check_circleStudy 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
  • - 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;

  • - 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
35
Trial Dates
November 2015 - November 2015
Phase
N/A
Could I Receive a placebo
No
Products
BAY987521
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Piscataway, 08854, United States

Primary Outcome

  • Intensity of skin reactions will be evaluated using the 5 point
    date_rangeTime Frame:
    Up to 48 hours
    enhanced_encryption
    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
1

Additional Information

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