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

Loreal USA

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Conditions

Sunburn

Interventions

Helioblock® SX CreamDRUG

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Testing Laboratories

Great Neck, New York, United States

Outcomes

Primary Outcomes

Long term safety after 6 months intermittent use in a pediatric population

Time frame: 6 months

Data from ClinicalTrials.gov

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