Study Completed

Sunscreening Agents

Bayer Identifier:

18348

ClinicalTrials.gov Identifier:

NCT02823483

EudraCT Number:

Not Available

EU CT Number:

Not Available

18348-Human Phototoxicity Test

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - 60 Years

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 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

Trial summary

Enrollment Goal

Trial Dates

November 2015 - November 2015

Phase

N/A

Could I Receive a placebo

Products

BAY987521

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		Piscataway, 08854, United States

Primary Outcome

Intensity of skin reactions will be evaluated using the 5 point
Time Frame:
Up to 48 hours
Safety Issue:
Yes

Trial design

Human Phototoxicity Test

Trial Type

Interventional

Intervention Type

Other

Trial Purpose

Other

Allocation

N/A

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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