Trial Condition(s):
Sunscreen agents
Supervised Outdoor-Use Test to Assess the Safety of a Sunscreen C-Spray on Sport Users
Bayer Identifier:
18317
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site St. Petersburg, United States, 33714 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Evaluation of Erythema as graded on a 5 point scale.Timeframe: approximately 24 hours
- Evaluation of AEs, including eye stingingReported as product related or likely product related by the investigator or trained designeeTimeframe: approximately 24 hours
Additional Information
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