Phase 2 Study Evaluating the Kinetic Properties of an Autologous Microbiome Transplant in Adult Atopic Dermatitis Patients

Status: Withdrawn
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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 Staphylococcal species such as Staphylococcus 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 study team will attempt to decrease S. aureus colonization and increase colonization by protective Staph species in AD patients by first culturing the bacteria on subjects' lesional AD skin. The study team will selectively grow the subject's protective Staph colonies and place them into a moisturizer. The first part of the study will determine the half-life of the bacteria-containing moisturizer. The bacteria-containing moisturizer will be applied to a subject's arm, and the subject will return at four different time points over the next three days for skin swabs of the arm that will be used to determine the amount and type of bacteria on the arm at those time points. In the second part of the study, the subject will apply moisturizer containing his own antimicrobial bacteria to one of his arms for a total of 6 times at a frequency determined by the half-life, which will be computed at the end of the first part of this experiment. The subject will return prior to the 7th application time point for skin swabs of the arm to ensure that there are still viable bacteria from the moisturizer present on the arm. In the third part of the study, each subject will receive both moisturizer as well as moisturizer plus his own antimicrobial bacteria. The subject will apply the moisturizer to one arm and the moisturizer plus bacteria to the other arm daily for a total of 15 days. Subjects will return to the clinic every 5 days for skin swabs and clinical evaluations. If the moisturizer containing bacteria is able to decrease the S. aureus colonization on subject's arms, the study team hypothesizes that subjects will have improvement of their AD symptoms.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of California San Diego Dermatology Clinic
San Diego
Time Frame
Start Date: 2015-07
Completion Date: 2022-07
Treatments
Experimental: Moisturizer with each subject's own antimicrobial bacteria
Each subject will have a moisturizer containing their own antimicrobial bacteria species spread over their arms in the clinic
Related Therapeutic Areas
Sponsors
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov