Healthy Volunteers
Conditions
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, subjects will have a 10 to 14-day Rest phase, after which they will enter the challenge Phase, which consists of one 48-hour patch application (occlusive) to a naïve site on the opposite side of the back.
Interventions
Sponsors
Maruho North America Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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 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 * Are pregnant, breastfeeding, or of childbearing potential and who wish to become pregnant during the study * Are deemed to be ineligible by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| inflammatory skin response score | 21 days | Drug application site will be evaluated for sign of inflammatory skin response (e.g. erythema, edema, papules) |
Countries
United States
Outcome results
None listed