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

L'Oreal

Status and phase: Completed; Phase 3

Conditions: Sunburn

Treatments: Drug: Helioblock® SX Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT00326274

PEN.750.04

Details and patient eligibility

About

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.

Sex: All

Ages: 6 months to 12 years old

Volunteers: No Healthy Volunteers

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