Supervised Outdoor-Use Test to Assess the Safety of a Sunscreen C-Spray on Sport Users

The objective of this study was to assess the safety and appropriateness of a sunscreen product for use on sport users, under supervised outdoor-use conditions. The study was conducted under the supervision of a Board-Certified Dermatologist at an outdoor, chlorinated swimming pool facility.

Completed

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Key information

Conditions

Sunscreen Agents

Age range

18 year–65 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

Male or female subjects, aged 18 to 65 years
No actinic keratosis, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions
Must not have visible erythema, blistering or peeling that would indicate recent sunburn
Must not have asthma. Must not be undergoing therapy with system or topical corticosteroids, anti-inflammatories or antihistamine agents
Must not be taking any medication in which exposure to the sun is contraindicated
Must be willing to obey all rules of the test facility

Treatment and study plan

BAY 987519, SPF 50, Y51-002

Drug

Sufficient amount to cover all exposed skin liberally two times - approximately 240 min.

BAY 987519, SPF 50, P04-147

Drug

Sufficient amount to cover all exposed skin liberally two times - approximately 240 min.

Primary outcomes

Evaluation of Erythema as graded on a 5 point scale.

Time frame: approximately 24 hours
Evaluation of AEs, including eye stinging

Time frame: approximately 24 hours

Reported as product related or likely product related by the investigator or trained designee

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

To Assess the Safety of a Sunscreen Product,BAY 987519, Bayer Sponsored, CC Products

Important dates

Study start: 2015
Primary completion: 2015
Study completion: 2015
First posted: Aug 5, 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.

Published trials that share one or more normalized conditions with this study.

Completed