Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma：a Randomized Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- reduction in the size of the lesion
研究概览
简要总结
The aim of this study was to evaluate the efficacy and safety of topical application of tacrolimus at different concentrations for superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA).
详细描述
Kaposiform hemangioendothelioma (KHE) and tufted angiomas (TA) are rare vascular tumors, which are apparent predominantly in infancy or early childhood. Currently, no standard treatment regimens exist for KHE/TA. The aim of this study was to evaluate the efficacy and safety of topical application of tacrolimus at different concentrations for superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA).
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA)
排除标准
- •Hypersensitivity to Tacrolimus Mucosal Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA)
研究组 & 干预措施
patients treated with tacrolimus 0.03% ointment
patients treated with tacrolimus 0.03% ointment
干预措施: Tacrolimus ointment (Drug)
patients treated with tacrolimus 0.1% ointment
patients treated with tacrolimus 0.1% ointment
干预措施: Tacrolimus ointment (Drug)
结局指标
主要结局
reduction in the size of the lesion
时间窗: 2.5 years
Therapeutic effect is evaluated by reduction in the size of the tumor measured by centimeters.
次要结局
- Rate of Adverse events(2.5 years)
研究者
Yi Ji
Doctor of Philosophy, Doctor of Medicine
West China Hospital