NCT00801086Unknown2 期
Phase II Double-Blind, Placebo-Controlled Study of the Safety and Preliminary Effectiveness of MTS-01 for the Prevention of Alopecia Induced by Whole Brain Radiotherapy
Mitos Pharmaceuticals2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Effectiveness will be based on a comparison of hair retention scores between MTS-01 and placebo.
研究概览
简要总结
Hair loss occurs commonly as a result of radiotherapy administered to the brain, and this can contribute to the distress and social isolation of patients with advanced cancer. In this study a topical gel will be applied directly to the scalp during each dose of radiotherapy. The goal is to determine to what extent the experimental drug is successful in lessening the hair loss.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Metastatic cancer to the brain for which palliative whole brain radiotherapy is recommended.
- •Hair that covers the scalp and is at least 1/4 inch in length
排除标准
- •Receiving chemotherapy known to cause alopecia within 60 days of study or during the study.
- •Pre-existing alopecia
- •Previous brain radiotherapy
- •scalp metastases or scalp wounds
- •use of hair dyes
研究组 & 干预措施
1
Experimental
MTS-01 (7% Tempol gel)
干预措施: 7% (w/v) Tempol alcohol-based gel (MTS-01) (Drug)
2
Placebo Comparator
Vehicle
干预措施: alcohol-based gel (Drug)
结局指标
主要结局
Effectiveness will be based on a comparison of hair retention scores between MTS-01 and placebo.
时间窗: Assessments occur weekly during treatment and follow-up assessments occur for 12 weeks following treatment.
次要结局
未报告次要终点
研究者
研究点 (2)
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