Clinical Safety Trial of Long-Term Intermittent Use of Helioblock® SX Cream
Completed · Phase 3
Conditions studied: Sunburn
In brief
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.
Key facts
- Study ID
- NCT00326274
- Run by
- Loreal USA
- Starts
- 2006-05-01
- Expected to finish
- 2006-11-01
- Last updated by the study team
- 2009-02-11
Who can join
Age: 1 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Research Testing Laboratories — Great Neck, New York, United States
Full record on ClinicalTrials.gov
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