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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02962856
Other study ID # 18823
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2, 2016
Est. completion date November 5, 2016

Study information

Verified date December 2018
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date November 5, 2016
Est. primary completion date November 5, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BAY987517
50 µl/cm*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each) on the lower or mid-back. (Formulation: Z43-078)
Other:
Untreated Skin
This site is patched without treatment as irradiated control

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intensity of skin reactions will be evaluated using the 5 point grading scale Up to 48 hours
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