<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/NCT01689857</url>
  </required_header>
  <id_info>
    <org_study_id>E-1004-048-004</org_study_id>
    <secondary_id>06-2010-049</secondary_id>
    <nct_id>NCT01689857</nct_id>
  </id_info>
  <brief_title>Clinical Trial to Evaluate the Safety and Efficacy of Scarclinic™ Thin in Surgical Scars</brief_title>
  <official_title>Phase 4 Study of Scarclinic™ Thin That Treats Surgical Scars.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Compare the efficacy and safety of Scarclinic™Thin and Scarclinic™ Normal for the treatment&#xD;
      of surgical scars.&#xD;
&#xD;
      Participant: 40 Treatment period : 3 months Medical device: Scarclinic™Thin , Scarclinic™&#xD;
      Normal Randomization: Table of random number&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For evaluating the efficacy&#xD;
&#xD;
        -  The investigator check Vancouver Scar Scale at 1 and 3 month after application to&#xD;
           evaluate vascularity, pigmentation, elasticity, height, pain and itchiness&#xD;
&#xD;
        -  The participant filled out survey included questions regarding convenience in use at 1&#xD;
           and 3 month after application.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2010</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</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>Change From Baseline in Vancouver Scar Scale Score(VSS) at 3 Months</measure>
    <time_frame>Baseline and 3 months</time_frame>
    <description>Scar assessment will be performed at the beginning of the treatment, and at the end of the 3 month when the treatment is completed by using the Vancouver scar scale.VSS assesses 6 variables.&#xD;
vascularity(range from normal(0 point) to purple(3point)&#xD;
pigmentation(range from normal(0 point) to hyper-pigmentation(3point)&#xD;
pliability(range from normal(0 point) to contracture(5point)&#xD;
height (range from flat(0 point) to above 5mm(3point)&#xD;
pain(range from none(0 point) to Require medication(2point)&#xD;
itchiness(range from none(0 point) to Require medication(2point)&#xD;
We assess total score that are minimum score is 0 and maximum is 18. The lowest score means the best scar condition.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satisfaction for Serviceability</measure>
    <time_frame>the end of the 3 month of the treatment</time_frame>
    <description>Satisfaction for serviceability will be performed at the end of the 3 month when the treatment was completed by using Questionaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Hypertrophic Surgical Scar</condition>
  <arm_group>
    <arm_group_label>Scarclinic™ Thin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Scarclinic™ Thin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Scarclinic™ Normal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Scarclinic™ Normal</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Scarclinic™ Thin</intervention_name>
    <description>Apply Scarclinic™ Thin on the scar and dispense 4 ea.for each participant for 3 month.</description>
    <arm_group_label>Scarclinic™ Thin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Scarclinic™ Normal</intervention_name>
    <description>Apply Scarclinic™ Normal on the scar and dispense 4 ea.for each participant for 3 month.</description>
    <arm_group_label>Scarclinic™ Normal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient who aged more than 18 years and less 55 years&#xD;
&#xD;
          -  Patient who has a surgical scar that is not over 3 months after the surgery&#xD;
&#xD;
          -  Patient who sign informed consent form for the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  need wound dressing for exudate&#xD;
&#xD;
          -  wound infection&#xD;
&#xD;
          -  general malaise&#xD;
&#xD;
          -  history of mental disorders&#xD;
&#xD;
          -  taking anticancer drugs or antiphlogistics or steroid&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ChanYoung Heo, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National Univ. Bundang Hospital</name>
      <address>
        <city>Bundang-gu</city>
        <state>Seongnam-si,Gyeonggi-do</state>
        <zip>463-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <results_first_submitted>December 3, 2012</results_first_submitted>
  <results_first_submitted_qc>April 12, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 15, 2013</results_first_posted>
  <last_update_submitted>April 12, 2013</last_update_submitted>
  <last_update_submitted_qc>April 12, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 15, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Chan-Yeong Heo</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>hypertropic scar, Vancouver scar scale, silicon gel sheet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cicatrix</mesh_term>
    <mesh_term>Hypertrophy</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was conducted at Seoul National University Bundang hospital. Forty subjects were recruited from May, 2010 to April,2012.</recruitment_details>
      <pre_assignment_details>In this study, we had no run-in period before study was commenced and there were no subjects who drop out before enrollment and randomization to groups.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Scarclinic™ Thin</title>
          <description>Scarclinic™ Thin applied on the surgical scar for 12weeks</description>
        </group>
        <group group_id="P2">
          <title>Scarclinic™ Normal</title>
          <description>Scarclinic™ Normal applied on the surgical scar for 12weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="2"/>
              </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="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Scarclinic™ Thin</title>
          <description>Scarclinic™ Thin applied on the surgical scar for 12weeks</description>
        </group>
        <group group_id="B2">
          <title>Scarclinic™ Normal</title>
          <description>Scarclinic™ Normal applied on the surgical scar for 12weeks</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="20"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="40"/>
          </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 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="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 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_list>
            </class>
          </class_list>
        </measure>
        <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="39.90" spread="10.47"/>
                    <measurement group_id="B2" value="36.00" spread="9.93"/>
                    <measurement group_id="B3" value="37.95" spread="10.26"/>
                  </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="16"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </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>Korea, Republic of</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Vancouver Scar Scale Score(VSS) at 3 Months</title>
        <description>Scar assessment will be performed at the beginning of the treatment, and at the end of the 3 month when the treatment is completed by using the Vancouver scar scale.VSS assesses 6 variables.&#xD;
vascularity(range from normal(0 point) to purple(3point)&#xD;
pigmentation(range from normal(0 point) to hyper-pigmentation(3point)&#xD;
pliability(range from normal(0 point) to contracture(5point)&#xD;
height (range from flat(0 point) to above 5mm(3point)&#xD;
pain(range from none(0 point) to Require medication(2point)&#xD;
itchiness(range from none(0 point) to Require medication(2point)&#xD;
We assess total score that are minimum score is 0 and maximum is 18. The lowest score means the best scar condition.</description>
        <time_frame>Baseline and 3 months</time_frame>
        <population>All participants for whom Vancouver Scar Scale measurements were recorded at Baseline and 3 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Scarclinic™ Thin</title>
            <description>Scarclinic™ Thin applied on the surgical scar for 12weeks</description>
          </group>
          <group group_id="O2">
            <title>Scarclinic™ Normal</title>
            <description>Scarclinic™ Normal applied on the surgical scar for 12weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vancouver Scar Scale Score(VSS) at 3 Months</title>
          <description>Scar assessment will be performed at the beginning of the treatment, and at the end of the 3 month when the treatment is completed by using the Vancouver scar scale.VSS assesses 6 variables.&#xD;
vascularity(range from normal(0 point) to purple(3point)&#xD;
pigmentation(range from normal(0 point) to hyper-pigmentation(3point)&#xD;
pliability(range from normal(0 point) to contracture(5point)&#xD;
height (range from flat(0 point) to above 5mm(3point)&#xD;
pain(range from none(0 point) to Require medication(2point)&#xD;
itchiness(range from none(0 point) to Require medication(2point)&#xD;
We assess total score that are minimum score is 0 and maximum is 18. The lowest score means the best scar condition.</description>
          <population>All participants for whom Vancouver Scar Scale measurements were recorded at Baseline and 3 months.</population>
          <units>units 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="15"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.80" spread="3.02"/>
                    <measurement group_id="O2" value="-2.61" spread="2.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction for Serviceability</title>
        <description>Satisfaction for serviceability will be performed at the end of the 3 month when the treatment was completed by using Questionaire</description>
        <time_frame>the end of the 3 month of the treatment</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Scarclinic™ Thin</title>
          <description>Scarclinic™ Thin applied on the surgical scar for 12weeks</description>
        </group>
        <group group_id="E2">
          <title>Scarclinic™ Normal</title>
          <description>Scarclinic™ Normal applied on the surgical scar for 12weeks</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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-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="12" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>itching sense</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="20"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>redness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Dr. Chanyeong Heo</name_or_title>
      <organization>Seoul National University Bundang Hospital</organization>
      <phone>82317877222</phone>
      <email>lionheo@snu.ac.kr</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/NCT01689857
org study id: E-1004-048-004
secondary id: 06-2010-049
nct id: NCT01689857
lead sponsor: 
has dmc: No
Compare the efficacy and safety of Scarclinic™Thin and Scarclinic™ Normal for the treatment
      of surgical scars.

