<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/NCT02242019</url>
  </required_header>
  <id_info>
    <org_study_id>EC_TFRS_004</org_study_id>
    <nct_id>NCT02242019</nct_id>
  </id_info>
  <brief_title>Study of Erchonia Low Level Laser Light Therapy to Treat Toenail Fungus</brief_title>
  <official_title>An Evaluation of the Effect of the Erchonia LUNULA on Treating 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether low level laser light therapy is effective&#xD;
      in the treatment of toenail onychomycosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An infection of toenail fungus, or onychomycosis, typically occurs when fungi (most commonly&#xD;
      dermatophytes) infect the nail, but may also be caused by yeasts and molds. The nail fungal&#xD;
      infection usually begins as a white or yellow spot under the tip of the toenail and then&#xD;
      spreads deeper into the nail causing discoloration, thickening and the development of&#xD;
      crumbling edges to the nail which can be unsightly and painful and may produce serious&#xD;
      physical and occupational limitations. Onychomycosis can also have a detrimental effect on an&#xD;
      individual's quality of life, affecting their psychosocial and emotional wellbeing.&#xD;
&#xD;
      Onychomycosis can be difficult to treat, and infections recur easily. Toenail fungus affects&#xD;
      approximately 23 million adults (about 10%) in the United States. It is more common among&#xD;
      older adults and tends to affect men more than women. Potential complications of&#xD;
      onychomycosis include pain, permanent damage to the nails and serious infections that can&#xD;
      spread beyond the feet.&#xD;
&#xD;
      Currently available treatments for onychomycosis include oral antifungal medications&#xD;
      (Lamisil, Sporanox); antifungal nail polish (Penlac); topical over-the-counter antifungal&#xD;
      creams; photodynamic therapy and in more severe cases, surgery to remove the nail. However,&#xD;
      there is no perfect cure for toenail fungus. Even the most effective oral medications are&#xD;
      only successful about half of the time, and topical medications are successful less than 10%&#xD;
      of the time. In addition, clearance of the infection and growth of new clear nail can be&#xD;
      slow, and the rate of recurrence of infection is high. Antifungal drugs may also cause side&#xD;
      effects ranging from skin rashes to liver damage.&#xD;
&#xD;
      Therefore, the need for a more effective and lasting cure is evident. Recently, research has&#xD;
      found laser therapy to show promise as a novel alternative treatment for toenail&#xD;
      onychomycosis. Unlike medication-driven treatments, laser therapy presents minimal risk of&#xD;
      side effects. Laser therapy is applied to toenail onychomycosis by shining a laser light&#xD;
      through the toenail. The laser light vaporizes the fungus while leaving the skin and&#xD;
      surrounding tissue unharmed.&#xD;
&#xD;
      Low level laser light therapy operates under the principle of photochemistry with a&#xD;
      photoacceptor molecule absorbing the emitted photons and inducing a biological cascade. Like&#xD;
      our eukaryotic cell, fungi contain the highly complex organelle the mitochondria, which is&#xD;
      responsible for the manufacturing of the energy molecule Adenosine triphosphate (ATP). Within&#xD;
      the inner mitochondrial membrane is cytochrome c oxidase, an identified photoacceptor&#xD;
      molecule. It is believed that laser therapy could perhaps provide a means to photo-destroy&#xD;
      the fungi responsible for onychomycosis by inducing the release of highly reactive&#xD;
      superoxides. Moreover, laser therapy has been shown to promote superoxide dismutase (SOD), a&#xD;
      process responsible for the destruction of foreign invaders. Extracellular release of low&#xD;
      levels of mediators associated with SOD can increase the expression of chemokines, cytokines,&#xD;
      and endothelial leukocyte adhesion molecules, amplifying the cascade that elicits the&#xD;
      inflammatory response. The physiologic function of hydrogen peroxide, superoxide anion, and&#xD;
      hydroxyl free radical is to destroy phagocytosed microbes. By enhancing the natural processes&#xD;
      of the immune system and impacting the structural integrity of the fungi strain, it is&#xD;
      believed that laser therapy may provide a means for clinicians to effectively treat&#xD;
      onychomycosis without the onset of any adverse events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</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 Toenails Attaining 3 Millimeters (mm) or More of Clear Nail Growth</measure>
    <time_frame>Baseline and 36 Weeks</time_frame>
    <description>Individual toenail success criteria was defined as 3 millimeter (mm) or more of clear nail growth at 36 weeks post-procedure administration as evaluated relative to baseline. Overall study success criteria was defined as an 60% or more of treated toenails meeting the individual success criteria.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Millimeters (mm) of Clear Nail Bed</measure>
    <time_frame>Baseline and 36 Weeks</time_frame>
    <description>Millimeter (mm) of clear nail from the base of the toenail was determined from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 36 weeks after the end of the procedure administration phase. An increase in mm of clear nail between the two measurement points indicates that the toenail has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail has worsened and is negative for study success.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Percent (%) of Onychomycosis Disease Involvement</measure>
    <time_frame>Baseline and 36 Weeks</time_frame>
