Sunscreening Agents
Conditions
Brief summary
To determine the phototoxic potential of a topically applied article in human subjects
Interventions
0.05 gm/cm2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each) on the lower or mid-back. After the test articles have dried for 5 to 15 min, the sites are covered by the appropriate patch.
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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 Health Insurance Portability and Accountability (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 is evaluated by 5 point scale | Up to 48 hours |
Countries
United States
Outcome results
None listed