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Up to 10 volunteers will be recruited to evaluate the microbial environment on their forearms. Following informed consent, bacterial swabs will be obtained at baseline from the forearms of all subjects. Their forearms will then be washed with one of the study cleansers. Subjects will then have their forearms swabbed for bacteria at the following time points: 10 minutes, 6 hours, and 24 hours after the wash. DNA will be extracted from all swabs and bacterial diversity evaluated by 16S pyrosequencing.
The timeline for the patients will be as follows:
On Day 0, after being given a witnessed, written, informed consent, a medical history and a limited physical exam will be performed. If using certain topical products and medications that are not allowed during this study, patients may be asked to withhold them for the remainder of the study. The study doctor or study coordinator will explain which medications and activities are not allowed during this study. Baseline bacterial swabs from the bilateral volar forearms will be collected followed by application and rinsing of a hand wash with an antimicrobial compound (benzalkonium chloride or triclocarban) on the right forearm, and a cleanser without an antimicrobial compound (control) on the left forearm. 200 microliters of water/hand wash will be applied to the volar forearms and lather generated for 15 seconds using a gloved hand. The lather will be allowed to stay in contact with the skin for an additional 30 seconds. The total contact time will be 60 sec. The forearm will be rinsed with running tap water for 15 seconds, air-dried for 5 minutes and the skin surface will again be swabbed for bacteria 10 minutes after the wash. The same procedure will be repeated on the 2nd volar forearm with the opposing wash. Subjects will then have repeat skin swabs at 6 hours +/- 1 hour and at 24 hours +/- 6 hours after washing. Subjects will be instructed to avoid rigorous exercise/swimming, significant sun exposure (i.e. sunbathing), cleaning the forearms with other antibacterial products, and showering during these 24 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Soap vs. Benzalkonium Chloride Soap | Other | Each subject's will have one forearm washed with a control soap and then the other forearm will be washed with benzalkonium chloride soap. The control forearm will be swabbed for bacteria at baseline, 10 minutes, 6 hours, and 24 hours. The benzalkonium chloride forearm will be swabbed at baseline and 6 hours. |
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| Control Soap vs. Triclocarban Soap | Other | Each subject's will have one forearm washed with a control soap and then the other forearm will be washed with triclocarban soap. The control forearm will be swabbed for bacteria at baseline, 10 minutes, 6 hours, and 24 hours. The triclocarban forearm will be swabbed at baseline and 6 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Hand Soap | Other | Commercially available soap will be used to wash the subject's forearms |
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| Measure | Description | Time Frame |
|---|---|---|
| Relative 16S Abundance - Control Soap | Total bacterial DNA abundance at baseline (relative to baseline), prior to washing with control soap (softsoap aquarium series hand soap) as measured by qPCR of 16S RNA | Baseline, 10 minutes, 6 hours, 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Abundance of Staphylococcus Epidermidis of Intervention Arms | Total bacterial DNA abundance of S. epidermidis (relative to baseline) at baseline and 6 hours, before washing with any soap as measured by qPCR of 16S RNA | Baseline, 6 hours |
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Inclusion Criteria:
Those who meet all of the following criteria are eligible for enrollment into the study:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Division of Dermatology | San Diego | California | 92122 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Soap vs. Benzalkonium Chloride Soap | Each subject's will have one forearm washed with a control soap and then the other forearm will be washed with benzalkonium chloride soap. The control forearm will be swabbed for bacteria at baseline, 10 minutes, 6 hours, and 24 hours. The benzalkonium chloride forearm will be swabbed at baseline and 6 hours. |
| FG001 | Control Soap vs. Triclocarban Soap | Each subject's will have one forearm washed with a control soap and then the other forearm will be washed with triclocarban soap. The control forearm will be swabbed for bacteria at baseline, 10 minutes, 6 hours, and 24 hours. The triclocarban forearm will be swabbed at baseline and 6 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Soap vs Benzalkonium Chloride Soap | Each subject's will have one forearm washed with a control soap and then the other forearm will be washed with benzalkonium chloride soap. The control forearm will be swabbed for bacteria at baseline, 10 minutes, 6 hours, and 24 hours. The benzalkonium chloride forearm will be swabbed at baseline and 6 hours. |
| 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, Continuous | Mean |
| 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 | Relative 16S Abundance - Control Soap | Total bacterial DNA abundance at baseline (relative to baseline), prior to washing with control soap (softsoap aquarium series hand soap) as measured by qPCR of 16S RNA | The control soap data for all 10 subjects (5 from each treatment arm) was pooled for this analysis. The control soap subjects' forearms were were assessed at the following time points--baseline, 10 minutes, 6 hours, and 24 hours. | Posted | Mean | Inter-Quartile Range | Percentage of Baseline | Baseline, 10 minutes, 6 hours, 24 hours |
|
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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 | Control Soap vs. Benzalkonium Chloride Soap | Each subject's will have one forearm washed with a control soap and then the other forearm will be washed with benzalkonium chloride soap. The control forearm will be swabbed for bacteria at baseline, 10 minutes, 6 hours, and 24 hours. The benzalkonium chloride forearm will be swabbed at baseline and 6 hours. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCSD Dermatology Clinical Trials Manager | UCSD Dermatology Clinical Trials | (858)657-8390 | dermstudies@ucsd.edu |
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| Benzalkonium Chloride Soap | Other | Commercially available soap containing benzalkonium chloride will be used to wash the subject's forearms |
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| Triclocarban Soap | Other | Commercially available soap containing triclocarban will be used to wash the subject's forearms |
|
| BG001 |
| Control Soap vs Triclocarban Soap |
Each subject's will have one forearm washed with a control soap and then the other forearm will be washed with triclocarban soap. The control forearm will be swabbed for bacteria at baseline, 10 minutes, 6 hours, and 24 hours. The triclocarban forearm will be swabbed at baseline and 6 hours. |
| BG002 | Total | Total of all reporting groups |
| Forearms |
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| years |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | Relative Abundance of Staphylococcus Epidermidis of Intervention Arms | Total bacterial DNA abundance of S. epidermidis (relative to baseline) at baseline and 6 hours, before washing with any soap as measured by qPCR of 16S RNA | The control soap data for all 10 subjects (5 from each treatment arm) was pooled for this analysis. The control soap subjects' forearms were were assessed at the following time points--baseline and 6 hours. The benzalkonium chloride and triclocarban forearms were assessed at the same time points. | Posted | Mean | Standard Error | Percentage of Baseline | Baseline, 6 hours |
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| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Control Soap vs. Triclocarban Soap | Each subject's will have one forearm washed with a control soap and then the other forearm will be washed with triclocarban soap. The control forearm will be swabbed for bacteria at baseline, 10 minutes, 6 hours, and 24 hours. The triclocarban forearm will be swabbed at baseline and 6 hours. | 0 | 5 | 0 | 5 |
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