Sunscreening Agents
Conditions
Brief summary
To evaluate the potential of a test material to produce a photoallergic response
Interventions
DRUGBAY987517
50 μl/ cm\*2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. Twenty-four (24) hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3μl/ 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. Forty-eight (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: Z43-078)
OTHERUntreated skin
One site is patched without treatment as control
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE
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 (Health Insurance Portability and Accountability Act) 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 (Contract Research Organization) 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 scale | Up to 72 hours |
Countries
United States
Outcome results
None listed