<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/NCT03289871</url>
  </required_header>
  <id_info>
    <org_study_id>14E0752</org_study_id>
    <nct_id>NCT03289871</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of the Efficacy of a Medical Device in Treatment of Toenail Onychomycosis</brief_title>
  <official_title>Clinical Evaluation of the Efficacy of a Medical Device in Treatment of Toenail Onychomycosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oystershell NV</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oystershell NV</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effect of the medical device &quot;Excilor® Fungal Nail Infection&quot; in the&#xD;
      treatment of toenail onychomycosis. Half of the participants will receive the tested product&#xD;
      and the other half will receive a comparator (Amorolfin 5%). Patients will be followed during&#xD;
      6 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>At the end of the study (day 168), evolution of the percentage of healthy surface versus baseline, was evaluated by a blinded investigator. Comparison with the comparator product.</measure>
    <time_frame>After 168 days of treatment</time_frame>
    <description>Percentage healthy surface was assessed using digital image analysis. Briefly, two macro-photographs (top and front) were made of the great toenail, placed beside a piece of graph paper to allow determination of the exact size of the nail during analysis (contour tracing). Consequently, all pictures were digitalised and recorded on the computer. Image analysis of the top picture was performed with Adobe Photoshop software. For each photograph, a blinded dermatologist traced the healthy surface.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>At different time points, evolution of the percentage of healthy surface versus baseline, was evaluated by a blinded investigator. Comparison with the comparator product.</measure>
    <time_frame>After 14, 28, 56 and 112 days of treatment</time_frame>
    <description>Percentage healthy surface was assessed using digital image analysis. Briefly, two macro-photographs (top and front) were made of the great toenail, placed beside a piece of graph paper to allow determination of the exact size of the nail during analysis (contour tracing). Consequently, all pictures were digitalised and recorded on the computer. Image analysis of the top picture was performed with Adobe Photoshop software. For each photograph, a blinded dermatologist traced the healthy surface.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the clinical efficacy assessed by the investigator with structured scales. Comparison with the comparator product.</measure>
    <time_frame>On Day 0, Day 14, Day 28, Day 56, Day 112 and Day 168</time_frame>
    <description>Onycholysis, nail dystrophy, nail discoloration and nail thickening were assessed using the following scores:&#xD;
0 = none, 1 = very slight, 2 = slight, 3 =moderate, and 4 = severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the microbiological efficacy of the product assessed by fungal culture and comparison with the comparator product.</measure>
    <time_frame>On baseline (day zero) and day 168</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the product tolerance, assessed by the investigator by clinical evaluation and subject interrogatory with a score from 0 (bad tolerance) to 3 (very good tolerance).</measure>
    <time_frame>After 14, 28, 56 and 112 days of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the quality of life of the subjects thanks to the questionnaire NailQoL . Comparison with the comparator product.</measure>
    <time_frame>On Day 0, Day 14, Day 28, Day 56, Day 112 and Day 168</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective evaluation by subjects by completing the subjective evaluation questionnaire at each visit.</measure>
    <time_frame>On Day 0, Day 14, Day 28, Day 56, Day 112 and Day 168</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">112</enrollment>
  <condition>Onychomycosis</condition>
  <arm_group>
    <arm_group_label>Excilor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 applications per day for 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Loceryl 5%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1 application per week for 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Excilor</intervention_name>
    <arm_group_label>Excilor</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Loceryl 5%</intervention_name>
    <arm_group_label>Loceryl 5%</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject having given her/his informed, written consent,&#xD;
&#xD;
          -  Subject cooperative and aware of the modalities of use and the necessity and duration&#xD;
             of the controls so that perfect adhesion to the protocol can be expected.&#xD;
&#xD;
          -  Subject being psychologically able to understand information and to give their/his/her&#xD;
             consent.&#xD;
&#xD;
          -  Age: more than 18 years.&#xD;
&#xD;
          -  Subject with superficial onychomycosis on at least one great toenail or light to&#xD;
             moderate disto-lateral onychomycosis (without matrix involvement and involvement &lt;2/3&#xD;
             of the tablet).&#xD;
&#xD;
          -  Subject with positive results of KOH staining.&#xD;
&#xD;
          -  Subject having stopped any systemic antifungal treatment since at least 6 months&#xD;
             before inclusion and/or any topical antifungal treatment since at least 3 months&#xD;
             before inclusion.&#xD;
&#xD;
