NCT02930746已完成不适用
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose
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
- 3
- 主要终点
- Minimal Erythema Dose (MED)
研究概览
简要总结
To evaluate the Sun Protection Factor efficacy on human skin.
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 l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
- •Male and female.
- •Aged between 18-70 years old.
- •Good health as determined from the HRL SHF (Subject History Form).
- •Signed and dated Informed Consent Form.
- •Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
- •An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)
排除标准
- •Subjects on test at any other research laboratory or clinic.
- •Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
- •Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.)which would interfere with this study.
- •Pre-existing other medical conditions (e.g. adult asthma, diabetes).
- •Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
- •Treatment with antibiotics within two weeks prior to initiation of the test.
- •Chronic medication which could affect the results of the study.
- •Known pregnant or nursing women.
研究组 & 干预措施
BAY987516
Experimental
Each test site area is divided into test sub site areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
干预措施: BAY987516 (Drug)
结局指标
主要结局
Minimal Erythema Dose (MED)
时间窗: Up to 15 minutes
Minimal Persistent Pigment Darkening Dose (MPPD)
时间窗: Up to 15 minutes
次要结局
未报告次要终点
研究者
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