Skin Safety Study to Evaluate the Sensitizing Potential in Healthy Volunteers

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase 1, Randomized, Evaluator Blinded, Controlled Study to Evaluate the Sensitizing Potential of M518101 in Healthy Volunteers Using a Repeat Insult Patch Test Design

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: M518101
* Drug: M518101 Vehicle
* Other: Sodium lauryl sulfate
* Other: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: M518101<br>M518101 will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions. | Drug: M518101<br> <br> |
| Placebo Comparator: M518101 Vehicle<br>M518101 Vehicle will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions. | Drug: M518101 Vehicle<br> <br> |
| Active Comparator: Sodium lauryl sulfate<br>The sodium lauryl sulfate will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions. | Other: Sodium lauryl sulfate<br> <br> |
| Sham Comparator: Saline<br>The saline will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions. | Other: Saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory skin response score | Drug application site will be evaluated for sign of inflammatory skin response (e.g. erythema, edema, papules) | 21 days |