18348-Human Phototoxicity Test
Not Applicable
Completed
- Conditions
- Sunscreening Agents
- Interventions
- Other: Sunscreen Lotion (BAY987521)Other: Untreated Skin
- Registration Number
- NCT02823483
- Lead Sponsor
- Bayer
- Brief Summary
To determine the phototoxic potential of a topically applied article in human subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
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 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 dermatosis;
- must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product.
- have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Sunscreen Lotion (BAY987521) All subjects are patched. Arm 1 Untreated Skin All subjects are patched.
- Primary Outcome Measures
Name Time Method Intensity of skin reactions will be evaluated using the 5 point Up to 48 hours
- Secondary Outcome Measures
Name Time Method