<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/NCT02242695</url>
  </required_header>
  <id_info>
    <org_study_id>Flu-380112</org_study_id>
    <nct_id>NCT02242695</nct_id>
  </id_info>
  <brief_title>Comparative Efficacy Study of 10 mg Dequalinium Chloride (Fluomizin) in the Treatment of Vulvovaginal Candidiasis</brief_title>
  <official_title>Comparative Study of the Efficacy of 10.0 mg Dequalinium Chloride (Fluomizin®) and 100 mg Clotrimazole (Canesten®) for the Treatment of Vulvovaginal Candidiasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medinova AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medinova AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A clinical study to compare the clinical efficacy of vaginal tablets containing 10mg&#xD;
      dequalinium chloride (Fluomizin) with the clinical efficacy of 100mg clotrimazole in patients&#xD;
      suffering from vulvovaginal candidiasis, to assess safety of the two medications during the&#xD;
      treatment, and to evaluate women's satisfaction with the two treatments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical cure rate</measure>
    <time_frame>Control 1 at day 4 after therapy end</time_frame>
    <description>Clinical cure rate is defined as Total Severity Score (TSC) ≤ 2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Microbiological cure rate</measure>
    <time_frame>Control 1 at 4 days after therapy end</time_frame>
    <description>Negative microscopy for showing yeast forms (hyphae/pseudohyphae) or budding yeasts and Negative Candida culture</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapeutic cure rate</measure>
    <time_frame>Control 1 at 4 days after therapy end</time_frame>
    <description>Clinically and microbiologically cured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Individual clinical signs and symptoms</measure>
    <time_frame>Control 1 at 4 days after therapy end</time_frame>
    <description>4-point rating scale for vaginal itching, vaginal burning or soreness, vulvo/vaginal erythema or edema, and vulvar excoriation ofr fissure formation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of dyspareunia</measure>
    <time_frame>Control 1 at 4 days after therapy end</time_frame>
    <description>yes/no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Direct microscopy (wet smear)</measure>
    <time_frame>Control 1 at 4 days after therapy end</time_frame>
    <description>Presence or absence of Candida hyphea or spores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vaginal pH</measure>
    <time_frame>Control 1 at 4 days after therapy end</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Candida culture</measure>
    <time_frame>Control 1 at 4 days after therapy end</time_frame>
    <description>positive / negative for Candida spp</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global assessment of efficacy</measure>
    <time_frame>Control 1 at 4 days after therapy end</time_frame>
    <description>4-point rating scale assessed by investigator and patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>Control 1 at 4 days after therapy end</time_frame>
    <description>presence of vaginal discomfort, increased discharge, burning sensation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse event</measure>
    <time_frame>Control 1 at 4 days after therapy end</time_frame>
    <description>Number of participants experiencing an adverse event</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global assessment of tolerability</measure>
    <time_frame>Control 1 at 4 days after therapy end</time_frame>
    <description>4-point rating scale by investigator and patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical cure rate</measure>
    <time_frame>Control 2 at 6 weeks after therapy end</time_frame>
    <description>Clinical cure rate defined as Total Symptom Score TSC ≤ 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of external dysuria</measure>
    <time_frame>Control 1 at 4 days after therapy end</time_frame>
    <description>yes/no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microbiological cure rate</measure>
    <time_frame>Control 2 at 6 weeks after therapy end</time_frame>
    <description>Negative microscopy for showing yeast forms (hyphae/pseudohyphae) or budding yeasts and Negative Candida culture</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapeutic cure rate</measure>
    <time_frame>Control 2 at 6 weeks after therapy end</time_frame>
    <description>Clinically and microbiologically cured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Individual clinical signs and symptoms</measure>
    <time_frame>Control 2 at 6 weeks after therapy end</time_frame>
    <description>4-point rating scale for vaginal itching, vaginal burning or soreness, vulvo/vaginal erythema or edema, and vulvar excoriation ofr fissure formation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of dyspareunia</measure>
    <time_frame>Control 2 at 6 weeks after therapy end</time_frame>
    <description>yes/no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Direct microscopy (wet smear)</measure>
    <time_frame>Control 2 at 6 weeks after therapy end</time_frame>
    <description>Presence or absence of Candida hyphea or spores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vaginal pH</measure>
    <time_frame>Control 2 at 6 weeks after therapy end</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Candida culture</measure>
    <time_frame>Control 2 at 6 weeks after therapy end</time_frame>
    <description>positive / negative for Candida spp</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global assessment of efficacy</measure>
