<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/NCT01666002</url>
  </required_header>
  <id_info>
    <org_study_id>Onycho-2012</org_study_id>
    <nct_id>NCT01666002</nct_id>
  </id_info>
  <brief_title>Treatment of Onychomycosis Using a 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser</brief_title>
  <official_title>Treatment of Onychomycosis Using a 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators would like to test the treatment of onychomycosis using a 0.65 millisecond&#xD;
      pulsed 1064 nm laser fitted with a special onychomycosis handpiece. The investigators will&#xD;
      compare the success rates of those receiving laser treatments with untreated patients. This&#xD;
      study will provide a clinical basis for determining the relative effectiveness of an&#xD;
      increasingly utilized treatment method.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Current antifungal treatments have low cure rates and numerous side effects. A new treatment&#xD;
      method, pulsed laser, has been purported to have high rates of treatment in a much shorter&#xD;
      time frame than other treatments. While the treatment method has become increasingly popular,&#xD;
      studies of its efficacy are few. The investigators hope to learn the cure rate of a novel&#xD;
      treatment that is being used by more and more patients. This knowledge will be essential to&#xD;
      physicians as they consider employing this new technology in their treatment methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Primary End Point Was the Percentage of Patients With a Negative Mycological Culture.</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proximal Clearance of Fungus on Nail</measure>
    <time_frame>1 year</time_frame>
    <description>The secondary end point was proximal nail plate clearance as assessed directly by a single study physician, who measured the clinical involvement defined as total length of abnormal nail per each nail of each of the patients' toenails, and confirmed by digital analysis of toenail photographs with ImageJ software.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Onychomycosis</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.&#xD;
nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>st visit: For the control group, no treatment will be given.&#xD;
nd visit: 2 weeks after initial visit, patient will be seen for second visit</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laser Treatment (Pulsed Nd:YAG 1064 nm Laser)</intervention_name>
    <description>0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have Onychomycosis on at least one toe.&#xD;
&#xD;
          -  Age 18 or older.&#xD;
&#xD;
          -  Consent to research use of their toenail clippings.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current immunosuppression (cancer, autoimmune disease) or taking immunosuppressive&#xD;
             drugs.&#xD;
&#xD;
          -  Pregnant female.&#xD;
&#xD;
          -  Age 75 or older.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean Tang, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tyler Hollmig, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Henderson, BA</last_name>
    <role>Study Director</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Hochman LG. Laser treatment of onychomycosis using a novel 0.65-millisecond pulsed Nd:YAG 1064-nm laser. J Cosmet Laser Ther. 2011 Feb;13(1):2-5. doi: 10.3109/14764172.2011.552616. Epub 2011 Jan 21.</citation>
    <PMID>21250792</PMID>
  </reference>
  <reference>
    <citation>Vural E, Winfield HL, Shingleton AW, Horn TD, Shafirstein G. The effects of laser irradiation on Trichophyton rubrum growth. Lasers Med Sci. 2008 Oct;23(4):349-53. doi: 10.1007/s10103-007-0492-4. Epub 2007 Sep 28.</citation>
    <PMID>17902014</PMID>
  </reference>
  <reference>
    <citation>Landsman AS, Robbins AH. Treatment of mild, moderate, and severe onychomycosis using 870- and 930-nm light exposure: some follow-up observations at 270 days. J Am Podiatr Med Assoc. 2012 Mar-Apr;102(2):169-71. doi: 10.7547/1020169.</citation>
    <PMID>22461276</PMID>
  </reference>
  <results_reference>
    <citation>Kimura U, Takeuchi K, Kinoshita A, Takamori K, Hiruma M, Suga Y. Treating onychomycoses of the toenail: clinical efficacy of the sub-millisecond 1,064 nm Nd: YAG laser using a 5 mm spot diameter. J Drugs Dermatol. 2012 Apr;11(4):496-504.</citation>
    <PMID>22453588</PMID>
  </results_reference>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <results_first_submitted>December 16, 2014</results_first_submitted>
  <results_first_submitted_qc>April 21, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 30, 2016</results_first_posted>
  <last_update_submitted>April 21, 2016</last_update_submitted>
  <last_update_submitted_qc>April 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Jean Yuh Tang</investigator_full_name>
    <investigator_title>Assistant Professor of Dermatology</investigator_title>
  </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>
      <recruitment_details>We enrolled adults (18-75 years) with a clinical diagnosis of onychomycosis from the dermatology clinic at Stanford between July and December 2011. The key inclusion criterion was a diagnosis of onychomycosis by clinical toenail morphology confirmed by positive culture.</recruitment_details>
      <pre_assignment_details>Patients were randomized following simple randomization procedures (computerized random number generator) in a 2:1 ratio into laser or control groups.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Treatment</title>
          <description>st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.&#xD;
nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.&#xD;
Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser&#xD;
42 patients were assessed and 27 met eligibility criteria of a diagnosis of onychomycosis by clinical toenail morphology confirmed by positive culture.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>st visit: For the control group, no treatment will be given.&#xD;
