Clinical Safety Trial of Long-Term Intermittent Use of Helioblock® SX Cream
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2006
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 15, 2006
CompletedFirst Posted
Study publicly available on registry
May 16, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedFebruary 11, 2009
February 1, 2009
6 months
May 15, 2006
February 10, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Long term safety after 6 months intermittent use in a pediatric population
6 months
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Loreal USAlead
Study Sites (1)
Research Testing Laboratories
Great Neck, New York, 11021, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 15, 2006
First Posted
May 16, 2006
Study Start
May 1, 2006
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
February 11, 2009
Record last verified: 2009-02