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

This study has been completed.
Sponsor:
Information provided by:
Loreal USA
ClinicalTrials.gov Identifier:
NCT00326274
First received: May 15, 2006
Last updated: February 10, 2009
Last verified: February 2009

May 15, 2006
February 10, 2009
May 2006
November 2006   (final data collection date for primary outcome measure)
Long term safety after 6 months intermittent use in a pediatric population [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00326274 on ClinicalTrials.gov Archive Site
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Clinical Safety Trial of Long-Term Intermittent Use of Helioblock® SX Cream
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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.

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Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Sunburn
Drug: Helioblock® SX Cream
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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November 2006
November 2006   (final data collection date for primary outcome measure)

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
Both
6 Months to 12 Years
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00326274
PEN.750.04
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Loreal USA
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Loreal USA
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP