Human Phototoxicity Test
Status: | Completed |
---|---|
Conditions: | Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - 60 |
Updated: | 12/15/2018 |
Start Date: | May 2, 2016 |
End Date: | May 6, 2016 |
To determine the phototoxic potential of a topically applied article in human subjects.
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.
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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