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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02962869
Other study ID # 18824
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 3, 2016
Est. completion date December 31, 2016

Study information

Verified date December 2018
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
BAY987517
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)
Other:
Untreated skin
One site is patched without treatment as control

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intensity of skin reactions is evaluated by 5 point scale Up to 72 hours
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