Double Blind, Three Cohort, Placebo-controlled Trial to Assess Safety, Tolerance and Induced Bacterial Colony Counts of Three Ascending Doses of AZT-04 in Healthy Adult Volunteers
This is a single-center, prospective, double-blind, three cohort pilot study to assess the tolerability and induced changes in skin microbiome population and diversity of three ascending doses of test article code AZT-04 in normal, healthy subjects. The study will consist of up to 7 scheduled study visits. There will be three cohorts in this study, each cohort composed of 6 subjects (total number of subjects is at least 18). Each cohort will be treated with both a placebo ointment and an ointment containing different concentrations of the Staphylococcus epidermidis. Approximately 1 ml of placebo ointment and 1 ml of AZT-04 ointment (test product composed of a commensal strain of Staphylococcus epidermidis) will be applied topically to two separate skin sites on the back, each site approximately 8 x 5 cm. Skin microbiome sampling will be performed before application of any test article (i.e., baseline) and each subsequent day for four (4) consecutive days. Samples will be shipped to a laboratory chosen by the Sponsor for analyses
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
21
Staphylococcus epidermidis
RCTS, Inc.
Irving, Texas, United States
Safety and Tolerance: mean erythema
to demonstrate the tolerability of three different doses of AZT-04 containing Staphylococcus epidermidis compared to placebo in healthy adult population--as s measured by mean erythema scores
Time frame: 9 days
Bacterial Count
to assess the colonization of the test articles and placebo treated sites as it relates to the number of colony forming units (CFU's) over time after application and overall change in the microbiome diversity
Time frame: 9 days
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