Sunscreening Agents
Conditions
Brief summary
To determine the phototoxic potential of a topically applied article in human subjects
Interventions
DRUGBAY987517
50 μl/cm\*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each) on the lower or mid-back. (Formulation: Z43-078)
OTHERUntreated Skin
This site is patched without treatment as irradiated control
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* be male or female between the ages of 18 and 60 inclusive; * be lightly pigmented (Fitzpatrick Skin Type I, II, III); * have read and signed the written Informed Consent Form and have completed a HIPAA Authorization Form in conformance with 45CFR Parts 160 and 164; * be in general good health as determined by the subject's medical history and in the discretion of the investigator;
Exclusion criteria
* have a visible sunburn; * have a history of sun hypersensitivity/photosensitivity or photosensitive dermatosis; * must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product. * have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intensity of skin reactions will be evaluated using the 5 point grading scale | Up to 48 hours |
Countries
United States
Outcome results
None listed