Human Phototoxicity Test

Bayer

Status: Completed

Conditions: Sunscreening Agents

Treatments: Drug: Sunscreen Sport Lotion (BAY987516); Other: Untreated Skin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02750475

18851

Details and patient eligibility

About

To determine the phototoxic potential of a topically applied article in human subjects

Enrollment: 35 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Arm 1

Experimental group

Description:

All subjects are patched.

Treatment:

Drug: Sunscreen Sport Lotion (BAY987516)

Other: Untreated Skin