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Human Photoallergy Test

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02750449
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE April 21, 2016
First Posted Date  ICMJE April 25, 2016
Last Update Posted Date December 13, 2018
Actual Study Start Date  ICMJE May 9, 2016
Actual Primary Completion Date July 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2016)
Intensity of skin reactions is evaluated by 5 point grading scale [ Time Frame: Up to 72 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Human Photoallergy Test
Official Title  ICMJE Human Photoallergy Test
Brief Summary To evaluate the potential of a test material to produce a photo allergic response.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE Sunscreening Agents
Intervention  ICMJE
  • Drug: Sun screening Sport Lotion, (BAY987516)
    50 μl/ cm*2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. 24 hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3 μl/ 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. 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 - RB# Y65-110)
  • Other: Untreated skin
    This site is patched without treatment as control
Study Arms  ICMJE Experimental: Arm 1
All subjects are patched.
Interventions:
  • Drug: Sun screening Sport Lotion, (BAY987516)
  • Other: Untreated skin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2016)
54
Original Estimated Enrollment  ICMJE
 (submitted: April 21, 2016)
55
Actual Study Completion Date  ICMJE July 1, 2016
Actual Primary Completion Date July 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
  • 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 and/or Bayer or is a household member of an employee;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02750449
Other Study ID Numbers  ICMJE 18852
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP