xml: <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/NCT06006455</url>
    </required_header>
    <id_info>
      <org_study_id>R-TOT</org_study_id>
      <nct_id>NCT06006455</nct_id>
    </id_info>
    <brief_title>Effect of the Erchonia® LunulaLaser™ for the Treatment of Toenail Onychomycosis</brief_title>
    <official_title>An Evaluation of the Effect of the Erchonia® LunulaLaser™ for the Treatment of Toenail Onychomycosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Erchonia Corporation</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Erchonia Corporation</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this clinical study is to demonstrate the efficacy of the Erchonia&#xD;
        LunulaLaser™, for the treatment of onychomycosis of the toenail.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This active test treatment group only study will evaluate the effectiveness of the Erchonia&#xD;
        LunulaLaser™ manufactured by Erchonia Corporation (the Sponsor) for the treatment of&#xD;
        onychomycosis of the toenail.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 15, 2020</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 1, 2024</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>Percent (%) of toenails attaining Complete Cure at study endpoint</measure>
      <time_frame>12 months</time_frame>
      <description>Complete Cure criteria is defined as a subject/toenail satisfying both the 'Clinical Cure' and the 'Mycological Cure' criteria in order to be considered a study responder, defined as follows:&#xD;
  (i) Clinical Cure: Measurement of clear nail increase as the following:&#xD;
  at least 12 mm increase in clear nail of the great toenail, with evidence of distal growth of the affected area, 12 months after the first treatment; or&#xD;
  complete clearance 12 months after the first treatment if less than 12 mm distal nail was involved prior to treatment.&#xD;
  The response should be progressive in at least 2 sequential timepoints that are at least 3 months apart, with projected increase of at least 1 mm per month.&#xD;
  (ii) Mycologic Cure: both negative KOH and negative Fungal Culture results (or two serial negative Fungal Culture results)</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Onychomycosis of Toenail</condition>
    <arm_group>
      <arm_group_label>Erchonia LunulaLaser</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The Erchonia LunulaLaser emits red light (635 nm) and violet light (405 nm) to the affected toenail for 12 minutes per treatment. The treatment phase involves an initial weekly treatment administration phase, 1 treatment a week for 4 weeks, followed by an every two-month maintenance treatment administration phase, months 3, 5, 7, 9, and 11.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Erchonia LunulaLaser</intervention_name>
      <description>405nm violet and 635nm red laser light therapy.</description>
      <arm_group_label>Erchonia LunulaLaser</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Confirmation of the presence of fungal infection through a positive KOH stain finding&#xD;
               and a positive fungal culture finding&#xD;
  &#xD;
            -  Identification through fungal culture of the growth of Trichophyton rubrum (T. rubrum)&#xD;
               or other common dermatophyte&#xD;
  &#xD;
            -  Visual clinical presentation of onychomycosis in the target great toenail is distal&#xD;
               subungual onychomycosis (DSO), visualized as a nail with normal surface texture and&#xD;
               thickness but variable &quot;bays&quot; of white nail that extend from the distal nail tip&#xD;
               proximally into the area of the nail bed&#xD;
  &#xD;
            -  Clinical involvement of onychomycosis in the target toenail is between 20%-50%&#xD;
  &#xD;
            -  Subject is willing and able to refrain from employing other (non-study) treatments&#xD;
               (traditional or alternative) for his or her toenail onychomycosis throughout study&#xD;
               participation.&#xD;
  &#xD;
            -  Subject is willing and able to refrain from the use of nail cosmetics such as clear&#xD;
               and/or colored nail lacquers throughout study participation&#xD;
  &#xD;
            -  Male or female&#xD;
  &#xD;
            -  18 years of age or older&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Lack of confirmation of the presence of fungal infection through a negative KOH stain&#xD;
               finding and/or a negative fungal culture finding&#xD;
  &#xD;
            -  Visual clinical presentations of onychomycosis in the target great toenail that are&#xD;
               inconsistent with the clinical presentation of distal subungual onychomycosis (DSO),&#xD;
               in whole or in part (i.e. indicative of mixed etiology); specifically visual clinical&#xD;
               presentations consistent with one or more of the following:&#xD;
  &#xD;
                 -  Proximal subungual onychomycosis (PSO): visualized as a white discoloration below&#xD;
                    the nail plate at the base of the nail, near the lunula. The distal nail retains&#xD;
                    normal appearance and texture. PSO involves infection near the matrix, deep to&#xD;
                    the nail. It may be associated with trauma to the nail or to immune compromise&#xD;
  &#xD;
                 -  Superficial white onychomycosis (SWO): visualized by the appearance of a white&#xD;
                    coating on the nail surface that can be eliminated by filing or buffing the&#xD;
                    surface of the affected portion of the nail&#xD;
  &#xD;
                 -  Complete dystrophy: Nails which are 100% dystrophic are manifested by yellowing&#xD;
                    and thickening of the entire nail unit&#xD;
  &#xD;
                 -  Other nail changes: Nails that visually present with changes that appear as&#xD;
                    parallel lines, small pinpoint depressions, brown spots, black or brown linear&#xD;
