NCT00713154终止2 期
A Phase II, Double-Blind Placebo-Controlled, Parallel Group Study of the Safety and Preliminary Efficacy of MTS-01, for the Prevention of Alopecia Induced by Whole Brain Radiotherapy
Mitos Pharmaceuticals0 个研究点目标入组 16 人开始时间: 2007年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 主要终点
- Investigator assessment of hair loss using a 10 point scale
研究概览
简要总结
The purpose of this study is to determine if MTS-01 is effective in preventing radiotherapy-induced hair loss in patients receiving whole brain radiotherapy
详细描述
Hair loss (alopecia) occurs commonly as a result of external beam radiotherapy to the brain, and contributes to the social isolation and distress of patients with cancer. MTS-01 is a topical gel formulation that can be applied to the scalp during delivery of radiotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •is >/= 18 years of age
- •Has metastatic cancer to the brain for which palliative or prophylactic whole brain radiotherapy is recommended. A histological diagnosis of cancer will be required, however, a biopsy of the brain metastases will not be required
- •Can understand and sign the IRB/IEC approved informed consent, can communicate with the Investigator, and can understand with the requirements of the protocol
- •has signed the HIPAA authorization
排除标准
- 未提供
研究组 & 干预措施
1
Placebo Comparator
Placebo group
干预措施: Placebo (Drug)
2
Active Comparator
Control Group
干预措施: MTS-01 (Drug)
结局指标
主要结局
Investigator assessment of hair loss using a 10 point scale
时间窗: up to 12 weeks
次要结局
- A time to event analysis of the hair loss(up to 12 weeks)
研究者
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