    <description>The percent (%) of the toenail that had onychomycosis disease involvement was determined. Change in the % of toenail onychomycosis disease involvement was calculated as the difference in the % of toenail onychomycosis disease involvement from baseline measurement to the measurement at 36 weeks after the end of the procedure administration phase. A decrease in the % of toenail onychomycosis disease involvement between the two measurement points indicates that the toenail onychomycosis involvement has decreased and is positive for study success. An increase in the % of toenail onychomycosis disease involvement between the two measurement points indicates that the toenail onychomycosis involvement has increased and is negative for study success.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">109</enrollment>
  <condition>Onychomycosis</condition>
  <arm_group>
    <arm_group_label>Erchonia LUNULA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Erchonia LUNULA</intervention_name>
    <description>The Erchonia LUNULA is administered to the infected toes for 12 minutes per treatment for 4 treatments, each treatment one week apart.</description>
    <arm_group_label>Erchonia LUNULA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Onychomycosis present in at least one great toenail, identified as current&#xD;
             bacterial/fungal infection classified by the investigator as onychomycosis, with the&#xD;
             nail presenting positive on visual inspection for somewhat thickened nail plate with a&#xD;
             cloudy appearance and some discoloration (white to yellow to brown).&#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;
        Exclusion Criteria:&#xD;
&#xD;
          -  Spikes of disease extending to nail matrix in the affected great toenail(s).&#xD;
&#xD;
          -  Infection involving lunula of the affected toenail(s), e.g., genetic nail disorders,&#xD;
             primentary disorders.&#xD;
&#xD;
          -  Affected great toenail(s) has less than 2mm clear (unaffected) nail plate length&#xD;
             beyond the proximal fold.&#xD;
&#xD;
          -  Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic&#xD;
             keratin between the nail plate and nail bed) on the affected great toenail(s).&#xD;
&#xD;
          -  Chronic plantar (moccasin) tinea pedis.&#xD;
&#xD;
          -  History of current or past psoriasis of the skin and/or nails.&#xD;
&#xD;
          -  Concurrent lichen planus.&#xD;
&#xD;
          -  Onychogryphosis.&#xD;
&#xD;
          -  Any of the following conditions of the affected great toenail(s) is present: proximal&#xD;
             subungual onychomycosis; white superficial onychomycosis; dermatophytoma or &quot;yellow&#xD;
             spike/streak&quot;; exclusively lateral disease&#xD;
&#xD;
          -  Confounding problems/abnormalities of the great toenail(s).&#xD;
&#xD;
          -  Any abnormality of the affected great toenail(s) that could prevent a normal appearing&#xD;
             nail if clearing of infection is achieved.&#xD;
&#xD;
          -  Inability for the affected great toenail(s) to become normal in the opinion of the&#xD;
             investigator.&#xD;
&#xD;
          -  History of multiple repeated failures with previous therapies for onychomycosis.&#xD;
&#xD;
          -  Trauma to the affected great toenail(s).&#xD;
&#xD;
          -  Use of oral antifungal agents in the past 6 months.&#xD;
&#xD;
          -  Use of topical antifungal agents in the past 1 month.&#xD;
&#xD;
          -  Prior surgical treatment of the affected great toe(s).&#xD;
&#xD;
          -  Subject is unwilling or unable to refrain from employing other (non-study) treatments&#xD;
             (traditional and alternative) for his or her toenail onychomycosis throughout study&#xD;
             participation.&#xD;
&#xD;
          -  Subject is unwilling or unable to refrain from the use of nail cosmetics such as clear&#xD;
             and/or colored nail lacquers until the end of study participation.&#xD;
&#xD;
          -  Cancer and/or treatment of any type of cancer within the last six months.&#xD;
&#xD;
          -  Peripheral vascular disease or peripheral circulatory impairment.&#xD;
&#xD;
          -  History of uncontrolled diabetes mellitus.&#xD;
&#xD;
          -  Known immunodeficiency.&#xD;
&#xD;
          -  Known sensitivity, or contraindication, to light therapy.&#xD;
&#xD;
          -  Pregnant, breast feeding, or planning pregnancy prior to the end of study&#xD;
             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>Robert Sullivan, Podiatry</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>Midleton Foot Clinical</name>
      <address>
        <city>Midleton</city>
        <state>Co. Cork</state>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <results_first_submitted>July 8, 2015</results_first_submitted>
  <results_first_submitted_qc>July 12, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 10, 2015</results_first_posted>
  <last_update_submitted>April 16, 2016</last_update_submitted>
  <last_update_submitted_qc>April 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 17, 2016</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>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Erchonia LUNULA</title>
          <description>The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="109"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="109"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Erchonia LUNULA</title>
          <description>The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="109"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43.89" spread="10.74"/>
                  </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="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                  </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="109"/>
                  </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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Ireland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of toenail onychomycosis Involvement</title>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.99" spread="18.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Percent Toenail Onychomycosis Disease Involvement</title>
