Human Phototoxicity Test
Not Applicable
Completed
- Conditions
- Sunscreening Agents
- Interventions
- Other: Bain De Soliel - Solid
- Registration Number
- NCT02751489
- 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 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;
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Exclusion Criteria
- Have a visible sunburn;
- Have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses;
- 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 Bain De Soliel - Solid Bain De Soliel - Solid 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 48 hours
- Secondary Outcome Measures
Name Time Method