Supervised Outdoor -Use Test to Assess the Safety of a Sunscreen Lotion on Sports Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 107
- 主要终点
- Dermatologist´s subjective and objective assessments of potential Adverse events
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Healthy males or females, 18 to 65 years of age with no medical conditions of the skin as determined by the subjects' dermatological medical history.
- •The subject must have Fitzpatrick skin types I to VI.
- •During the selection process, potential subjects must agree to restrict their sun exposure activities for at least 5 days immediately preceding participation in the study. Subjects must be willing and physically able to spend approximately 3 continuous hours in the sun, must agree to immerse their entire body under water (including face and hair) at least 2 times during the water activity phase, and must agree to refrain from taking any medications during the study that might alter their response to sun exposure
- •Subjects must agree to refrain from alcohol and tobacco use during the course of the study
- •Subjects must obey all rules of the test facility
- •Subjects must agree to refrain from tanning bed usage and significant non study related sun exposure during the study
排除标准
- 未提供
研究组 & 干预措施
SPF 50 Y65 110
All subjects received baseline skin evaluation and 1 day of sun exposure.
干预措施: SPF 50 Y65 110 (BAY 987516) (Drug)
结局指标
主要结局
Dermatologist´s subjective and objective assessments of potential Adverse events
时间窗: 2 days
• "product related," • "likely product related," • "unlikely product related, or "not product related.
Final Skin Evaluation
时间窗: 2 days
• Score 0 (no response): Normal skin. No visible response or erythema. up to Score 3 (severe response): A well demarcated area of very intense or "beet" red erythema or an area of the skin affected by significant edema, papules, and/or vesicles. Usually symptomatic and may require therapeutic intervention.
次要结局
未报告次要终点