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Examination of Whether Host Preconditioning Modifies Short-term Transplant Survival

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ClinicalTrials.gov Identifier: NCT01960764
Recruitment Status : Withdrawn (This sub-study was not done because main study results reached significance.)
First Posted : October 11, 2013
Last Update Posted : November 5, 2020
Sponsor:
Information provided by (Responsible Party):
Richard Gallo, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Eczema Drug: Pre-Treatment with Dial liquid antibacterial soap Other: Control Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Whether Host Preconditioning Modifies Short-term Transplant Survival
Study Start Date : June 2016
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Eczema

Arm Intervention/treatment
Experimental: Pre-Treatment
Prior to receiving the transplant, this arm will be washed with an antimicrobial regimen
Drug: Pre-Treatment with Dial liquid antibacterial soap
This arm will be pre-treated with Dial liquid antibacterial soap and alcohol prior to the autologous microbiome transplant.

Placebo Comparator: Control
This arm will still be transplanted with the autologous microbiome transplant cream, however it will not be pre-treated with an antimicrobial regimen
Other: Control
Other Name: This arm will not be pre-treated, but rather will have the autologous microbiome transplant cream applied without any pre-treatment regimen.




Primary Outcome Measures :
  1. Abundance of antimicrobial Staph colonies [ Time Frame: 24-hours post-transplant ]
    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 :
  1. Adverse events [ Time Frame: 24 hours post-transplant ]
    All adverse events associated with use of the transplant cream will be recorded



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT01960764


Locations
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United States, California
UCSD Division of Dermatology
San Diego, California, United States, 92122
Sponsors and Collaborators
University of California, San Diego
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Responsible Party: Richard Gallo, Professor and Chief, Division of Dermatology, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01960764    
Other Study ID Numbers: UCSD 131244.2
First Posted: October 11, 2013    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Keywords provided by Richard Gallo, University of California, San Diego:
Autologous microbiome transplant
Bacteria transplant
Treatment for atopic dermatitis
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Anti-Bacterial Agents
Anti-Infective Agents