Overview

Outdoor-Use Test for Sunscreen Products in Children Ages 3 to 9 Years Old

Status:
Completed
Trial end date:
2016-07-10
Target enrollment:
0
Participant gender:
All
Summary
To assess the safety of a sunscreen product under supervised outdoor-use conditions with the target consumer
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Bayer
Treatments:
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.