Status:
COMPLETED
Skin Safety Study to Evaluate the Sensitizing 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 sensitization potential of M518101 on normal skin under occlusive patch condition.
Detailed Description
During the Induction Phase of the study, the study drugs and controls will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions. Following induction, ...
Eligibility Criteria
Inclusion
- Health male or female subjects are 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 requirement 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
- 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 :
August 1 2015
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT02256930
Start Date
September 1 2014
End Date
August 1 2015
Last Update
August 11 2015
Active Locations (1)
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1
TKL research
Fair Lawn, New Jersey, United States, 07410