Effect of Surfactants on the Skin Microbiome



Status:Recruiting
Healthy:No
Age Range:18 - 60
Updated:10/19/2013
Start Date:September 2013
Contact:Aimee Two, MD
Email:ucsddermstudies@gmail.com
Phone:858-657-8390

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Up to 20 volunteers will be recruited to evaluate the microbial environment on their
forearms. Following informed consent, bacterial swabs will be obtained on day 0 from the
forearms of all subjects. Their forearms will then be washed with one of the study
cleansers. Subjects will then be instructed to return at different timepoints over the next
several days for repeat bacterial swabbing of their forearms. For the first 10 participants,
these timepoints will be every 24 hours for a total of 3 days. For the following
participants, these timepoints will be at 10 minutes, 6 hours, and 24 hours after the wash.
DNA will be extracted from all swabs and bacterial diversity evaluated by 16S
pyrosequencing.


The timeline for the first 10 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 hand
wash on the right forearm, and water wash 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. The same procedure will be repeated on the 2nd volar forearm
with the opposing wash. Subjects will return at 24 hours +/- 6 hours for repeat bacterial
swabbings for AMPs for three subsequent visits. Subjects will be instructed to avoid
rigorous exercise/swimming, significant sun exposure (i.e. sunbathing), cleaning the
forearms with other antibacterial products, and to wrap forearms in saran wrap when
showering/bathing during the period of measurements.

On Day 1(24 hours +/- 6 hours from day 0)- Day 0 procedures will be repeated with new
bacterial swab samples taken.

On Day 2(24 hours +/- 6 hours from day 1)- Day 0 procedures will be repeated with new
bacterial swab samples taken.

On Day 3 (-24 hours +/- 6 hours from day 2)- Day 0 procedures will be repeated with new
bacterial swab samples taken.

The timeline for subsequent 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 on the right forearm, and a cleanser without an
antimicrobial compound 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.
The same procedure will be repeated on the 2nd volar forearm with the opposing wash.
Subjects will then have repeat skin swabs at 7 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.

On day 7, the exact procedures completed on Day 0 will be repeated, however this time the
procedures will be done using a soap with a different antimicrobial compound on the right
forearm. The same control soap will again be used on the left forearm. The forearm
washings and skin swabbings will be conducted exactly as before.

Inclusion Criteria:

Those who meet all of the following criteria are eligible for enrollment into the study:

1. Age 18-60 years

2. Male or female of any race and ethnicity

3. Subject agrees to comply with study requirements.

Exclusion Criteria:

1. Subjects with severe medical condition(s) that in the view of the investigator
prohibits participation in the study

2. Dermatologic disease such as psoriasis or atopic dermatitis which may have inherently
abnormal antimicrobial peptide levels

3. Subject has Netherton's syndrome or other genodermatoses that result in a defective
epidermal barrier

4. Pregnant or nursing females

5. 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.

6. 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

7. 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)

8. Active viral or fungal skin infections at the target areas

9. Are currently receiving lithium, antimalarials, or intramuscular gold now or within
the last 4 weeks.

10. Ongoing participation in an investigational drug trial

11. Use of any oral or topical antibiotic during the study and up to one week prior to
entering the study

12. Use of any local topical medications less than one week prior to screening

13. Use of any systemic immunosuppressive therapy less than four weeks prior to
screening.

14. Subjects with a history of or propensity to developing reactions after use of over
the counter cleansers

15. Subjects with diabetes
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