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OpenTrials
Completed

NCT Number: NCT02831478

Outdoor-Use Test for Sunscreen Products in Children Ages 3 to 9 Years Old

To assess the safety of a sunscreen product under supervised outdoor-use conditions with the target consumer

Completed

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Key information

Conditions

Sunscreening Agent

Age range

3 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Petersburg, Florida, 33714, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subject must be healthy, males or females between 3 to 9 years of age with no medical conditions of the skin.
  • Subjects must have Fitzpatrick Skin Type I, II, III or IV.
  • Subjects must agree to restrict their sun exposure activities for at least five days immediately preceding participation in the study.

Exclusion criteria

  • Subjects must not have actinic keratoses, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions.
  • Subjects must not have visible erythema, blistering, or peeling that would indicate recent sunburn as determined by the baseline skin evaluation.
  • Subjects must not have significantly tanned skin.

Treatment and study plan

BAY987517

Drug

Applied liberally to the skin (Formulation: RB# Z16-071)

Sunscreen Lotion (RB# T78-190B)

Drug

Applied liberally to the skin

Primary outcomes

  1. Skin response to sun exposure according to the Skin Evaluation Response Scale from 0 to 3

    Time frame: From the beginning of the study until 24 hours after study

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 13, 2016
Registry last updated
Dec 12, 2018

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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