18850 - Human Photoallergy Test

Not Applicable

Completed

• Conditions: Sunscreening Agents
• Interventions: Drug: Sunscreening Sport Spray Rest (BAY987519); Other: Untreated skin

• Registration Number: NCT02751463
• 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 First Submitted: 2016-04-22
• Study First Submitted QC: 2016-04-22
• Study First Posted: 2016-04-26
• Study Start: 2016-05-09
• Primary Completion: 2016-07-01
• Study Completion: 2016-07-01
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-11
• Last Update Posted: 2018-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 Health Insurance Portability and Accountability Act (HIPAA) Authorization Form 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 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
BAY987519	Sunscreening Sport Spray Rest (BAY987519)	All subjects are patched .
BAY987519	Untreated skin	All subjects are patched .

Primary Outcome Measures

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