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

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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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