Human Photoallergy Test (824/2016)

Sunscreening Agents Clinical Trial

Official title:

Human Photoallergy Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02962869
• Other study ID #: 18824
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Dermatitis, Photoallergic
• Sunscreening Agents

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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