Human Phototoxicity Test

• Status: Completed
• Trial end date: 2016-05-06
• 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
• Treatments: Sunscreening Agents

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 Health Insurance Portability and Accountability Act (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;