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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.
 
ClinicalTrials.gov Identifier: NCT03820076
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : July 9, 2020
Sponsor:
Collaborator:
RCTs
Information provided by (Responsible Party):
Azitra Inc.

Tracking Information
First Submitted Date  ICMJE January 25, 2019
First Posted Date  ICMJE January 29, 2019
Last Update Posted Date July 9, 2020
Actual Study Start Date  ICMJE January 17, 2019
Actual Primary Completion Date January 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
Safety and Tolerance: mean erythema scores [ 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of AZT-04 for Cosmetic Use
Official Title  ICMJE 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
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
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double blind
Primary Purpose: Other
Condition  ICMJE Study of Three Doses of AZT-04 for Skin Appearance
Intervention  ICMJE Other: AZT-04
Staphylococcus epidermidis
Study Arms  ICMJE
  • Experimental: dose 1
    AZT-04
    Intervention: Other: AZT-04
  • Experimental: dose 2
    AZT-04
    Intervention: Other: AZT-04
  • Experimental: dose 3
    AZT-04
    Intervention: Other: AZT-04
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2019)
21
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 31, 2019
Actual Primary Completion Date January 21, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03820076
Other Study ID Numbers  ICMJE AZT04-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Azitra Inc.
Study Sponsor  ICMJE Azitra Inc.
Collaborators  ICMJE RCTs
Investigators  ICMJE Not Provided
PRS Account Azitra Inc.
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP