Skin Safety Study to Evaluate the Irritation Potential in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT02227069
- Lead Sponsor
- Maruho North America Inc.
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description M518101 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 Vehicle 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 Saline 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. sodium lauryl sulfate 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.
- Primary Outcome Measures
Name Time Method Inflammatory skin responses 21 Days Drug application sites will be evaluated for signs of inflammatory skin responses (e.g. erythema, edema, papules) and superficial effects.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
TKL research
🇺🇸Fair Lawn, New Jersey, United States