Sun Protection Factor (SPF) Efficacy 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
- Sun Protection Factor (SPF) efficacy on the skin of human subjects before a total of 2 hours of water Immersion
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
- •Fitzpatrick Skin Type I, II and/or 111 for UVB testing; Fitzpatrick Skin Type II, 111 and/or IV for UVA testing.
- •Sex: Male or female.
- •Age: 18-70 years.
- •Good health as determined from the HRL SHF.
- •Signed and dated lnformed Consent Form.
- •Signed and dated HIPAA Form.
- •An unambiguous MED or MPPD
排除标准
- 未提供
研究组 & 干预措施
SPF evaluation + Control
Fair-skinned subjects in good health with Skin Types I, II or III.
干预措施: BAY987516 (Drug)
SPF evaluation + Control
Fair-skinned subjects in good health with Skin Types I, II or III.
干预措施: SPF 15 Control (Drug)
结局指标
主要结局
Sun Protection Factor (SPF) efficacy on the skin of human subjects before a total of 2 hours of water Immersion
时间窗: up to 24 hours post-exposure
The subsites on each of the protected test sites \[test sunscreen and/or Control\] shall be exposed to UV light. The value of each subsite exposure shall be as appropriate to the test Method: the subject's Minimal Erythema Dose (MED) or MPPD Minimal Persistent Pigment Darkening Dose (MPPD) multiplied by the specific time intervals required. The unprotected skin site is divided into five subsites and shall also be exposed to UV light. The time intervals selected are a geometric series represented by (1.25)n, (n = the subjects MED or MPPD, at the middle \[3"'\] subsite) wherein each exposure time interval is 25 percent greater than the previous time or intensity. The SPF of each TM for each subject is then calculated from the exposure time interval required to produce the MED or MPPD of the protected skin, and from the exposure time interval required to produce the MED or MPPD of the unprotected skin.
Sun Protection Factor (SPF) efficacy on the skin of human subjects after a total of 2 hours of water Immersion
时间窗: up to 24 hours post-exposure
The subsites on each of the protected test sites \[test sunscreen and/or Control\] shall be exposed to UV light. The value of each subsite exposure shall be as appropriate to the test Method: the subject's Minimal Erythema Dose (MED) or MPPD Minimal Persistent Pigment Darkening Dose (MPPD) multiplied by the specific time intervals required. The unprotected skin site is divided into five subsites and shall also be exposed to UV light. The time intervals selected are a geometric series represented by (1.25)n, (n = the subjects MED or MPPD, at the middle \[3"'\] subsite) wherein each exposure time interval is 25 percent greater than the previous time or intensity. The SPF of each TM for each subject is then calculated from the exposure time interval required to produce the MED or MPPD of the protected skin, and from the exposure time interval required to produce the MED or MPPD of the unprotected skin.
次要结局
未报告次要终点