      Participant: 40 Treatment period : 3 months Medical device: Scarclinic™Thin , Scarclinic™
      Normal Randomization: Table of random number
For evaluating the efficacy

        -  The investigator check Vancouver Scar Scale at 1 and 3 month after application to
           evaluate vascularity, pigmentation, elasticity, height, pain and itchiness

        -  The participant filled out survey included questions regarding convenience in use at 1
           and 3 month after application.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change From Baseline in Vancouver Scar Scale Score(VSS) at 3 Months
time frame: Baseline and 3 months
description: Scar assessment will be performed at the beginning of the treatment, and at the end of the 3 month when the treatment is completed by using the Vancouver scar scale.VSS assesses 6 variables.
vascularity(range from normal(0 point) to purple(3point)
pigmentation(range from normal(0 point) to hyper-pigmentation(3point)
pliability(range from normal(0 point) to contracture(5point)
height (range from flat(0 point) to above 5mm(3point)
pain(range from none(0 point) to Require medication(2point)
itchiness(range from none(0 point) to Require medication(2point)
We assess total score that are minimum score is 0 and maximum is 18. The lowest score means the best scar condition.
measure: Satisfaction for Serviceability
time frame: the end of the 3 month of the treatment
description: Satisfaction for serviceability will be performed at the end of the 3 month when the treatment was completed by using Questionaire
arm group label: Scarclinic™ Thin
arm group type: Experimental
description: Scarclinic™ Thin
arm group label: Scarclinic™ Normal
arm group type: Active Comparator
description: Scarclinic™ Normal
intervention type: Device
intervention name: Scarclinic™ Thin
description: Apply Scarclinic™ Thin on the scar and dispense 4 ea.for each participant for 3 month.
arm group label: Scarclinic™ Thin
intervention type: Device
intervention name: Scarclinic™ Normal
description: Apply Scarclinic™ Normal on the scar and dispense 4 ea.for each participant for 3 month.
arm group label: Scarclinic™ Normal
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: ChanYoung Heo, Ph.D
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Chan-Yeong Heo
investigator title: Assistant Professor
mesh term: Cicatrix
mesh term: Hypertrophy
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 