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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00326274
Recruitment Status : Completed
First Posted : May 16, 2006
Last Update Posted : February 11, 2009
Information provided by:
Loreal USA

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

Primary Outcome Measures :
  1. 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

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 identifier (NCT number): NCT00326274

United States, New York
Research Testing Laboratories
Great Neck, New York, United States, 11021
Sponsors and Collaborators
Loreal USA 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:
Photosensitivity Disorders
Skin Diseases
Wounds and Injuries