<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/NCT03290547</url>
  </required_header>
  <id_info>
    <org_study_id>C-15-EN10</org_study_id>
    <nct_id>NCT03290547</nct_id>
  </id_info>
  <brief_title>Pilot Study of Multi-wavelength Laser for Tattoo Removal</brief_title>
  <official_title>A Multi-Center Pilot Study of a Novel Multi-Wavelength Laser for Tattoo Removal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cutera Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cutera Inc.</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety and efficacy of an investigational version of the Cutera enLighten&#xD;
      laser that offers muliple wavelengths for tattoo removal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently, the enLighten laser offers two wavelengths: 532nm and 1064nm. The version of the&#xD;
      laser under investigation allows the user to choose a wavelength between 640nm to 800nm.&#xD;
&#xD;
      This is a multi-center prospective, open-label, uncontrolled pilot study in up to 75 male or&#xD;
      female subjects, age 18 to 65 years, who desire laser removal of a tattoo containing single&#xD;
      or multi-color ink. Subjects will receive laser treatments and will be followed at 6 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 8, 2015</start_date>
  <completion_date type="Actual">November 29, 2017</completion_date>
  <primary_completion_date type="Actual">November 29, 2017</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>Degree of Tattoo Clearing at 6 Weeks Post-final Treatment as Assessed by the Investigator</measure>
    <time_frame>6 weeks post-final treatment</time_frame>
    <description>Degree of tattoo clearing using the GAIS (Global Assessment of Improvement Scale) 3 = Very Significant Improvement, 2 = Significant Improvement, 1 = Moderate Improvement, or 0 = Mild or No Improvement Higher scores indicate better outcomes</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Tattoo Removal</condition>
  <arm_group>
    <arm_group_label>arm-1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Cutera enLighten laser treatments that allows the user to choose a wavelength between 640nm to 800nm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cutera enLighten laser</intervention_name>
    <description>Subjects will receive laser treatments.</description>
    <arm_group_label>arm-1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Female or Male, 18 to 65 years of age (inclusive).&#xD;
&#xD;
          2. Fitzpatrick Skin Type I - VI (Appendix 3).&#xD;
&#xD;
          3. Target tattoo contains single or multi-color ink.&#xD;
&#xD;
          4. Subject must be able to read, understand and sign the Informed Consent Form.&#xD;
&#xD;
          5. Must be willing and able to adhere to the treatment and follow-up schedule and&#xD;
             post-treatment care instructions.&#xD;
&#xD;
          6. Wiling to cover tattoos with a bandage or clothing; and/or have very limited sun&#xD;
             exposure and use an approved sunscreen of SPF 50 or higher on the treated area&#xD;
             starting 2 to 4 weeks before the treatment and/or every day for the duration of the&#xD;
             study, including the follow-up period.&#xD;
&#xD;
          7. Willing to have digital photographs taken of the treatment area and agree to use of&#xD;
             photographs for presentation, educational or marketing purposes.&#xD;
&#xD;
          8. Agree to not undergo any other procedure(s) for tattoo removal during the study (as&#xD;
             applicable).&#xD;
&#xD;
          9. Post-menopausal or surgically sterilized, or using a medically acceptable form of&#xD;
             birth control at least 3 months prior to enrollment and during the entire course of&#xD;
             the study, and no plans to become pregnant for the duration of the study.&#xD;
&#xD;
             -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participation in a clinical trial of a drug or another device in the target area&#xD;
             during the study..&#xD;
&#xD;
          2. Target tattoo contains only black ink.&#xD;
&#xD;
          3. History of allergic reaction to pigments following tattooing..&#xD;
&#xD;
          4. History of allergy to local anesthetics.&#xD;
&#xD;
          5. History of allergy to topical antibiotics.&#xD;
&#xD;
          6. History of malignant tumors in the target area.&#xD;
&#xD;
          7. Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large&#xD;
             moles.&#xD;
&#xD;
          8. Pregnant and/or breastfeeding.&#xD;
&#xD;
          9. Having an infection, dermatitis or a rash in the treatment area.&#xD;
&#xD;
         10. Significant concurrent illness, such as diabetes mellitus or cardiovascular disease,&#xD;
             e.g., uncontrolled hypertension.&#xD;
&#xD;
         11. Suffering from coagulation disorders or taking prescription anticoagulation&#xD;
             medications.&#xD;
&#xD;
         12. History of keloid scarring, hypertrophic scarring or of abnormal wound healing.&#xD;
&#xD;
         13. History of immunosuppression/immune deficiency disorders or currently using&#xD;
             immunosuppressive medications.&#xD;
&#xD;
         14. History of vitiligo, eczema, or psoriasis.&#xD;
&#xD;
         15. History of connective tissue disease, such as systemic lupus erythematosus or&#xD;
             scleroderma.&#xD;
&#xD;
         16. History of seizure disorders due to light.&#xD;
&#xD;
         17. Any use of medication that is known to increase sensitivity to light according to&#xD;
             Investigator's discretion.&#xD;
&#xD;
         18. History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes&#xD;
             zoster (shingles) in the treatment area, unless treatment is conducted following a&#xD;
             prophylactic regimen.&#xD;
&#xD;
         19. History of radiation to the treatment area or undergoing systemic chemotherapy for the&#xD;
             treatment of cancer.&#xD;
&#xD;
