Validation of the Short-term Antimicrobial Action of Transplanted Bacteria
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01959113|
Recruitment Status : Active, not recruiting
First Posted : October 9, 2013
Last Update Posted : June 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Biological: Autologous Microbiome Transplant Other: Placebo Arm||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Phase 1 Study of the Short-term Antimicrobial Action of Transplanted Bacteria in Adult Patients With Atopic Dermatitis|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Experimental: Autologous Microbiome Transplant
Each individual's autologous microbiome transplant cream will be applied to one of their arms. This arm is the treatment arm.
Biological: Autologous Microbiome Transplant
Placebo Comparator: Placebo Arm
This arm will have a base moisturizer alone applied to it during the third visit.
Other: Placebo Arm
Other Name: The placebo arm will have a commercially available moisturizer applied to it.
- Staphylococcus aureus abundance [ Time Frame: 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
- Adverse events [ Time Frame: 24 hours post-transplant ]Any adverse events associated with use of the autologous microbiome transplant cream will be recorded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01959113
|United States, California|
|UCSD Division of Dermatology|
|San Diego, California, United States, 92122|