<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03820076</url>
  </required_header>
  <id_info>
    <org_study_id>AZT04-001</org_study_id>
    <nct_id>NCT03820076</nct_id>
  </id_info>
  <brief_title>Safety Study of AZT-04 for Cosmetic Use</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azitra Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>RCTs</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Azitra Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Double Blind, Three Cohort, Placebo-controlled Trial to Assess Safety, Tolerance and Induced&#xD;
      Bacterial Colony Counts of Three Ascending Doses of AZT-04 in Healthy Adult Volunteers&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-center, prospective, double-blind, three cohort pilot study to assess the&#xD;
      tolerability and induced changes in skin microbiome population and diversity of three&#xD;
      ascending doses of test article code AZT-04 in normal, healthy subjects.&#xD;
&#xD;
      The study will consist of up to 7 scheduled study visits. There will be three cohorts in this&#xD;
      study, each cohort composed of 6 subjects (total number of subjects is at least 18). Each&#xD;
      cohort will be treated with both a placebo ointment and an ointment containing different&#xD;
      concentrations of the Staphylococcus epidermidis. Approximately 1 ml of placebo ointment and&#xD;
      1 ml of AZT-04 ointment (test product composed of a commensal strain of Staphylococcus&#xD;
      epidermidis) will be applied topically to two separate skin sites on the back, each site&#xD;
      approximately 8 x 5 cm. Skin microbiome sampling will be performed before application of any&#xD;
      test article (i.e., baseline) and each subsequent day for four (4) consecutive days. Samples&#xD;
      will be shipped to a laboratory chosen by the Sponsor for analyses&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2019</start_date>
  <completion_date type="Actual">July 31, 2019</completion_date>
  <primary_completion_date type="Actual">January 21, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and Tolerance: mean erythema</measure>
    <time_frame>9 days</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bacterial Count</measure>
    <time_frame>9 days</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Study of Three Doses of AZT-04 for Skin Appearance</condition>
  <arm_group>
    <arm_group_label>dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AZT-04</description>
  </arm_group>
  <arm_group>
    <arm_group_label>dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AZT-04</description>
  </arm_group>
  <arm_group>
    <arm_group_label>dose 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AZT-04</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>AZT-04</intervention_name>
    <description>Staphylococcus epidermidis</description>
    <arm_group_label>dose 1</arm_group_label>
    <arm_group_label>dose 2</arm_group_label>
    <arm_group_label>dose 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fluent in English, willing and able to read, understand, and sign the informed consent&#xD;
             form&#xD;
&#xD;
          -  Ability to complete the course of the study and comply with instructions&#xD;
&#xD;
          -  Makes and Females ages 18-65 years, inclusively, in good general health as deemed by&#xD;
             the investigator&#xD;
&#xD;
          -  Individuals with Fitzpatrick skin type I, II, III, IV&#xD;
&#xD;
          -  Individuals free of any systemic or dermatological disorder including a known history&#xD;
             of allergies or other medical conditions which, in the opinion of the investigator,&#xD;
             could interfere with the conduct of the study, interpretation of results or increase&#xD;
             the risk of adverse reactions.&#xD;
&#xD;
          -  Females practicing an acceptable method of birth control&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  individuals with any visible skin disease, skin condition including baseline erythema&#xD;
             assessment &gt; 0.5, or tattoos in the test area&#xD;
&#xD;
          -  individuals with abnormal skin pigmentation at the test sites, which might interfere&#xD;
             with subsequent evaluations of dermal responsiveness&#xD;
&#xD;
          -  individuals with recent prolonged sun or tanning bed exposure in the test area&#xD;
&#xD;
          -  individuals with excessive dryness or redness at the sites of application&#xD;
&#xD;
          -  individuals with a known hypersensitivity to cosmetic or personal care formulations&#xD;
&#xD;
          -  subjects must not have applied any lotions creams, powders, or oils to their backs the&#xD;
             morning of the study. Additionally 2 hours must have passed since bathing or showering&#xD;
&#xD;
          -  women who are pregnant or nursing&#xD;
&#xD;
          -  individuals who have participated on a s study involving the test sites (back) in the&#xD;
             previous 14 days&#xD;
&#xD;
          -  individuals participating in another clinical study&#xD;
&#xD;
          -  individuals with open or healing cuts/incisions abrasions, lesions, pustules, fissures&#xD;
             or broken mucosa/skin in the test site&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>RCTS, Inc.</name>
      <address>
        <city>Irving</city>
        <state>Texas</state>
        <zip>75062</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03820076
org study id: AZT04-001
nct id: NCT03820076
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double blind
measure: Safety and Tolerance: mean erythema
time frame: 9 days
description: 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
measure: Bacterial Count
time frame: 9 days
description: 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
arm group label: dose 1
arm group type: Experimental
description: AZT-04
arm group label: dose 2
arm group type: Experimental
description: AZT-04
arm group label: dose 3
arm group type: Experimental
description: AZT-04
intervention type: Other
intervention name: AZT-04
description: Staphylococcus epidermidis
arm group label: dose 1
arm group label: dose 2
arm group label: dose 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided