Healthy SkinNCT01951391
Effect of Surfactants on the Skin Microbiome
A study testing Benzalkonium Chloride Soap and Triclocarban Soap in people with Healthy Skin, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Skin
- What is being tested?
- Benzalkonium Chloride Soap and Triclocarban Soap
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Dec 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 15Show 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Division of Dermatology
San Diego, California, 92122
About this study
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.
Read the 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.
- Conditions
- Healthy Skin
- Being tested
- Control Hand Soap, Benzalkonium Chloride Soap, Triclocarban Soap
- Keywords
- study, subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Hand SoapOther
Commercially available soap will be used to wash the subject's forearms
Benzalkonium Chloride SoapOther
Commercially available soap containing benzalkonium chloride will be used to wash the subject's forearms
Triclocarban SoapOther
Commercially available soap containing triclocarban will be used to wash the subject's forearms
| Study group | Role | What they receive |
|---|---|---|
| Control Soap vs. Benzalkonium Chloride Soap | Other | 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. Receives: Other: Control Hand Soap; Other: Benzalkonium Chloride Soap |
| Control Soap vs. Triclocarban Soap | Other | 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. Receives: Other: Control Hand Soap; Other: Triclocarban Soap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 10 minutes, 6 hours, 24 hours
Secondary outcomes (1)
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
Measured: Baseline, 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionJan 2015
- Study completionDec 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 Healthy SkinStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tissa Hata, MD, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951391
- Sponsor's protocol ID
- UCSD 111296
- Status last verified
- Nov 2019
- First submitted
- 23 Sep 2013
- Last updated
- 4 Dec 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 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Surfactants on the Skin Microbiome
- ClinicalTrials.gov ID
- NCT01951391
- Acronym / sponsor ID
- UCSD 111296
- Conditions
- Healthy Skin
- Keywords
- study, subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Sep 2013 (estimated)
- Results
- Posted 4 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Soap vs. Benzalkonium Chloride Soap | Other | Other: Control Hand Soap, Other: Benzalkonium Chloride SoapEach 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 | Other | Other: Control Hand Soap, Other: Triclocarban SoapEach 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. |
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 (15 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 |
|---|---|---|
| Control Hand SoapCommercially available soap will be used to wash the subject's forearms | Other | Control Soap vs. Benzalkonium Chloride Soap, Control Soap vs. Triclocarban Soap |
| Benzalkonium Chloride SoapCommercially available soap containing benzalkonium chloride will be used to wash the subject's forearms | Other | Control Soap vs. Benzalkonium Chloride Soap |
| Triclocarban SoapCommercially available soap containing triclocarban will be used to wash the subject's forearms | Other | Control Soap vs. Triclocarban Soap |
Primary outcome
Relative 16S Abundance - Control Soap
Time frame: 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
1 secondary outcome
Relative Abundance of Staphylococcus Epidermidis of Intervention Arms
Time frame: Baseline, 6 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Benzalkonium Chloride Soap and Triclocarban Soap in people with Healthy Skin, 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 15 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 4 Dec 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. 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 4 Dec 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 16S Abundance - Control Soap (time frame: Baseline, 10 minutes, 6 hours, 24 hours). 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 4 Dec 2019.