Skin Safety Study to Evaluate the Irritation Potential in Healthy Volunteers
NCT ID: NCT02227069
Last Updated: 2015-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2014-09-30
2015-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
DOUBLE
Study Groups
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M518101
M518101 is applied topically under occlusive patch conditions to the infrascapular area of the back, once daily for 21 consecutive days over 3 weeks
M518101
M518101 Vehicle
M518101 vehicle is applied topically under occlusive patch conditions to the infrascapular area of the back, once daily for 21 consecutive days over 3 weeks
M518101 Vehicle
sodium lauryl sulfate
A solution of 0.2% sodium lauryl sulfate is applied topically under occlusive patch conditions to the infrascapular area of the back once daily for 21 days over 3 weeks, will serve as a positive control.
sodium lauryl sulfate
Saline
A solution of 0.9% saline is applied topically under occlusive patch conditions to the infrascapular area of the back once daily for 21 days over 3 weeks, will serve as a negative control.
saline
Interventions
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M518101
M518101 Vehicle
sodium lauryl sulfate
saline
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Maruho North America Inc.
INDUSTRY
Responsible Party
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Locations
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TKL research
Fair Lawn, New Jersey, United States
Countries
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Other Identifiers
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M518101-US06
Identifier Type: -
Identifier Source: org_study_id
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