Skin Safety Study to Evaluate the Sensitizing 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 sensitization potential of M518101 on normal skin under occlusive patch condition.
Key facts
- Study ID
- NCT02256930
- Run by
- Maruho North America Inc.
- People needed
- 240
- Starts
- 2014-09-01
- Expected to finish
- 2015-08-01
- Last updated by the study team
- 2015-08-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
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
- 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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