<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/NCT02207738</url>
  </required_header>
  <id_info>
    <org_study_id>2012-1062</org_study_id>
    <nct_id>NCT02207738</nct_id>
  </id_info>
  <brief_title>Comparison of Efficacy Between Fractional Microneedling Radiofrequency and Bipolar Radiofrequency for Acne Scar</brief_title>
  <official_title>Comparative Study of Efficacy and Safety Between Fractional Microneedling Radiofrequency and Bipolar Radiofrequency Treatment for Acne Scar</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Compare the efficacy and safety profile of microneedling radiofrequency and that of bipolar&#xD;
      radiofrequency treatment for acne scar.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Efficacy and safety of microneedling radiofrequency for acne scar Efficacy and safety bipolar&#xD;
      radiofrequency treatment for acne scar compare the efficacy and safety profile of&#xD;
      microneedling radiofrequency and that of bipolar radiofrequency treatment for acne scar&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Global assessment of acne scar</measure>
    <time_frame>12 weeks</time_frame>
    <description>5-point grading of acne scar quartile assessment of acne scar improvement through comparing the photos taken before treatment and after treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ECCA</measure>
    <time_frame>12 weeks</time_frame>
    <description>quantitative assessment of acne scar ECCA assessment is established by previous article. this method quantifies severity of acne scar by counting the number of acne scar categorized by their shape. Then, the number of scars are multiplied by weighing factors determined by scar types. ECCA is the total sum of these points. please refer the Dreno et al, Dermatology, 2007;214:46-51</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse effect</measure>
    <time_frame>12 weeks</time_frame>
    <description>adverse effects were measured by Epithelization Scale. ES is the total sum of evaluation of three components after wounding. please refer this article Min et al, Wound Repair and Regen, 2014;22(2):212-9</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Acne</condition>
  <condition>Scar</condition>
  <arm_group>
    <arm_group_label>microneedling radiofrequency device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>microneedling radiofrequency</description>
  </arm_group>
  <arm_group>
    <arm_group_label>bipolar radiofrequency device</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>bipolar radiofrequency treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>microneedling radiofrequency device</intervention_name>
    <description>Microneedling radiofrequency device is composed of 49 insulated microneedle which emit radiofrequency from the needle tip. This radiofreqeuncy generates dermal heat which evokes biological effect.</description>
    <arm_group_label>microneedling radiofrequency device</arm_group_label>
    <other_name>INFINI(Lutronics, Goyang, Korea)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>bipolar radiofrequency</intervention_name>
    <description>bipolar radiofrequency instrument gives out bipolar radiofrequency from the hand piece tip. This bipolar radiofrequency generates dermal heat which has a lot of bilogical effect.</description>
    <arm_group_label>bipolar radiofrequency device</arm_group_label>
    <other_name>Polaris(syneron, israel)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  moderate acne scar&#xD;
&#xD;
          -  mild to moderate acne lesions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  taking acne medication oral drugs within 2 months topical drugs within 2 weeks&#xD;
&#xD;
          -  taken anu procedures for acne scar within 6 months&#xD;
&#xD;
          -  taking steroid,nonsteroidal antiinflammtory drugs, isotretinoin&#xD;
&#xD;
          -  underlying diabetes mellitus, keloid, or any malignancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dae Hun Suh, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Dermatology, Seoul National University College of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Seonguk Min, Msc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Dermatology, Seoul National University College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Dermatology, Seoul National University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Yeung CK, Chan NP, Shek SY, Chan HH. Evaluation of combined fractional radiofrequency and fractional laser treatment for acne scars in Asians. Lasers Surg Med. 2012 Oct;44(8):622-30. doi: 10.1002/lsm.22063. Epub 2012 Aug 16.</citation>
    <PMID>22899398</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 26, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>July 31, 2014</last_update_submitted>
  <last_update_submitted_qc>July 31, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 4, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acne</keyword>
  <keyword>acne scar</keyword>
  <keyword>microneedling radiofrequency</keyword>
  <keyword>bipolar radiofrequency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acne Vulgaris</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/NCT02207738
org study id: 2012-1062
nct id: NCT02207738
lead sponsor: 
has dmc: Yes
Compare the efficacy and safety profile of microneedling radiofrequency and that of bipolar
      radiofrequency treatment for acne scar.
Efficacy and safety of microneedling radiofrequency for acne scar Efficacy and safety bipolar
      radiofrequency treatment for acne scar compare the efficacy and safety profile of
      microneedling radiofrequency and that of bipolar radiofrequency treatment for acne scar
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Global assessment of acne scar
time frame: 12 weeks
description: 5-point grading of acne scar quartile assessment of acne scar improvement through comparing the photos taken before treatment and after treatment
measure: ECCA
time frame: 12 weeks
description: quantitative assessment of acne scar ECCA assessment is established by previous article. this method quantifies severity of acne scar by counting the number of acne scar categorized by their shape. Then, the number of scars are multiplied by weighing factors determined by scar types. ECCA is the total sum of these points. please refer the Dreno et al, Dermatology, 2007;214:46-51
measure: Adverse effect
time frame: 12 weeks
description: adverse effects were measured by Epithelization Scale. ES is the total sum of evaluation of three components after wounding. please refer this article Min et al, Wound Repair and Regen, 2014;22(2):212-9
arm group label: microneedling radiofrequency device
arm group type: Experimental
description: microneedling radiofrequency
arm group label: bipolar radiofrequency device
arm group type: Active Comparator
description: bipolar radiofrequency treatment
intervention type: Device
intervention name: microneedling radiofrequency device
description: Microneedling radiofrequency device is composed of 49 insulated microneedle which emit radiofrequency from the needle tip. This radiofreqeuncy generates dermal heat which evokes biological effect.
arm group label: microneedling radiofrequency device
other name: INFINI(Lutronics, Goyang, Korea)
intervention type: Device
intervention name: bipolar radiofrequency
description: bipolar radiofrequency instrument gives out bipolar radiofrequency from the hand piece tip. This bipolar radiofrequency generates dermal heat which has a lot of bilogical effect.
arm group label: bipolar radiofrequency device
other name: Polaris(syneron, israel)
criteria: 
gender: All
minimum age: 19 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dae Hun Suh, PhD
role: Study Chair
affiliation: Department of Dermatology, Seoul National University College of Medicine
last name: Seonguk Min, Msc
role: Principal Investigator
affiliation: Department of Dermatology, Seoul National University College of Medicine
facility: 
country: Korea, Republic of
citation: Yeung CK, Chan NP, Shek SY, Chan HH. Evaluation of combined fractional radiofrequency and fractional laser treatment for acne scars in Asians. Lasers Surg Med. 2012 Oct;44(8):622-30. doi: 10.1002/lsm.22063. Epub 2012 Aug 16.
PMID: 22899398
responsible party type: Sponsor
mesh term: Acne Vulgaris