                    streaks, complete yellowing of all nails without textural change, green debris&#xD;
                    below the nail, or notches in the nail margin&#xD;
  &#xD;
            -  Less than 2mm clear (unaffected) nail plate length beyond the proximal fold&#xD;
  &#xD;
            -  Presence of dermatophytoma (thick masses of fungal hyphae and necrotic keratin between&#xD;
               the nail plate and nail bed)&#xD;
  &#xD;
            -  Infection involving lunula e.g., genetic nail disorders, primentary disorders&#xD;
  &#xD;
            -  Severe plantar (moccasin) tinea pedis&#xD;
  &#xD;
            -  Psoriasis of the skin and/or nails, lichen planus, or other medical conditions known&#xD;
               to induce nail changes&#xD;
  &#xD;
            -  Onychogryphosis&#xD;
  &#xD;
            -  Trauma from ill-fitting shoes, running, or overly-aggressive nail care&#xD;
  &#xD;
            -  Previous toenail surgery&#xD;
  &#xD;
            -  Uncontrolled diabetes mellitus&#xD;
  &#xD;
            -  Peripheral vascular disease&#xD;
  &#xD;
            -  Recurrent cellulitis&#xD;
  &#xD;
            -  Lymphatic insufficiency&#xD;
  &#xD;
            -  Immune compromise (whether due to underlying medical disorders or immunosuppressive&#xD;
               treatments)&#xD;
  &#xD;
            -  Other compromised states of health&#xD;
  &#xD;
            -  Known photosensitivity disorder&#xD;
  &#xD;
            -  Use of oral antifungal drugs in the prior 6 months&#xD;
  &#xD;
            -  Use of topical treatment of the skin or nails within the prior 2 months&#xD;
  &#xD;
            -  Any abnormality of the toenail that could prevent a normal appearing nail from&#xD;
               occurring if clearing of infection is achieved.&#xD;
  &#xD;
            -  Current trauma, open wound on or about the treatment area&#xD;
  &#xD;
            -  Deformity of the target toe/toenail secondary to fungal infection/onychomycosis due to&#xD;
               prior injury, surgical procedures or another medical condition&#xD;
  &#xD;
            -  Pregnant or planning pregnancy prior to the end of study participation&#xD;
  &#xD;
            -  Serious mental health illness such as dementia or schizophrenia; psychiatric&#xD;
               hospitalization in the past two years&#xD;
  &#xD;
            -  Developmental disability or cognitive impairment that would preclude adequate&#xD;
               comprehension of the informed consent form and/or ability to follow study subject&#xD;
               requirements and/or record the necessary study measurements&#xD;
  &#xD;
            -  Involvement in litigation and/or receiving disability benefits related in any way to&#xD;
               the parameters of the study&#xD;
  &#xD;
            -  Participation in a clinical study or other type of research in the past 30 days.&#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>Robin Stones, MB.ChB</last_name>
      <role>Principal Investigator</role>
      <affiliation>Blemish Clinic</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Travis Sammons</last_name>
      <phone>8882420571</phone>
      <phone_ext>501</phone_ext>
      <email>tsammons@erchonia.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Blemish Clinic</name>
        <address>
          <city>Edenfield</city>
          <state>Cheshire</state>
          <zip>BL00JN</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jan Birch</last_name>
        <phone>+44 1706 822689</phone>
        <email>jan@alamedtech.co.uk</email>
      </contact>
      <investigator>
        <last_name>Robin Stones, MB.ChB</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06006455
  org study id: R-TOT
  nct id: NCT06006455
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  The purpose of this clinical study is to demonstrate the efficacy of the Erchonia
        LunulaLaser™, for the treatment of onychomycosis of the toenail.
  This active test treatment group only study will evaluate the effectiveness of the Erchonia
        LunulaLaser™ manufactured by Erchonia Corporation (the Sponsor) for the treatment of
        onychomycosis of the toenail.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Percent (%) of toenails attaining Complete Cure at study endpoint
  time frame: 12 months
  description: Complete Cure criteria is defined as a subject/toenail satisfying both the 'Clinical Cure' and the 'Mycological Cure' criteria in order to be considered a study responder, defined as follows:
  (i) Clinical Cure: Measurement of clear nail increase as the following:
  at least 12 mm increase in clear nail of the great toenail, with evidence of distal growth of the affected area, 12 months after the first treatment; or
  complete clearance 12 months after the first treatment if less than 12 mm distal nail was involved prior to treatment.
  The response should be progressive in at least 2 sequential timepoints that are at least 3 months apart, with projected increase of at least 1 mm per month.
  (ii) Mycologic Cure: both negative KOH and negative Fungal Culture results (or two serial negative Fungal Culture results)
  arm group label: Erchonia LunulaLaser
  arm group type: Experimental
  description: The Erchonia LunulaLaser emits red light (635 nm) and violet light (405 nm) to the affected toenail for 12 minutes per treatment. The treatment phase involves an initial weekly treatment administration phase, 1 treatment a week for 4 weeks, followed by an every two-month maintenance treatment administration phase, months 3, 5, 7, 9, and 11.
  intervention type: Device
  intervention name: Erchonia LunulaLaser
  description: 405nm violet and 635nm red laser light therapy.
  arm group label: Erchonia LunulaLaser
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Robin Stones, MB.ChB
  role: Principal Investigator
  affiliation: Blemish Clinic
  last name: Travis Sammons
  phone: 8882420571
  phone ext: 501
  email: tsammons@erchonia.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Onychomycosis
  sharing ipd: No