jRCT2051210126进行中（未招募）不适用
A randomized, multicenter, double-blind, placebo-controlled clinical trial of sirolimus gel in cutaneous manifestation of patients with vascular
未提供0 个研究点目标入组 50 人开始时间: 2021年12月7日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 01month old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients who are at least one month old
- •Patients with skin lesions diagnosed as venous malformation or lymphatic malformation (lymphangioma or lymphangiomatosis) according to the criteria by center for specific pediatric chronic diseases, or diagnosed as tufted hemangioma or Kaposiform hemangioendothelioma according to Japanese clinical practice guidelines for vascular anomalies 2017
- •Patients with target lesions that do not show a tendency to disappear within 4 weeks of interview and are visible on photographs.
- •Patients for whom written consent for participation in the study has been obtained from the subject and/or a substitute (if the subject is under 20 years of age at the time of obtaining consent).
- •Patients who have no intention to participate in other clinical trials, clinical studies, or observational studies while participating in this study
排除标准
- •Patients who have received oral treatment with mTOR inhibitors (sirolimus, everolimus, temsirolimus, etc.) within 12 weeks prior to registration
- •Patients who have participated in other clinical trials within 6 months prior to registration
- •Patients who have received treatment for the target lesion (surgical, endovascular, laser, phototherapy, liquid nitrogen therapy, elastic bandage) within 3 months prior to registration
- •Patients who have received drugs used for the treatment of the target disease, such as immunosuppressive agents (oral and topical), anticancer drugs, propranolol, radiotherapy, steroid pulse therapy, oral steroids for more than one month, interferon, Yuexuekazhu Tang, Huangqi Jianzhong Tang, etc., within 3 months prior to registration
- •Patients with skin lesions such as severe erosions or ulcers on the target lesion
- •Patients with significant bleeding in the target lesion
- •Patients with infectious diseases in the target lesion
- •Patients with malignant tumors, infections, serious cardiac, hepatic, renal, or hematological diseases (determined by the investigator referring to grade 2 or higher in the Japanese translation of CTCAEv5.0 JCOG)
- •Patients with a history of allergy to sirolimus, macrolide antibiotics, or additives used in the investigational product
- •Patients with immunodeficiency such as HIV, primary immunodeficiency, etc.
- •Patients who fall under at least one of the following
- •Pregnant or may be pregnant
- •Breast-feeding
- •Do not agree to use contraception during this study
- •Patients who do not agree to avoid direct sunlight to the application site during this study
- •Patients who are judged by the investigator to be inappropriate for this study
结局指标
主要结局
-
Improvement of target lesions by central judgment after 12 weeks of treatment
次要结局
未报告次要终点
研究者
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