Sunburn
Conditions
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.
Interventions
DRUGHelioblock® SX Cream
Sponsors
Loreal USA
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 12 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Long term safety after 6 months intermittent use in a pediatric population | 6 months |
Countries
United States
Outcome results
None listed