<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/NCT03022903</url>
  </required_header>
  <id_info>
    <org_study_id>F150128007</org_study_id>
    <nct_id>NCT03022903</nct_id>
  </id_info>
  <brief_title>Blue Light Photodynamic Therapy Treatment for Distal and Lateral Subungual Toenail Onychomycosis</brief_title>
  <official_title>Blue Light Photodynamic Therapy Treatment for Distal and Lateral Subungual Toenail Onychomycosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>DUSA Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study will evaluate the safety and efficacy of using blue light photodynamic&#xD;
      therapy (PDT) for treating toenail fungal infections.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research study will evaluate the safety and efficacy of using blue light photodynamic&#xD;
      therapy (PDT) for treating toenail fungal infections.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2015</start_date>
  <completion_date type="Actual">December 2021</completion_date>
  <primary_completion_date type="Actual">September 2019</primary_completion_date>
  <phase>N/A</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>Number of subjects diagnosed with presence of subungual culture after 3rd treatment session</measure>
    <time_frame>3 weeks after baseline</time_frame>
    <description>Based on presence of fungal infection from culture assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinical cure based on photographs after the 3rd treatment session</measure>
    <time_frame>3 weeks after baseline</time_frame>
    <description>Based on visual assessment of photographs: presence or absence of fungal infection</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare rates of mycological and clinical cure after three treatments between two groups with different ALA incubation times</measure>
    <time_frame>3 weeks after baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the durability of treatment outcomes with subungual culture and photographs at 24 weeks</measure>
    <time_frame>24 weeks after first treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit</measure>
    <time_frame>1 week after baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit</measure>
    <time_frame>2 weeks after baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit</measure>
    <time_frame>3 weeks after baseline</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Toenail Onychomycosis</condition>
  <condition>Distal and Lateral Subungual Toenail Onychomycosis</condition>
  <arm_group>
    <arm_group_label>Photodynamic Therapy (PDT)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>PDT with ALA (photosensitizer) for 3 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Aminolevulinic Acid (ALA)</intervention_name>
    <description>Photosensitizing</description>
    <arm_group_label>Photodynamic Therapy (PDT)</arm_group_label>
    <other_name>ALA is a topical drug used in the administration of PDT.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 19 and younger than 70 years&#xD;
&#xD;
          -  Give written informed consent prior to any study procedures being conducted, and&#xD;
             candidates will authorize the release and use of protected health information (PHI)&#xD;
&#xD;
          -  Diagnosed with distal lateral subungual onychomycosis (DLSO) of the great toe with&#xD;
             both positive potassium hydroxide (KOH) and positive culture growth of Trichophyton&#xD;
             rubrum&#xD;
&#xD;
          -  No topical treatment for DLSO in the preceding 2 weeks and no oral treatment for DLSO&#xD;
             (itraconazole or terbinafine) in the preceding 8 weeks&#xD;
&#xD;
          -  At lease 20% of target great toe nail affected&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to comply with the protocol (as defined y the investigator; i.e. drug or&#xD;
             alcohol abuse or history of noncompliance)&#xD;
&#xD;
          -  Patients with active nail disease that would confound evaluation of DLSO, such as&#xD;
             psoriasis&#xD;
&#xD;
          -  Patients with greater than 6 toenails affected&#xD;
&#xD;
          -  Over 90% of target great toe affected&#xD;
&#xD;
          -  Evidence of fingernail fungal infection&#xD;
&#xD;
          -  Patients with recurrent serious infections or have been hospitalized in the preceding&#xD;
             6 months for infection&#xD;
&#xD;
          -  Patients with known history of HIV or hepatitis B or C infection&#xD;
&#xD;
          -  Patients with severe, progressive, or uncontrolled with renal, hepatic, hematological,&#xD;
             gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurologic&#xD;
             disease&#xD;
&#xD;
          -  Any subject who, in the opinion of the investigator, will be uncooperative or unable&#xD;
             to comply with study procedures&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boni E Elewski, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dermatology at the Whitaker 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>February 2022</verification_date>
  <study_first_submitted>October 16, 2015</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>February 3, 2022</last_update_submitted>
  <last_update_submitted_qc>February 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2022</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</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </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>Aminolevulinic Acid</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/NCT03022903
org study id: F150128007
nct id: NCT03022903
lead sponsor: 
collaborator: 
has dmc: No
This research study will evaluate the safety and efficacy of using blue light photodynamic
      therapy (PDT) for treating toenail fungal infections.
This research study will evaluate the safety and efficacy of using blue light photodynamic
      therapy (PDT) for treating toenail fungal infections.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of subjects diagnosed with presence of subungual culture after 3rd treatment session
time frame: 3 weeks after baseline
description: Based on presence of fungal infection from culture assessment
measure: Number of subjects with clinical cure based on photographs after the 3rd treatment session
time frame: 3 weeks after baseline
description: Based on visual assessment of photographs: presence or absence of fungal infection
measure: Compare rates of mycological and clinical cure after three treatments between two groups with different ALA incubation times
time frame: 3 weeks after baseline
measure: Evaluate the durability of treatment outcomes with subungual culture and photographs at 24 weeks
time frame: 24 weeks after first treatment
measure: Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit
time frame: 1 week after baseline
measure: Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit
time frame: 2 weeks after baseline
measure: Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit
time frame: 3 weeks after baseline
arm group label: Photodynamic Therapy (PDT)
arm group type: Other
description: PDT with ALA (photosensitizer) for 3 hours
intervention type: Procedure
intervention name: Aminolevulinic Acid (ALA)
description: Photosensitizing
arm group label: Photodynamic Therapy (PDT)
other name: ALA is a topical drug used in the administration of PDT.
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 70 Years
healthy volunteers: No
last name: Boni E Elewski, MD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Boni Elewski
investigator title: Principal Investigator
mesh term: Onychomycosis
mesh term: Aminolevulinic Acid