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

Sunburn Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00326274
• Other study ID #: PEN.750.04
• Status: Completed
• Phase: Phase 3
• First received: May 15, 2006
• Last updated: February 10, 2009
• Start date: May 2006
• Est. completion date: November 2006

Study information

• Verified date: February 2009
• Source: Loreal USA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Gender: Both
• Age group: 6 Months to 12 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Sunburn

Intervention

Drug:
• Helioblock® SX Cream

Locations

Country	Name	City	State
United States	Research Testing Laboratories	Great Neck	New York

Sponsors (1)

Lead Sponsor	Collaborator
Loreal USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long term safety after 6 months intermittent use in a pediatric population		6 months	Yes