Sunscreening Agents
Conditions
Brief summary
To determine the phototoxic potential of a topically applied article in human subjects.
Interventions
DRUGBAY 987517
50 μl/cm\*2 or 0.05 gm/cm\*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each). After the test articles have dried for 5 to 15 min, the sites are covered by the appropriate patch.24 hours later, the set of patches covering the product are removed. Three (3) μl/ cm2 or 0.003 gm/cm\*2 of the test product is reapplied to the test site, air dried for 5 to 15 minutes for volatilization and then the test site is exposed to UVA radiation.
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 dermatoses; * 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 5 point grading scale | Up to 48 hours |
Countries
United States
Outcome results
None listed