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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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Evaluate the effect of two hand antiseptic products on hand skin conditions of healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avagard | Experimental | 3M Avagard Surgical and healthcare Personnel Hand Antiseptic with Moisturizers |
|
| Purell | Active Comparator | Purell Surgical Scrub with Moisturizers |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avagard | Drug | Topical solution, 6 mL, 6 applications/day for 14 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days | Observe VSS score at 14 days, and graded change of skin health from baseline using scale of 0 (normal) - 5 (very scaly). | Baseline and 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary L Grove, PhD | cyberDERM Clinical Research | Principal Investigator |
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After screening, there was a 5-days washout prior to enrollment into period 1. This was then followed by another 5-days washout between periods 1 and 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Purell First Followed by Avagard | Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days. |
| FG001 | Avagard First Followed by Purell | Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Wash-out |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Purell First Followed by Avagard | Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days. |
| BG001 | Avagard First Followed by Purell | Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Skin Health, Visual Skin Score (VSS) at 14 Days | Observe VSS score at 14 days, and graded change of skin health from baseline using scale of 0 (normal) - 5 (very scaly). | Analysis was done per protocol | Posted | Mean | Standard Deviation | units on a scale | Baseline and 14 days |
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The number of participants affected/at risk in the adverse event reporting section was recorded as "0". Adverse events and Serious adverse events were collected and assessed, but none observed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Purell First Followed by Avagard | Using Purell for 14 days. Rest for 5 days(no product used). Then use Avagard for 14 days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chou Eyberg | 3M Company | 651-737-0934 | cieyberg1@mmm.com |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
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| Purell Surgical Scrub |
| Drug |
Topical solution, 4 mL, 6 applications/day for 14 days. |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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|
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| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Avagard First Followed by Purell | Using Avagard for 14 days. Rest for 5 days(no product used). Then use Purell for 14 days. | 0 | 17 | 0 | 17 |
PI was a test lab, and they do not publish study result. Sponsor can choose to publish.