Skin Safety Study to Evaluate the Irritation Potential in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/8/2014 |
| Start Date: | September 2014 |
| End Date: | December 2014 |
| Contact: | Maruho North America |
| Email: | mnaictinfo@mii.maruho.co.jp |
A Phase 1, 21-Day, Randomized, Evaluator Blinded, Controlled Study to Evaluate the Irritation Potential of M518101 in Healthy Volunteers, Using a Cumulative Irritant Patch Test Design
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.
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.
Inclusion Criteria:
- 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 Criteria:
- 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
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