18794 - Human Photo Toxicity Test

Not Applicable

Completed

• Conditions: Sunscreening Agents
• Interventions: Drug: BAY 987517; Other: Untreated Skin

• Registration Number: NCT02751372
• Lead Sponsor: Bayer

Brief Summary

To determine the phototoxic potential of a topically applied article in human subjects.

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: 2016-05-02
• Primary Completion: 2016-05-06
• Study Completion: 2016-05-06
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-11
• Last Update Posted: 2018-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 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;
• Must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product.
• Have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BAY 987517	BAY 987517	All subjects are patched .
BAY 987517	Untreated Skin	All subjects are patched .

Primary Outcome Measures

Name	Time	Method
Intensity of skin reactions will be evaluated using 5 point grading scale	Up to 48 hours