Evaluation of the Efficacy of an Autologous Microbiome Transplant in Adult Atopic Dermatitis Patients



Status:Recruiting
Conditions:Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 60
Updated:5/18/2017
Start Date:April 2016
End Date:May 2018
Contact:Richard Gallo, MD, PhD
Email:ucsddermstudies@gmail.com

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Unlike healthy control skin, the skin of patients with atopic dermatitis (AD) is frequently
colonized by Staphylococcus aureus (S. aureus), putting these patients at increased risk of
S. aureus skin infections. In addition, research in the investigator's lab has shown that
these patients have fewer protective antimicrobial Staphylococcal species such as
Staphylococcal epidermidis (S. epidermidis) that are known to produce antimicrobial peptides
that play a role in protecting the skin from invading pathogens. In this study, the
investigator will attempt to decrease S. aureus colonization and increase colonization of
protective Staph species in AD patients. First the investigator will capture the bacteria on
subjects' skin. Next the investigator will selectively grow the subject's antimicrobial
Staphylococcal colonies and place them into a base moisturizer. The moisturizer plus
bacteria will be applied to one of the subject's arms for one week. Some subjects will
receive placebo, which is the moisturizer alone (without bacteria). The investigator will
then swab the arms at specified time points during and after the one week application in
order to determine whether the S. aureus abundance was affected by the application of the
transplanted bacteria.


Inclusion Criteria:

1. Male or female subjects who are not pregnant or lactating. Female subjects of
child-bearing potential must have a negative urine pregnancy test on the day of the
screening visit in order to be eligible for the study.

2. 18-60 years of age

3. Diagnosis of atopic dermatitis for at least 6 months using the Hanifin and Rajka
Diagnostic Criteria for atopic dermatitis

4. Presence of lesional atopic dermatitis skin in both antecubital fossae

5. Positive S. aureus colonization based on results of a skin culture taken from one of
their AD-affected antecubital fossae

6. Positive for antimicrobial CoNS species from non-lesional AD skin

Exclusion Criteria:

1. Use of any topical AD treatments (including topical steroids, topical calcineurin
inhibitors) to either arm within one week of the Treatment visit

2. Use of any antihistamines 7 days within one week of the Treatment visit

3. Use of any oral/systemic AD therapies (steroids) within 28 days of the Treatment
visit

4. Severe AD that would worsen significantly from holding a participant's usual
topical/oral AD medications for the time periods required in the inclusion/exclusion
criteria (one week prior to the Treatment visit for topical medications and
antihistamines and 28 days prior to Treatment visits for oral medications)

5. Subjects who have taken a bleach bath within a week prior to the Treatment visit, or
who take bleach baths during the study

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

7. Subjects with Netherton's syndrome or other genodermatoses that result in a defective
epidermal barrier

8. Any subject who is immunocompromised (e.g. provides researchers with a history
lymphoma, HIV/AIDS, Wiskott-Aldrich Syndrome) or has a history of malignant disease
(with the exception of non-melanomatous skin cancer). This information will be
gathered verbally from the patient while taking a medical history from the patient,
and will not involve further testing such as an HIV test.

9. 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

10. Active bacterial, viral or fungal skin infections

11. Any noticeable breaks or cracks in the skin on either arm, including severely
excoriated skin or skin with open or weeping wounds suggestive of an active infection
or increased susceptibility to infection.

12. Ongoing participation in another investigational trial

13. Use of any oral or topical antibiotic for up to four weeks prior to the Treatment
visit

14. Use of any systemic immunosuppressive therapy (e.g. CsA, MTX, etc.) within four weeks
of the Treatment visit.

15. Sensitivity to or difficulty tolerating Dove fragrance-free bar soap or Cetaphil
lotion

16. Subjects with prosthetic heart valves, pacemakers, intravascular catheters, or other
foreign or prosthetic devices.

17. Allergy or intolerability to soy or macadamia nuts.

18. Participant who has a condition or is in a situation that, in the investigator's
opinion, may put the patient at significant risk, or may significantly interfere with
the patient's participation in the study.
We found this trial at
1
site
San Diego, California 92122
Principal Investigator: Richard L Gallo, MD, PhD
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mi
from
San Diego, CA
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