<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/NCT03022916</url>
  </required_header>
  <id_info>
    <org_study_id>X150817005</org_study_id>
    <nct_id>NCT03022916</nct_id>
  </id_info>
  <brief_title>Real-World Evaluation of the Effect of Jublia on Nail Polish</brief_title>
  <official_title>Real-World Evaluation of the Effect of Jublia on Nail Polish</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A recent publication using cadaver nails suggests that Jublia application has a negative&#xD;
      effect on nail polish texture.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is believed that investigating the affect of Jublia is an important question with regards&#xD;
      to how it affects how various nail polished and top coats will be used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2015</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Observe Stability of Nail Polish as Evidenced by Serial Photography With Efinaconazole Application in Terms of Days</measure>
    <time_frame>Baseline to 14 days</time_frame>
    <description>Observation: Serial photographs were combined with patient reported outcomes to assess the stability of self-applied toenail polish when efinaconazole was applied topically to the nail. (Expected stability of polish less than 14 days with application of Jublia as compared to nails without Jublia application)</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Evaluation of Jublia on Nail Polish With Healthy Toenails</condition>
  <arm_group>
    <arm_group_label>Nail Polish + Efinaconazole Solution</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One big toe will receive application of Efinaconazole Solution on top of nail polish (without the presence of a top coat or base coat)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nail Polish Only</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Both big toes will use nail polish only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Base Coat + Nail Polish + Top Coat + Efinaconazole Solution</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One big toe will receive application of Efinaconazole solution on top of nail polish with base coat and top coat.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nail Polish + Top Coat + Efinaconazole Solution</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One big toe will receive application of Efinaconazole solution on top of nail polish with top coat.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nail Polish + Efinaconazole Solution</intervention_name>
    <description>Application of Jublia to the nail of one big toe on top of the nail polish</description>
    <arm_group_label>Nail Polish + Efinaconazole Solution</arm_group_label>
    <other_name>Jublia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nail polish</intervention_name>
    <description>Application of nail polish only to both big toe nails</description>
    <arm_group_label>Nail Polish Only</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Base Coat + Nail Polish + Top Coat + Efinaconazole Solution</intervention_name>
    <description>Application of Jublia to the nail of one big toe on top of the nail polish with layers of top coat and base coat</description>
    <arm_group_label>Base Coat + Nail Polish + Top Coat + Efinaconazole Solution</arm_group_label>
    <other_name>Jublia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nail Polish + Top Coat + Efinaconazole Solution</intervention_name>
    <description>Application of Jublia to the nail of one big toe on top of the nail polish with layer of top coat</description>
    <arm_group_label>Nail Polish + Top Coat + Efinaconazole Solution</arm_group_label>
    <other_name>Jublia</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Exhibit distal lateral subungual onychomycosis (DLSO)&#xD;
&#xD;
          -  Has the informed consent been signed and patient's questions answered.&#xD;
&#xD;
          -  Age ≥ 18&#xD;
&#xD;
          -  Patient willing and able to participate for the full duration of the study&#xD;
&#xD;
          -  No onychomycosis&#xD;
&#xD;
          -  Greater than 4 weeks from prior major surgery for any indication&#xD;
&#xD;
          -  Willing to abstain from:&#xD;
&#xD;
          -  The application of other topical medications or cosmetic products to the toenail&#xD;
&#xD;
          -  Professional pedicures for the duration of the study.&#xD;
&#xD;
          -  Females of childbearing potential must:&#xD;
&#xD;
          -  Have been using adequate contraception (abstinence, IUD, birth control pills or&#xD;
             spermicidal gel with diaphragm or condom) since their last menses&#xD;
&#xD;
          -  Agree to continue using adequate means of contraception (abstinence, IUD, birth&#xD;
             control pills or spermicidal gel with diaphragm or condom) for the duration of study&#xD;
             participation&#xD;
&#xD;
          -  Females are not considered to be of childbearing potential if they are at least 1 year&#xD;
             postmenopausal or have had a tubal ligation, bilateral oophorectomy or hysterectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active onychomycosis of the toenails or fingernails&#xD;
&#xD;
          -  Any of the following in the 4 weeks (or as indicated) prior to randomization:&#xD;
&#xD;
          -  Major surgery for any indication&#xD;
&#xD;
