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This is a safety study to determine the cumulative skin irritation potential of ZuraPrepâ„¢ and ZuraPrepâ„¢ without Isopropyl Alcohol after repetitive patch applications to skin of human subjects.
This cumulative irritation evaluation is designed to determine the skin irritation potential of ZuraPrepâ„¢ and ZuraPrepâ„¢ without Isopropyl Alcohol (IPA) after repetitive patch application to skin of healthy human subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZuraPrep | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChloraPrep | Drug | The degree of skin irritation caused by ChloraPrep will be graded and compared to ZuraPrep and ZuraPrep without IPA. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esther Campbell | BioScience Laboratories, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioScience Laboratories | Bozeman | Montana | 59718 | United States |
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| 0.1% Sodium Lauryl Sulfate | Drug | The degree of skin irritation caused by 0.1% Sodium Lauryl Sulfate will be graded and compared to ZuraPrep and ZuraPrep without IPA. |
|
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| 0.9% Physiological Saline | Drug | The degree of skin irritation caused by 0.9% Physiological Saline will be graded and compared to ZuraPrep and ZuraPrep without IPA. |
|
|
| ZuraPrep without IPA | Other | Results from exposure to ZuraPrep will be compared statistically those from exposure to ZuraPrep without IPA |
|
|
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
| D012967 | Sodium Dodecyl Sulfate |
| C547847 | citrate, isopropyl alcohol, methylene blue, parabens drug combination |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D007851 | Dodecanol |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D008055 | Lipids |
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