<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/NCT02244554</url>
  </required_header>
  <id_info>
    <org_study_id>C-14-TPS05</org_study_id>
    <nct_id>NCT02244554</nct_id>
  </id_info>
  <brief_title>Comparison Study of Picosecond and Nanosecond Pulse Durations Using a Q-switched Nd:YAG Laser for Tattoo Removal</brief_title>
  <official_title>Prospective, Open-Label Comparison Study of Picosecond and Nanosecond Pulse Durations Using a Q-switched Nd:YAG 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and efficacy of laser tattoo removal with&#xD;
      picosecond pulse durations as compared to treatment with nanosecond pulse durations using a&#xD;
      single novel Q-Switched (QS) Nd:YAG laser.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, split-tattoo, open-label, single-center study of up to 25 subjects with&#xD;
      tattoos containing black or dark blue ink, alone or in combination with other colors. It will&#xD;
      compare the safety and efficacy of nanosecond and picosecond pulse durations with the Cutera&#xD;
      Picosecond Q-Switched Nd:YAG laser for tattoo removal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Level of Tattoo Clearing at 12 Weeks for Each Treatment Arm as Assessed by the Blinded Reviewers.</measure>
    <time_frame>12 weeks</time_frame>
    <description>Physician's Global Assessment (min=0; Max=4) Higher scores indicate better outcomes</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Tattoo Removal</condition>
  <arm_group>
    <arm_group_label>enLighten Laser Picosecond Pulse</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Picosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) laser treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>enLighten Laser Nanosecond Pulse</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nanosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) laser treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>enLighten Laser</intervention_name>
    <description>Picosecond pulse-duration or Nanosecond pulse-duration tattoo treatment with enLighten Q-switched Laser Treatment</description>
    <arm_group_label>enLighten Laser Nanosecond Pulse</arm_group_label>
    <arm_group_label>enLighten Laser Picosecond Pulse</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females or Males, 18 to 55 years of age (inclusive).&#xD;
&#xD;
          -  Fitzpatrick Skin Type I - VI.&#xD;
&#xD;
          -  Tattoos containing black/blue ink alone or in combination with other colors. No&#xD;
             tribal, scarred, high-ink density, or highly colorful tattoos.&#xD;
&#xD;
          -  Target tattoos older than 1 year.&#xD;
&#xD;
          -  Must be able to read, understand and sign the Informed Consent Form.&#xD;
&#xD;
          -  Must be willing and able to adhere to the treatment and follow-up schedule and&#xD;
             post-treatment care instructions.&#xD;
&#xD;
          -  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;
          -  Willing to use hydroquinone approximately 4 weeks pre-treatment and post-treatment if&#xD;
             required by Investigator.&#xD;
&#xD;
          -  Willingness to have digital photographs taken of the treated area.&#xD;
&#xD;
          -  Agree not to undergo any other procedure(s) for the tattoo removal during the study.&#xD;
&#xD;
          -  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.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in a study of another device or drug within 6 months prior to enrollment&#xD;
             or during the study.&#xD;
&#xD;
          -  History of allergic reaction to pigments following tattooing.&#xD;
&#xD;
          -  Presence of double tattoo in the treatment area or presence of tribal, scarred,&#xD;
             high-ink density, or highly colorful single tattoos.&#xD;
&#xD;
          -  History of allergy to local anesthetics.&#xD;
&#xD;
          -  History of allergy to topical antibiotics.&#xD;
&#xD;
          -  History of malignant tumors in the target area.&#xD;
&#xD;
          -  Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large&#xD;
             moles.&#xD;
&#xD;
          -  Pregnant and/or breastfeeding.&#xD;
&#xD;
          -  Having an infection, dermatitis or a rash in the treatment area.&#xD;
&#xD;
          -  Significant concurrent illness, such as diabetes mellitus or cardiovascular disease,&#xD;
             e.g., uncontrolled hypertension.&#xD;
&#xD;
          -  Suffering from coagulation disorders or taking prescription anticoagulation&#xD;
             medications.&#xD;
&#xD;
          -  History of keloid scarring, hypertrophic scarring or of abnormal wound healing.&#xD;
&#xD;
          -  History of immunosuppression/immune deficiency disorders or currently using&#xD;
             immunosuppressive medications.&#xD;
&#xD;
          -  History of vitiligo, eczema, or psoriasis.&#xD;
&#xD;
          -  History of connective tissue disease, such as systemic lupus erythematosus or&#xD;
             scleroderma.&#xD;
&#xD;
          -  History of seizure disorders due to light.&#xD;
&#xD;
          -  Any use of medication that is known to increase sensitivity to light according to the&#xD;
             Investigator's discretion.&#xD;
&#xD;
          -  History of herpes simplex and/or herpes zoster (shingles).&#xD;
&#xD;
          -  History of radiation to the treatment area or undergoing systemic chemotherapy for the&#xD;
             treatment of cancer.&#xD;
&#xD;
          -  History of pigmentary disorders, particularly tendency for hyper- or&#xD;
             hypo-pigmentation.&#xD;
&#xD;
          -  Systemic use of corticosteroid within 12 months of study participation.&#xD;
&#xD;
          -  Use of oral isotretinoin within 12 months of study participation and topical use of&#xD;
             isotretinoin within 6 months on the treated area.&#xD;
&#xD;
          -  Anytime in life, having have used gold therapy (gold salts) for disorders such as&#xD;
             rheumatologic disease or lupus.&#xD;
&#xD;
          -  Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning&#xD;
             during the study.&#xD;
&#xD;
          -  Current smoker or history of smoking within 6 months of study participation.&#xD;
&#xD;
