<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/NCT02221232</url>
  </required_header>
  <id_info>
    <org_study_id>131112-103 (ZX-ZP-0035)</org_study_id>
    <nct_id>NCT02221232</nct_id>
  </id_info>
  <brief_title>Efficacy Study to Evaluate Antimicrobial Effectiveness of ZuraPrep™</brief_title>
  <acronym>ZX-ZP-0035</acronym>
  <official_title>A Pilot Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZuraPrep™</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zurex Pharma, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zurex Pharma, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this pilot study is to evaluate antimicrobial properties of a single test&#xD;
      product, a vehicle product and a reference product applied in two different areas when used&#xD;
      as a patient preoperative skin preparation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open label pilot study to evaluate antimicrobial properties of a single test&#xD;
      product, a vehicle product and a reference product applied bilaterally to the skin of the&#xD;
      abdomen and the inguina. Testing will be performed according to FDA TFM for Effectiveness&#xD;
      Testing of a Patient Preoperative Skin Preparation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    To assess product performance (test and reference products), move into further testing.&#xD;
  </why_stopped>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 2</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Calculations of mean log10 reductions from baseline populations</measure>
    <time_frame>0-24 hours post dose</time_frame>
    <description>Antimicrobial efficacy will be evaluated based upon calculation of mean log10 reductions from baseline populations by subtracting the log10 number of viable microorganisms recovered at each post-product application sample from the log10 number of viable microorganisms recovered in the baseline samples. The performance criteria are mean reductions in microbial flora of ≥2 log10 per square cm on skin of the abdomen and ≥3 log10 per square cm on skin of the inguen.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Surgical Site Infection</condition>
  <arm_group>
    <arm_group_label>ZuraPrep Config 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Isopropyl alcohol (IPA) 70% Standard scrub time.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ZuraPrep Config 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Isopropyl alcohol (IPA) 70% Half scrub time.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ZuraPrep Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>ZuraPrep without IPA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ChloraPrep</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chloraprep</intervention_name>
    <description>Apply topically.</description>
    <arm_group_label>ChloraPrep</arm_group_label>
    <other_name>2% chlorhexidine gluconate / 70% Isopropyl alcohol</other_name>
    <other_name>CHG 2% / IPA 70%</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ZuraPrep</intervention_name>
    <description>Apply topically.</description>
    <arm_group_label>ZuraPrep Config 1</arm_group_label>
    <arm_group_label>ZuraPrep Config 2</arm_group_label>
    <other_name>Isopropyl alcohol 70%</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ZuraPrep Vehicle</intervention_name>
    <description>Apply topically.</description>
    <arm_group_label>ZuraPrep Vehicle</arm_group_label>
    <other_name>ZuraPrep without IPA</other_name>
    <other_name>ZuraPrep Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects may be of either sex, at least 18 years of age and of any race.&#xD;
&#xD;
          -  Subjects must be in good general health, as evidenced by the Subject Confidential&#xD;
             Information and Acceptance Criteria&#xD;
&#xD;
          -  Subjects must read and sign an Informed Consent Form, Authorization to Use and&#xD;
             Disclose Protected Health Information Form, and List of Restricted Products&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exposure of test sites to antimicrobial agents, medicated soaps, medicated shampoos,&#xD;
             or medicated lotions, use of biocide-treated pools or hot tubs, use of tanning beds,&#xD;
             or sunbathing during the 14-day pre-test conditioning period or during the test&#xD;
             period.&#xD;
&#xD;
          -  Use of topical or systemic antimicrobials, antibiotics, or steroids (other than&#xD;
             hormones for contraception or post-menopausal indications), or any other product known&#xD;
             to affect the normal microbial flora of the skin during the 14-day pre-test&#xD;
             conditioning period or during the test period.&#xD;
&#xD;
          -  Exposure of the test sites to strong detergents, solvents, or other irritants during&#xD;
             the 14-day pre-test conditioning period or during the test period.&#xD;
&#xD;
          -  Known allergies to vinyl, latex (rubber), alcohols, metals, inks, or tape adhesives,&#xD;
             or to common antibacterial agents found in soaps, lotions, or ointments, particularly&#xD;
             chlorhexidine gluconate (CHG), citric acid, methylene blue, methylparaben,&#xD;
             propylparaben, or isopropyl alcohol.&#xD;
&#xD;
          -  A medical diagnosis of a physical condition, such as a current or recent severe&#xD;
             illness, asthma, diabetes, hepatitis, an organ transplant, mitral valve prolapse,&#xD;
             congenital heart disease, internal prostheses, or any immunocompromised conditions&#xD;
             such as AIDS (or HIV positive).&#xD;
&#xD;
          -  Subjects must be unable to become pregnant, or willing to use an acceptable method of&#xD;
             contraception to prevent pregnancy, if female of child-bearing potential.&#xD;
&#xD;
        Inability to become pregnant would include subjects who are:&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Females unable to become pregnant (i.e., postmenopausal for at least 1 year or&#xD;