          <units>percentage of toenail</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.21" spread="23.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Millimeter (mm) of Clear Nail From the Lunula</title>
          <units>millimeters (mm)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.90" spread="4.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Toenails Attaining 3 Millimeters (mm) or More of Clear Nail Growth</title>
        <description>Individual toenail success criteria was defined as 3 millimeter (mm) or more of clear nail growth at 36 weeks post-procedure administration as evaluated relative to baseline. Overall study success criteria was defined as an 60% or more of treated toenails meeting the individual success criteria.</description>
        <time_frame>Baseline and 36 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Erchonia LUNULA</title>
            <description>The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Toenails Attaining 3 Millimeters (mm) or More of Clear Nail Growth</title>
          <description>Individual toenail success criteria was defined as 3 millimeter (mm) or more of clear nail growth at 36 weeks post-procedure administration as evaluated relative to baseline. Overall study success criteria was defined as an 60% or more of treated toenails meeting the individual success criteria.</description>
          <units>toenails</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>toenails</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="139"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Percent (%) of Onychomycosis Disease Involvement</title>
        <description>The percent (%) of the toenail that had onychomycosis disease involvement was determined. Change in the % of toenail onychomycosis disease involvement was calculated as the difference in the % of toenail onychomycosis disease involvement from baseline measurement to the measurement at 36 weeks after the end of the procedure administration phase. A decrease in the % of toenail onychomycosis disease involvement between the two measurement points indicates that the toenail onychomycosis involvement has decreased and is positive for study success. An increase in the % of toenail onychomycosis disease involvement between the two measurement points indicates that the toenail onychomycosis involvement has increased and is negative for study success.</description>
        <time_frame>Baseline and 36 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Erchonia LUNULA</title>
            <description>The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Percent (%) of Onychomycosis Disease Involvement</title>
          <description>The percent (%) of the toenail that had onychomycosis disease involvement was determined. Change in the % of toenail onychomycosis disease involvement was calculated as the difference in the % of toenail onychomycosis disease involvement from baseline measurement to the measurement at 36 weeks after the end of the procedure administration phase. A decrease in the % of toenail onychomycosis disease involvement between the two measurement points indicates that the toenail onychomycosis involvement has decreased and is positive for study success. An increase in the % of toenail onychomycosis disease involvement between the two measurement points indicates that the toenail onychomycosis involvement has increased and is negative for study success.</description>
          <units>percentage of disease involvement</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>toenails</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="139"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.76" spread="21.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Millimeters (mm) of Clear Nail Bed</title>
        <description>Millimeter (mm) of clear nail from the base of the toenail was determined from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 36 weeks after the end of the procedure administration phase. An increase in mm of clear nail between the two measurement points indicates that the toenail has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail has worsened and is negative for study success.</description>
        <time_frame>Baseline and 36 Weeks</time_frame>
        <population>Some subjects had multiple toenails with onychomycosis disease involvement that were treated and analyzed, resulting in a total of 139 study toenails being analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Erchonia LUNULA</title>
            <description>The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Millimeters (mm) of Clear Nail Bed</title>
          <description>Millimeter (mm) of clear nail from the base of the toenail was determined from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 36 weeks after the end of the procedure administration phase. An increase in mm of clear nail between the two measurement points indicates that the toenail has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail has worsened and is negative for study success.</description>
          <population>Some subjects had multiple toenails with onychomycosis disease involvement that were treated and analyzed, resulting in a total of 139 study toenails being analyzed.</population>
          <units>millimeters (mm)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>toenails</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="139"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.36" spread="4.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Erchonia LUNULA</title>
          <description>The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="109"/>
              </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="109"/>
              </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>Clinical Consultant</name_or_title>
      <organization>Regulatory Insight, Inc.</organization>
      <phone>615-712-9743</phone>
      <email>elvira@reginsight.com</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/NCT02242019
org study id: EC_TFRS_004
nct id: NCT02242019
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether low level laser light therapy is effective
      in the treatment of toenail onychomycosis.
