<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/NCT02197182</url>
  </required_header>
  <id_info>
    <org_study_id>CDA 0801</org_study_id>
    <nct_id>NCT02197182</nct_id>
  </id_info>
  <brief_title>LUXSOL(TM) Topical Cream for the Treatment of Symptomatic Bacterial Vaginosis; A Proof of Concept Study</brief_title>
  <official_title>An Open-Label, Randomized Study to Determine the Safety and Efficacy of LUXSOL(TM) Cream for the Treatment of Bacterial Vaginosis: A Proof of Concept Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CDA Research Group, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CDA Research Group, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      LUXSOL Cream may be useful for the treatment of bacterial Vaginosis. In this study, LUXSOL&#xD;
      Cream is compared to a control arm group using metronidazole cream. LUXSOL is administered&#xD;
      intravaginally for 10 days, each evening before bedtime to treat bacterial Vaginosis..&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      LUXSOL Topical Cream is a copper containing topical cream indicated for the treatment of&#xD;
      bacterial vaginosis (BV). The study is an open-label, randomized, controlled study comparing&#xD;
      LUXSOL Cream to Metrogel in patients with a diagnosis of BV. The investigational product or&#xD;
      the comparator product will be self-administered by the patient for 10 consecutive nights. A&#xD;
      successful patient outcome is cured BV at 30 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Not for safety reasons&#xD;
  </why_stopped>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Presence or absence of bacterial vaginosis at the end of the study</measure>
    <time_frame>30 days</time_frame>
    <description>Patients will be assessed at day 30 for the presence or absence of bacterial Vaginosis (BV). Absence of BV will be considered a cure.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Bacterial Vaginosis (BV)</condition>
  <arm_group>
    <arm_group_label>LUXSOL Cream</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LUXSOL Cream is a copper containing cream to be administered intravaginally before bedtime for 10 consecutive nights.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Metronidazole cream</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Metronidazole cream is the active comparator drug to be self-administered intravaginally each night before bedtime for 10 consecutive nights. Dosage is per package insert.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LUXSOL copper containing cream</intervention_name>
    <description>Active comparator arm</description>
    <arm_group_label>LUXSOL Cream</arm_group_label>
    <other_name>LUXSOL Topical Cream</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metronidazole gel</intervention_name>
    <description>Active comparator for treatment of bacterial vaginosis</description>
    <arm_group_label>Metronidazole cream</arm_group_label>
    <other_name>Metrogel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject agrees to participate and signs informed consent&#xD;
&#xD;
          -  Female age 18 or older&#xD;
&#xD;
          -  Subject has clinical BV with 4 of 4 Amsel's criteria&#xD;
&#xD;
          -  Off-white (milky or gray), thin, adherent, homogenous discharge with minimal or absent&#xD;
             pruritus and inflammation of the vulva and vagina&#xD;
&#xD;
          -  Presence of 'clue cells' &gt;/=20% of the total epithelial cells on microscopic&#xD;
             examination of the saline 'wet mount.'&#xD;
&#xD;
          -  Virginal secretion pH of &gt;4.5&#xD;
&#xD;
          -  A fishy odor of the vaginal discharge with the addition of a drop of 10% KOH (i.e. a&#xD;
             positive 'whiff test')&#xD;
&#xD;
          -  Subject agrees to refrain from use of douches, intravaginal products for treatment&#xD;
             period&#xD;
&#xD;
          -  Subject agrees to refrain from taking oral or intravaginal antibiotics or antifungal&#xD;
             agents during entire study period&#xD;
&#xD;
          -  Subject agrees to refrain from vaginal intercourse during treatment period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has another infectious or noninfectious cause of vulvovaginitis&#xD;
&#xD;
          -  Subject has another vaginal or vulvar condition that would confound the determination&#xD;
             of study endpoints.&#xD;
&#xD;
          -  Subject has received antifungal or antimicrobial therapy (systemic or intravaginal)&#xD;
             within the last 14 days prior to enrollment.&#xD;
&#xD;
          -  Subject is under treatment for cervical intra-epithelial neoplasia or cervical&#xD;
             carcinoma&#xD;
&#xD;
          -  Subject is known to be HIV positive&#xD;
&#xD;
          -  Subject has a positive pregnancy test&#xD;
&#xD;
          -  Subject has any abnormal anatomy or pathology of the vagina&#xD;
&#xD;
          -  Subject has untreated sexually transmitted disease&#xD;
&#xD;
          -  Subject is currently having menstrual period or may have her period during treatment&#xD;
             days.&#xD;
&#xD;
          -  Subject's PAP smear &gt;/= to LSIL&#xD;
&#xD;
          -  Subjects with known sensitivity or allergic reactions to copper or Metronidazole&#xD;
             vaginal gel&#xD;
&#xD;
          -  Subject has known Wilson's disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Harper University Hospital Department of Infectious Diseases</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Temple University Hospital Department of OB/GYN</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>July 20, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>April 4, 2018</last_update_submitted>
  <last_update_submitted_qc>April 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bacterial Vaginosis (BV)</keyword>
  <keyword>Amsel's criteria</keyword>
  <keyword>Pap smear</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaginosis, Bacterial</mesh_term>
    <mesh_term>Vaginal Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Copper</mesh_term>
    <mesh_term>Metronidazole</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/NCT02197182
org study id: CDA 0801
nct id: NCT02197182
lead sponsor: 
has dmc: No
LUXSOL Cream may be useful for the treatment of bacterial Vaginosis. In this study, LUXSOL
      Cream is compared to a control arm group using metronidazole cream. LUXSOL is administered
      intravaginally for 10 days, each evening before bedtime to treat bacterial Vaginosis..
LUXSOL Topical Cream is a copper containing topical cream indicated for the treatment of
      bacterial vaginosis (BV). The study is an open-label, randomized, controlled study comparing
      LUXSOL Cream to Metrogel in patients with a diagnosis of BV. The investigational product or
      the comparator product will be self-administered by the patient for 10 consecutive nights. A
      successful patient outcome is cured BV at 30 days.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Presence or absence of bacterial vaginosis at the end of the study
time frame: 30 days
description: Patients will be assessed at day 30 for the presence or absence of bacterial Vaginosis (BV). Absence of BV will be considered a cure.
arm group label: LUXSOL Cream
arm group type: Experimental
description: LUXSOL Cream is a copper containing cream to be administered intravaginally before bedtime for 10 consecutive nights.
arm group label: Metronidazole cream
arm group type: Active Comparator
description: Metronidazole cream is the active comparator drug to be self-administered intravaginally each night before bedtime for 10 consecutive nights. Dosage is per package insert.
intervention type: Drug
intervention name: LUXSOL copper containing cream
description: Active comparator arm
arm group label: LUXSOL Cream
other name: LUXSOL Topical Cream
intervention type: Drug
intervention name: Metronidazole gel
description: Active comparator for treatment of bacterial vaginosis
arm group label: Metronidazole cream
other name: Metrogel
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Vaginosis, Bacterial
mesh term: Vaginal Diseases
mesh term: Copper
mesh term: Metronidazole