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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00326274
Other study ID # PEN.750.04
Secondary ID
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
Accepts healthy volunteers
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


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
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