Overview
Outdoor-Use Test for Sunscreen Products in Children Ages 3 to 9 Years Old
Status:
Completed
Completed
Trial end date:
2016-07-10
2016-07-10
Target enrollment:
0
0
Participant gender:
All
All
Summary
To assess the safety of a sunscreen product under supervised outdoor-use conditions with the target consumerPhase:
N/AAccepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
BayerTreatments:
Sunscreening Agents
Criteria
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.