<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/NCT01696513</url>
  </required_header>
  <id_info>
    <org_study_id>STU66710</org_study_id>
    <nct_id>NCT01696513</nct_id>
  </id_info>
  <brief_title>Effect of Subcision and Suction on Acne Scars</brief_title>
  <official_title>Pilot Split Face Randomized, Evaluator Blinded Study on the Effect of Subcision and Suctioning With a Microdermabrasion Device on Rolling Acne Scars</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to determine whether the use of standard treatment in&#xD;
      conjunction with suction will improve acne scars compared to a standard treatment alone.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in acne scarring compared to baseline after treatments</measure>
    <time_frame>Baseline and 4 months</time_frame>
    <description>The change in acne scarring is measured using a global scarring grading system to compare baseline scarring to the treatments.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Acne Scars</condition>
  <arm_group>
    <arm_group_label>Subcision &amp; Suction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard treatment for acne scars followed by suction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subcision</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard treatment for acne scars only</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Suction</intervention_name>
    <arm_group_label>Subcision &amp; Suction</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Subcision</intervention_name>
    <arm_group_label>Subcision</arm_group_label>
    <arm_group_label>Subcision &amp; Suction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 and over&#xD;
&#xD;
          -  Have bilateral rolling acne scars&#xD;
&#xD;
          -  Are in good health&#xD;
&#xD;
          -  Subject has the willingness and ability to understand and provide informed consent for&#xD;
             the use of their tissue and communicate with the investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years of age&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Unable to understand the protocol or give informed consent&#xD;
&#xD;
          -  Has mental illness&#xD;
&#xD;
          -  Recent Accutane use in the past 6 months&#xD;
&#xD;
          -  Prone to hypertrophic and keloidal scarring&#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>Murad Alam, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University Feinberg School of Medicine, Department of Dermatology</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <last_update_submitted>February 17, 2023</last_update_submitted>
  <last_update_submitted_qc>February 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Murad Alam</investigator_full_name>
    <investigator_title>Professor in Dermatology, Otolaryngology- Head and Neck Surgery, and Surgery-Organ Transplantation</investigator_title>
  </responsible_party>
  <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/NCT01696513
org study id: STU66710
nct id: NCT01696513
lead sponsor: 
has dmc: No
The primary objective of this study is to determine whether the use of standard treatment in
      conjunction with suction will improve acne scars compared to a standard treatment alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in acne scarring compared to baseline after treatments
time frame: Baseline and 4 months
description: The change in acne scarring is measured using a global scarring grading system to compare baseline scarring to the treatments.
arm group label: Subcision & Suction
arm group type: Experimental
description: Standard treatment for acne scars followed by suction.
arm group label: Subcision
arm group type: Active Comparator
description: Standard treatment for acne scars only
intervention type: Procedure
intervention name: Suction
arm group label: Subcision & Suction
intervention type: Procedure
intervention name: Subcision
arm group label: Subcision
arm group label: Subcision & Suction
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Murad Alam, MD
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Murad Alam
investigator title: Professor in Dermatology, Otolaryngology- Head and Neck Surgery, and Surgery-Organ Transplantation
mesh term: Acne Vulgaris