To Assess the Safety of a Sunscreen Product,BAY 987519, Bayer Sponsored, CC Products
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
- Evaluation of AEs, including eye stinging
研究概览
简要总结
The objective of this study was to assess the safety and appropriateness of a sunscreen product for use on sport users, under supervised outdoor-use conditions. The study was conducted under the supervision of a Board-Certified Dermatologist at an outdoor, chlorinated swimming pool facility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects, aged 18 to 65 years
- •No actinic keratosis, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions
- •Must not have visible erythema, blistering or peeling that would indicate recent sunburn
- •Must not have asthma. Must not be undergoing therapy with system or topical corticosteroids, anti-inflammatories or antihistamine agents
- •Must not be taking any medication in which exposure to the sun is contraindicated
- •Must be willing to obey all rules of the test facility
排除标准
- 未提供
研究组 & 干预措施
Safety of a Sunscreen product
Sunscreen product safety evaluation under supervised out-door conditions on sport users.
干预措施: BAY 987519, SPF 50, Y51-002 (Drug)
Safety of a Sunscreen product
Sunscreen product safety evaluation under supervised out-door conditions on sport users.
干预措施: BAY 987519, SPF 50, P04-147 (Drug)
结局指标
主要结局
Evaluation of AEs, including eye stinging
时间窗: approximately 24 hours
Reported as product related or likely product related by the investigator or trained designee
Evaluation of Erythema as graded on a 5 point scale.
时间窗: approximately 24 hours
次要结局
未报告次要终点