Focus: Healthy Skin MicrobiomeNCT02057055
The Effect of Surfactants on the Bacterial Composition of the Layers of the Skin
A study testing Soap 300000027003 and Soap 300000029240 in people with Focus: Healthy Skin Microbiome, run by University of California, San Diego at 1 site in United States.
Trial summary
Recent research in the investigator's lab has shown that bacteria are present not only on the outer surface of our skin, but also in the deeper components as well. In this study, the investigator will study the bacteria present in different components of the skin including the epidermis, dermis, subcutaneous fat, and… Read more about this study
- Who is it for?
- Ages 21 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Focus: Healthy Skin Microbiome
- What is being tested?
- Soap 300000027003 and Soap 300000029240
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 21-35 years
- Male subject 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
- 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
- Allergy to local anesthetic medications, including lidocaine
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego Division of Dermatology
San Diego, California, 92122
About this study
Recent research in the investigator's lab has shown that bacteria are present not only on the outer surface of our skin, but also in the deeper components as well. In this study, the investigator will study the bacteria present in different components of the skin including the epidermis, dermis, subcutaneous fat, and hair follicle, and determine if and how these bacteria change after repeated use of different commercially available hand soaps. It is expected that the bacteria populations in the different skin components will change with the use of different soaps.
Read the detailed description
This study will consist of 5 visits over approximately 2 months. All study procedures will occur at the University of California San Diego Division of Dermatology Outpatient Clinic. The procedures for each visit will be described below.
Visit 1 (Day 0) At this visit, after obtaining informed consent from subjects, the inclusion/exclusion criteria will be reviewed. This step will require a brief medical history and skin examination to be performed. Both the history and physical exam will be performed by a licensed physician. Eligible subjects will proceed with the remainder of the study. These subjects will be provided with a mild soap (ID# 100000049586) to use whenever they shower for the remainder of the study. These subjects will also be instructed that they may not apply any topical lotions, creams, or other products to their arms during the remainder of the study. Subjects will also be told to avoid excessive sun exposure on their arms, including tanning or the use of tanning beds, while participating in this study.
Visit 2 (Day 14) Subjects will return on Day 14 for Visit 2. Any adverse events will be recorded, and the subject's interim medical history will be taken. Two skin swabs will then be taken from the skin on subject's the upper inner arm. One swab will be from the right arm and the other from the left arm. A 4-mm punch biopsy will then be taken from one of the arms near the area that was swabbed. To perform this procedure, the skin is injected with about 1-2 cc of local anesthetic. A 4 mm punch will be used to remove the biopsy specimen from the location previously agreed upon by the investigator and subject. A 4.0 nylon suture will be used to close the biopsy site, and ointment and a Band-Aid applied.
Visit 3 (Day 28 +/- 4) Subjects will return around Day 28 for their third visit. At this visit, any adverse events since the last visit will be recorded, and the subject's interim medical history will be taken. The suture will be removed from the site of the biopsy taken at Visit 2. Subjects will then be provided with two body washes (ID# 300000027003 and ID# 300000029240) to use in the shower when washing their upper inner arms. One soap will be used to wash the upper half of the right arm, and the other soap will be used to wash the upper half of the left arm. The subject will continue using the Mild Body Wash in the shower when washing all other body parts. The subject will also be instructed not to apply any other creams, ointments or medications to their arms, and to avoid excess sun exposure to their upper arms during this time.
Visit 4 (Day 49 +/- 4) Subjects will return around Day 49 for their next visit. Any adverse events as well as changes to their interim medical history since their last visit will be recorded. A skin swab of each upper inner arm will then be taken. A 4-mm punch biopsy will then be taken from an area of skin in the upper inner region of both the right and left arms for a total of 2 biopsies taken during this visit. At the termination of this visit, subjects can resume use of their normal shower production and application of any creams or lotions they normally use on their arms.
Visit 5 (Day 59 +/- 4) Subjects will return on this day to have their sutures removed. Any adverse events will be recorded. This visit will conclude all study-related activities.