An infection of toenail fungus, or onychomycosis, typically occurs when fungi (most commonly
      dermatophytes) infect the nail, but may also be caused by yeasts and molds. The nail fungal
      infection usually begins as a white or yellow spot under the tip of the toenail and then
      spreads deeper into the nail causing discoloration, thickening and the development of
      crumbling edges to the nail which can be unsightly and painful and may produce serious
      physical and occupational limitations. Onychomycosis can also have a detrimental effect on an
      individual's quality of life, affecting their psychosocial and emotional wellbeing.

      Onychomycosis can be difficult to treat, and infections recur easily. Toenail fungus affects
      approximately 23 million adults (about 10%) in the United States. It is more common among
      older adults and tends to affect men more than women. Potential complications of
      onychomycosis include pain, permanent damage to the nails and serious infections that can
      spread beyond the feet.

      Currently available treatments for onychomycosis include oral antifungal medications
      (Lamisil, Sporanox); antifungal nail polish (Penlac); topical over-the-counter antifungal
      creams; photodynamic therapy and in more severe cases, surgery to remove the nail. However,
      there is no perfect cure for toenail fungus. Even the most effective oral medications are
      only successful about half of the time, and topical medications are successful less than 10%
      of the time. In addition, clearance of the infection and growth of new clear nail can be
      slow, and the rate of recurrence of infection is high. Antifungal drugs may also cause side
      effects ranging from skin rashes to liver damage.

      Therefore, the need for a more effective and lasting cure is evident. Recently, research has
      found laser therapy to show promise as a novel alternative treatment for toenail
      onychomycosis. Unlike medication-driven treatments, laser therapy presents minimal risk of
      side effects. Laser therapy is applied to toenail onychomycosis by shining a laser light
      through the toenail. The laser light vaporizes the fungus while leaving the skin and
      surrounding tissue unharmed.

      Low level laser light therapy operates under the principle of photochemistry with a
      photoacceptor molecule absorbing the emitted photons and inducing a biological cascade. Like
      our eukaryotic cell, fungi contain the highly complex organelle the mitochondria, which is
      responsible for the manufacturing of the energy molecule Adenosine triphosphate (ATP). Within
      the inner mitochondrial membrane is cytochrome c oxidase, an identified photoacceptor
      molecule. It is believed that laser therapy could perhaps provide a means to photo-destroy
      the fungi responsible for onychomycosis by inducing the release of highly reactive
      superoxides. Moreover, laser therapy has been shown to promote superoxide dismutase (SOD), a
      process responsible for the destruction of foreign invaders. Extracellular release of low
      levels of mediators associated with SOD can increase the expression of chemokines, cytokines,
      and endothelial leukocyte adhesion molecules, amplifying the cascade that elicits the
      inflammatory response. The physiologic function of hydrogen peroxide, superoxide anion, and
      hydroxyl free radical is to destroy phagocytosed microbes. By enhancing the natural processes
      of the immune system and impacting the structural integrity of the fungi strain, it is
      believed that laser therapy may provide a means for clinicians to effectively treat
      onychomycosis without the onset of any adverse events.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Toenails Attaining 3 Millimeters (mm) or More of Clear Nail Growth
time frame: Baseline and 36 Weeks
description: Individual toenail success criteria was defined as 3 millimeter (mm) or more of clear nail growth at 36 weeks post-procedure administration as evaluated relative to baseline. Overall study success criteria was defined as an 60% or more of treated toenails meeting the individual success criteria.
measure: Change in Millimeters (mm) of Clear Nail Bed
time frame: Baseline and 36 Weeks
description: Millimeter (mm) of clear nail from the base of the toenail was determined from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 36 weeks after the end of the procedure administration phase. An increase in mm of clear nail between the two measurement points indicates that the toenail has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail has worsened and is negative for study success.
measure: Change in Percent (%) of Onychomycosis Disease Involvement
time frame: Baseline and 36 Weeks
description: The percent (%) of the toenail that had onychomycosis disease involvement was determined. Change in the % of toenail onychomycosis disease involvement was calculated as the difference in the % of toenail onychomycosis disease involvement from baseline measurement to the measurement at 36 weeks after the end of the procedure administration phase. A decrease in the % of toenail onychomycosis disease involvement between the two measurement points indicates that the toenail onychomycosis involvement has decreased and is positive for study success. An increase in the % of toenail onychomycosis disease involvement between the two measurement points indicates that the toenail onychomycosis involvement has increased and is negative for study success.
arm group label: Erchonia LUNULA
arm group type: Experimental
description: The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
intervention type: Device
intervention name: Erchonia LUNULA
description: The Erchonia LUNULA is administered to the infected toes for 12 minutes per treatment for 4 treatments, each treatment one week apart.
arm group label: Erchonia LUNULA
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert Sullivan, Podiatry
role: Principal Investigator
facility: 
country: Ireland
responsible party type: Sponsor
mesh term: Onychomycosis
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 