Safety Study of AZT-04 for Cosmetic Use

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

Study Overview

• Status: Completed
• Conditions: Study of Three Doses of AZT-04 for Skin Appearance
• Intervention / Treatment: Other: AZT-04

Detailed Description

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
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Irving, Texas, United States, 75062
      • RCTS, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Fluent in English, willing and able to read, understand, and sign the informed consent form
• Ability to complete the course of the study and comply with instructions
• Makes and Females ages 18-65 years, inclusively, in good general health as deemed by the investigator
• Individuals with Fitzpatrick skin type I, II, III, IV
• Individuals free of any systemic or dermatological disorder including a known history of allergies or other medical conditions which, in the opinion of the investigator, could interfere with the conduct of the study, interpretation of results or increase the risk of adverse reactions.
• Females practicing an acceptable method of birth control

Exclusion Criteria:

• individuals with any visible skin disease, skin condition including baseline erythema assessment > 0.5, or tattoos in the test area
• individuals with abnormal skin pigmentation at the test sites, which might interfere with subsequent evaluations of dermal responsiveness
• individuals with recent prolonged sun or tanning bed exposure in the test area
• individuals with excessive dryness or redness at the sites of application
• individuals with a known hypersensitivity to cosmetic or personal care formulations
• subjects must not have applied any lotions creams, powders, or oils to their backs the morning of the study. Additionally 2 hours must have passed since bathing or showering
• women who are pregnant or nursing
• individuals who have participated on a s study involving the test sites (back) in the previous 14 days
• individuals participating in another clinical study
• individuals with open or healing cuts/incisions abrasions, lesions, pustules, fissures or broken mucosa/skin in the test site

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dose 1; AZT-04	Other: AZT-04; Staphylococcus epidermidis
Experimental: dose 2; AZT-04	Other: AZT-04; Staphylococcus epidermidis
Experimental: dose 3; AZT-04	Other: AZT-04; Staphylococcus epidermidis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	9 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	9 days

Collaborators and Investigators

• Sponsor: Azitra Inc.
• Collaborators: RCTs

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2019
• Primary Completion (Actual): January 21, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: AZT04-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No