A Phase 1 interventional study of Autologous Microbial Transplant in Atopic Dermatitis Eczema, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-11-07.
Sponsored by University of California, San Diego · Phase 1, Interventional, and Treatment
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 15 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: Autologous Microbial Transplant
Biological: Autologous Microbial Transplant
Twice-daily application of Active or Placebo comparators to the right and left ventral arms of patients
Relative Abundance of Staphylococcus Aureus Compared to Baseline
Relative abundance of S. aureus 24 hours after initial treatment application (baseline).
Time frame: 24 Hours
| Milestone | Active Treatment | Placebo Treatment |
|---|---|---|
| Started | 8 | 7 |
| Completed | 8 | 6 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
Relative abundance of S. aureus 24 hours after initial treatment application (baseline).
| Relative abundance of S. aureus | Active Treatment | Placebo Treatment |
|---|---|---|
| Relative Abundance of Staphylococcus Aureus Compared to Baseline | 0.106 (0 to 0.4) | 12.9 (1.5 to 25) |
Collected over 1 Month(Screening-Last Phone Call). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Treatment | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) |
| Placebo Treatment | 0/6 (0%) | 0/6 (0%) | 2/6 (33.3%) |
| Event | Active Treatment | Placebo Treatment |
|---|---|---|
| RashGeneral disorders | 1/8 | 2/6 |
| Age, Categorical(Participants) | Active Treatment | Placebo Treatment | Total |
|---|---|---|---|
| <=18 years | 1 | 2 | 3 |
| Between 18 and 65 years | 7 | 4 | 11 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Active Treatment | Placebo Treatment | Total |
|---|---|---|---|
| Mean | 29.63 ± 14.30 | 25.5 ± 12.24 | 27.85 ± 13.12 |
| Sex: Female, Male(Participants) | Active Treatment | Placebo Treatment | Total |
|---|---|---|---|
| Female | 5 | 4 | 9 |
| Male | 3 | 2 | 5 |
| Ethnicity (NIH/OMB)(Participants) | Active Treatment | Placebo Treatment | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 8 | 5 | 13 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Active Treatment | Placebo Treatment | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 4 | 3 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 3 | 2 | 5 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Active Treatment | Placebo Treatment | Total |
|---|---|---|---|
| United States | 8 | 6 | 14 |
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University of California, San Diego