Human Phototoxicity Test

Not Applicable

Completed

• Conditions: Sunscreening Agents
• Interventions: Drug: Sunscreen Sport Spray (BAY987519); Other: Untreated Skin

• Registration Number: NCT02751541
• 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
BAY987519	Sunscreen Sport Spray (BAY987519)	All subjects are patched
BAY987519	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