Human Photoallergy Test (824/2016)

Not Applicable

Completed

• Conditions: Sunscreening Agents
• Interventions: Drug: BAY987517; Other: Untreated skin

• Registration Number: NCT02962869
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-03
• Study First Submitted: 2016-11-10
• Study First Submitted QC: 2016-11-10
• Study First Posted: 2016-11-11
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-11
• Last Update Posted: 2018-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BAY987517	BAY987517	All subjects are patched with the same product
BAY987517	Untreated skin	All subjects are patched with the same product

Primary Outcome Measures

Name	Time	Method
Intensity of skin reactions is evaluated by 5 point scale	Up to 72 hours