Atopic Dermatitis Eczema
Conditions
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 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.
Interventions
BIOLOGICALAutologous Microbial Transplant
Twice-daily application of Active or Placebo comparators to the right and left ventral arms of patients
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative Abundance of Staphylococcus Aureus Compared to Baseline | 24 Hours | Relative abundance of S. aureus 24 hours after initial treatment application (baseline). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Treatment Autologous Microbial Transplant: Twice-daily application of Active comparators to the right and left ventral arms of patients | 8 |
| Placebo Treatment Autologous Microbial Transplant: Twice-daily application of Placebo comparators to the right and left ventral arms of patients | 6 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Active Treatment | Placebo Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 4 Participants | 11 Participants |
| Age, Continuous | 29.63 years STANDARD_DEVIATION 14.3 | 25.5 years STANDARD_DEVIATION 12.24 | 27.85 years STANDARD_DEVIATION 13.12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 5 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 2 Participants | 5 Participants |
| Region of Enrollment United States | 8 Participants | 6 Participants | 14 Participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 6 |
| other Total, other adverse events | 1 / 8 | 2 / 6 |
| serious Total, serious adverse events | 0 / 8 | 0 / 6 |
Outcome results
Primary
Relative Abundance of Staphylococcus Aureus Compared to Baseline
Relative abundance of S. aureus 24 hours after initial treatment application (baseline).
Time frame: 24 Hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Treatment | Relative Abundance of Staphylococcus Aureus Compared to Baseline | 0.106 Relative abundance of S. aureus |
| Placebo Treatment | Relative Abundance of Staphylococcus Aureus Compared to Baseline | 12.9 Relative abundance of S. aureus |