Human Photoallergy Test (824/2016)

N/ACompletedNCT02962869

Bayer53 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Sunscreening Agents

Interventions

BAY987517DRUG

50 μl/ cm\*2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. Twenty-four (24) hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3μl/ cm\*2 of test article is reapplied directly to the skin of the test site designated for irradiation, and lightly spread over the test site. Forty-eight (48) hours later the procedure is repeated to the same test sites. This process is repeated twice weekly for a total of six exposures. (Formulation number: Z43-078)

Untreated skinOTHER

One site is patched without treatment as control

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Piscataway, New Jersey, United States

Outcomes

Primary Outcomes

Intensity of skin reactions is evaluated by 5 point scale

Time frame: Up to 72 hours

Data from ClinicalTrials.gov

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