Status:
COMPLETED
Skin Safety Study to Evaluate the Irritation Potential in Healthy Volunteers
Lead Sponsor:
Maruho North America Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 st...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02227069
Start Date
September 1 2014
End Date
March 1 2015
Last Update
March 30 2015
Active Locations (1)
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1
TKL research
Fair Lawn, New Jersey, United States, 07410