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
- 35
- 主要终点
- Intensity of skin reactions will be evaluated using the 5 point grading scale
研究概览
简要总结
To determine the phototoxic potential of a topically applied article in human subjects
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
- 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 Act (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;
- •must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product;
- •have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products;
研究组 & 干预措施
Arm 1
Experimental
All subjects are patched.
干预措施: Sunscreen Sport Lotion (BAY987516) (Drug)
Arm 1
Experimental
All subjects are patched.
干预措施: Untreated Skin (Other)
结局指标
主要结局
Intensity of skin reactions will be evaluated using the 5 point grading scale
时间窗: Up to 48 hours
次要结局
未报告次要终点
研究者
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