          -  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;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>E. Victor Ross, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Scripps Clinic Carmel Valley</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Scripps Clinic Carmel Valley</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <results_first_submitted>January 24, 2023</results_first_submitted>
  <results_first_submitted_qc>January 26, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 21, 2023</results_first_posted>
  <last_update_submitted>January 26, 2023</last_update_submitted>
  <last_update_submitted_qc>January 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>tattoo removal</keyword>
  <keyword>Q-switched laser</keyword>
  <keyword>Nd:YAG laser</keyword>
  <keyword>nanosecond laser</keyword>
  <keyword>picosecond laser</keyword>
  <keyword>laser therapy</keyword>
  <keyword>tattoo</keyword>
  <keyword>pulsed-laser</keyword>
  <keyword>laser treatment</keyword>
  <keyword>remove tattoo</keyword>
  <keyword>tattoo clearing</keyword>
  <keyword>tattoo lightening</keyword>
  <keyword>tattoo lighten</keyword>
  <keyword>resistant tattoo</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>All Study Participants</title>
          <description>Subject tattoos were divided into 2 sides for assignment into 2 arms for treatment by the Picosecond and Nanosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) : active control arm and treatment arm. One side will receive treatment with the picosecond pulse duration and one side will receive treatment with the nanosecond pulse duration.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treatment With Picosecond Pulse Duration</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treatment With Nanosecond Pulse Duration</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </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>All Enrolled Subjects All Enrolled Subjects</title>
          <description>Picosecond and Nanosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) laser treatment</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Level of Tattoo Clearing at 12 Weeks for Each Treatment Arm as Assessed by the Blinded Reviewers.</title>
        <description>Physician's Global Assessment (min=0; Max=4) Higher scores indicate better outcomes</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>enLighten Laser Picosecond Pulse</title>
            <description>Picosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) laser treatment&#xD;
enLighten Laser: Picosecond pulse-duration pulse-duration tattoo treatment with enLighten Q-switched Laser Treatment</description>
          </group>
          <group group_id="O2">
            <title>enLighten Laser Nanosecond Pulse</title>
            <description>Nanosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) laser treatment&#xD;
enLighten Laser: Nanosecond pulse-duration tattoo treatment with enLighten Q-switched Laser Treatment</description>
          </group>
        </group_list>
        <measure>
          <title>Level of Tattoo Clearing at 12 Weeks for Each Treatment Arm as Assessed by the Blinded Reviewers.</title>
          <description>Physician's Global Assessment (min=0; Max=4) 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="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" spread=".94"/>
                    <measurement group_id="O2" value="3" spread=".82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>enLighten Laser Picosecond Pulse</title>
          <description>Picosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) laser treatment&#xD;
enLighten Laser: Picosecond pulse-duration or Nanosecond pulse-duration tattoo treatment with enLighten Q-switched Laser Treatment</description>
        </group>
        <group group_id="E2">
          <title>enLighten Laser Nanosecond Pulse</title>
          <description>Nanosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) laser treatment&#xD;
enLighten Laser: Picosecond pulse-duration or Nanosecond pulse-duration tattoo treatment with enLighten Q-switched Laser Treatment</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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </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="10" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="10"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Edema</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Purpura</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="5" 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>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/NCT02244554
org study id: C-14-TPS05
nct id: NCT02244554
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the safety and efficacy of laser tattoo removal with
      picosecond pulse durations as compared to treatment with nanosecond pulse durations using a
      single novel Q-Switched (QS) Nd:YAG laser.
This is a randomized, split-tattoo, open-label, single-center study of up to 25 subjects with
      tattoos containing black or dark blue ink, alone or in combination with other colors. It will
      compare the safety and efficacy of nanosecond and picosecond pulse durations with the Cutera
      Picosecond Q-Switched Nd:YAG laser for tattoo removal.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Level of Tattoo Clearing at 12 Weeks for Each Treatment Arm as Assessed by the Blinded Reviewers.
time frame: 12 weeks
description: Physician's Global Assessment (min=0; Max=4) Higher scores indicate better outcomes
arm group label: enLighten Laser Picosecond Pulse
arm group type: Experimental
description: Picosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) laser treatment
arm group label: enLighten Laser Nanosecond Pulse
arm group type: Experimental
description: Nanosecond Pulse-duration with enLighten Q-switched Nd:YAG (1064 nm and 532 nm) laser treatment
intervention type: Device
intervention name: enLighten Laser
description: Picosecond pulse-duration or Nanosecond pulse-duration tattoo treatment with enLighten Q-switched Laser Treatment
arm group label: enLighten Laser Nanosecond Pulse
arm group label: enLighten Laser Picosecond Pulse
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: E. Victor Ross, MD
role: Principal Investigator
affiliation: Scripps Clinic Carmel Valley
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 