Back to resultsExamination of Whether Host Preconditioning Modifies Short-term Transplant Survival
Primary Purpose
Atopic Dermatitis, Eczema
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pre-Treatment with Dial liquid antibacterial soap
Control
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Autologous microbiome transplant, Bacteria transplant, Treatment for atopic dermatitis
Eligibility Criteria
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 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/exclusion criteria (one week prior to the screening visits and during the study for topical medications and 28 days prior to screening visits and during the study for oral medications)
- Subjects who have taken a bleach bath within a week prior to screening, or who take bleach baths during the study
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- Subjects with Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier
- Any subject who is immunocompromised (e.g. provides researchers with a history lymphoma, HIV/AIDS, Wiskott-Aldrich Syndrome) or has a history of malignant disease (with the exception of non-melanomatous skin cancer). This information will be gathered verbally from the patient while taking a medical history from the patient, and will not involve further testing such as an HIV test.
- Subjects with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol
- Active bacterial, viral or fungal skin infections
- Any noticeable breaks or cracks in the skin on either arm, including severely excoriated skin or skin with open or weeping wounds suggestive of an active infection or increased susceptibility to infection.
- Ongoing participation in another investigational trial
- Use of any oral or topical antibiotic for up to four weeks prior to screening
- Use of any systemic immunosuppressive therapy (e.g. cyclosporine, methotrexate, etc.) within four weeks of screening.
- Sensitivity to or difficulty tolerating Dove fragrance-free bar soap, Dial antibacterial liquid soap, Cetaphil lotion, or alcohol-based cleaners
Sites / Locations
- UCSD Division of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Pre-Treatment
Control
Arm Description
Prior to receiving the transplant, this arm will be washed with an antimicrobial regimen
This arm will still be transplanted with the autologous microbiome transplant cream, however it will not be pre-treated with an antimicrobial regimen
Outcomes
Primary Outcome Measures
Abundance of antimicrobial Staph colonies
Quantitative washes will be used to measure the abundance of antimicrobial Staph colonies on both the pre-treated and the not pre-treated arms 24 hours after the microbial transplant
Secondary Outcome Measures
Adverse events
All adverse events associated with use of the transplant cream will be recorded
Full Information
NCT ID
NCT01960764
First Posted
September 30, 2013
Last Updated
November 3, 2020
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT01960764
Brief Title
Examination of Whether Host Preconditioning Modifies Short-term Transplant Survival
Official Title
Phase 1 Study of Whether Host Preconditioning Modifies Short-term Transplant Survival
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Withdrawn
Why Stopped
This sub-study was not done because main study results reached significance.
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Data Monitoring Committee
No
5. Study Description
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) 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. First the investigator will culture the bacteria on subjects' lesional AD skin. The investigator will selectively grow the subject's antimicrobial Staph colonies and place them into a base moisturizer. The moisturizer plus bacteria will be applied to both of the subject's arms. Prior to applying this, though, one arm will first be pre-treated with an antimicrobial regiment of Dial liquid antibacterial soap and alcohol. We will then compare the abundance of antimicrobial Staph species on each subject's arms 24 hours later to determine whether the pre-treatment regimen increased survival of the transplanted antimicrobial Staph species. The investigator expects that the arm pre-treated with the antimicrobial regimen will have more antimicrobial Staph species at this time point.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Eczema
Keywords
Autologous microbiome transplant, Bacteria transplant, Treatment for atopic dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre-Treatment
Arm Type
Experimental
Arm Description
Prior to receiving the transplant, this arm will be washed with an antimicrobial regimen
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
This arm will still be transplanted with the autologous microbiome transplant cream, however it will not be pre-treated with an antimicrobial regimen
Intervention Type
Drug
Intervention Name(s)
Pre-Treatment with Dial liquid antibacterial soap
Intervention Description
This arm will be pre-treated with Dial liquid antibacterial soap and alcohol prior to the autologous microbiome transplant.
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
This arm will not be pre-treated, but rather will have the autologous microbiome transplant cream applied without any pre-treatment regimen.
Primary Outcome Measure Information:
Title
Abundance of antimicrobial Staph colonies
Description
Quantitative washes will be used to measure the abundance of antimicrobial Staph colonies on both the pre-treated and the not pre-treated arms 24 hours after the microbial transplant
Time Frame
24-hours post-transplant
Secondary Outcome Measure Information:
Title
Adverse events
Description
All adverse events associated with use of the transplant cream will be recorded
Time Frame
24 hours post-transplant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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/exclusion criteria (one week prior to the screening visits and during the study for topical medications and 28 days prior to screening visits and during the study for oral medications)
Subjects who have taken a bleach bath within a week prior to screening, or who take bleach baths during the study
Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
Subjects with Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier
Any subject who is immunocompromised (e.g. provides researchers with a history lymphoma, HIV/AIDS, Wiskott-Aldrich Syndrome) or has a history of malignant disease (with the exception of non-melanomatous skin cancer). This information will be gathered verbally from the patient while taking a medical history from the patient, and will not involve further testing such as an HIV test.
Subjects with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol
Active bacterial, viral or fungal skin infections
Any noticeable breaks or cracks in the skin on either arm, including severely excoriated skin or skin with open or weeping wounds suggestive of an active infection or increased susceptibility to infection.
Ongoing participation in another investigational trial
Use of any oral or topical antibiotic for up to four weeks prior to screening
Use of any systemic immunosuppressive therapy (e.g. cyclosporine, methotrexate, etc.) within four weeks of screening.
Sensitivity to or difficulty tolerating Dove fragrance-free bar soap, Dial antibacterial liquid soap, Cetaphil lotion, or alcohol-based cleaners
Facility Information:
Facility Name
UCSD Division of Dermatology
City
San Diego
State/Province
California
ZIP/Postal Code
92122
Country
United States
12. IPD Sharing Statement
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Examination of Whether Host Preconditioning Modifies Short-term Transplant Survival
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