<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/NCT03280927</url>
  </required_header>
  <id_info>
    <org_study_id>JBL_OM_IV</org_study_id>
    <nct_id>NCT03280927</nct_id>
  </id_info>
  <brief_title>Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Jublia® in Mild to Moderate Toenail Onychomycosis</brief_title>
  <official_title>A Multicenter, Open-label, Non-controlled, Single-arm Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Jublia® in Mild to Moderate Toenail Onychomycosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dong-A ST Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dong-A ST Co., Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The antifungal efficacy and safety of Jublia® topical solution will be assessed through an&#xD;
      administration for 48 weeks to patients diagnosed with a mild or moderate onychomycosis due&#xD;
      to dermatophyte.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evaluate anti-fungal activity and safety of efinaconazole in patients with mild to moderate&#xD;
      toenail onychomycosis caused by dermatophytes that received a 48-week administration of&#xD;
      efinaconazole.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 10, 2017</start_date>
  <completion_date type="Actual">January 22, 2020</completion_date>
  <primary_completion_date type="Actual">January 22, 2020</primary_completion_date>
  <phase>Phase 4</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>Completely cured subjects</measure>
    <time_frame>52 weeks</time_frame>
    <description>The ratio of completely cured subjects</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complete or almost complete cure rates</measure>
    <time_frame>52 weeks</time_frame>
    <description>The ratio of subjects showing less than 5% of infection area</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mycologic cure rates</measure>
    <time_frame>52 weeks</time_frame>
    <description>Negative results from both the KOH Direct Microscopic Inspection and Fungi Cultivation Inspection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical efficacy rates</measure>
    <time_frame>52 weeks</time_frame>
    <description>The ratio of subjects affected target nail area less than 10%</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">97</enrollment>
  <condition>Mild to Moderate Onychomycosis Due to Dermatophyte</condition>
  <arm_group>
    <arm_group_label>Jublia®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Jublia®</intervention_name>
    <description>Jublia® topical solution</description>
    <arm_group_label>Jublia®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult male and female subjects of ages in the range over 19.&#xD;
&#xD;
          -  The subjects diagnosed with onychomycosis in up to 6 toenails at least&#xD;
&#xD;
             1 great toenail woth no fingernails&#xD;
&#xD;
          -  The subjects diagnosed with a mild to moderate onychomycosis (20% to 50% of surface of&#xD;
             target nail without nail matrix infection or dermatophytoma)&#xD;
&#xD;
          -  The subjects having target nails less than 3mm in thickness and over 3mm in length&#xD;
&#xD;
          -  Positive indication on KOH Direct Microscopic Inspection on target nail&#xD;
&#xD;
          -  Positive dermatophyte or dermatophyte/candida on Fungi Cultivation Inspection on&#xD;
             target nail&#xD;
&#xD;
          -  The subjects completely understood the clinical trial through detailed explanation&#xD;
             presented, determined to participate in the clinical trial spontaneously, and agreed&#xD;
             to observe precautions suggested thereby through written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subjects suffering other diseases that may cause nail abnormalities or are&#xD;
             supposed to be affecting the assessment of the efficacy of study agent by the judgment&#xD;
             of investigators&#xD;
&#xD;
          -  The subjects having a case history of hypersensitivity reaction to the component of&#xD;
             Jublia® topical solution or Azole derivatives.&#xD;
&#xD;
          -  The pregnant, lactating, or fertile woman free from pertinent contraception&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Konkuk University Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>April 26, 2021</last_update_submitted>
  <last_update_submitted_qc>April 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Onychomycosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Onychomycosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Efinaconazole</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/NCT03280927
org study id: JBL_OM_IV
nct id: NCT03280927
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The antifungal efficacy and safety of Jublia® topical solution will be assessed through an
      administration for 48 weeks to patients diagnosed with a mild or moderate onychomycosis due
      to dermatophyte.
Evaluate anti-fungal activity and safety of efinaconazole in patients with mild to moderate
      toenail onychomycosis caused by dermatophytes that received a 48-week administration of
      efinaconazole.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Completely cured subjects
time frame: 52 weeks
description: The ratio of completely cured subjects
measure: Complete or almost complete cure rates
time frame: 52 weeks
description: The ratio of subjects showing less than 5% of infection area
measure: Mycologic cure rates
time frame: 52 weeks
description: Negative results from both the KOH Direct Microscopic Inspection and Fungi Cultivation Inspection.
measure: Clinical efficacy rates
time frame: 52 weeks
description: The ratio of subjects affected target nail area less than 10%
arm group label: Jublia®
arm group type: Experimental
intervention type: Drug
intervention name: Jublia®
description: Jublia® topical solution
arm group label: Jublia®
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Onychomycosis
mesh term: Efinaconazole