check_circleStudy Completed

Sunscreening Agents

Bayer Identifier:

18600

ClinicalTrials.gov Identifier:

NCT02751489

EudraCT Number:

Not Available

EU CT Number:

Not Available
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 Health Insurance Portability and Accountability (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 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

Trial summary

Enrollment Goal
35
Trial Dates
May 2016 - May 2016
Phase
N/A
Could I Receive a placebo
No
Products
No Drug
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Piscataway, 08854, United States

Primary Outcome

  • Intensity of skin reactions is evaluated by 5 point scale
    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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