All samples will be processed in the lab. Skin swabs will undergo pyrosequencing to determine the different strains of bacteria present on the subject's skin, as well as quantitative polymerase chain reaction to determine the abundance of S. aureus, S. epidermidis, and P. acnes on each subject's skin surface. Biopsy specimens will be sectioned and each section will be placed on a glass slide. The sections will undergo immunostaining to stain for bacteria. Laser-capture microdissection of each section into its four skin components will be used to assist in evaluating the bacteria present in the different skin layers.
- Conditions
- Focus: Healthy Skin Microbiome
- Being tested
- Soap 300000027003, Soap 300000029240
- Keywords
- Antibacterial soaps, Microbiome, Commensal bacteria, Pyrosequencing, Innate immunity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soap 300000027003Other
Soap 300000029240Other
| Study group | Role | What they receive |
|---|---|---|
| Soap 300000027003 | Experimental | Subjects will apply this soap to one of their arms daily in the shower for 3 weeks Receives: Other: Soap 300000027003 |
| Soap 300000029240 | Experimental | Subjects will apply this soap to one of their arms daily in the shower for 3 weeks Receives: Other: Soap 300000029240 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bacteria
The number of bacteria present on/in the epidermis, dermis, subcutaneous fat and hair follicle will be determined using both polymerase chain reaction and colony counting methods after subjects have used each of the body washes on their arms for a total of 3 weeks.
Measured: 3 weeks
Secondary outcomes (5)
Type of bacteria
The type (i.e. strain) of bacteria present on the skin surface will be determined after subjects use each of the body washes on their arms for three weeks
Measured: 3 weeks
Change in type of bacteria
The change in the type (i.e. strain) of bacteria present on the skin surface will be determined after subjects use each of the body washes on their arms for three weeks and compared to the types of bacteria present at the time of the baseline swabs
Measured: 3 weeks
Change in number of bacteria
The change in the number of bacteria present in the different skin compartments will be determined after subjects use each of the body washes on their arms for three weeks and compared to the number of bacteria present at the time of the baseline biopsies
Measured: 3 weeks
Type of bacteria
The baseline type (i.e. strain) of bacteria present on the skin surface will be determined after subjects use a mild body wash on their arms for two weeks
Measured: Baseline
Number of bacteria
The baseline number of bacteria present on the skin surface will be determined after subjects use each a mild body wash for two weeks
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Why it stopped: study not executed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus: Healthy Skin MicrobiomeStudies 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
- 0 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
- Investigators
- Tissa Hata, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057055
- Sponsor's protocol ID
- UCSD 131420
- Status last verified
- Aug 2018
- First submitted
- 4 Feb 2014
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Surfactants on the Bacterial Composition of the Layers of the Skin
- ClinicalTrials.gov ID
- NCT02057055
- Acronym / sponsor ID
- UCSD 131420
- Conditions
- Focus: Healthy Skin Microbiome
- Keywords
- Antibacterial soaps, Microbiome, Commensal bacteria, Pyrosequencing, Innate immunity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study not executed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 6 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent research in the investigator's lab has shown that bacteria are present not only on the outer surface of our skin, but also in the deeper components as well. In this study, the investigator will study the bacteria present in different components of the skin including the epidermis, dermis, subcutaneous fat, and hair follicle, and determine if and how these bacteria change after repeated use of different commercially available hand soaps. It is expected that the bacteria populations in the different skin components will change with the use of different soaps.
Detailed description
This study will consist of 5 visits over approximately 2 months. All study procedures will occur at the University of California San Diego Division of Dermatology Outpatient Clinic. The procedures for each visit will be described below.
Visit 1 (Day 0) At this visit, after obtaining informed consent from subjects, the inclusion/exclusion criteria will be reviewed. This step will require a brief medical history and skin examination to be performed. Both the history and physical exam will be performed by a licensed physician. Eligible subjects will proceed with the remainder of the study. These subjects will be provided with a mild soap (ID# 100000049586) to use whenever they shower for the remainder of the study. These subjects will also be instructed that they may not apply any topical lotions, creams, or other products to their arms during the remainder of the study. Subjects will also be told to avoid excessive sun exposure on their arms, including tanning or the use of tanning beds, while participating in this study.
