Targeted Microbiome Transplant in Atopic Dermatitis

Conditions:Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Age Range:18 - 60
Start Date:September 28, 2017
End Date:June 2020

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A First in Man Evaluation of the Safety and Efficacy of an Allogeneic Targeted Microbiome Transplant in Adults With Moderate-to-Severe Atopic Dermatitis (ADRN-08)

The purpose of this study is to examine the safety and effectiveness of a new therapy,
commensal lotion containing infection fighting bacteria, on decreasing or eliminating the
infection causing bacteria found on the skin of Atopic Dermatitis (AD) patients.

This study will enroll adult participants, 18-60 years of age, with moderate-to-severe atopic
dermatitis (AD) and a positive Staphylococcus aureus (S. aureus) colonized lesion (at least
15 cm^2 in size) on the upper extremities.

Participants who are eligible based on their positive Staph culture results will be
randomized to one of two treatments: Targeted Microbiome Transplant Lotion (TMT) or Placebo
(2:1 randomization). One lesional site measuring at least 15 cm^2 and one non-lesional site
of equal size will be identified on the participant's ventral upper extremities as the target
swabbing areas. These sites will be photographed and marked for swabbing for reference at the
participant's future visits. Participants will be instructed to apply investigational product
with gloved hands to their ventral upper extremities bilaterally from the wrist to the upper
humerus, which will include the identified lesional and non-lesional swabbing sites twice a
day for 1 week starting on Day 0. Participants will return to clinic on Day 4 for the
assessment of adverse events(s), the collection of skin swabs from the identified target
sites, and to obtain additional investigational product and gloves. Participants will
complete an additional clinic visit on Day 7 to correspond with the end of their 1 week
treatment. During this visit, participants will be assessed for AEs and provide skin swab
samples. All unused product and empty packets will be returned during the Day 4 and Day 7
visits. Three additional clinic visits on Days 8, 9, and 11 will be scheduled for additional
skin swabs to assess the safety and the stability of the microbiome transplant and time to
recurrence of Staph colonization. Participants will be followed through Day 38 to assess for
safety and disease status.

Inclusion Criteria:

Individuals who meet all of the following criteria are eligible for enrollment as study

- Participant must be able to understand and provide informed consent;

- Fulfills the Atopic Dermatitis Research Network (ADRN) Standard Diagnostic Criteria
(Appendix A) for active Atopic Dermatitis (AD);

- A Staphylococcus aureus (S. aureus) positive culture colonized lesion, at least 15
cm^2 in size, located on a ventral upper extremity (e.g., arm);

- An Investigator Global Assessment (IGA) score, on the ventral arms, of at least
moderate severity;

- A body surface area (BSA), as measured by Mosteller BSA Calculator, between 1.26 m^2
(e.g., 4 feet, 10 inches and 85 pounds [38.6 Kg])and 2.25 m^2 (e.g., 6 feet, 3 inches
and 210 pounds [95.5 Kg]); and

- Females of childbearing potential who are willing to use adequate contraception 30
days prior to the Screening Visit and until participation in the study is complete.

--Females of childbearing potential must agree to use an acceptable method of birth
control (e.g. total abstinence, oral contraceptives, intrauterine device (IUD),
barrier method with spermicide, surgical sterilization or surgically sterilized
partner, Depo-Provera, Norplant, NuvaRing, or hormonal implants) for the duration of
study participation.

- Male participants who are willing to use an acceptable method of contraception (e.g.
barrier methods with spermicide, surgical sterilization or surgically sterilized
partner) or practice abstinence until participation in the study is complete.

Exclusion Criteria:

- Inability or unwillingness of participant to give written informed consent or comply
with study protocol;

- Pregnant or lactating females, or females who desire to become pregnant and/or breast
feed within the duration of study participation;

- Active bacterial, viral, or fungal skin infections;

- Any noticeable breaks or cracks in the skin on the upper extremities, including
severely excoriated skin or skin with open or weeping wounds suggestive of an active
infection or increased susceptibility to infection;

- Sensitivity to or difficulty tolerating Dove fragrance-free bar soap, Cetaphil(R)
Lotion, alcohol-based cleaners, , macadamia nuts, soy, Vegetable glycerin, or palm

- Participants with prosthetic heart valves, pacemakers, intravascular catheters, or
other foreign or prosthetic devices;

- Participants with Netherton's syndrome or other genodermatoses that result in a
defective epidermal barrier;

- Any participant who is immunocompromised (e.g. history of lymphoma, Human
Immunodeficiency Virus (HIV)/ Acquired Immune Deficiency Syndrome (AIDS),
Wiskott-Aldrich Syndrome) or has a history of malignant disease (with the exception of
non-melanoma skin cancer);

- Participants 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;

- Past or current medical problems or findings from physical examination or laboratory
testing that are not listed above, which, in the opinion of the investigator, may pose
additional risks from participation in the study, may interfere with the participant's
ability to comply with study requirements or that may impact the quality or
interpretation of the data obtained from the study;

- Ongoing participation in another investigational trial or use of investigational drugs
within 8 weeks, or 5 half-lives (if known), whichever is longer, of the Screening

- Treatment with biologics within 16 weeks of Screening Visit;

- Participants with close contacts (e.g. spouses, children, or members in the same
household) that have severe barrier defects or are immunocompromised;

- Use of topical (including steroids and calcineurin inhibitors) Atopic Dermatitis (AD)
treatments within 7 days of the Treatment Visit; Use of topical steroids on areas
outside of where investigational product is to be applied may be permitted, per
investigator discretion;

- Treatment of AD with prescription moisturizers classified as medical device (e.g.,
Atopiclair(®, MimyX®, Epicerum®, Cerave®, etc.) within 7 days of the Treatment Visit;

- Use of any oral or topical antibiotics within 7 days of the Treatment Visit;

- Participants who have taken a bleach bath within 7 days of the Treatment Visit;

- Use of any oral AD therapies (antihistamines, steroids, immunosuppressive therapies)
within 28 days of the Treatment Visit; or

- Any phototherapy for skin disease (such as narrow band ultraviolet B [NBUVB],
ultraviolet B [UVB], ultraviolet A1 [UVA1], psoralen + UVA [PUVA]) or regular use
(more than 2 visits per week) of a tanning bed within 28 days of the Treatment Visit.
We found this trial at
San Diego, California 92093
Principal Investigator: Tissa Hata, MD
Phone: 858-657-1697
San Diego, CA
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1400 Jackson Street
Denver, Colorado 80206
Principal Investigator: Donald Leung, MD, PhD
Phone: 301-398-1409
Denver, CO
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