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Safety Study of AZT-04 for Cosmetic Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03820076
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : July 9, 2020
Information provided by (Responsible Party):
Azitra Inc.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Study of Three Doses of AZT-04 for Skin Appearance Other: AZT-04 Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind
Primary Purpose: Other
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
Actual Study Start Date : January 17, 2019
Actual Primary Completion Date : January 21, 2019
Actual Study Completion Date : July 31, 2019

Arm Intervention/treatment
Experimental: dose 1
Other: AZT-04
Staphylococcus epidermidis

Experimental: dose 2
Other: AZT-04
Staphylococcus epidermidis

Experimental: dose 3
Other: AZT-04
Staphylococcus epidermidis

Primary Outcome Measures :
  1. Safety and Tolerance: mean erythema [ Time Frame: 9 days ]
    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

Secondary Outcome Measures :
  1. Bacterial Count [ Time Frame: 9 days ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03820076

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United States, Texas
RCTS, Inc.
Irving, Texas, United States, 75062
Sponsors and Collaborators
Azitra Inc.
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Responsible Party: Azitra Inc. Identifier: NCT03820076    
Other Study ID Numbers: AZT04-001
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No