Visit 2 (Day 14) Subjects will return on Day 14 for Visit 2. Any adverse events will be recorded, and the subject's interim medical history will be taken. Two skin swabs will then be taken from the skin on subject's the upper inner arm. One swab will be from the right arm and the other from the left arm. A 4-mm punch biopsy will then be taken from one of the arms near the area that was swabbed. To perform this procedure, the skin is injected with about 1-2 cc of local anesthetic. A 4 mm punch will be used to remove the biopsy specimen from the location previously agreed upon by the investigator and subject. A 4.0 nylon suture will be used to close the biopsy site, and ointment and a Band-Aid applied.
Visit 3 (Day 28 +/- 4) Subjects will return around Day 28 for their third visit. At this visit, any adverse events since the last visit will be recorded, and the subject's interim medical history will be taken. The suture will be removed from the site of the biopsy taken at Visit 2. Subjects will then be provided with two body washes (ID# 300000027003 and ID# 300000029240) to use in the shower when washing their upper inner arms. One soap will be used to wash the upper half of the right arm, and the other soap will be used to wash the upper half of the left arm. The subject will continue using the Mild Body Wash in the shower when washing all other body parts. The subject will also be instructed not to apply any other creams, ointments or medications to their arms, and to avoid excess sun exposure to their upper arms during this time.
Visit 4 (Day 49 +/- 4) Subjects will return around Day 49 for their next visit. Any adverse events as well as changes to their interim medical history since their last visit will be recorded. A skin swab of each upper inner arm will then be taken. A 4-mm punch biopsy will then be taken from an area of skin in the upper inner region of both the right and left arms for a total of 2 biopsies taken during this visit. At the termination of this visit, subjects can resume use of their normal shower production and application of any creams or lotions they normally use on their arms.
Visit 5 (Day 59 +/- 4) Subjects will return on this day to have their sutures removed. Any adverse events will be recorded. This visit will conclude all study-related activities.
All samples will be processed in the lab. Skin swabs will undergo pyrosequencing to determine the different strains of bacteria present on the subject's skin, as well as quantitative polymerase chain reaction to determine the abundance of S. aureus, S. epidermidis, and P. acnes on each subject's skin surface. Biopsy specimens will be sectioned and each section will be placed on a glass slide. The sections will undergo immunostaining to stain for bacteria. Laser-capture microdissection of each section into its four skin components will be used to assist in evaluating the bacteria present in the different skin layers.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soap 300000027003 | Experimental | Other: Soap 300000027003Subjects will apply this soap to one of their arms daily in the shower for 3 weeks |
| Soap 300000029240 | Experimental | Other: Soap 300000029240Subjects will apply this soap to one of their arms daily in the shower for 3 weeks |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 21-35 years
- Male subject 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 |
|---|---|---|
| Soap 300000027003 | Other | Soap 300000027003 |
| Soap 300000029240 | Other | Soap 300000029240 |
Primary outcome
Number of bacteria
Time frame: 3 weeks
The number of bacteria present on/in the epidermis, dermis, subcutaneous fat and hair follicle will be determined using both polymerase chain reaction and colony counting methods after subjects have used each of the body washes on their arms for a total of 3 weeks.
5 secondary outcomes
Type of bacteria
Time frame: 3 weeks
Change in type of bacteria
Time frame: 3 weeks
Change in number of bacteria
Time frame: 3 weeks
Type of bacteria
Time frame: Baseline
Number of bacteria
Time frame: Baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
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.
Tissa Hata, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soap 300000027003 and Soap 300000029240 in people with Focus: Healthy Skin Microbiome, 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 3 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: withdrawn, as of the sponsor's last update on 22 Aug 2018. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of bacteria (time frame: 3 weeks). 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 22 Aug 2018.