Study of Three Doses of AZT-04 for Skin Appearance Clinical Trial
Official title:
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
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
;