Human Photoallergy Test (824/2016)

Bayer

Status: Completed

Conditions: Sunscreening Agents

Treatments: Other: Untreated skin; Drug: BAY987517

Study type: Interventional

Funder types: Industry

Identifiers

NCT02962869

18824

Details and patient eligibility

About

To evaluate the potential of a test material to produce a photoallergic response

Enrollment: 53 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 HIPAA Authorization Form (Health Insurance Portability and Accountability Act) 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
• have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products
• subjects who are employees of the CRO (Contract Research Organization) and/or Bayer or is a household member of an employee

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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53 participants in 1 patient group

BAY987517

Experimental group

Description:

All subjects are patched with the same product

Treatment:

Other: Untreated skin

Drug: BAY987517