    <time_frame>Control 2 at 6 weeks after therapy end</time_frame>
    <description>4-point rating scale assessed by investigator and patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>Control 2 at 6 weeks after therapy end</time_frame>
    <description>presence of vaginal discomfort, increased discharge, burning sensation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse event</measure>
    <time_frame>Control 2 at 6 weeks after therapy end</time_frame>
    <description>Number of participants experiencing an adverse event</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global assessment of tolerability</measure>
    <time_frame>Control 2 at 6 weeks after therapy end</time_frame>
    <description>4-point rating scale by investigator and patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of external dysuria</measure>
    <time_frame>Control 2 at 6 weeks after therapy end</time_frame>
    <description>yes/no</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Vulvovaginal Candidiasis</condition>
  <arm_group>
    <arm_group_label>Fluomizin vaginal tablets</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fluomizin vaginal tablets containing 10mg dequalinium chloride once daily for 6 days and one placebo vaginal tablet on day 7</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Canesten vaginal tablets</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Canesten vaginal tablets containing 100mg clotrimazole once daily for 7 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluomizin vaginal tablets</intervention_name>
    <description>One vaginal tablet for 6 days and 1 placebo tablet on day 7</description>
    <arm_group_label>Fluomizin vaginal tablets</arm_group_label>
    <other_name>10 mg dequalinium chloride vaginal tablets</other_name>
    <other_name>Donaxyl vaginal tablets</other_name>
    <other_name>Naxyl vaginal tablets</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Canesten vaginal tablets</intervention_name>
    <description>one vaginal tablet for 7 days</description>
    <arm_group_label>Canesten vaginal tablets</arm_group_label>
    <other_name>100mg clotrimazole vaginal tablets</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical signs and symptoms of vulvovaginal candididiasis as Total Severity Score,&#xD;
             Total Severity Score of at least 4 (0-15: vaginal itching (0-3), vaginal burning or&#xD;
             soreness (0-3), abnormal vaginal discharge (0-3),vulvo/vaginal erythema or edema(0-3),&#xD;
             vulvar excoriation or fissure formation (0-3).&#xD;
&#xD;
          -  Direct microscopy (Wet smear) positive for yeast forms (hyphae/pseudohyphae) or&#xD;
             budding yeasts.&#xD;
&#xD;
          -  normal vaginal pH (higher than 4.5) at baseline.&#xD;
&#xD;
          -  Women aged 18 - 45 years old.&#xD;
&#xD;
          -  Women can comply with all clinical trial instructions, and can return to all follow-up&#xD;
             visits.&#xD;
&#xD;
          -  Signed Written Informed Consent to participate in this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recurrent vulvovaginal candidiasis(4 episodes of VVC in the last 12 months).&#xD;
&#xD;
          -  Women with other cause of vaginal infections, e.g. bacterial vaginosis, aerobic&#xD;
             vaginitis, trichomoniasis, and mixed infections&#xD;
&#xD;
          -  Women using oral or vaginal antifungals within 2 weeks prior to enrolment and during&#xD;
             the study.&#xD;
&#xD;
          -  Women using any intra-vaginal products, also vaginal douches containing soaps and&#xD;
             other anionic, surface-active substances, within 2 weeks prior to enrolment and during&#xD;
             the study.&#xD;
&#xD;
          -  Women using any antibiotic or anti-infective within 2 weeks prior to enrolment.&#xD;
&#xD;
          -  Cervicitis, abnormal PAP smear in the last 6 month.&#xD;
&#xD;
          -  Severe systemic diseases (HIV infection, diabetes mellitus, cancer, tuberculosis,&#xD;
             autoimmune diseases, severe psychiatric conditions, etc.).&#xD;
&#xD;
          -  Women with confirmed Neisseria gonorrhoea or Chlamydia trachomatis.&#xD;
&#xD;
          -  Women having menstruation bleeding at enrolment.&#xD;
&#xD;
          -  Known or suspected hypersensitivity to one of the study medications, inclusive their&#xD;
             excipients.&#xD;
&#xD;
          -  Participation of patient in another investigational drug study concomitantly or within&#xD;
             30 days prior to entry in the study.&#xD;
&#xD;
          -  Patient is relative of, or staff directly reporting to, the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manopchai Thamkhantho, Prof MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Siriraj Gynaecologic ID and Female STD Unit, Mahidol University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Siriraj Gynaecologic ID and Female STD Unit, Department of Obstetrics &amp; Gynaecology, Faculty of Medicine Siriraj Hospital, Mahidol University</name>
      <address>
        <city>Bangkok</city>
        <state>Bangkok Noi district</state>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>October 23, 2013</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>September 14, 2016</last_update_submitted>
  <last_update_submitted_qc>September 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vulvovaginal candidiasis</keyword>
  <keyword>vulvovaginal candidosis</keyword>
  <keyword>mycotic vaginal infection</keyword>
  <keyword>dequalinium chloride</keyword>
  <keyword>Fluomizin</keyword>
  <keyword>clotrimazole</keyword>
  <keyword>canesten</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Candidiasis</mesh_term>
