Back to resultsHuman Photoallergy Test (824/2016)
Primary Purpose
Sunscreening Agents
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BAY987517
Untreated skin
Sponsored by
About this trial
This is an interventional other trial for Sunscreening Agents
Eligibility 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 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BAY987517
Arm Description
All subjects are patched with the same product
Outcomes
Primary Outcome Measures
Intensity of skin reactions is evaluated by 5 point scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02962869
Brief Title
Human Photoallergy Test (824/2016)
Official Title
Human Photoallergy Test
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 3, 2016 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the potential of a test material to produce a photoallergic response
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sunscreening Agents
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BAY987517
Arm Type
Experimental
Arm Description
All subjects are patched with the same product
Intervention Type
Drug
Intervention Name(s)
BAY987517
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Untreated skin
Intervention Description
One site is patched without treatment as control
Primary Outcome Measure Information:
Title
Intensity of skin reactions is evaluated by 5 point scale
Time Frame
Up to 72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Human Photoallergy Test (824/2016)
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