         20. History of pigmentary disorders, particularly tendency for hyper- or&#xD;
             hypo-pigmentation.&#xD;
&#xD;
         21. Systemic use of corticosteroid or isotretinoin within 6 months of study participation.&#xD;
&#xD;
         22. Anytime in life, having have used gold therapy (gold salts) for disorders such as&#xD;
             rheumatologic disease or lupus.&#xD;
&#xD;
         23. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning&#xD;
             during the study.&#xD;
&#xD;
         24. Current smoker or history of smoking within 6 months of study participation.&#xD;
&#xD;
         25. As per the Investigator's discretion, any physical or mental condition which might&#xD;
             make it unsafe for the subject to participate in this study.&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen Ronan, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cutera Research Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeffrey Dover, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Skin Care Physicians</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cutera Research Center</name>
      <address>
        <city>Brisbane</city>
        <state>California</state>
        <zip>94005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skin Care Physicians</name>
      <address>
        <city>Chestnut Hill</city>
        <state>Massachusetts</state>
        <zip>02467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <results_first_submitted>August 21, 2023</results_first_submitted>
  <results_first_submitted_qc>September 12, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">September 15, 2023</results_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 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 25, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/47/NCT03290547/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cutera enLighten Laser</title>
          <description>Cutera enLighten laser treatments that allows the user to choose a wavelength between 640nm to 800nm.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Enrolled Subjects</title>
          <description>Cutera enLighten laser treatments that allows the user to choose a wavelength between 640nm to 800nm.&#xD;
Cutera enLighten laser: Subjects will receive up to 10 laser treatments.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="22"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Degree of Tattoo Clearing at 6 Weeks Post-final Treatment as Assessed by the Investigator</title>
        <description>Degree of tattoo clearing using the GAIS (Global Assessment of Improvement Scale) 3 = Very Significant Improvement, 2 = Significant Improvement, 1 = Moderate Improvement, or 0 = Mild or No Improvement Higher scores indicate better outcomes</description>
        <time_frame>6 weeks post-final treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cutera enLighten Laser</title>
            <description>Cutera enLighten laser treatments that allows the user to choose a wavelength between 640nm to 800nm.</description>
          </group>
        </group_list>
        <measure>
          <title>Degree of Tattoo Clearing at 6 Weeks Post-final Treatment as Assessed by the Investigator</title>
          <description>Degree of tattoo clearing using the GAIS (Global Assessment of Improvement Scale) 3 = Very Significant Improvement, 2 = Significant Improvement, 1 = Moderate Improvement, or 0 = Mild or No Improvement Higher scores indicate better outcomes</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks post final treatment, up to 15 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>All Enrolled Subjects</title>
          <description>Cutera enLighten laser treatments that allows the user to choose a wavelength between 640nm to 800nm.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Edema</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Frosting</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="22"/>
              </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>Margot Doucette</name_or_title>
      <organization>Cutera</organization>
      <phone>415-657-5518</phone>
      <email>mdoucette@cutera.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/NCT03290547
org study id: C-15-EN10
nct id: NCT03290547
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
To evaluate the safety and efficacy of an investigational version of the Cutera enLighten
      laser that offers muliple wavelengths for tattoo removal.
Currently, the enLighten laser offers two wavelengths: 532nm and 1064nm. The version of the
      laser under investigation allows the user to choose a wavelength between 640nm to 800nm.

      This is a multi-center prospective, open-label, uncontrolled pilot study in up to 75 male or
      female subjects, age 18 to 65 years, who desire laser removal of a tattoo containing single
      or multi-color ink. Subjects will receive laser treatments and will be followed at 6 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Degree of Tattoo Clearing at 6 Weeks Post-final Treatment as Assessed by the Investigator
time frame: 6 weeks post-final treatment
description: Degree of tattoo clearing using the GAIS (Global Assessment of Improvement Scale) 3 = Very Significant Improvement, 2 = Significant Improvement, 1 = Moderate Improvement, or 0 = Mild or No Improvement Higher scores indicate better outcomes
arm group label: arm-1
arm group type: Other
description: Cutera enLighten laser treatments that allows the user to choose a wavelength between 640nm to 800nm.
intervention type: Device
intervention name: Cutera enLighten laser
description: Subjects will receive laser treatments.
arm group label: arm-1
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stephen Ronan, M.D.
role: Principal Investigator
affiliation: Cutera Research Center
last name: Jeffrey Dover, M.D.
role: Principal Investigator
affiliation: Skin Care Physicians
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 