             surgically sterile due to hysterectomy, bilateral oophorectomy, uterine ablation, or&#xD;
             bilateral tubal ligation)&#xD;
&#xD;
          -  Females of child-bearing potential but using acceptable methods of contraception,&#xD;
             including one of the following methods that have been used for at least 2 weeks prior&#xD;
             to Treatment Day Visit.&#xD;
&#xD;
        Acceptable methods of contraception include one of the following methods:&#xD;
&#xD;
          -  Systemic birth control (the same type of birth control for at least 3 months prior to&#xD;
             entering the study and continuation of this type of birth control throughout the&#xD;
             study)&#xD;
&#xD;
          -  Double barrier methods (condom with spermicide or diaphragm with spermicide)&#xD;
&#xD;
          -  IUD&#xD;
&#xD;
          -  Vasectomized partner; or&#xD;
&#xD;
          -  Abstinence from sexual intercourse&#xD;
&#xD;
               -  Any large tattoos, scars, active skin rashes, or breaks in the skin of the test&#xD;
                  sites.&#xD;
&#xD;
               -  Dermatoses, cuts, lesions, or other skin disorders on or around the test sites&#xD;
&#xD;
               -  A currently active skin disease or inflammatory skin condition (e.g., contact&#xD;
                  dermatitis) that, in the opinion of the Consulting Physician or Principal&#xD;
                  Investigator, would compromise subject safety or study integrity.&#xD;
&#xD;
               -  Showering, bathing, or swimming within the 72 hour period prior to Baseline Day,&#xD;
                  the first Test Day, and throughout the test period.&#xD;
&#xD;
               -  Participation in another clinical study in the past 30 days or current&#xD;
                  participation in another clinical study.&#xD;
&#xD;
               -  Any medical condition or use of any medications that, in the opinion of the&#xD;
                  Medical Expert/Consulting Physician or Principal Investigator, should preclude&#xD;
                  participation.&#xD;
&#xD;
               -  Unwillingness to fulfill the performance requirements of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chris Beausoleil</last_name>
    <role>Principal Investigator</role>
    <affiliation>BioScience Laboratories, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BioSciences Laboratories, Inc.</name>
      <address>
        <city>Bozeman</city>
        <state>Montana</state>
        <zip>59718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <disposition_first_submitted>July 11, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>July 12, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">July 14, 2016</disposition_first_posted>
  <last_update_submitted>July 13, 2016</last_update_submitted>
  <last_update_submitted_qc>July 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ZuraPrep</keyword>
  <keyword>Antimicrobial</keyword>
  <keyword>Bio-Science Laboratories</keyword>
  <keyword>Zurex Pharma</keyword>
  <keyword>Surgical/Patient preoperative skin preparation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Surgical Wound Infection</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ethanol</mesh_term>
    <mesh_term>Chlorhexidine</mesh_term>
    <mesh_term>Chlorhexidine gluconate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT02221232
org study id: 131112-103 (ZX-ZP-0035)
nct id: NCT02221232
lead sponsor: 
has dmc: No
The purpose of this pilot study is to evaluate antimicrobial properties of a single test
      product, a vehicle product and a reference product applied in two different areas when used
      as a patient preoperative skin preparation.
This is an open label pilot study to evaluate antimicrobial properties of a single test
      product, a vehicle product and a reference product applied bilaterally to the skin of the
      abdomen and the inguina. Testing will be performed according to FDA TFM for Effectiveness
      Testing of a Patient Preoperative Skin Preparation.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Calculations of mean log10 reductions from baseline populations
time frame: 0-24 hours post dose
description: Antimicrobial efficacy will be evaluated based upon calculation of mean log10 reductions from baseline populations by subtracting the log10 number of viable microorganisms recovered at each post-product application sample from the log10 number of viable microorganisms recovered in the baseline samples. The performance criteria are mean reductions in microbial flora of ≥2 log10 per square cm on skin of the abdomen and ≥3 log10 per square cm on skin of the inguen.
arm group label: ZuraPrep Config 1
arm group type: Experimental
description: Isopropyl alcohol (IPA) 70% Standard scrub time.
arm group label: ZuraPrep Config 2
arm group type: Experimental
description: Isopropyl alcohol (IPA) 70% Half scrub time.
arm group label: ZuraPrep Vehicle
arm group type: Placebo Comparator
description: ZuraPrep without IPA
arm group label: ChloraPrep
arm group type: Active Comparator
description: Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%
intervention type: Drug
intervention name: Chloraprep
description: Apply topically.
arm group label: ChloraPrep
other name: 2% chlorhexidine gluconate / 70% Isopropyl alcohol
other name: CHG 2% / IPA 70%
intervention type: Drug
intervention name: ZuraPrep
description: Apply topically.
arm group label: ZuraPrep Config 1
arm group label: ZuraPrep Config 2
other name: Isopropyl alcohol 70%
intervention type: Drug
intervention name: ZuraPrep Vehicle
description: Apply topically.
arm group label: ZuraPrep Vehicle
other name: ZuraPrep without IPA
other name: ZuraPrep Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Chris Beausoleil
role: Principal Investigator
affiliation: BioScience Laboratories, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Surgical Wound Infection
mesh term: Ethanol
mesh term: Chlorhexidine
mesh term: Chlorhexidine gluconate