check_circleStudy 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
  • - 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

Trial summary

Enrollment Goal
98
Trial Dates
June 2015 - June 2015
Phase
N/A
Could I Receive a placebo
No
Products
BAY987519
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
St. Petersburg, 33714, United States

Primary Outcome

  • Evaluation of Erythema as graded on a 5 point scale.
    date_rangeTime Frame:
    approximately 24 hours
    enhanced_encryption
    Safety Issue:
    Yes
  • Evaluation of AEs, including eye stinging
    Reported as product related or likely product related by the investigator or trained designee
    date_rangeTime Frame:
    approximately 24 hours
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    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
1

Additional Information

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