    <mesh_term>Candidiasis, Vulvovaginal</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clotrimazole</mesh_term>
    <mesh_term>Dequalinium</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/NCT02242695
org study id: Flu-380112
nct id: NCT02242695
lead sponsor: 
collaborator: 
has dmc: No
A clinical study to compare the clinical efficacy of vaginal tablets containing 10mg
      dequalinium chloride (Fluomizin) with the clinical efficacy of 100mg clotrimazole in patients
      suffering from vulvovaginal candidiasis, to assess safety of the two medications during the
      treatment, and to evaluate women's satisfaction with the two treatments.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Clinical cure rate
time frame: Control 1 at day 4 after therapy end
description: Clinical cure rate is defined as Total Severity Score (TSC) ≤ 2
measure: Microbiological cure rate
time frame: Control 1 at 4 days after therapy end
description: Negative microscopy for showing yeast forms (hyphae/pseudohyphae) or budding yeasts and Negative Candida culture
measure: Therapeutic cure rate
time frame: Control 1 at 4 days after therapy end
description: Clinically and microbiologically cured
measure: Individual clinical signs and symptoms
time frame: Control 1 at 4 days after therapy end
description: 4-point rating scale for vaginal itching, vaginal burning or soreness, vulvo/vaginal erythema or edema, and vulvar excoriation ofr fissure formation
measure: Presence of dyspareunia
time frame: Control 1 at 4 days after therapy end
description: yes/no
measure: Direct microscopy (wet smear)
time frame: Control 1 at 4 days after therapy end
description: Presence or absence of Candida hyphea or spores
measure: vaginal pH
time frame: Control 1 at 4 days after therapy end
measure: Candida culture
time frame: Control 1 at 4 days after therapy end
description: positive / negative for Candida spp
measure: Global assessment of efficacy
time frame: Control 1 at 4 days after therapy end
description: 4-point rating scale assessed by investigator and patient
measure: Patient Satisfaction
time frame: Control 1 at 4 days after therapy end
description: presence of vaginal discomfort, increased discharge, burning sensation
measure: Adverse event
time frame: Control 1 at 4 days after therapy end
description: Number of participants experiencing an adverse event
measure: Global assessment of tolerability
time frame: Control 1 at 4 days after therapy end
description: 4-point rating scale by investigator and patient
measure: Clinical cure rate
time frame: Control 2 at 6 weeks after therapy end
description: Clinical cure rate defined as Total Symptom Score TSC ≤ 2
measure: Presence of external dysuria
time frame: Control 1 at 4 days after therapy end
description: yes/no
measure: Microbiological cure rate
time frame: Control 2 at 6 weeks after therapy end
description: Negative microscopy for showing yeast forms (hyphae/pseudohyphae) or budding yeasts and Negative Candida culture
measure: Therapeutic cure rate
time frame: Control 2 at 6 weeks after therapy end
description: Clinically and microbiologically cured
measure: Individual clinical signs and symptoms
time frame: Control 2 at 6 weeks after therapy end
description: 4-point rating scale for vaginal itching, vaginal burning or soreness, vulvo/vaginal erythema or edema, and vulvar excoriation ofr fissure formation
measure: Presence of dyspareunia
time frame: Control 2 at 6 weeks after therapy end
description: yes/no
measure: Direct microscopy (wet smear)
time frame: Control 2 at 6 weeks after therapy end
description: Presence or absence of Candida hyphea or spores
measure: vaginal pH
time frame: Control 2 at 6 weeks after therapy end
measure: Candida culture
time frame: Control 2 at 6 weeks after therapy end
description: positive / negative for Candida spp
measure: Global assessment of efficacy
time frame: Control 2 at 6 weeks after therapy end
description: 4-point rating scale assessed by investigator and patient
measure: Patient Satisfaction
time frame: Control 2 at 6 weeks after therapy end
description: presence of vaginal discomfort, increased discharge, burning sensation
measure: Adverse event
time frame: Control 2 at 6 weeks after therapy end
description: Number of participants experiencing an adverse event
measure: Global assessment of tolerability
time frame: Control 2 at 6 weeks after therapy end
description: 4-point rating scale by investigator and patient
measure: Presence of external dysuria
time frame: Control 2 at 6 weeks after therapy end
description: yes/no
arm group label: Fluomizin vaginal tablets
arm group type: Experimental
description: Fluomizin vaginal tablets containing 10mg dequalinium chloride once daily for 6 days and one placebo vaginal tablet on day 7
arm group label: Canesten vaginal tablets
arm group type: Active Comparator
description: Canesten vaginal tablets containing 100mg clotrimazole once daily for 7 days
intervention type: Drug
intervention name: Fluomizin vaginal tablets
description: One vaginal tablet for 6 days and 1 placebo tablet on day 7
arm group label: Fluomizin vaginal tablets
other name: 10 mg dequalinium chloride vaginal tablets
other name: Donaxyl vaginal tablets
other name: Naxyl vaginal tablets
intervention type: Drug
intervention name: Canesten vaginal tablets
description: one vaginal tablet for 7 days
arm group label: Canesten vaginal tablets
other name: 100mg clotrimazole vaginal tablets
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Manopchai Thamkhantho, Prof MD
role: Principal Investigator
affiliation: Siriraj Gynaecologic ID and Female STD Unit, Mahidol University
facility: 
country: Thailand
responsible party type: Sponsor
mesh term: Candidiasis
mesh term: Candidiasis, Vulvovaginal
mesh term: Clotrimazole
mesh term: Dequalinium