适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Intensity of skin reactions is evaluated by 5 point scale
研究概览
简要总结
To evaluate the potential of a test material to produce a photoallergic response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be male or female between the ages of 18 and 60 inclusive
- •Be lightly pigmented (Fitzpatrick Skin Type I, II, III)
- •Have read and signed the written Informed Consent Form and have completed a Health Insurance Portability and Accountability (HIPAA) Authorization Form in conformance with 45CFR Parts 160 and 164
- •Be in general good health as determined by the subject's medical history and in the discretion of the investigator
排除标准
- •Have a visible sunburn
- •Have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses
- •Have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products
- •Subjects who are employees of the Contract Research Organization (CRO) and/or Bayer or is a household member of an employee
结局指标
主要结局
Intensity of skin reactions is evaluated by 5 point scale
时间窗: Up to 72 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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