NCT02831478已完成不适用
Outdoor-Use Test for Sunscreen Products in Children Ages 3 to 9 Years Old
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
- 98
- 主要终点
- Skin response to sun exposure according to the Skin Evaluation Response Scale from 0 to 3
研究概览
简要总结
To assess the safety of a sunscreen product under supervised outdoor-use conditions with the target consumer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 3 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must be healthy, males or females between 3 to 9 years of age with no medical conditions of the skin.
- •Subjects must have Fitzpatrick Skin Type I, II, III or IV.
- •Subjects must agree to restrict their sun exposure activities for at least five days immediately preceding participation in the study.
排除标准
- •Subjects must not have actinic keratoses, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions.
- •Subjects must not have visible erythema, blistering, or peeling that would indicate recent sunburn as determined by the baseline skin evaluation.
- •Subjects must not have significantly tanned skin.
研究组 & 干预措施
BAY987517
Experimental
2/3 of subjects testing the test article
干预措施: BAY987517 (Drug)
Sunscreen Lotion
Active Comparator
1/3 of subjects testing the marketed control
干预措施: Sunscreen Lotion (RB# T78-190B) (Drug)
结局指标
主要结局
Skin response to sun exposure according to the Skin Evaluation Response Scale from 0 to 3
时间窗: From the beginning of the study until 24 hours after study
次要结局
未报告次要终点
研究者
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