Trial Outcomes & Findings for Effect of Surfactants on the Skin Microbiome (NCT NCT01951391)
NCT ID: NCT01951391
Last Updated: 2019-12-04
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Baseline, 10 minutes, 6 hours, 24 hours
Results posted on
2019-12-04
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Surfactants on the Skin Microbiome
Baseline characteristics by cohort
| Measure |
Control Soap vs Benzalkonium Chloride Soap
n=10 Forearms
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.
|
Control Soap vs Triclocarban Soap
n=10 Forearms
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.
|
Total
n=20 Forearms
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34 years
n=5 Participants
|
31.8 years
n=7 Participants
|
32.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 10 minutes, 6 hours, 24 hoursPopulation: 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.
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
Outcome measures
| Measure |
Control Hand Soap
n=10 Participants
Prior to washing, each subjects' forearms will be swabbed for bacteria. Each subject will then be washed with Softsoap aquarium series hand soap. They will then be swabbed at 10 minutes, 6 hours, and 24 hours to determine changes in bacteria levels.
|
Benzalkonium Chloride Soap
Prior to washing, each subject's benzalkonium chloride forearm will be swabbed for bacteria. Each subject will then be washed with a soap containing benzalkonium chloride. They will then be swabbed at 6 hours to determine changes in staphylococcus epidermidis levels.
|
Triclocarban Soap
Prior to washing, each subject's triclocarban forearm will be swabbed for bacteria. Each subject will then be washed with a soap containing triclocarban. They will then be swabbed at 6 hours to determine changes in staphylococcus epidermidis levels.
|
|---|---|---|---|
|
Relative 16S Abundance - Control Soap
Baseline
|
100 Percentage of Baseline
Interval 100.0 to 100.0
|
—
|
—
|
|
Relative 16S Abundance - Control Soap
10 Minutes
|
74 Percentage of Baseline
Interval 58.0 to 110.0
|
—
|
—
|
|
Relative 16S Abundance - Control Soap
6 Hours
|
84 Percentage of Baseline
Interval 58.0 to 680.0
|
—
|
—
|
|
Relative 16S Abundance - Control Soap
24 Hours
|
100 Percentage of Baseline
Interval 42.0 to 680.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 6 hoursPopulation: 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.
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
Outcome measures
| Measure |
Control Hand Soap
n=10 Participants
Prior to washing, each subjects' forearms will be swabbed for bacteria. Each subject will then be washed with Softsoap aquarium series hand soap. They will then be swabbed at 10 minutes, 6 hours, and 24 hours to determine changes in bacteria levels.
|
Benzalkonium Chloride Soap
n=5 Participants
Prior to washing, each subject's benzalkonium chloride forearm will be swabbed for bacteria. Each subject will then be washed with a soap containing benzalkonium chloride. They will then be swabbed at 6 hours to determine changes in staphylococcus epidermidis levels.
|
Triclocarban Soap
n=5 Participants
Prior to washing, each subject's triclocarban forearm will be swabbed for bacteria. Each subject will then be washed with a soap containing triclocarban. They will then be swabbed at 6 hours to determine changes in staphylococcus epidermidis levels.
|
|---|---|---|---|
|
Relative Abundance of Staphylococcus Epidermidis of Intervention Arms
Baseline
|
100 Percentage of Baseline
Standard Error 0
|
100 Percentage of Baseline
Standard Error 0
|
100 Percentage of Baseline
Standard Error 0
|
|
Relative Abundance of Staphylococcus Epidermidis of Intervention Arms
6 Hours
|
283 Percentage of Baseline
Standard Error 190
|
100 Percentage of Baseline
Standard Error 32
|
200 Percentage of Baseline
Standard Error 150
|
Adverse Events
Control Soap vs. Benzalkonium Chloride Soap
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Soap vs. Triclocarban Soap
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
UCSD Dermatology Clinical Trials Manager
UCSD Dermatology Clinical Trials
Phone: (858)657-8390
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place