Atopic Dermatitis
Conditions
Keywords
Microbiome, Bacteria transplant, Atopic dermatitis treatments
Brief summary
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 by protective Staph species in AD patients. First the investigator will capture the bacteria on subjects' lesional AD 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, and the moisturizer alone (without bacteria) to the other arm. The investigator will then do a quantitative wash of the bacteria growing on each arm one day later in order to determine whether the S. aureus abundance was affected by the application of the transplanted bacteria.
Interventions
BIOLOGICALAutologous Microbiome Transplant
OTHERPlacebo Arm
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subjects who are not pregnant or lactating * 18-80 years of age * Diagnosis of atopic dermatitis for at least 6 months using the Hanifin and Rajka Diagnostic Criteria for atopic dermatitis * Presence of lesional atopic dermatitis skin in both antecubital fossae * Positive methicillin-sensitive S. aureus colonization based on results of a skin culture taken from one of their AD-affected antecubital fossae during the screening visit
Exclusion criteria
* Use of any topical AD treatments (including topical steroids, topical calcineurin inhibitors) to either arm within one week of either screening visit * Use of any oral/systemic AD therapies (antihistamines, steroids) within 28 days of either screening visit * Severe AD that would worsen significantly from holding a participant's usual topical/oral AD medications for the time periods required in the inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative Staphylococcus Aureus Abundance | 24-hours post-transplant | The technique of quantitative washes will be used to determine the Staphylococcus aureus abundance on an area of lesional AD skin on the subject's forearm as a ratio of baseline S. aureus abundance |
Countries
United States
Participant flow
Recruitment details
Adults with AD were recruited from the University of California, San Diego (UCSD), La Jolla, CA, and the National Jewish Health (NJH), Denver, CO.
Pre-assignment details
All subjects avoided any treatments and therapies that may potentially affect skin microbiome before sample collection.
Participants by arm
| Arm | Count |
|---|---|
| Autologous Microbiome Transplant and Placebo (Split-design) Each individual's autologous microbiome transplant cream will be applied to one of their arms. This arm is the treatment arm.
Autologous Microbiome Transplant
Placebo vehicle cream will be applied to the contralateral arm. This arm is the placebo arm. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Autologous Microbiome Transplant and Placebo (Split-design) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 23.8 years STANDARD_DEVIATION 2.05 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
Relative Staphylococcus Aureus Abundance
The technique of quantitative washes will be used to determine the Staphylococcus aureus abundance on an area of lesional AD skin on the subject's forearm as a ratio of baseline S. aureus abundance
Time frame: 24-hours post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Arm | Relative Staphylococcus Aureus Abundance | 0.13 ratio to baseline S. aureus abundance | Standard Deviation 0.2 |
| Autologous Microbiome Transplant | Relative Staphylococcus Aureus Abundance | 12.2 ratio to baseline S. aureus abundance | Standard Deviation 10.1 |