Human Phototoxicity Test (823/2016)
Status: | Completed |
---|---|
Conditions: | Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - 60 |
Updated: | 12/15/2018 |
Start Date: | November 2, 2016 |
End Date: | November 5, 2016 |
Human Phototoxicity Test
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 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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