          -  Any personal history of:&#xD;
&#xD;
          -  Invasive cancer diagnosed or treated within the past 5 years. Participants who have&#xD;
             been in remission for 5 years or more and have not required treatment in the past 5&#xD;
             years may be eligible if the principal investigator believes there is little to no&#xD;
             risk of recurrence.&#xD;
&#xD;
          -  Concurrent use of the following medications or treatments&#xD;
&#xD;
          -  Other topical antifungals for any concomitant infection&#xD;
&#xD;
          -  Females who are pregnant or lactating. Should a woman become pregnant or suspect she&#xD;
             is pregnant while she is participating in this study she should notify the study&#xD;
             physician immediately.&#xD;
&#xD;
          -  Uncontrolled concurrent illness including ongoing or active infection, psychiatric&#xD;
             illness or social situations that would limit compliance with study requirements or&#xD;
             other underlying serious medical condition which, in the investigator's opinion, might&#xD;
             preclude study participation.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Kirklin Clinic</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>October 16, 2015</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <results_first_submitted>August 14, 2018</results_first_submitted>
  <results_first_submitted_qc>December 17, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 6, 2020</results_first_posted>
  <last_update_submitted>December 17, 2019</last_update_submitted>
  <last_update_submitted_qc>December 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Boni Elewski, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>toenail polish</keyword>
  <keyword>jublia</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Efinaconazole</mesh_term>
    <mesh_term>Pharmaceutical Solutions</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 30, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT03022916/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Each patient served as their own control. One big toenail received nail polish only and the other big toenail was treated with nail polish and efinaconazole solution.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Efinaconazole Solution and Nail Polish</title>
          <description>Efinaconazole Solution and Nail Polish only (no base coat and no top coat) applied to great toenail</description>
        </group>
        <group group_id="P2">
          <title>Nail Polish Only</title>
          <description>No efinaconazole applied to one great toe. Only Nail per treatment arm</description>
        </group>
        <group group_id="P3">
          <title>Efinaconazole Solution, Nail Polish, Top Coat, and Base Coat</title>
          <description>One big toe will receive application of Efinaconazole solution on top of nail polish with base coat and top coat.</description>
        </group>
        <group group_id="P4">
          <title>Nail Polish + Top Coat + Efinaconazole Solution</title>
          <description>One big toe will receive application of Efinaconazole solution on top of nail polish with top coat.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Nail Polish</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Nail Polish, Base Coat</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Nail Polish, Top Coat</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Healthy adult with large toenail present</population>
      <group_list>
        <group group_id="B1">
          <title>Jublia</title>
          <description>Both big toes will receive application of toenail polish. One big toe will not use Jublia.&#xD;
Jublia: Application of Jublia to one big toenail&#xD;
Nail polish: Application of nail polish to both big toe nails&#xD;
Subjects had to be healthy and have a big toenail</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Observe Stability of Nail Polish as Evidenced by Serial Photography With Efinaconazole Application in Terms of Days</title>
        <description>Observation: Serial photographs were combined with patient reported outcomes to assess the stability of self-applied toenail polish when efinaconazole was applied topically to the nail. (Expected stability of polish less than 14 days with application of Jublia as compared to nails without Jublia application)</description>
        <time_frame>Baseline to 14 days</time_frame>
        <population>Healthy adults with normal appearing big toenails applied toenail polish to both big toes. Jublia was applied to one big toe daily on top of the nail polish. Serial photography and participant report demonstrated the day until the nail polish degraded (became damaged). Control results were not analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Nail Polish and Efinaconazole Solution</title>
            <description>Nail polish and Efinaconazole solution application (daily application of Efinaconazole solution)</description>
          </group>
          <group group_id="O2">
            <title>Efinaconazole Solution, Nail Polish, and Top Coat</title>
            <description>Efinaconazole solution applied daily to nail with top coat and nail polish</description>
          </group>
          <group group_id="O3">
            <title>Placebo Comparator: Nail Polish Only</title>
