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Completed

NCT Number: NCT00326274

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

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.

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Key information

Conditions

Sunburn Burns Photosensitivity Disorders Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Testing Laboratories

Great Neck, New York, 11021, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Helioblock® SX Cream

Drug

Primary outcomes

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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Loreal USA

Industry

Registry information

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
May 16, 2006
Registry last updated
Feb 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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