Sun Protection Factor (SPF) / UVA Protection Factor (UVAPF) Assay
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 11
- 主要终点
- Evaluation of water resistant SPF
研究概览
简要总结
Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection Factor (SPF) on the skin of 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
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female of an age of 18 to 70 years inclusive;
- •Fitzpatrick Skin Type I, II and/or III for SPF testing;
- •Good health as determined from the CRO Subject History Form (SHF);
- •Signed and dated Informed Consent Form;
- •Signed and dated Health Insurance Portability and Accountability Act (HIPAA) Form;
- •An unambiguous minimal erythema dose (MED).
排除标准
- 未提供
研究组 & 干预措施
SPF evaluation
Subjects with good health as determined from the CRO Subject History Form (SHF) and Fitzpatrick Skin Type I, II and/or III were included for SPF testing.
干预措施: BAY 987516 (Drug)
SPF evaluation
Subjects with good health as determined from the CRO Subject History Form (SHF) and Fitzpatrick Skin Type I, II and/or III were included for SPF testing.
干预措施: SPF 15 Control (Drug)
结局指标
主要结局
Evaluation of water resistant SPF
时间窗: 16-24 hours post exposure
For the sunscreen Test Material, two test sites were used; one for before immersion and one for after 2 hours of water immersion. One additional test site area was used for the control SPF determination, on each subject, as per the COLIPA Sun Protection Factor Test Method.
次要结局
未报告次要终点