Human Photoallergy Test
Not Applicable
Completed
- Conditions
- Sunscreening Agents
- Interventions
- Drug: Sun screening Sport Lotion, (BAY987516)Other: Untreated skin
- Registration Number
- NCT02750449
- Lead Sponsor
- Bayer
- Brief Summary
To evaluate the potential of a test material to produce a photo allergic response.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
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 Act (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;
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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 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 Arm 1 Sun screening Sport Lotion, (BAY987516) All subjects are patched. Arm 1 Untreated skin All subjects are patched.
- Primary Outcome Measures
Name Time Method Intensity of skin reactions is evaluated by 5 point grading scale Up to 72 hours
- Secondary Outcome Measures
Name Time Method