Study Completed

Sunscreening Agents

Bayer Identifier:

18824

ClinicalTrials.gov Identifier:

NCT02962869

EudraCT Number:

Not Available

EU CT Number:

Not Available

Human Photoallergy Test (824/2016)

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - 60 Years

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

Trial summary

Enrollment Goal

Trial Dates

November 2016 - December 2016

Phase

N/A

Could I Receive a placebo

Products

BAY987517

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		Piscataway, 08854, United States

Primary Outcome

Intensity of skin reactions is evaluated by 5 point scale
Time Frame:
Up to 72 hours
Safety Issue:
Yes

Trial design

Human Photoallergy Test

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Other

Allocation

N/A

Blinding

Single Blind

Assignment

Single Group Assignment

Trial Arms

Additional Information

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