适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 53
- 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
- 主要目的
- Other
- 盲法
- Single
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 HIPAA Authorization Form (Health Insurance Portability and Accountability Act) 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 CRO (Contract Research Organization) and/or Bayer or is a household member of an employee
研究组 & 干预措施
BAY987517
Experimental
All subjects are patched with the same product
干预措施: BAY987517 (Drug)
BAY987517
Experimental
All subjects are patched with the same product
干预措施: Untreated skin (Other)
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
相似试验
已完成
不适用
18850 - Human Photoallergy TestSunscreening AgentsNCT02751463Bayer54
已完成
不适用
18349-Human Photoallergy TestSunscreening AgentsNCT02823496Bayer60
撤回
不适用
18776 - Human Photoallergy TestSunscreening AgentsNCT02751567Bayer
已完成
不适用
Human Photoallergy TestSunscreening AgentsNCT02751515Bayer54
已完成
不适用
18793 - Human Photoallergy TestSunscreening AgentsNCT02750488Bayer54