Survival of Bacteria on Skin After Using Different SoapsNCT02012348
Analysis of the Effect of Antimicrobial Soap on Bacterial Survival
A study testing Antibacterial soap with triclocarban and Antibacterial soap + benzalkonium chloride in people with Survival of Bacteria on Skin After Using Different Soaps, run by University of California, San Diego at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Survival of Bacteria on Skin After Using Different Soaps
- What is being tested?
- Antibacterial soap with triclocarban and Antibacterial soap + benzalkonium chloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Those who meet all of the following criteria are eligible for enrollment into the study:
- Age 18-60 years
- Male or female of any race and ethnicity
- Subject agrees to comply with study requirements.
Who cannot join
- Subjects with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- Dermatologic disease such as psoriasis or atopic dermatitis which may have inherently abnormal antimicrobial peptide levels
- Subject has Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier
- Pregnant or nursing females
- 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.
- 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
Show all 16Show fewer
- 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)
- Active viral or fungal skin infections at the target areas
- Are currently receiving lithium, antimalarials, or intramuscular gold now or within the last 4 weeks.
- Ongoing participation in an investigational drug trial
- Use of any oral or topical antibiotic during the study and up to one week prior to entering the study
- Use of any local topical medications less than one week prior to screening
- Use of any systemic immunosuppressive therapy less than four weeks prior to screening.
- Subjects with a history of or propensity to developing reactions after use of over the counter cleansers
- Subjects with diabetes
- Injured, broken skin that, per the investigator, may cause injury if exposed to low virulence GAS.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Being tested
- Antibacterial soap with triclocarban, Antibacterial soap + benzalkonium chloride, Control soap
- Keywords
- bacteria survival, surfactants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibacterial soap with triclocarbanOther
Antibacterial soap + benzalkonium chlorideOther
Control soapOther
| Study group | Role | What they receive |
|---|---|---|
| Control soap | Placebo comparator | Forearms of subjects in this arm will be washed with control (non-antibacterial) soap Receives: Other: Control soap |
| Antibacterial soap with triclocarban | Experimental | The forearms of subjects in this group will be washed with antibacterial soap containing triclocarban Receives: Other: Antibacterial soap with triclocarban |
| Antibacterial soap + benzalkonium chloride | Active comparator | The forearms of subjects in this group will be washed with antibacterial soap containing benzalkonium chloride Receives: Other: Antibacterial soap + benzalkonium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes post-bacteria application
Secondary outcomes (1)
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.
Measured: 1 hour after bacteria application / 2 hours post washing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Survival of Bacteria on Skin After Using Different SoapsStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Colgate Palmolive
- Responsible party
- Principal investigator, Richard Gallo, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012348
- Sponsor's protocol ID
- UCSD 121622
- Status last verified
- Sep 2019
- First submitted
- 10 Dec 2013
- Last updated
- 3 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Effect of Antimicrobial Soap on Bacterial Survival
- ClinicalTrials.gov ID
- NCT02012348
- Acronym / sponsor ID
- UCSD 121622
- Keywords
- bacteria survival, surfactants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Colgate Palmolive
- Study start
- Dec 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 16 Dec 2013 (estimated)
- Results
- Posted 3 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control soap | Placebo comparator | Other: Control soapForearms of subjects in this arm will be washed with control (non-antibacterial) soap |
| Antibacterial soap with triclocarban | Experimental | Other: Antibacterial soap with triclocarbanThe forearms of subjects in this group will be washed with antibacterial soap containing triclocarban |
| Antibacterial soap + benzalkonium chloride | Active comparator | Other: Antibacterial soap + benzalkonium chlorideThe forearms of subjects in this group will be washed with antibacterial soap containing benzalkonium chloride |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-60 years
- Male or female of any race and ethnicity
- Subject agrees to comply with study requirements.
Key exclusion criteria (16 listed)
- Subjects with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- Dermatologic disease such as psoriasis or atopic dermatitis which may have inherently abnormal antimicrobial peptide levels
- Subject has Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier
- Pregnant or nursing females
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibacterial soap with triclocarban | Other | Antibacterial soap with triclocarban |
| Antibacterial soap + benzalkonium chloride | Other | Antibacterial soap + benzalkonium chloride |
| Control soap | Other | Control soap |
Primary outcome
Relative GAS Survival
Time frame: 30 minutes post-bacteria application
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.
1 secondary outcome
Relative GAS Survival
Time frame: 1 hour after bacteria application / 2 hours post washing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibacterial soap with triclocarban and Antibacterial soap + benzalkonium chloride in people with Survival of Bacteria on Skin After Using Different Soaps, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative GAS Survival (time frame: 30 minutes post-bacteria application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2019.