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This is a safety study to determine the skin sensitization potential of ZuraPrepâ„¢ and ZuraPrepâ„¢ without isopropyl alcohol (IPA) after repetitive patch applications to skin of human subjects. Indications of both sensitization and skin irritation will be evaluated.
This study is designed to determine if the test product, ZuraPrepâ„¢ is a skin sensitizing agent when applied to human skin. The study, a modified Draize skin sensitization evaluation, will be conducted in three discrete phases: 1) induction, 2) rest, and 3) challenge. During the Induction Phase, skin sites are exposed to the test product repeatedly for 21 consecutive days. The Rest Phase, a 14-day period when no treatment is performed, serves to provide adequate time for the immune system to react to ZuraPrepâ„¢, given any of its components serve as antigens. During the Challenge Phase, the subjects' skin is re-exposed to the test product (ZuraPrepâ„¢) to determine if it is likely to be immunosensitizing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZuraPrep | Active Comparator | Irritation scores of the following applied to test sites will be compared: ZuraPrep, ZuraPrep without IPA, ChloraPrep, and 0.9% Physiological Saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chloraprep | Drug | ChloraPrep will be compared to ZuraPrep with regard to skin sensitization and irritation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skin sites evaluated and graded for irritancy or sensitization | Only frank sensitization will be categorized, as a positive control (known sensitizing agent) is prohibitive due to ethical considerations/risk of life-time sensitization. Reactions observed will be assessed as to whether indicative of sensitization or of irritation. | 0-40 days post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Statistics of irritation scores | Irritation scores, relative to the Test Products, Reference Product, and the Negative Control applied to skin on each test day will be compared as well as the total cumulative irritation scores across all test days. | 0-40 days post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maggie Butler, PhD | BioScience Laboratories, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioScience Laboratories, Inc. | Bozeman | Montana | 59718 | United States |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
| C547847 | citrate, isopropyl alcohol, methylene blue, parabens drug combination |
| D019840 | 2-Propanol |
| ID | Term |
|---|---|
| D020005 | Propanols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| 0.9% Physiological Saline | Drug | 0.9% Physiological Saline will be compared to ZuraPrep with regard to skin sensitization and irritation. |
|
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| ZuraPrep without IPA | Other | ZuraPrep without IPA will be compared to ZuraPrep with regard to skin sensitization and irritation |
|
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |