUS (RAPAMUNE*) (Drug)
C
Active Comparator
TOPICAL BETAMETHASONE 0.05% in ORABASE AND PHOSAL
干预措施: TOPICAL BETAMETHASONE 0.05% (Drug)
结局指标
主要结局
COMPLETE CLEARING OF ORAL EROSIVE LESIONS
时间窗: THREE MONTHS
次要结局
- REGRESSION OF EROSIVE SURFACE AREA(THREE MONTHS)
研究者
研究点 (9)
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