Human Phototoxicity Test

Not Applicable

Completed

• Conditions: Sunscreening Agents
• Interventions: Other: Sunscreen Spray- Liquid (BAY987516)

• Registration Number: NCT02754102
• 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: 2016-04-26
• Study First Posted: 2016-04-28
• Study Start: 2016-05-03
• Primary Completion: 2016-05-06
• Study Completion: 2016-05-06
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-28
• Last Update Posted: 2017-05-01

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 (Health Insurance Portability and Accountability Act) Authorization Form in conformance with 45CFR (Code of Federal Regulations ) Parts 160 and 164;
• be in general good health as determined by the subject's medical history and in the discretion of the investigator.

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Exclusion Criteria

• have a visible sunburn;
• have a history of sun hypersensitivity/photosensitivity or photosensitive dermatosis;
• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sunscreen Spray-Liquid	Sunscreen Spray- Liquid (BAY987516)	All subjects are patched with the same product

Primary Outcome Measures

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