Skin Safety Study to Evaluate the Irritation 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 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.

Official Title
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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

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 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

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 is applied topically under occlusive patch conditions to the infrascapular area of the back, once daily for 21 consecutive days over 3 weeks | Drug: M518101<br> <br> |
| Placebo Comparator: M518101 Vehicle<br>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 | Drug: M518101 Vehicle<br> <br> |
| Active Comparator: sodium lauryl sulfate<br>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. | Other: sodium lauryl sulfate<br> <br> |
| Sham Comparator: Saline<br>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. | Other: saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory skin responses | Drug application sites will be evaluated for signs of inflammatory skin responses (e.g. erythema, edema, papules) and superficial effects. | 21 Days |