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

• Sponsor: Loreal USA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00326274
• Collaborator: (none)
• Location: 1
• Duration (Months): 6

Study Details

Study Description

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 Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Study Start Date: May 1, 2006
• Actual Primary Completion Date: Nov 1, 2006
• Study Completion Date: Nov 1, 2006

Outcome Measures

Primary Outcome Measures

1. Long term safety after 6 months intermittent use in a pediatric population [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 12 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Testing Laboratories	Great Neck	New York	United States	11021

Sponsors and Collaborators

• Loreal USA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00326274
• Other Study ID Numbers: PEN.750.04
• First Posted: May 16, 2006
• Last Update Posted: Feb 11, 2009
• Last Verified: Feb 1, 2009

• Additional relevant MeSH terms: Sunburn

Study Results

No Results Posted as of Feb 11, 2009