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

Sunscreen Agents Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02857478
• Other study ID #: 18317
• Status: Completed
• Phase: N/A
• Start date: June 27, 2015
• Est. completion date: June 28, 2015

Study information

• Verified date: December 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: June 28, 2015
• Est. primary completion date: June 28, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Sunscreen Agents

Intervention

Drug:
• BAY 987519, SPF 50, Y51-002
Sufficient amount to cover all exposed skin liberally two times - approximately 240 min.
• BAY 987519, SPF 50, P04-147
Sufficient amount to cover all exposed skin liberally two times - approximately 240 min.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Erythema as graded on a 5 point scale.		approximately 24 hours
Primary	Evaluation of AEs, including eye stinging	Reported as product related or likely product related by the investigator or trained designee	approximately 24 hours

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