Examination of Whether Host Preconditioning Modifies Short-term Transplant Survival

Phase 1 Study of Whether Host Preconditioning Modifies Short-term Transplant Survival

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.

Study Overview

• Status: Withdrawn
• Conditions: Eczema; Atopic Dermatitis
• Intervention / Treatment: Other: Control; Drug: Pre-Treatment with Dial liquid antibacterial soap

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92122
      • UCSD Division of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: This arm will not be pre-treated, but rather will have the autologous microbiome transplant cream applied without any pre-treatment regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24-hours post-transplant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	All adverse events associated with use of the transplant cream will be recorded	24 hours post-transplant

Collaborators and Investigators

• Sponsor: University of California, San Diego

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: September 30, 2013
• First Submitted That Met QC Criteria: October 10, 2013
• First Posted (Estimate): October 11, 2013

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Autologous microbiome transplant; Bacteria transplant; Treatment for atopic dermatitis
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: UCSD 131244.2