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18793 - Human Photoallergy Test

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ClinicalTrials.gov Identifier: NCT02750488
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

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

Condition or disease Intervention/treatment Phase
Sunscreening Agents Drug: BAY987517 Other: Untreated skin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Human Photoallergy Test
Actual Study Start Date : May 9, 2016
Actual Primary Completion Date : July 1, 2016
Actual Study Completion Date : July 1, 2016

Arm Intervention/treatment
Experimental: BAY987517
All subjects are patched with the same product
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.

Other: Untreated skin
One site is patched without treatment as control




Primary Outcome Measures :
  1. Intensity of skin reactions is evaluated by 5 point scale [ Time Frame: Up to 72 hours ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750488


Locations
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United States, New Jersey
Piscataway, New Jersey, United States, 08854
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02750488     History of Changes
Other Study ID Numbers: 18793
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dermatitis, Photoallergic
Dermatitis, Allergic Contact
Dermatitis, Contact
Dermatitis
Skin Diseases
Photosensitivity Disorders
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Hypersensitivity
Immune System Diseases