Sunscreening Agent
Conditions
Brief summary
To assess the safety of a sunscreen product under supervised outdoor-use conditions with the target consumer
Interventions
DRUGBAY987517
Applied liberally to the skin (Formulation: RB# Z16-071)
DRUGSunscreen Lotion (RB# T78-190B)
Applied liberally to the skin
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 9 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin response to sun exposure according to the Skin Evaluation Response Scale from 0 to 3 | From the beginning of the study until 24 hours after study |
Countries
United States
Outcome results
None listed