Safety Study to Evaluate the Cumulative Irritation Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA

Study Overview
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Brief Summary
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This is a safety study to determine the cumulative skin irritation potential of ZuraPrep™ and ZuraPrep™ without Isopropyl Alcohol after repetitive patch applications to skin of human subjects.

Detailed Description
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This cumulative irritation evaluation is designed to determine the skin irritation potential of ZuraPrep™ and ZuraPrep™ without Isopropyl Alcohol (IPA) after repetitive patch application to skin of healthy human subjects.

Official Title
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A 21-Day Evaluation of the Cumulative Irritation Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA in Healthy Adult Volunteers

Conditions
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Surgical Site Infection

Intervention / Treatment
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* Drug: ChloraPrep
* Drug: 0.1% Sodium Lauryl Sulfate
* Drug: 0.9% Physiological Saline
* Other: ZuraPrep without IPA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects may be of either sex, at least 18 years of age and of any race Subjects must be free of tattoos, sunburn, dermatoses, cuts, lesions or other disorders of the skin of the back. Subjects must be in good general health Exclusion Criteria: Known allergies to latex, metals, tape and/or adhesives, soap, citric acid, methylene blue, methylparaben, propylparaben, chlorhexidine gluconate, isopropyl alcohol, and sodium lauryl sulfate. Exposure of the back region to antimicrobial agents, medicated soaps, medicated shampoos, medicated lotions, strong detergents, sun-tanning, use of tanning beds, or swimming or soaking in pools or hot tubs, in the 7 days prior to, or during the 3-week test period. Use of topical or systemic corticosteroid, antihistamine, or anti-inflammatory medications in the 7 days prior to, or during the 3-week test period. Current or recent severe illness such as asthma, diabetes, hepatitis, organ transplant, mitral valve prolapse, congenital heart disease, internal prostheses, or any immunocompromised condition such as AIDS or HIV positive. Pregnancy, plans to become pregnant, breast-feeding Any active skin rash or breaks in the skin of the back Any sunburn or tattoos on the skin of the back Current active skin disease or inflammatory skin condition including contact dermatitis Participation in a clinical study in the past 7 days or current participation in another clinical study Any medical condition or use of any medications that, in the opinion of the Principal Investigator, would preclude participation Unwillingness to fulfill the performance requirements of the study

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

Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ZuraPrep<br>ZuraPrep will be compared statistically to ZuraPrep without IPA and both to the Positive Control (0.1% Sodium Lauryl Sulfate). The degree of skin irritation caused by the Reference Product (ChloraPrep) and the Negative Control (0.9% Physiological Saline) will be graded. | Drug: ChloraPrep<br>* The degree of skin irritation caused by ChloraPrep will be graded and compared to ZuraPrep and ZuraPrep without IPA.<br>* Other names: 2% Chlorhexidine Gluconate and 70% IPA;Drug: 0.1% Sodium Lauryl Sulfate<br>* The degree of skin irritation caused by 0.1% Sodium Lauryl Sulfate will be graded and compared to ZuraPrep and ZuraPrep without IPA.<br>* Other names: Positive Control;Drug: 0.9% Physiological Saline<br>* The degree of skin irritation caused by 0.9% Physiological Saline will be graded and compared to ZuraPrep and ZuraPrep without IPA.<br>* Other names: Negative Control;Other: ZuraPrep without IPA<br>* Results from exposure to ZuraPrep will be compared statistically those from exposure to ZuraPrep without IPA<br>* Other names: ZuraPrep without Isopropol Alcohol (IPA);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scoring Scale (0-7) for Visual Evaluation of Skin Condition | Results from skin scores of ZuraPrep and ZuraPrep without IPA will be compared statistically, and both will be compared to the Positive Control (0.1% Sodium Lauryl Sulfate). | 0-21 days post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scoring Scale (0-7) for Visual Evaluation of Skin Condition | The degree of skin irritation caused by the Reference Product (ChloraPrep) and the Negative Control (0.9% Physiological Saline) will be graded. | 0-21 days post dose |