NCT02842268已完成不适用
Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating
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
- 15
- 主要终点
- Change of face coverage post exercise compared to the full coverage observed prior to exercise (in percent).
研究概览
简要总结
To visually evaluate the retention of coverage of the Test Product(s) (TP) on the face after exercise compared to the full coverage observed prior to exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects may be male or female, of an age of 18-55 years inclusive.
- •Subjects must be capable of understanding and providing written informed consent.
- •Subjects must sign a written confidentiality agreement including a photography release form.
- •Subjects must be in good general health as judged by a specified licensed physician, who will indicate their suitability to participate in this study.
- •Female subjects must be willing to take a rapid screen pregnancy test prior to each exercise session.
- •Subjects must be willing to follow study instructions as set forth in the protocol.
- •Subjects must not have facial piercing(s).
- •Subjects must be Fitzpatrick Skin Type I, II, or III.
排除标准
- •Subjects must not have received or used an Investigational New Drug within the last 30 days.
- •Subjects must not have been active participants in another clinical or subjective TP performance study within the last 30 days unless authorized by this Sponsor.
- •Subjects must not have a known physical or medical condition that would preclude vigorous exercise
- •Subjects must not have a five-minute resting pulse rate greater than 80 bpm.
- •Subjects must not take any chronic medication other than vitamins, hormone replacement therapy, low-dose aspirin, or oral contraceptives.
- •Subjects must not have applied prescription or over-the-counter medicines to their face at least 96 hours prior to exercise session
- •Subjects must not have a known allergy or sensitivity to sunscreen products or Cetaphil cleanser.
- •Female subjects must not be pregnant (self-reported) or test positive using an on-site pregnancy test.
- •Female subjects must not be nursing a child.
- •Subjects must not have smoked cigarettes, pipes, or cigars in the last 60 days.
- •Subjects who in the judgment of the Investigator have any condition that would make study participation inappropriate.
- •Subjects must not be a member or relative of the clinical trial staff or the Sponsor directly involved in the study.
研究组 & 干预措施
BAY987517
Experimental
Subject will self-apply the test sunscreen formula to his/her face with the goal of applying 0.65 to 0.85 grams.Subject should sweat profusely.
干预措施: BAY987517 (Drug)
结局指标
主要结局
Change of face coverage post exercise compared to the full coverage observed prior to exercise (in percent).
时间窗: At baseline and post exercise (30 minutes)
Done with a Skin Scanner( before and after each exercise session) using the 11-point scale
次要结局
- Eye Stinging on grading scale(Up to 30 mins)
研究者
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