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In this study we will test the ability of different commercially available hand soaps to effect the amount of anti-microbial peptides present on the surface of the human skin after washing with these soaps. Based on our experiments on pig skin, we expect the amount of antimicrobial peptide expression to decrease after using these different soaps.
We will use tape-stripping methods to determine the level of antimicrobial peptides (specifically LL-37) present on the human skin after washing with different commercially available hand soaps. First we will do a baseline tape-stripping procedure to measure the amount of LL-37 on subjects' forearms. Tape stripping involves applying small, round tapes (CuDerm, Dallas, TX) to the skin, massaging them for about 10 second, and then removing them. This process is repeated 9 times for each tape. After doing baseline tape stripping samples, each participant's forearms will be washed with a different soap. The soap will be rinsed off, and the skin allowed to dry. After the forearms are dry (about 5 minutes later), repeat tape-stripping will be performed. This tape-stripping process will then be repeated 4 hours later, and then 24 hours later as well. Results of the LL-37 expression at each time point will then be compared between soaps.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soap recipient | Experimental | The forearms of all subjects will eventually be washed with the same soaps. There is only one arm for this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soap | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Normalized LL-37 Expression | LL-37 expression was measured using tape-stripping methods and expressed relative to baseline. | Baseline |
| Normalized LL-37 Expression | LL-37 was measured using tape-stripping methods and is expressed relative to baseline levels | 4 hours |
| Normalized LL-37 Expression | LL-37 expression was measured using tape-stripping methods and expressed relative to baseline. | 5 minutes |
| Normalized LL-37 Expression | LL-37 expression was measured using tape-stripping methods and expressed relative to baseline. | 24 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 | Soap Recipient | The forearms of all subjects will eventually be washed with the same soaps. There is only one arm for this study. Soap |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Soap Recipient | The forearms of all subjects will eventually be washed with the same soaps. There is only one arm for this study. Soap |
| 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 | Normalized LL-37 Expression | LL-37 expression was measured using tape-stripping methods and expressed relative to baseline. | Posted | Mean | Standard Deviation | percentage of baseline | Baseline |
|
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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 | Soap Recipient | The forearms of all subjects will eventually be washed with the same soaps. There is only one arm for this study. Soap |
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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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| ID | Term |
|---|---|
| D012915 | Soaps |
| ID | Term |
|---|---|
| D003902 | Detergents |
| D013501 | Surface-Active Agents |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
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| Primary | Normalized LL-37 Expression | LL-37 was measured using tape-stripping methods and is expressed relative to baseline levels | Posted | Mean | Standard Deviation | percentage of baseline | 4 hours |
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| Primary | Normalized LL-37 Expression | LL-37 expression was measured using tape-stripping methods and expressed relative to baseline. | Posted | Mean | Standard Deviation | percentage of baseline | 5 minutes |
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| Primary | Normalized LL-37 Expression | LL-37 expression was measured using tape-stripping methods and expressed relative to baseline. | Posted | Mean | Standard Deviation | percentage of baseline | 24 hours |
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| 0 |
| 10 |
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| 10 |
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| D006795 |
| Household Products |
| D013676 | Technology, Industry, and Agriculture |