NCT00326274已完成3 期
Clinical Safety Trial of Long-Term Intermittent Use of Helioblock® SX Cream
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Loreal USA
- 试验地点
- 2
- 主要终点
- Long term safety after 6 months intermittent use in a pediatric population
研究概览
简要总结
The purpose of this study is to determine the safety potential of Helioblock® SX Cream as a sunscreen product in long term intermittent use conditions among pediatric subjects.. Each subject will be enrolled to participate for six months. The test product should be applied every day that outdoor activities are planned, prior to any significant sun exposure during out-door activities (such as the beach, outdoor sport activities), or whenever the subject needs to be protected against sunburn or other damage due to the sun. A minimum of 14 days test product use and sun exposure is required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects of any race or skin type, 6 months to 12 years of age inclusive, willing to use the test product intermittently for six months during outside activities
排除标准
- •Subjects with known sensitivities to any of the study ingredients or subjects with a condition or in a situation, which in the Investigator's opinion, may suggest a significant hazard for the subject, may confound the study results, or interfere with the subject's participation in the study.
- •Subjects who are pregnant or lactating
结局指标
主要结局
Long term safety after 6 months intermittent use in a pediatric population
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (2)
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