<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/NCT01693055</url>
  </required_header>
  <id_info>
    <org_study_id>E-1207/162-004</org_study_id>
    <secondary_id>L-2012-408-3</secondary_id>
    <nct_id>NCT01693055</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid</brief_title>
  <official_title>Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid,Phase 4.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ulthera, Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study title&#xD;
&#xD;
        -  Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid Study design&#xD;
&#xD;
        -  single arm and Investigator Initiative pilot study&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</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>The distance from the inferior orbital rim to the skin</measure>
    <time_frame>Change from Screening in distance at 12weeks after Ulthera treatment</time_frame>
    <description>Difference between the distance ( from the inferior orbital rim to the skin) measured by orbital CT at Screening and 12weeks after UltheraTM treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The distance from the most protrusive baggy eyelid to the orbital septum</measure>
    <time_frame>Change from Screening in distance at 12weeks after UltheraTM treatment</time_frame>
    <description>The distance(mm),from the most protrusive baggy eyelid to the orbital septum will be measured by a plastic surgeon with orbital CT films. Each participant will do Orbital CT scan 2 times, at screening and 12weeks after treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Satisfaction for baggy lower eyelid</measure>
    <time_frame>Change from Screening in satisfaction at 4 weeks and 12weeks</time_frame>
    <description>5-point scale for Subject Satisfaction in baggy lower eyelid. The subject satisfaction is calculated as a score between 0 and 4( 0= very poor, 4= very good).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of baggy lower eyelid</measure>
    <time_frame>Change from Screening in baggy lower eyelid at 12weeks after UltheraTM treatment</time_frame>
    <description>Improvement of baggy lower eyelid will be assessed by Two plastic surgeons. Both assessors will evaluate Improvement of baggy lower eyelid including skin laxity and orbital fat prolapse using 5-point scale.&#xD;
0= no involvement&#xD;
mild&#xD;
moderate&#xD;
marked&#xD;
severe</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Orbital Fat Prolapse</condition>
  <arm_group>
    <arm_group_label>UltheraTM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>UltheraTM 100 shots (infraorbital region 30shots, lateral orbital region 40shots, upper eyelid 30 shots) on the Rt, and Lt periorbital area, respectively using 1.5mm and 3.0mm probe</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>UltheraTM 100 shots</intervention_name>
    <description>UltheraTM 100 shots (infraorbital region 30shots, lateral orbital region 40shots, upper eyelid 30 shots) on the Rt, and Lt periorbital area, respectively using 1.5mm and 3.0mm probe</description>
    <arm_group_label>UltheraTM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;20 years, Age &lt; 50 years&#xD;
&#xD;
          -  people who want to improve baggy eyelid&#xD;
&#xD;
          -  Information consent obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous lower eyelid surgical history&#xD;
&#xD;
          -  scar on lower eyelid after trauma&#xD;
&#xD;
          -  bleeding tendency&#xD;
&#xD;
          -  aesthetic addiction, drug abuse, alcohol abuse&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chanyeong Heo, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National Univ. Bundang Hospital, Gumi-dong, Bundang-gu</name>
      <address>
        <city>Seongnam-si,</city>
        <state>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 2014</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>April 4, 2014</last_update_submitted>
  <last_update_submitted_qc>April 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 7, 2014</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>orbital Computed Tomography</keyword>
  <keyword>baggy eyelids</keyword>
  <keyword>orbital fat prolapse</keyword>
  <keyword>UltheraTM</keyword>
  <keyword>high intensity focused ultrasound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prolapse</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01693055
org study id: E-1207/162-004
secondary id: L-2012-408-3
nct id: NCT01693055
lead sponsor: 
collaborator: 
has dmc: No
Study title

        -  Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid Study design

        -  single arm and Investigator Initiative pilot study
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The distance from the inferior orbital rim to the skin
time frame: Change from Screening in distance at 12weeks after Ulthera treatment
description: Difference between the distance ( from the inferior orbital rim to the skin) measured by orbital CT at Screening and 12weeks after UltheraTM treatment
measure: The distance from the most protrusive baggy eyelid to the orbital septum
time frame: Change from Screening in distance at 12weeks after UltheraTM treatment
description: The distance(mm),from the most protrusive baggy eyelid to the orbital septum will be measured by a plastic surgeon with orbital CT films. Each participant will do Orbital CT scan 2 times, at screening and 12weeks after treatment
measure: Subject Satisfaction for baggy lower eyelid
time frame: Change from Screening in satisfaction at 4 weeks and 12weeks
description: 5-point scale for Subject Satisfaction in baggy lower eyelid. The subject satisfaction is calculated as a score between 0 and 4( 0= very poor, 4= very good).
measure: Improvement of baggy lower eyelid
time frame: Change from Screening in baggy lower eyelid at 12weeks after UltheraTM treatment
description: Improvement of baggy lower eyelid will be assessed by Two plastic surgeons. Both assessors will evaluate Improvement of baggy lower eyelid including skin laxity and orbital fat prolapse using 5-point scale.
0= no involvement
mild
moderate
marked
severe
arm group label: UltheraTM
arm group type: Experimental
description: UltheraTM 100 shots (infraorbital region 30shots, lateral orbital region 40shots, upper eyelid 30 shots) on the Rt, and Lt periorbital area, respectively using 1.5mm and 3.0mm probe
intervention type: Device
intervention name: UltheraTM 100 shots
description: UltheraTM 100 shots (infraorbital region 30shots, lateral orbital region 40shots, upper eyelid 30 shots) on the Rt, and Lt periorbital area, respectively using 1.5mm and 3.0mm probe
arm group label: UltheraTM
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chanyeong Heo, Ph.D
role: Principal Investigator
affiliation: Seoul National University Bundang 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: Prolapse