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NCT03158012 · ClinicalTrials.gov registry record · Phase 1
Evaluation of the Efficacy of an Autologous Microbiome Transplant in Adult Atopic Dermatitis Patients
A Phase 1 study of Atopic Dermatitis Eczema, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT03158012 is a Phase 1 study of Atopic Dermatitis Eczema that has completed, run by University of California, San Diego. The registered enrollment target is 15 participants, below the 200-participant average among 8 other Atopic Dermatitis Eczema trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03158012, a Phase 1 study of Atopic Dermatitis Eczema, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL Autologous Microbial Transplant
Study Locations (1)
California
- University of California San Diego Dermatology Clinic - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2016-04 |
| Est. Completion | 2018-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03158012
The ClinicalTrials.gov registry entry for NCT03158012 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 200-participant average among 8 other Atopic Dermatitis Eczema trials with a reported enrollment target (92% lower). The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Atopic Dermatitis Eczema appearing as the primary indexed condition, and to 1 intervention - of which Autologous Microbial Transplant is the first listed.
NCT03158012 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03158012 about?
NCT03158012 is a clinical study titled "Evaluation of the Efficacy of an Autologous Microbiome Transplant in Adult Atopic Dermatitis Patients". 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 ...
What is the current status of trial NCT03158012?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2016-04. Estimated completion is 2018-08.
What conditions does trial NCT03158012 study?
This clinical trial studies the following conditions: Atopic Dermatitis Eczema.
What interventions are being tested in trial NCT03158012?
The interventions under investigation include: Autologous Microbial Transplant (BIOLOGICAL).
Who is sponsoring clinical trial NCT03158012?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03158012 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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