Sunscreening Agents
Conditions
Brief summary
To evaluate the potential of a test material to produce a photo allergic response.
Interventions
DRUGSun screening Sport Lotion, (BAY987516)
50 μl/ cm\*2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. 24 hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3 μl/ cm\*2 of test article is reapplied directly to the skin of the test site designated for irradiation, and lightly spread over the test site. 48 hours later the procedure is repeated to the same test sites. This process is repeated twice weekly for a total of six exposures. (Formulation Number - RB# Y65-110)
OTHERUntreated skin
This site is patched without treatment as control
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Subject)
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 Act (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; * have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products; * subjects who are employees of the CRO and/or Bayer or is a household member of an employee;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intensity of skin reactions is evaluated by 5 point grading scale | Up to 72 hours |
Countries
United States
Outcome results
None listed