Trial Condition(s):
Sunscreening Agent
Outdoor-Use Test for Sunscreen Products in Children Ages 3 to 9 Years Old
Bayer Identifier:
18533
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
To assess the safety of a sunscreen product under supervised outdoor-use conditions with the target consumer
Inclusion Criteria
- Subject must be healthy, males or females between 3 to 9 years of age with no medical conditions of the skin. - Subjects must have Fitzpatrick Skin Type I, II, III or IV. - Subjects must agree to restrict their sun exposure activities for at least five days immediately preceding participation in the study.
Exclusion Criteria
- Subjects must not have actinic keratoses, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions. - Subjects must not have visible erythema, blistering, or peeling that would indicate recent sunburn as determined by the baseline skin evaluation. - Subjects must not have significantly tanned skin.
Trial Summary
Enrollment Goal
98
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
BAY987517
Accepts Healthy Volunteers
Yes
Where to Participate
Loading...
Locations
| Locations | |
|---|---|
Locations Investigative Site St. Petersburg, United States, 33714 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Outdoor-Use Test for Sunscreen Products in Children Ages 3 to 9 Years Old
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Skin response to sun exposure according to the Skin Evaluation Response Scale from 0 to 3Timeframe: From the beginning of the study until 24 hours after study
Additional Information
Copyright © Bayer
Powered by