nd visit: 2 weeks after initial visit, patient will be seen for second visit</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Sample size calculations (STATA 10, Stat Corp, College Station, TX) indicated that we needed to enroll 24 patients at a 2:1 ratio for 80% power to detect a minimal proximal nail plate difference of 2.5 mm in the 2 groups with a 2-sided alpha of 0.05.</population>
      <group_list>
        <group group_id="B1">
          <title>Treatment</title>
          <description>st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.&#xD;
nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.&#xD;
Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>st visit: For the control group, no treatment will be given.&#xD;
nd visit: 2 weeks after initial visit, patient will be seen for second visit</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="17"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="27"/>
          </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="53" spread="14"/>
                    <measurement group_id="B2" value="65" spread="8"/>
                    <measurement group_id="B3" value="59" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </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="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="22"/>
                  </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>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Primary End Point Was the Percentage of Patients With a Negative Mycological Culture.</title>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.&#xD;
nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.&#xD;
Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser&#xD;
After 3 months, 4 of 12 patients (33%) in the laser group had negative fungal cultures. Of the 4 patients in the laser group with baseline cultures positive for a non-dermatophyte mold, 2 (50%) had negative fungal cultures. After 3 months of observation, 2 of 10 (20%) control subjects had negative cultures. Of the 3 patients in the control group with baseline cultures positive for a non-dermatophyte mold, 1 (33%) had a negative fungal culture. There was no significant difference in the percentage of patients with negative nail cultures between laser versus control groups (P = .49).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>st visit: For the control group, no treatment will be given.&#xD;
nd visit: 2 weeks after initial visit, patient will be seen for second visit</description>
          </group>
        </group_list>
        <measure>
          <title>The Primary End Point Was the Percentage of Patients With a Negative Mycological Culture.</title>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proximal Clearance of Fungus on Nail</title>
        <description>The secondary end point was proximal nail plate clearance as assessed directly by a single study physician, who measured the clinical involvement defined as total length of abnormal nail per each nail of each of the patients' toenails, and confirmed by digital analysis of toenail photographs with ImageJ software.</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment</title>
            <description>st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.&#xD;
nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.&#xD;
Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>st visit: For the control group, no treatment will be given.&#xD;
nd visit: 2 weeks after initial visit, patient will be seen for second visit</description>
          </group>
        </group_list>
        <measure>
          <title>Proximal Clearance of Fungus on Nail</title>
          <description>The secondary end point was proximal nail plate clearance as assessed directly by a single study physician, who measured the clinical involvement defined as total length of abnormal nail per each nail of each of the patients' toenails, and confirmed by digital analysis of toenail photographs with ImageJ software.</description>
          <units>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="10"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>nails</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.44" spread="1.1"/>
                    <measurement group_id="O2" value="0.15" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Treatment</title>
          <description>st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.&#xD;
nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.&#xD;
Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser&#xD;
No patients reported complications or adverse events after 2 sessions.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>st visit: For the control group, no treatment will be given.&#xD;
nd visit: 2 weeks after initial visit, patient will be seen for second visit</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="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </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="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </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>Jean Tang MD PhD, assistant professor</name_or_title>
      <organization>Stanford University</organization>
      <phone>650-723-6316</phone>
      <email>tangy@stanford.edu</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/NCT01666002
org study id: Onycho-2012
nct id: NCT01666002
lead sponsor: 
has dmc: No
The investigators would like to test the treatment of onychomycosis using a 0.65 millisecond
      pulsed 1064 nm laser fitted with a special onychomycosis handpiece. The investigators will
      compare the success rates of those receiving laser treatments with untreated patients. This
      study will provide a clinical basis for determining the relative effectiveness of an
      increasingly utilized treatment method.