            <description>Both big toes will use nail polish only</description>
          </group>
          <group group_id="O4">
            <title>Base Coat + Nail Polish + Top Coat + Efinaconazole Solution</title>
            <description>Active Comparator: Base Coat + Nail Polish + Top Coat + Efinaconazole Solution One big toe will receive application of Efinaconazole solution on top of nail polish with base coat and top coat.</description>
          </group>
        </group_list>
        <measure>
          <title>Observe Stability of Nail Polish as Evidenced by Serial Photography With Efinaconazole Application in Terms of Days</title>
          <description>Observation: Serial photographs were combined with patient reported outcomes to assess the stability of self-applied toenail polish when efinaconazole was applied topically to the nail. (Expected stability of polish less than 14 days with application of Jublia as compared to nails without Jublia application)</description>
          <population>Healthy adults with normal appearing big toenails applied toenail polish to both big toes. Jublia was applied to one big toe daily on top of the nail polish. Serial photography and participant report demonstrated the day until the nail polish degraded (became damaged). Control results were not analyzed.</population>
          <units>days of stability</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>nail polish cycle</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>nail polish cycle</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="0.5"/>
                    <measurement group_id="O2" value="5" spread="2"/>
                    <measurement group_id="O3" value="15" spread="0"/>
                    <measurement group_id="O4" value="5" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>50 nail application cycles, 14 days of jublia application.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Jublia</title>
          <description>Both big toes will receive application of nail polish. . Only one big toe will use efinaconazole.&#xD;
Jublia: Application of Jublia to one big toes&#xD;
Nail polish: Application of nail polish to both big toe nails&#xD;
Subjects had to be healthy and have a big toenail</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director of Clinical Trials, UAB Dermatology</name_or_title>
      <organization>UAB</organization>
      <phone>2055029960</phone>
      <email>Lmroop@uabmc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03022916
org study id: X150817005
nct id: NCT03022916
lead sponsor: 
has dmc: No
A recent publication using cadaver nails suggests that Jublia application has a negative
      effect on nail polish texture.
It is believed that investigating the affect of Jublia is an important question with regards
      to how it affects how various nail polished and top coats will be used.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Observe Stability of Nail Polish as Evidenced by Serial Photography With Efinaconazole Application in Terms of Days
time frame: Baseline to 14 days
description: Observation: Serial photographs were combined with patient reported outcomes to assess the stability of self-applied toenail polish when efinaconazole was applied topically to the nail. (Expected stability of polish less than 14 days with application of Jublia as compared to nails without Jublia application)
arm group label: Nail Polish + Efinaconazole Solution
arm group type: Active Comparator
description: One big toe will receive application of Efinaconazole Solution on top of nail polish (without the presence of a top coat or base coat)
arm group label: Nail Polish Only
arm group type: Placebo Comparator
description: Both big toes will use nail polish only
arm group label: Base Coat + Nail Polish + Top Coat + Efinaconazole Solution
arm group type: Active Comparator
description: One big toe will receive application of Efinaconazole solution on top of nail polish with base coat and top coat.
arm group label: Nail Polish + Top Coat + Efinaconazole Solution
arm group type: Active Comparator
description: One big toe will receive application of Efinaconazole solution on top of nail polish with top coat.
intervention type: Drug
intervention name: Nail Polish + Efinaconazole Solution
description: Application of Jublia to the nail of one big toe on top of the nail polish
arm group label: Nail Polish + Efinaconazole Solution
other name: Jublia
intervention type: Other
intervention name: Nail polish
description: Application of nail polish only to both big toe nails
arm group label: Nail Polish Only
intervention type: Drug
intervention name: Base Coat + Nail Polish + Top Coat + Efinaconazole Solution
description: Application of Jublia to the nail of one big toe on top of the nail polish with layers of top coat and base coat
arm group label: Base Coat + Nail Polish + Top Coat + Efinaconazole Solution
other name: Jublia
intervention type: Drug
intervention name: Nail Polish + Top Coat + Efinaconazole Solution
description: Application of Jublia to the nail of one big toe on top of the nail polish with layer of top coat
arm group label: Nail Polish + Top Coat + Efinaconazole Solution
other name: Jublia
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Boni Elewski, MD
investigator title: Principal Investigator
mesh term: Efinaconazole
mesh term: Pharmaceutical Solutions
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 