EUCTR2011-006308-12-ES进行中（未招募）不适用
phase II clinical trial, to study the efficacy and safety of topical rapamycin in reducing facial angiofibromas.
Fundación Investigación Hospital Ramón y Cajal0 个研究点开始时间: 2012年3月29日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Patients, who, after receiving information about the design, the purpose of the study, the potential risks it can occur and that at any time may refuse your help, give written consent to participate in the study and for the provision material for cellular and molecular studies.
- •-Subject is male or female and over 13 years of age.
- •-Subject has a diagnosis of TSC and has visible fibromatosus lesions (angiofibromas or angifibromata)
- •-women of childbearing age should get a negative pregnancy test the screening visit; further agree to use adequate contraception (among them are considered: double barrier as condom + diaphragm, surgical sterilization) within 14 days following administration of study drug.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 25
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Pregnant, intention to become pregnant during treatment phase of the trial, or breastfeeding.
- •2. Patient is currently participating or has participated within the last two months in any clinical trial.
- •3.Patient is actually receiving or has received in the last three mounths any m-TOR inhibitor treatment or any form of immunosuppression drug.
- •4. Hypersensitivity to rapamycin
- •5.Any serious medical or psychiatric illness currently ongoing, or experienced within the past three months, that in the opinion of the investigator would compromise the study
研究者
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