Skin Safety Study to Evaluate the Irritation Potential in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

This is a single center, randomized, controlled, within-subject comparison, multiple dose study to determine the irritation potential of M518101 on normal skin under occlusive patch condition. The study drug will be applied for 21 days under occlusive patch condition. The irritation potential of M518101 will be compared with positive, negative control and M518101 vehicle. The study duration is 21days and there will be at least 23 visits to study center including screening visit.

Key facts

Study ID

NCT02227069

Run by

Maruho North America Inc.

People needed

30

Starts

2014-09-01

Expected to finish

2015-03-01

Last updated by the study team

2015-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Health male or female subjects age 18 years or older
• Signed and dated Informed Consent Form obtained prior to any study-related activities
• Subjects are free of any systemic or dermatologic disorder
• For Female, females of non-childbearing potential or who agree to use a highly effective method of birth control during the study and have a negative urine pregnancy test.
• Subjects must be able to communicate with the investigator and understand and comply with the requirements of the study and visit schedule

You may not qualify if…

• Have any visible skin disease at the application site which will interfere with the evaluation of the test site reaction
• Have damaged skin in or around the test sites
• Have a history of sensitivity to adhesive tape
• Have a known sensitivity to constituents present in the material being evaluated
• Have a history of, or are currently being treated for skin cancer
• have used any study drug and/or participate in any clinical study within 60 days prior to Randomization
• to engage in any type of strenuous exercise (swimming, running, etc.) or who intended to use hot tubs or saunas during the study
• Are pregnant, breastfeeding, or of childbearing potential and who wish to become pregnant during the study
• Are deemed to be ineligible by the investigator

Where it is running

• TKL research — Fair Lawn, New Jersey, United States

Full record on ClinicalTrials.gov

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