<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/NCT02216864</url>
  </required_header>
  <id_info>
    <org_study_id>STU97928</org_study_id>
    <nct_id>NCT02216864</nct_id>
  </id_info>
  <brief_title>Effect of Multiple Subcisions on Rolling Acne Scars</brief_title>
  <official_title>Pilot Split Face Randomized, Evaluator Blinded Study on the Effect of Multiple Subcisions 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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find out whether the use of multiple subcisions over several&#xD;
      visits will improve the appearance of rolling acne scars compared to no treatment.&#xD;
&#xD;
      This study was a pilot study designed to determine feasibility of this procedure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>August 2014</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 36 weeks</time_frame>
    <description>The change in acne scarring is measured using a quantitative global scarring grading system to compare baseline to the treatment.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Acne Scars</condition>
  <arm_group>
    <arm_group_label>Multiple Subcision</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive multiple subcision treatments to their randomized side of the face 5 times total spaced 4 weeks apart.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects will receive no intervention control on the other side of the face.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Multiple Subcision</intervention_name>
    <description>At the start of the procedure, a straight vitrectomy knife will be inserted subdermally and will be slowly advanced parallel to the dermis. Rapid advancement and retraction of the needle under the scarred area in a lancing motion will be performed to abrade the underside of the dermis followed by side to side sweeping motions attempting to break any fibrous attachments to the deeper tissues.</description>
    <arm_group_label>Multiple Subcision</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 to 65&#xD;
&#xD;
          2. Have bilateral rolling acne scars on each side of their face&#xD;
&#xD;
          3. No active or ongoing acne.&#xD;
&#xD;
          4. The subjects are in good health&#xD;
&#xD;
          5. The subject has the willingness and the ability to understand and provide informed&#xD;
             consent for the use of their tissue and communicate with the investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Under 18 years of age&#xD;
&#xD;
          2. Pregnancy or Lactation&#xD;
&#xD;
          3. Subjects who are unable to understand the protocol or to give informed consent&#xD;
&#xD;
          4. Subjects with mental illness&#xD;
&#xD;
          5. Recent Accutane use in the past 6 months&#xD;
&#xD;
          6. Subjects prone to hypertrophic and keloidal scarring&#xD;
&#xD;
          7. Subjects reporting any blood diseases (HIV, Hepatitis, etc.)&#xD;
&#xD;
          8. Subjects reporting a history of Herpes (oral or genital)&#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>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</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</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/NCT02216864
org study id: STU97928
nct id: NCT02216864
lead sponsor: 
has dmc: Yes
The purpose of this study is to find out whether the use of multiple subcisions over several
      visits will improve the appearance of rolling acne scars compared to no treatment.

      This study was a pilot study designed to determine feasibility of this procedure.
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 36 weeks
description: The change in acne scarring is measured using a quantitative global scarring grading system to compare baseline to the treatment.
arm group label: Multiple Subcision
arm group type: Experimental
description: Subjects will receive multiple subcision treatments to their randomized side of the face 5 times total spaced 4 weeks apart.
arm group label: Control
arm group type: No Intervention
description: Subjects will receive no intervention control on the other side of the face.
intervention type: Procedure
intervention name: Multiple Subcision
description: At the start of the procedure, a straight vitrectomy knife will be inserted subdermally and will be slowly advanced parallel to the dermis. Rapid advancement and retraction of the needle under the scarred area in a lancing motion will be performed to abrade the underside of the dermis followed by side to side sweeping motions attempting to break any fibrous attachments to the deeper tissues.
arm group label: Multiple Subcision
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
mesh term: Acne Vulgaris