Human Photoallergy Test (824/2016)
Not Applicable
Completed
- Conditions
- Sunscreening Agents
- Interventions
- Drug: BAY987517Other: Untreated skin
- Registration Number
- NCT02962869
- Lead Sponsor
- Bayer
- Brief Summary
To evaluate the potential of a test material to produce a photoallergic response
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BAY987517 BAY987517 All subjects are patched with the same product BAY987517 Untreated skin All subjects are patched with the same product
- Primary Outcome Measures
Name Time Method Intensity of skin reactions is evaluated by 5 point scale Up to 72 hours
- Secondary Outcome Measures
Name Time Method