Overview

Human Phototoxicity Test (823/2016)

Status:
Completed
Trial end date:
2016-11-05
Target enrollment:
0
Participant gender:
All
Summary
To determine the phototoxic potential of a topically applied article in human subjects
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
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