Sunscreening Agents Clinical Trial
Official title:
Human Photoallergy Test
Verified date | July 2016 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
To evaluate the potential of a test material to produce a photoallergic response.
Status | Completed |
Enrollment | 54 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intensity of skin reactions is evaluated by 5 point scale | Up to 72 hours | Yes |
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