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临床试验/NCT00326274
NCT00326274已完成3 期

Clinical Safety Trial of Long-Term Intermittent Use of Helioblock® SX Cream

Loreal USA2 个研究点 分布在 1 个国家开始时间: 2006年5月最近更新:
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

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

发起方
Loreal USA
申办方类型
Industry

研究点 (2)

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