Sunscreening Agents Clinical Trial
Official title:
Human Photoallergy Test
Verified date | December 2018 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the potential of a test material to produce a photoallergic response
Status | Completed |
Enrollment | 53 |
Est. completion date | December 31, 2016 |
Est. primary completion date | December 31, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
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 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 |
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 |
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