18793 - Human Photoallergy Test

Human Photoallergy Test

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

Study Overview

• Status: Completed
• Conditions: Sunscreening Agents
• Intervention / Treatment: Other: Untreated skin; Drug: BAY987517

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Piscataway, New Jersey, United States, 08854

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: BAY987517; All subjects are patched with the same product

Other: Untreated skin; One site is patched without treatment as control; Drug: BAY987517; 50 μl/ cm2 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/ cm2 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intensity of skin reactions is evaluated by 5 point scale	Up to 72 hours

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2016
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: April 21, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimate): April 25, 2016

Study Record Updates

• Last Update Posted (Actual): December 13, 2018
• Last Update Submitted That Met QC Criteria: December 11, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity; Dermatitis; Skin Diseases, Eczematous; Hypersensitivity, Delayed; Dermatitis, Contact; Photosensitivity Disorders; Dermatitis, Allergic Contact; Dermatitis, Photoallergic
• Other Study ID Numbers: 18793

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No