Sunscreening Agents
Conditions
Brief summary
To evaluate the potential of a test material to produce a photoallergic response.
Interventions
0.05gm/ cm2 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 3μl/ cm2 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.
OTHERUntreated skin
One site is patched without treatment as control
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 * 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 Contract Research Organization (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 scale | Up to 72 hours |
Countries
United States
Outcome results
None listed