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/NCT06036654</url>
    </required_header>
    <id_info>
      <org_study_id>HH20230410</org_study_id>
      <nct_id>NCT06036654</nct_id>
    </id_info>
    <brief_title>Infrared Bioeffect System for the Treatment of Onychomycosis</brief_title>
    <official_title>A Multicenter Clinical Trial of Infrared Bioeffect System for the Treatment of Onychomycosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gao Xinghua</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Jining Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Binzhou Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>First Hospital of China Medical University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Onychomycosis is a common nail plate infection caused by dermatophytes, non-dermatophytic&#xD;
        molds, and yeasts. The disease is difficult to achieve self-healing and predisposed to&#xD;
        secondary bacterial infections. There are currently multiple medications that can be used for&#xD;
        the treatment of onychomycosis. The limitations are high recurrence rate and high cost,&#xD;
        time-consuming and drug interactions. Several FDA approved laser devices have been available&#xD;
        for the treatment of onychomycosis since 2010. As an emerging physical therapy modality,&#xD;
        laser and light have advantages including extensive applicable range, simple operation, less&#xD;
        trauma, and it will not lead to generation of new resistant strains. Therefore, it has been&#xD;
        popularized and applied in clinics, especially among elderly, immunocompromised patients, or&#xD;
        those with liver and kidney dysfunction. Laser systems in the near-infrared spectrum (780 nm∼&#xD;
        3,000 nm wavelength), which are commonly used in onychomycosis, exert their effect by direct&#xD;
        heating of target tissues, but it can cause unbearable physical pain to the patient. Compared&#xD;
        with laser, controllable infrared bioeffect system has the advantages of high safety, less&#xD;
        trauma, and less pain. Reported in the literature, it has been observed that regression of&#xD;
        distant, untreated skin lesions in patients treated locally with controllable infrared&#xD;
        bioeffect system, especially in inflammatory skin diseases such as viral warts and&#xD;
        sporotrichosis. The aim of the research is to evaluate the safety and efficacy of&#xD;
        controllable infrared bioeffect system in treatment of onychomycosis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Mild local hyperthermia with a certain temperature range has been successfully used in&#xD;
        treatment of some diseases. It has been applied in the treatment of some neoplasm, fungal and&#xD;
        HPV infections. Previous studies regarding viral warts and sporotrichosis found that in&#xD;
        patients with multiple lesions, the clearance of the target lesion is commonly followed by&#xD;
        clearance of other distant lesions, a phenomenon suggesting that local hyperthermia could aid&#xD;
        in establishing a specific immune response to eliminate pathogenic microorganisms.&#xD;
        Investigators speculate that mild local hyperthermia was a potential treatment for&#xD;
        onychomycosis. A prospective single arm clinical trial was conducted to evaluate the&#xD;
        effectiveness and safety of mild local hyperthermia in the treatment of onychomycosis.&#xD;
        Participants with onychomycosis with at least 2 nails involved were included. The treatment&#xD;
        effect of the treated and the untreated nail onychomycosis was measured after 6 months and 12&#xD;
        months of initial treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 24, 2023</start_date>
    <completion_date type="Anticipated">August 24, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 24, 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>
      <intervention_model_description>Local hyperthermia for the Treatment of Onychomycosis</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cure rate of the target nail</measure>
      <time_frame>6 months, 9 months and 12 months after the first treatment</time_frame>
      <description>Clinical and mycological cure rate of the target nail at 6 months, 9 months and12 months after the first treatment</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cure rate of non-targeted nail</measure>
      <time_frame>6 months, 9 months, 12 months after the first treatment</time_frame>
      <description>Clinical and mycological cure rate of non-target nail at 6 months, 9 months and12 months after the first treatment</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Hyperthermia</condition>
    <arm_group>
      <arm_group_label>Local Hyperthermia for the Treatment of Onychomycosis</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>(1) In months 0-2, local hyperthermia treatment was given once a week for 20 minutes each time, for a total of 9 times; (2) In months 2-4, at the same target lesion, once every 2 weeks, for a total of 4 times; (3) In months 4-6, once every 4 weeks, for a total of 2 times. The frequency of this course of treatment was 15 times lasting for 6 months, and follow-up ended 12 months from the first treatment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>infrared thermotherapy instrument</intervention_name>
      <description>Only a single target nail was chosen among multiple onychomycosis to receive local hyperthermia treatment.</description>
      <arm_group_label>Local Hyperthermia for the Treatment of Onychomycosis</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male and female patients between 18 and 70 years old.&#xD;
  &#xD;
            2. Patients with Onychomycosis confirmed by clinic and microscopic examination or culture&#xD;
               of fungi.&#xD;
  &#xD;
            3. All subjects voluntarily joined this study with informed consents.&#xD;
  &#xD;
            4. The subjects have good compliance and can cooperate with investigators follow-up&#xD;
               study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. The patients during the period of pregnancy or breastfeeding.&#xD;
  &#xD;
