Clinical Safety Trial of Long-Term Intermittent Use of Helioblock® SX Cream
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| ClinicalTrials.gov Identifier: NCT00326274 |
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Recruitment Status
:
Completed
First Posted
: May 16, 2006
Last Update Posted
: February 11, 2009
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Sponsor:
Loreal USA
Information provided by:
Loreal USA
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sunburn | Drug: Helioblock® SX Cream | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Study Start Date : | May 2006 |
| Actual Primary Completion Date : | November 2006 |
| Study Completion Date : | November 2006 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Sun Exposure
U.S. FDA Resources
Primary Outcome Measures
:
- Long term safety after 6 months intermittent use in a pediatric population [ Time Frame: 6 months ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 6 Months to 12 Years (Child) |
| Sexes Eligible for Study: | All |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00326274
Locations
| United States, New York | |
| Research Testing Laboratories | |
| Great Neck, New York, United States, 11021 | |
Sponsors and Collaborators
Loreal USA
| ClinicalTrials.gov Identifier: | NCT00326274 History of Changes |
| Other Study ID Numbers: |
PEN.750.04 |
| First Posted: | May 16, 2006 Key Record Dates |
| Last Update Posted: | February 11, 2009 |
| Last Verified: | February 2009 |
Additional relevant MeSH terms:
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Sunburn Photosensitivity Disorders Skin Diseases Burns Wounds and Injuries |