Study Completed

Sunscreen agents

Bayer Identifier:

18317

ClinicalTrials.gov Identifier:

NCT02857478

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 65 Years

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
Exclusion Criteria

Trial summary

Enrollment Goal

Trial Dates

June 2015 - June 2015

Phase

N/A

Could I Receive a placebo

Products

BAY987519

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		St. Petersburg, 33714, United States

Primary Outcome

Evaluation of Erythema as graded on a 5 point scale.
Time Frame:
approximately 24 hours
Safety Issue:
Yes
Evaluation of AEs, including eye stinging
Reported as product related or likely product related by the investigator or trained designee
Time Frame:
approximately 24 hours
Safety Issue:
Yes

Trial design

To assess the safety of a sunscreen product,BAY 987519, Bayer sponsored, CC Products

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Prevention

Allocation

N/A

Blinding

Single Blind

Assignment

Single Group Assignment

Trial Arms

Additional Information

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