            2. The systemic and topical antifungal drugs were withdrawn 1 year and 3 months before&#xD;
               enrollment, respectively.&#xD;
  &#xD;
            3. Patients who suffered from progressive disease, autoimmune, tumor diseases or other&#xD;
               diseases adjudged by the investigator to be inappropriate for inclusion into the&#xD;
               study.&#xD;
  &#xD;
            4. Other conditions adjudged by the investigator to be inappropriate for inclusion into&#xD;
               the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Xinghua Gao, PhD</last_name>
      <phone>+86 13940152467</phone>
      <email>gaobarry@hotmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>The First Affiliated Hospital of China Medical University</name>
        <address>
          <city>Shenyang</city>
          <state>Liaoning</state>
          <zip>110001</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rui qun Qi, Doctor</last_name>
        <phone>18204027799</phone>
        <email>xiaoqiliumin@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>First Hospital of China Medical University</investigator_affiliation>
      <investigator_full_name>Gao Xinghua</investigator_full_name>
      <investigator_title>Vice President</investigator_title>
    </responsible_party>
    <keyword>hyperthermia</keyword>
    <keyword>onychomycosis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Onychomycosis</mesh_term>
      <mesh_term>Hyperthermia</mesh_term>
      <mesh_term>Fever</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/NCT06036654
  org study id: HH20230410
  nct id: NCT06036654
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Onychomycosis is a common nail plate infection caused by dermatophytes, non-dermatophytic
        molds, and yeasts. The disease is difficult to achieve self-healing and predisposed to
        secondary bacterial infections. There are currently multiple medications that can be used for
        the treatment of onychomycosis. The limitations are high recurrence rate and high cost,
        time-consuming and drug interactions. Several FDA approved laser devices have been available
        for the treatment of onychomycosis since 2010. As an emerging physical therapy modality,
        laser and light have advantages including extensive applicable range, simple operation, less
        trauma, and it will not lead to generation of new resistant strains. Therefore, it has been
        popularized and applied in clinics, especially among elderly, immunocompromised patients, or
        those with liver and kidney dysfunction. Laser systems in the near-infrared spectrum (780 nm∼
        3,000 nm wavelength), which are commonly used in onychomycosis, exert their effect by direct
        heating of target tissues, but it can cause unbearable physical pain to the patient. Compared
        with laser, controllable infrared bioeffect system has the advantages of high safety, less
        trauma, and less pain. Reported in the literature, it has been observed that regression of
        distant, untreated skin lesions in patients treated locally with controllable infrared
        bioeffect system, especially in inflammatory skin diseases such as viral warts and
        sporotrichosis. The aim of the research is to evaluate the safety and efficacy of
        controllable infrared bioeffect system in treatment of onychomycosis.
  Mild local hyperthermia with a certain temperature range has been successfully used in
        treatment of some diseases. It has been applied in the treatment of some neoplasm, fungal and
        HPV infections. Previous studies regarding viral warts and sporotrichosis found that in
        patients with multiple lesions, the clearance of the target lesion is commonly followed by
        clearance of other distant lesions, a phenomenon suggesting that local hyperthermia could aid
        in establishing a specific immune response to eliminate pathogenic microorganisms.
        Investigators speculate that mild local hyperthermia was a potential treatment for
        onychomycosis. A prospective single arm clinical trial was conducted to evaluate the
        effectiveness and safety of mild local hyperthermia in the treatment of onychomycosis.
        Participants with onychomycosis with at least 2 nails involved were included. The treatment
        effect of the treated and the untreated nail onychomycosis was measured after 6 months and 12
        months of initial treatment.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Local hyperthermia for the Treatment of Onychomycosis
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Cure rate of the target nail
  time frame: 6 months, 9 months and 12 months after the first treatment
  description: Clinical and mycological cure rate of the target nail at 6 months, 9 months and12 months after the first treatment
  measure: Cure rate of non-targeted nail
  time frame: 6 months, 9 months, 12 months after the first treatment
  description: Clinical and mycological cure rate of non-target nail at 6 months, 9 months and12 months after the first treatment
  arm group label: Local Hyperthermia for the Treatment of Onychomycosis
  arm group type: Experimental
  description: (1) In months 0-2, local hyperthermia treatment was given once a week for 20 minutes each time, for a total of 9 times; (2) In months 2-4, at the same target lesion, once every 2 weeks, for a total of 4 times; (3) In months 4-6, once every 4 weeks, for a total of 2 times. The frequency of this course of treatment was 15 times lasting for 6 months, and follow-up ended 12 months from the first treatment.
  intervention type: Device
  intervention name: infrared thermotherapy instrument
  description: Only a single target nail was chosen among multiple onychomycosis to receive local hyperthermia treatment.
  arm group label: Local Hyperthermia for the Treatment of Onychomycosis
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Xinghua Gao, PhD
  phone: +86 13940152467
  email: gaobarry@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: First Hospital of China Medical University
  investigator full name: Gao Xinghua
  investigator title: Vice President
  mesh term: Onychomycosis
  mesh term: Hyperthermia
  mesh term: Fever
  sharing ipd: No