Sunscreen Agents
Conditions
Brief 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.
Interventions
DRUGBAY 987519, SPF 50, Y51-002
Sufficient amount to cover all exposed skin liberally two times - approximately 240 min.
DRUGBAY 987519, SPF 50, P04-147
Sufficient amount to cover all exposed skin liberally two times - approximately 240 min.
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Erythema as graded on a 5 point scale. | approximately 24 hours | — |
| Evaluation of AEs, including eye stinging | approximately 24 hours | Reported as product related or likely product related by the investigator or trained designee |
Countries
United States
Outcome results
None listed