<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/NCT03250923</url>
  </required_header>
  <id_info>
    <org_study_id>IRB2017-0042</org_study_id>
    <nct_id>NCT03250923</nct_id>
  </id_info>
  <brief_title>CelAgace™ OraRinse Solution for Treatment of Candidiasis</brief_title>
  <official_title>CelAgace™ OraRinse (CAOR) Pilot Clinical Study for Management of Candidiasis Associated With Grade 0-II Mucositis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CelaCare Technologies, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Texas A&amp;M University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>CelaCare Technologies, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      CelAgace™ OraRinse (silver citrate complex and acemannan) Solution is planned to be evaluated&#xD;
      for safety and effectiveness as a potential treatment for candidiasis, a yeast infection,&#xD;
      commonly known as thrush, which is associated with mouth sores.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CelAgace™ contains two active ingredients, a silver citrate complex salt (0.01mg/ml) that has&#xD;
      demonstrated laboratory effectiveness against yeast organisms and acemannan (4.0mg/ml), a&#xD;
      purified extract isolated from the inner leaf gel of the Aloe vera plant that has been used&#xD;
      as a key ingredient in other oral care products. Patients will swish and spit the product 4&#xD;
      times daily (after meals and at bedtime) for 14 days. Following an initial office visit,&#xD;
      patients will be evaluated on days 7 and 14 to determine response to the product.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">September 2023</start_date>
  <completion_date type="Anticipated">November 2024</completion_date>
  <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical cure as demonstrated by change and reduction from baseline in typical candida lesions and a negative candida rinse culture</measure>
    <time_frame>Days 1(Baseline), 3, 7 and 14</time_frame>
    <description>Rinse culture will be taken on Days 1, 7 and 14 to quantify Candidal Colony Forming Units and observational assessment will be done at study entry, Day 1, Days 3, 7, 14 using the WHO grading scale for response evaluation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction in Pain</measure>
    <time_frame>Days 1, 3, 7, 14</time_frame>
    <description>Patients will complete a pain quality assessment rating scale (PQAS) during the course of the study.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Candidiasis, Oral</condition>
  <arm_group>
    <arm_group_label>silver citrate complex and acemannan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is a single arm open pilot trial. All participants will receive study drug.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>silver citrate complex and acemannan</intervention_name>
    <description>Oral rinse solution with each dose containing 100μg silver citrate complex and 40mg acemannan</description>
    <arm_group_label>silver citrate complex and acemannan</arm_group_label>
    <other_name>CelAgace™ OraRinse Solution</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Radiation induced oral mucositis with resulting candidiasis&#xD;
&#xD;
          -  Chemotherapy induced oral mucositis with resulting candidiasis&#xD;
&#xD;
          -  Oral mucositis due to being immunocompromised with resulting candidiasis&#xD;
&#xD;
          -  Stomatitis due to other causes with resulting candidiasis&#xD;
&#xD;
          -  Currently have mild to moderate mucositis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patient:&#xD;
&#xD;
          -  under the age of 18&#xD;
&#xD;
          -  pregnant or breastfeeding&#xD;
&#xD;
          -  inability to use an oral rinse&#xD;
&#xD;
          -  hypersensitivity to Aloe Vera and/or Silver&#xD;
&#xD;
          -  whose candida rinse culture was performed greater than 10 days prior to study entry.&#xD;
&#xD;
          -  has any sort of removable dental appliance&#xD;
&#xD;
          -  with previous or current history of any cancer of the oral cavity&#xD;
&#xD;
          -  who received therapy for candidiasis within the past 30 days&#xD;
&#xD;
          -  who used antifungal medication in the last 30 days&#xD;
&#xD;
          -  who has severe to life threatening oral muositis (Grade III-IV) oral mucositis&#xD;
&#xD;
          -  with impaired renal or hepatic function&#xD;
&#xD;
          -  receiving high dose chemotherapy and total body irradiation in preparation for&#xD;
             Hemopoietic Stem Cell Transplant (HSCT) or Concomitant use of Kepivance® (palifermin&#xD;
             or rhKGF)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacqueline M. Plemons, DDS, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas A&amp;M University College of Dentistry</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jacqueline M. Plemons, DDS, MS</last_name>
    <phone>214-828-8467</phone>
    <email>jplemons@tamhsc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Celeste M. Abraham, DDS, MS</last_name>
    <phone>214-828-8467</phone>
    <email>cabraham@tamhsc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Texas A&amp;M University College of Dentistry</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Jacqueline M. Plemons, DDS, MS</last_name>
      <phone>214-828-8467</phone>
      <email>jplemons@tamhsc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Celeste M. Abraham, DDS, MS</last_name>
      <phone>214-828-8467</phone>
      <email>cabraham@tamhsc.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Celeste M. Abraham, DDS, MS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jacqueline M. Plemons, DDS, MS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oral Candidiasis, Thrush, Oral Moniliasis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Candidiasis</mesh_term>
    <mesh_term>Candidiasis, Oral</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acemannan</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03250923
org study id: IRB2017-0042
nct id: NCT03250923
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
CelAgace™ OraRinse (silver citrate complex and acemannan) Solution is planned to be evaluated
      for safety and effectiveness as a potential treatment for candidiasis, a yeast infection,
      commonly known as thrush, which is associated with mouth sores.
CelAgace™ contains two active ingredients, a silver citrate complex salt (0.01mg/ml) that has
      demonstrated laboratory effectiveness against yeast organisms and acemannan (4.0mg/ml), a
      purified extract isolated from the inner leaf gel of the Aloe vera plant that has been used
      as a key ingredient in other oral care products. Patients will swish and spit the product 4
      times daily (after meals and at bedtime) for 14 days. Following an initial office visit,
      patients will be evaluated on days 7 and 14 to determine response to the product.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical cure as demonstrated by change and reduction from baseline in typical candida lesions and a negative candida rinse culture
time frame: Days 1(Baseline), 3, 7 and 14
description: Rinse culture will be taken on Days 1, 7 and 14 to quantify Candidal Colony Forming Units and observational assessment will be done at study entry, Day 1, Days 3, 7, 14 using the WHO grading scale for response evaluation.
measure: Reduction in Pain
time frame: Days 1, 3, 7, 14
description: Patients will complete a pain quality assessment rating scale (PQAS) during the course of the study.
arm group label: silver citrate complex and acemannan
arm group type: Experimental
description: This is a single arm open pilot trial. All participants will receive study drug.
intervention type: Drug
intervention name: silver citrate complex and acemannan
description: Oral rinse solution with each dose containing 100μg silver citrate complex and 40mg acemannan
arm group label: silver citrate complex and acemannan
other name: CelAgace™ OraRinse Solution
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jacqueline M. Plemons, DDS, MS
role: Principal Investigator
affiliation: Texas A&M University College of Dentistry
last name: Jacqueline M. Plemons, DDS, MS
phone: 214-828-8467
email: jplemons@tamhsc.edu
last name: Celeste M. Abraham, DDS, MS
phone: 214-828-8467
email: cabraham@tamhsc.edu
facility: 
contact: 
contact backup: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Candidiasis
mesh term: Candidiasis, Oral
mesh term: Acemannan