<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/NCT02219074</url>
  </required_header>
  <id_info>
    <org_study_id>SEB-0005</org_study_id>
    <nct_id>NCT02219074</nct_id>
  </id_info>
  <brief_title>Multiple Arm Study of Sebacia Microparticles in the Treatment of Acne Vulgaris</brief_title>
  <official_title>A Feasibility Study to Evaluate the Safety and Preliminary Efficacy of the Sebacia Acne Treatment System for the Treatment of Acne Vulgaris</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sebacia, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sebacia, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, multicenter study with multiple arms to examine the safety and effectiveness of&#xD;
      the Sebacia Acne Treatment System for the treatment of acne vulgaris.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2011</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</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 inflammatory lesion count</measure>
    <time_frame>Week 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>Screening to 26 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Investigator Global Assessment</measure>
    <time_frame>Week 12</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">350</enrollment>
  <condition>Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>Sebacia microparticle and laser treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle and laser treatment</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sebacia microparticle and laser treatment</intervention_name>
    <arm_group_label>Sebacia microparticle and laser treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vehicle and laser treatment</intervention_name>
    <arm_group_label>Vehicle and laser treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical diagnosis of moderate to severe acne vulgaris&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  use of oral retinoid therapy in the past 12 months&#xD;
&#xD;
          -  pregnancy, lactating, or planning to become pregnant&#xD;
&#xD;
          -  excessive scarring in the treatment area, or other condition that would impact the&#xD;
             ability to evaluate acne&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Specjalistyczny Gabinet Dermatologiczny</name>
      <address>
        <city>Krakow</city>
        <zip>31-530</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Military Institute of Health Services</name>
      <address>
        <city>Warsaw</city>
        <zip>04-141</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>September 5, 2017</last_update_submitted>
  <last_update_submitted_qc>September 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT02219074
org study id: SEB-0005
nct id: NCT02219074
lead sponsor: 
has dmc: No
Prospective, multicenter study with multiple arms to examine the safety and effectiveness of
      the Sebacia Acne Treatment System for the treatment of acne vulgaris.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in inflammatory lesion count
time frame: Week 12
measure: Number of adverse events
time frame: Screening to 26 weeks
measure: Investigator Global Assessment
time frame: Week 12
arm group label: Sebacia microparticle and laser treatment
arm group type: Experimental
arm group label: Vehicle and laser treatment
arm group type: Sham Comparator
intervention type: Device
intervention name: Sebacia microparticle and laser treatment
arm group label: Sebacia microparticle and laser treatment
intervention type: Device
intervention name: Vehicle and laser treatment
arm group label: Vehicle and laser treatment
criteria: 
gender: All
minimum age: 16 Years
maximum age: 35 Years
healthy volunteers: No
facility: 
facility: 
country: Poland
responsible party type: Sponsor
mesh term: Acne Vulgaris