          -  Female subjects of childbearing potential should use an accepted contraceptive regimen&#xD;
             since at least 12 weeks before the beginning of the study, during all the study and at&#xD;
             least 1 month after the study end.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject considered by the Investigator likely to be non-compliant with the protocol.&#xD;
&#xD;
          -  Patient enrolled in another clinical trial during the test period.&#xD;
&#xD;
          -  Woman being pregnant, nursing or planning a pregnancy during the course of this study.&#xD;
&#xD;
          -  Subject having a known allergy to one of the constituents of the tested products.&#xD;
&#xD;
          -  Patient suffering from serious or progressive diseases (to investigator's discretion),&#xD;
             such as diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus,&#xD;
             immunosuppressive pathology….&#xD;
&#xD;
          -  Subject with cutaneous pathology on studied zone (other than onychomycosis like&#xD;
             angioma, dermatitis…).&#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>Nejib Doss, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Principal Instruction military hospital of Tunis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Habib Thameur</name>
      <address>
        <city>Tunis</city>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Principal instruction military hospital</name>
      <address>
        <city>Tunis</city>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tunisia</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>May 3, 2016</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>September 18, 2017</last_update_submitted>
  <last_update_submitted_qc>September 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Amorolfine</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/NCT03289871
org study id: 14E0752
nct id: NCT03289871
lead sponsor: 
has dmc: No
This study evaluates the effect of the medical device "Excilor® Fungal Nail Infection" in the
      treatment of toenail onychomycosis. Half of the participants will receive the tested product
      and the other half will receive a comparator (Amorolfin 5%). Patients will be followed during
      6 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: At the end of the study (day 168), evolution of the percentage of healthy surface versus baseline, was evaluated by a blinded investigator. Comparison with the comparator product.
time frame: After 168 days of treatment
description: Percentage healthy surface was assessed using digital image analysis. Briefly, two macro-photographs (top and front) were made of the great toenail, placed beside a piece of graph paper to allow determination of the exact size of the nail during analysis (contour tracing). Consequently, all pictures were digitalised and recorded on the computer. Image analysis of the top picture was performed with Adobe Photoshop software. For each photograph, a blinded dermatologist traced the healthy surface.
measure: At different time points, evolution of the percentage of healthy surface versus baseline, was evaluated by a blinded investigator. Comparison with the comparator product.
time frame: After 14, 28, 56 and 112 days of treatment
description: Percentage healthy surface was assessed using digital image analysis. Briefly, two macro-photographs (top and front) were made of the great toenail, placed beside a piece of graph paper to allow determination of the exact size of the nail during analysis (contour tracing). Consequently, all pictures were digitalised and recorded on the computer. Image analysis of the top picture was performed with Adobe Photoshop software. For each photograph, a blinded dermatologist traced the healthy surface.
measure: Evaluation of the clinical efficacy assessed by the investigator with structured scales. Comparison with the comparator product.
time frame: On Day 0, Day 14, Day 28, Day 56, Day 112 and Day 168
description: Onycholysis, nail dystrophy, nail discoloration and nail thickening were assessed using the following scores:
0 = none, 1 = very slight, 2 = slight, 3 =moderate, and 4 = severe.
measure: Evaluation of the microbiological efficacy of the product assessed by fungal culture and comparison with the comparator product.
time frame: On baseline (day zero) and day 168
measure: Evaluation of the product tolerance, assessed by the investigator by clinical evaluation and subject interrogatory with a score from 0 (bad tolerance) to 3 (very good tolerance).
time frame: After 14, 28, 56 and 112 days of treatment
measure: Evaluation of the quality of life of the subjects thanks to the questionnaire NailQoL . Comparison with the comparator product.
time frame: On Day 0, Day 14, Day 28, Day 56, Day 112 and Day 168
measure: Subjective evaluation by subjects by completing the subjective evaluation questionnaire at each visit.
time frame: On Day 0, Day 14, Day 28, Day 56, Day 112 and Day 168
arm group label: Excilor
arm group type: Experimental
description: 2 applications per day for 6 months
arm group label: Loceryl 5%
arm group type: Active Comparator
description: 1 application per week for 6 months
intervention type: Device
intervention name: Excilor
arm group label: Excilor
intervention type: Drug
intervention name: Loceryl 5%
arm group label: Loceryl 5%
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nejib Doss, MD
role: Principal Investigator
affiliation: Principal Instruction military hospital of Tunis
facility: 
facility: 
country: Tunisia
responsible party type: Sponsor
mesh term: Onychomycosis
mesh term: Amorolfine