Current antifungal treatments have low cure rates and numerous side effects. A new treatment
      method, pulsed laser, has been purported to have high rates of treatment in a much shorter
      time frame than other treatments. While the treatment method has become increasingly popular,
      studies of its efficacy are few. The investigators hope to learn the cure rate of a novel
      treatment that is being used by more and more patients. This knowledge will be essential to
      physicians as they consider employing this new technology in their treatment methods.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The Primary End Point Was the Percentage of Patients With a Negative Mycological Culture.
time frame: 1 year
measure: Proximal Clearance of Fungus on Nail
time frame: 1 year
description: The secondary end point was proximal nail plate clearance as assessed directly by a single study physician, who measured the clinical involvement defined as total length of abnormal nail per each nail of each of the patients' toenails, and confirmed by digital analysis of toenail photographs with ImageJ software.
arm group label: Treatment
arm group type: Experimental
description: st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.
nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.
arm group label: Placebo
arm group type: No Intervention
description: st visit: For the control group, no treatment will be given.
nd visit: 2 weeks after initial visit, patient will be seen for second visit
intervention type: Device
intervention name: Laser Treatment (Pulsed Nd:YAG 1064 nm Laser)
description: 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jean Tang, MD, PhD
role: Principal Investigator
affiliation: Stanford University
last name: Tyler Hollmig, MD
role: Study Chair
affiliation: Stanford University
last name: Michael Henderson, BA
role: Study Director
affiliation: Stanford University
facility: 
country: United States
citation: Hochman LG. Laser treatment of onychomycosis using a novel 0.65-millisecond pulsed Nd:YAG 1064-nm laser. J Cosmet Laser Ther. 2011 Feb;13(1):2-5. doi: 10.3109/14764172.2011.552616. Epub 2011 Jan 21.
PMID: 21250792
citation: Vural E, Winfield HL, Shingleton AW, Horn TD, Shafirstein G. The effects of laser irradiation on Trichophyton rubrum growth. Lasers Med Sci. 2008 Oct;23(4):349-53. doi: 10.1007/s10103-007-0492-4. Epub 2007 Sep 28.
PMID: 17902014
citation: Landsman AS, Robbins AH. Treatment of mild, moderate, and severe onychomycosis using 870- and 930-nm light exposure: some follow-up observations at 270 days. J Am Podiatr Med Assoc. 2012 Mar-Apr;102(2):169-71. doi: 10.7547/1020169.
PMID: 22461276
citation: Kimura U, Takeuchi K, Kinoshita A, Takamori K, Hiruma M, Suga Y. Treating onychomycoses of the toenail: clinical efficacy of the sub-millisecond 1,064 nm Nd: YAG laser using a 5 mm spot diameter. J Drugs Dermatol. 2012 Apr;11(4):496-504.
PMID: 22453588
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Jean Yuh Tang
investigator title: Assistant Professor of Dermatology
mesh term: Onychomycosis
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 