Evaluation of a Gel Sunscreen in Controlled Use Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 72
- 主要终点
- Feeling any discomfort after applying the product assessed by questionnaire
研究概览
简要总结
To explore and quantify potential issues with application of a gel sunscreen in Outdoor Use testing, in a controlled indoor environment
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 45 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects may be male or female.
- •Subjects must be adults between 18 and 45 years of age.
- •Subjects must have and have had a consistently active lifestyle for at least the previous few years (exercise
- •outdoors and in direct sun exposure at least 2 times per week for at least 30 minutes-acceptable activities include tennis, running, jogging, walking, golf, etc.), i.e., outdoor activity should not be a new behavior.
- •Subjects must have used a sunscreen with SPF 50 or higher within the previous 9 months.
排除标准
- •Subjects who have received or used an Investigational New Drug within the last 30 days.
- •Subjects who have been active participants in another clinical or subjective product performance study within the last 30 days.
- •Subjects who have a known allergy or sensitivity to sunscreen ingredients or test materials.
- •Subjects with respiratory allergies or asthma.
研究组 & 干预措施
Sunscreen Users
Subjects will participate in a 2-Day study involving three applications of a single test article each day. The first application will be followed by an exposure of 30 minutes in a hot room.
干预措施: BAY987517 (Drug)
Sunscreen Users
Subjects will participate in a 2-Day study involving three applications of a single test article each day. The first application will be followed by an exposure of 30 minutes in a hot room.
干预措施: BullFrog Gel Sunscreen Land Sport SPF-50 (Drug)
结局指标
主要结局
Feeling any discomfort after applying the product assessed by questionnaire
时间窗: 15 minutes after each application
次要结局
未报告次要终点
