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

This study has been completed.
Information provided by:
Loreal USA Identifier:
First received: May 15, 2006
Last updated: February 10, 2009
Last verified: February 2009
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 Intervention Phase
Drug: Helioblock® SX Cream
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label

Resource links provided by NLM:

Further study details as provided by Loreal USA:

Primary Outcome Measures:
  • Long term safety after 6 months intermittent use in a pediatric population [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Study Start Date: May 2006
Estimated Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   6 Months to 12 Years
Genders Eligible for Study:   Both

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00326274

United States, New York
Research Testing Laboratories
Great Neck, New York, United States, 11021
Sponsors and Collaborators
Loreal USA
  More Information Identifier: NCT00326274     History of Changes
Other Study ID Numbers: PEN.750.04 
Study First Received: May 15, 2006
Last Updated: February 10, 2009
Health Authority: United States: Food and Drug Administration processed this record on May 26, 2016