Trial Outcomes & Findings for Analysis of the Effect of Antimicrobial Soap on Bacterial Survival (NCT NCT02012348)
NCT ID: NCT02012348
Last Updated: 2019-10-03
Results Overview
A skin swab will be used to measure the bacterial survival 30 minutes after bacteria application and soap treatment. The bacteria being applied and subsequently measured is Group A Streptococcus (GAS). The bacterial survival is expressed as abundance of GAS relative to abundance of other bacterial species isolated from the swab.
COMPLETED
NA
30 participants
30 minutes post-bacteria application
2019-10-03
Participant Flow
Participant milestones
| Measure |
Control Soap
Forearms of subjects in this arm will be washed with control (non-antibacterial) soap
Control soap
|
Antibacterial Soap With Triclocarban
The forearms of subjects in this group will be washed with antibacterial soap containing triclocarban
Antibacterial soap with triclocarban
|
Antibacterial Soap + Benzalkonium Chloride
The forearms of subjects in this group will be washed with antibacterial soap containing benzalkonium chloride
Antibacterial soap + benzalkonium chloride
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Analysis of the Effect of Antimicrobial Soap on Bacterial Survival
Baseline characteristics by cohort
| Measure |
Control Soap
n=10 Participants
Forearms of subjects in this arm will be washed with control (non-antibacterial) soap
Control soap
|
Antibacterial Soap With Triclocarban
n=10 Participants
The forearms of subjects in this group will be washed with antibacterial soap containing triclocarban
Antibacterial soap with triclocarban
|
Antibacterial Soap + Benzalkonium Chloride
n=10 Participants
The forearms of subjects in this group will be washed with antibacterial soap containing benzalkonium chloride
Antibacterial soap + benzalkonium chloride
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32.2 years
STANDARD_DEVIATION 5 • n=5 Participants
|
32.2 years
STANDARD_DEVIATION 5 • n=7 Participants
|
32.2 years
STANDARD_DEVIATION 5 • n=5 Participants
|
32.2 years
STANDARD_DEVIATION 5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 minutes post-bacteria applicationA skin swab will be used to measure the bacterial survival 30 minutes after bacteria application and soap treatment. The bacteria being applied and subsequently measured is Group A Streptococcus (GAS). The bacterial survival is expressed as abundance of GAS relative to abundance of other bacterial species isolated from the swab.
Outcome measures
| Measure |
Control Soap
n=10 Participants
Forearms of subjects in this arm will be washed with control (non-antibacterial) soap
Control soap
|
Antibacterial Soap With Triclocarban
n=10 Participants
The forearms of subjects in this group will be washed with antibacterial soap containing triclocarban
Antibacterial soap with triclocarban
|
Antibacterial Soap + Benzalkonium Chloride
n=10 Participants
The forearms of subjects in this group will be washed with antibacterial soap containing benzalkonium chloride
Antibacterial soap + benzalkonium chloride
|
|---|---|---|---|
|
Relative GAS Survival
|
100 percentage overall bacterial abundance
Standard Error 15
|
75 percentage overall bacterial abundance
Standard Error 20
|
90 percentage overall bacterial abundance
Standard Error 21.7
|
SECONDARY outcome
Timeframe: 1 hour after bacteria application / 2 hours post washingA skin swab will be used to measure the bacterial survival 1 hour after bacteria application (2 hours post washing with soap). The bacteria being applied and subsequently measured is Group A Streptococcus (GAS). The bacterial survival is expressed as abundance of GAS relative to abundance of other bacterial species isolated from the swab.
Outcome measures
| Measure |
Control Soap
n=10 Participants
Forearms of subjects in this arm will be washed with control (non-antibacterial) soap
Control soap
|
Antibacterial Soap With Triclocarban
n=10 Participants
The forearms of subjects in this group will be washed with antibacterial soap containing triclocarban
Antibacterial soap with triclocarban
|
Antibacterial Soap + Benzalkonium Chloride
n=10 Participants
The forearms of subjects in this group will be washed with antibacterial soap containing benzalkonium chloride
Antibacterial soap + benzalkonium chloride
|
|---|---|---|---|
|
Relative GAS Survival
|
100 percentage overall bacterial abundance
Standard Error 12.5
|
86.7 percentage overall bacterial abundance
Standard Error 23.3
|
61.7 percentage overall bacterial abundance
Standard Error 13.3
|
Adverse Events
Control Soap
Antibacterial Soap With Triclocarban
Antibacterial Soap + Benzalkonium Chloride
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place