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| Name | Class |
|---|---|
| BioScience Laboratories, Inc. | INDUSTRY |
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This study is an evaluation of the irritation potential of 9 test products and 2 control materials applied to the backs of at least 44 volunteer human subjects over the course of a 96-hour period to determine and compare irritation scores. Subjects will be required to complete a 7-day pre-test conditioning period prior to the test period. Finn Chambers® on Scanpor® will be used to apply each test material to a designated site on the skin of the parascapular region of the upper back every 24 hours for 96 hours. The sites will be evaluated visually prior to the first patch application and immediately following each patch removal. Instrument measurements of transepidermal water loss (TEWL) will also be performed prior to the first patch application and will start between 15 to 30 minutes, following removal of each patch.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Product 1 (4% CHG) | Active Comparator | Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back |
|
| Test Product 2 (2% CHG) | Active Comparator | Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back |
|
| Test Product 3 (2% CHG) | Active Comparator | Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back |
|
| Test Product 4 (4% CHG) | Active Comparator | Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back |
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| Test Product 5 (4% CHG) | Active Comparator | Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine Gluconate | Drug | Antimicrobial Skin Wash |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Evaluation of Skin Condition | The grading scale for skin condition is from 0-7 (0 - no evidence of irritation and 7-a strong reaction spreading beyond the test site) Reapplication stopped for any grade above 3. | assessed every 24 hours for a total of 96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Transepidermal water loss | By quantitating the rate of water evaporation of the skin using a multi probe adapter system and Tewameter (r) TM 300 probe | assessed every 24 hours for a total of 96 hours |
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Inclusion Criteria:
Exclusion Criteria:
Note - 81 mg of aspirin for preventative health reasons does not reduce inflammatory responses, and as such is not considered to be an exclusion to testing.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Scott | Contact | (+44) 7967769991 | caroline.scott@molnlycke.com |
| Name | Affiliation | Role |
|---|---|---|
| Kendra Drake | BSLI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bioscience Laboratories, Inc | Bozeman | Montana | 59718 | United States |
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| Test Product 6 (4% CHG) | Active Comparator | Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back |
|
| Test Product 7 (4% CHG) | Active Comparator | Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back |
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| Test Product 8 (4% CHG) | Active Comparator | Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back |
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| Test Product 9 (4% CHG) | Active Comparator | Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back |
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| 0.1% Sodium Lauryl Sulfate | Placebo Comparator | Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back. Product with known irritancy potential. |
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| Distilled Water | Placebo Comparator | Product applied to patch and randomly assigned application site on right and left parascapular regions of upper back. Product known not to cause irritancy |
|
| Hibi Universal Bathing System | Device | Cloths used for patient bathing |
|
| 0.1% SLS | Other | Positive control |
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| Distilled Water | Other | Negative Control |
|
| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
| C038828 | long-chain-aldehyde dehydrogenase |
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