Healthy Skin
Conditions
Keywords
study, subjects
Brief summary
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.
Detailed description
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.
Interventions
OTHERControl Hand Soap
Commercially available soap will be used to wash the subject's forearms
OTHERBenzalkonium Chloride Soap
Commercially available soap containing benzalkonium chloride will be used to wash the subject's forearms
OTHERTriclocarban Soap
Commercially available soap containing triclocarban will be used to wash the subject's forearms
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Those who meet all of the following criteria are eligible for enrollment into the study: 1. Age 18-60 years 2. Male or female of any race and ethnicity 3. Subject agrees to comply with study requirements.
Exclusion criteria
1. Subjects with severe medical condition(s) that in the view of the investigator prohibits participation in the study 2. Dermatologic disease such as psoriasis or atopic dermatitis which may have inherently abnormal antimicrobial peptide levels 3. Subject has Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier 4. Pregnant or nursing females 5. Immunocompromised subjects (e.g., lymphoma, HIV/AIDS, Wiskott-Aldrich Syndrome), or with a history of active or malignant disease (excluding non-melanoma skin cancer) as determined by the participant's medical history. 6. Subjects with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol 7. Subjects with significant concurrent medical condition(s) at screening that in the view of the investigator prohibits participation in the study (e.g., severe concurrent allergic disease, condition associated with malignancy, and condition associated with immunosuppression) 8. Active viral or fungal skin infections at the target areas 9. Are currently receiving lithium, antimalarials, or intramuscular gold now or within the last 4 weeks. 10. Ongoing participation in an investigational drug trial 11. Use of any oral or topical antibiotic during the study and up to one week prior to entering the study 12. Use of any local topical medications less than one week prior to screening 13. Use of any systemic immunosuppressive therapy less than four weeks prior to screening. 14. Subjects with a history of or propensity to developing reactions after use of over the counter cleansers 15. Subjects with diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative 16S Abundance - Control Soap | Baseline, 10 minutes, 6 hours, 24 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative Abundance of Staphylococcus Epidermidis of Intervention Arms | Baseline, 6 hours | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| 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. | 10 |
| 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. | 5 |
| 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. | 10 |
| Total | 30 |
Baseline characteristics
| Characteristic | Control Soap vs Benzalkonium Chloride Soap | Control Soap vs Triclocarban Soap | Total |
|---|---|---|---|
| Age, Continuous | 34 years | 31.8 years | 32.9 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 5 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
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
Time frame: Baseline, 10 minutes, 6 hours, 24 hours
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Control Hand Soap | Relative 16S Abundance - Control Soap | Baseline | 100 Percentage of Baseline |
| Control Hand Soap | Relative 16S Abundance - Control Soap | 10 Minutes | 74 Percentage of Baseline |
| Control Hand Soap | Relative 16S Abundance - Control Soap | 6 Hours | 84 Percentage of Baseline |
| Control Hand Soap | Relative 16S Abundance - Control Soap | 24 Hours | 100 Percentage of Baseline |
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
Time frame: Baseline, 6 hours
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Hand Soap | Relative Abundance of Staphylococcus Epidermidis of Intervention Arms | Baseline | 100 Percentage of Baseline | Standard Error 0 |
| Control Hand Soap | Relative Abundance of Staphylococcus Epidermidis of Intervention Arms | 6 Hours | 283 Percentage of Baseline | Standard Error 190 |
| Benzalkonium Chloride Soap | Relative Abundance of Staphylococcus Epidermidis of Intervention Arms | Baseline | 100 Percentage of Baseline | Standard Error 0 |
| Benzalkonium Chloride Soap | Relative Abundance of Staphylococcus Epidermidis of Intervention Arms | 6 Hours | 100 Percentage of Baseline | Standard Error 32 |
| Triclocarban Soap | Relative Abundance of Staphylococcus Epidermidis of Intervention Arms | Baseline | 100 Percentage of Baseline | Standard Error 0 |
| Triclocarban Soap | Relative Abundance of Staphylococcus Epidermidis of Intervention Arms | 6 Hours | 200 Percentage of Baseline | Standard Error 150 |