An interventional study of Antibacterial soap with triclocarban and Antibacterial soap + benzalkonium chloride in Survival of Bacteria on Skin After Using Different Soaps, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-03.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Prevention
This study will recruit up to 10 healthy volunteers. An avirulent strain of S. pyogenes will be applied to their forearms after washing each of their forearms with different types of soap, one with an antimicrobial compound, and the other without an antimicrobial compound. After several hours of incubation, the subject's forearms will be swabbed for bacteria. The forearms will then be cleansed with antibacterial soap and water followed by 70% ethanol. The bacterial swabs will be analyzed and compared between the different soaps that were used to cleanse each digit prior to the application of S. pyogenes. The investigator expects the number of bacteria surviving on the skin of forearms washed with antimicrobial soaps will be fewer than with control soap.
The study timeline will be as follows:
Day -7 to -1 - After obtaining informed consent, potential participants will be screened. A brief history and physical exam will be done on those who meet enrollment criteria. They will be assigned a start date to coincide with Day 0 below.
Day 0 - Participants will be instructed not to shower on this day. They may shower the evening before Day 0, however starting at midnight on Day 0, the participant will be advised not to shower. They will also be asked to wear a shirt with long sleeves. Significant exercise, sunbathing, and the use of creams or lotions on the forearms should also be avoided starting on Day 0, and these restrictions will remain in place until all Day 1 study-related procedures are completed. In the late afternoon on this day, the subject will have six (6) 2 cm x 2 cm squares drawn on each forearm using a skin marker. The volar forearms will be washed with soap, taking care to not remove the skin markings. One forearm will be washed with a soap containing an antibacterial compound. The other forearm will be washed using a control soap that does not contain an antibacterial compound. Each washing will consist of the application of 1.5 mL of test product to the volar forearm. A lather will be generated for 20 seconds using a gloved hand. The forearm will be rinsed with running tap water for 30 seconds and allowed to air-dry. Each forearm will be wrapped in gauze once dry. The gauze should be kept dry and in place until removed by the study staff the following day.
Day 1 - On the morning of Day 1, the gauze will be removed from participants' forearms, and 10 µL PBS containing 104 CFU of avirulent Streptococcus pyogenes (strain NZ131 M49) will be applied to the center of each of the squares previously drawn on participants' forearms. The bacteria will be spread within each square to evenly coat the surface of the skin within the square. The bacteria will then be allowed to air dry. Once dry, skin swabs will be rubbed over two of the squares on each forearm to collect a sample of the bacteria on the forearm at that location. After swabbing, these areas will be immediately disinfected with 70% alcohol. The forearms will then be wrapped again in gauze. One hour later, the gauze will be removed, and two more squares on each forearm will be swabbed for bacteria. These squares will then be disinfected with 70% alcohol, and gauze reapplied to the forearms. One hour later (two hours post-washing), the gauze will be removed, and the remaining two squares on each forearm will be swabbed for bacteria. Both forearms will then be washed with 70% ethanol and rinsed with water to remove any remaining bacteria. This will conclude the study-related procedures for Day 1. Participants are then free to shower, sunbathe, exercise and apply any creams or lotions to their forearms until the following week.
These same study procedures as above will be repeated again on Days 7 and 8, however the antibacterial soap will be used to wash one of the forearms will be replaced by a different antibacterial soap. The exact details are described in the paragraphs below.
Day 7 - Participants will be instructed not to shower on this day. They may shower the evening before Day 7, however starting at midnight on Day 7, the participant will be advised not to shower. They will also be asked to wear a shirt with long sleeves. Significant exercise, sunbathing, and the use of creams or lotions on the forearms should also be avoided starting on Day 7, and these restrictions will continue until all Day 8 study-related procedures are completed. In the late afternoon on this day, the subject will have six (6) 2 cm x 2 cm squares drawn on each forearm using a skin marker. The volar forearms will be washed with soap, taking care to not remove the skin markings. One forearm will be washed with a soap containing an antibacterial compound. The other forearm will be washed using a control soap that does not contain an antibacterial compound. Each washing will consist of the application of 1.5 mL of test product to the volar forearm. A lather will be generated for 20 seconds using a gloved hand. The forearm will be rinsed with running tap water for 30 seconds and allowed to air-dry. Each forearm will be wrapped in gauze once dry. The gauze should be kept dry and in place until removed by the study staff the following day.
