Overview
Human Phototoxicity Test (823/2016)
Status:
Completed
Completed
Trial end date:
2016-11-05
2016-11-05
Target enrollment:
0
0
Participant gender:
All
All
Summary
To determine the phototoxic potential of a topically applied article in human subjectsPhase:
N/AAccepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Bayer
Criteria
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