Focus: Healthy Skin Microbiome Clinical Trial
Official title:
The Effect of Surfactants on the Bacterial Composition of the Layers of the Skin
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.
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.
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