Day 8 - On the morning of Day 8, the gauze will be removed from participants' forearms, and 10 µL PBS containing 104 CFU of avirulent Streptococcus pyogenes (strain NZ131 M49) will be applied to the center of each of the squares previously drawn on participants' forearms. The bacteria will be spread within each square to evenly coat the surface of the skin within the square. The bacteria will then be allowed to air dry. Once dry, skin swabs will be rubbed over two of the squares on each forearm to collect a sample of the bacteria on the forearm at that location. After swabbing, these areas will be immediately disinfected with 70% alcohol. The forearms will then be wrapped again in gauze. One hour later, the gauze will be removed, and two more squares on each forearm will be swabbed for bacteria. These squares will then be disinfected with 70 alcohol, and gauze reapplied to the forearms. One hour later (two hours post-washing), the gauze will be removed, and the remaining two squares on each forearm will be swabbed for bacteria. Both forearms will then be washed with 70% ethanol and rinsed with water to remove any remaining bacteria. This will conclude all study-related procedures. Participants are then free to shower, sunbathe, exercise and apply any creams or lotions to their forearms.
University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Those who meet all of the following criteria are eligible for enrollment into the study:
Exclusion Criteria:
Forearms of subjects in this arm will be washed with control (non-antibacterial) soap
Other: Control soap
The forearms of subjects in this group will be washed with antibacterial soap containing triclocarban
Other: Antibacterial soap with triclocarban
The forearms of subjects in this group will be washed with antibacterial soap containing benzalkonium chloride
Other: Antibacterial soap + benzalkonium chloride
Relative GAS Survival
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.
Time frame: 30 minutes post-bacteria application
Relative GAS Survival
A 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.
Time frame: 1 hour after bacteria application / 2 hours post washing
| Milestone | Control Soap | Antibacterial Soap With Triclocarban | Antibacterial Soap + Benzalkonium Chloride |
|---|---|---|---|
| Started | 10 | 10 | 10 |
| Completed | 10 | 10 | 10 |
| Not completed | 0 | 0 | 0 |
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.
| percentage overall bacterial abundance | Control Soap | Antibacterial Soap With Triclocarban | Antibacterial Soap + Benzalkonium Chloride |
|---|---|---|---|
| Relative GAS Survival | 100 ± 15 | 75 ± 20 | 90 ± 21.7 |
A 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.
| percentage overall bacterial abundance | Control Soap | Antibacterial Soap With Triclocarban | Antibacterial Soap + Benzalkonium Chloride |
|---|---|---|---|
| Relative GAS Survival | 100 ± 12.5 | 86.7 ± 23.3 | 61.7 ± 13.3 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Soap | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Antibacterial Soap With Triclocarban | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Antibacterial Soap + Benzalkonium Chloride | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Continuous(years) | Control Soap | Antibacterial Soap With Triclocarban | Antibacterial Soap + Benzalkonium Chloride | Total |
|---|---|---|---|---|
| Mean | 32.2 ± 5 | 32.2 ± 5 | 32.2 ± 5 | 32.2 ± 5 |
| Sex: Female, Male(Participants) | Control Soap | Antibacterial Soap With Triclocarban | Antibacterial Soap + Benzalkonium Chloride | Total |
|---|---|---|---|---|
| Female | 4 | 4 | 4 | 12 |
| Male | 6 | 6 | 6 | 18 |
| Ethnicity (NIH/OMB)(Participants) | Control Soap | Antibacterial Soap With Triclocarban | Antibacterial Soap + Benzalkonium Chloride | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 1 | 3 |
| Not Hispanic or Latino | 3 | 3 | 3 | 9 |
| Unknown or Not Reported | 6 | 6 | 6 | 18 |
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, San Diego