<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/NCT02217228</url>
  </required_header>
  <id_info>
    <org_study_id>SEB-0121</org_study_id>
    <secondary_id>IDE #G120273</secondary_id>
    <nct_id>NCT02217228</nct_id>
  </id_info>
  <brief_title>Pivotal Study of Sebacia Microparticles in the Treatment of Acne Vulgaris</brief_title>
  <official_title>A Randomized, Prospective, Multicenter, Controlled Study With Blinded Assessment to Determine the Safety and Effectiveness of the Sebacia Acne Treatment System in the Treatment of Inflammatory 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, randomized multicenter study to examine the safety and effectiveness of Sebacia&#xD;
      microparticles with or without laser in the treatment of moderate to moderately-severe&#xD;
      inflammatory acne vulgaris&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Mean percent change in inflammatory lesion count from Baseline to Week 12</measure>
    <time_frame>Week 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of of adverse events</measure>
    <time_frame>Screening to 12 Weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean absolute change in inflammatory lesion count from Baseline to Week 12</measure>
    <time_frame>Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Success by Investigator's Global Assessment at Week 12 (defined as 2-point decrease from Baseline IGA)</measure>
    <time_frame>Week 12</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">394</enrollment>
  <condition>Inflammatory Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>Sebacia microparticles and laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gold microparticle suspension + laser treatment x 3 over the course of two weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle suspension and laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vehicle suspension + laser treatment x 3 over the course of two weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sebacia microparticles without laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gold microparticle suspension treatment x 3 over the course of two weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sebacia microparticles and laser</intervention_name>
    <arm_group_label>Sebacia microparticles and laser</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vehicle suspension and laser</intervention_name>
    <arm_group_label>Vehicle suspension and laser</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sebacia microparticles without laser</intervention_name>
    <arm_group_label>Sebacia microparticles without laser</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females, 15 - 45 years of age&#xD;
&#xD;
          -  Able to provide informed consent/assent; minors will provide assent while parent or&#xD;
             legal guardian will provide consent&#xD;
&#xD;
          -  Moderate to moderately severe (3 or 4) inflammatory acne vulgaris by Investigator's&#xD;
             Global Assessment&#xD;
&#xD;
          -  Subject has 25 to 75 inflammatory lesions on the cheeks, chin and forehead, not&#xD;
             concentrated in one area&#xD;
&#xD;
          -  Subject has Fitzpatrick skin phototype I, II or III&#xD;
&#xD;
          -  Subject is in good health, willing to participate and able to comply with protocol&#xD;
             requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe acne (Investigator's Global Assessment 5) with significant scarring potential&#xD;
             and greater than 2 nodular lesions&#xD;
&#xD;
          -  Clinically relevant history of keloids&#xD;
&#xD;
          -  Facial tattoos&#xD;
&#xD;
          -  Acne conglobata, acne fulminans, chloracne, drug-induced acne&#xD;
&#xD;
          -  Active concomitant skin disease, excessive scarring or excess facial hair&#xD;
&#xD;
          -  Heavily tanned skin; unable or unwilling to avoid tanning beds/excessive sun exposure&#xD;
&#xD;
          -  Acne medication and therapy restrictions - time period prior to Baseline (below)&#xD;
&#xD;
               1. Oral retinoids - 6 months&#xD;
&#xD;
               2. Other systemic medications - 4 weeks&#xD;
&#xD;
               3. Topical retinoids, steroids, antibiotics - 2 weeks&#xD;
&#xD;
               4. OTC topical treatments - 1 week&#xD;
&#xD;
               5. Light treatments (including IPL or laser), microdermabrasion and/or peels - 8&#xD;
                  weeks&#xD;
&#xD;
               6. Investigational drug, biologic or device - 30 days&#xD;
&#xD;
               7. Gold therapy of any type for any reason - EXCLUDED&#xD;
&#xD;
          -  Pregnant, lactating, nursing or planning to become pregnant during the study period&#xD;
&#xD;
          -  Known allergy to gold, ethanol, diisopropyl adipate, Polysorbate 80&#xD;
&#xD;
          -  Clinically relevant condition that makes participation unsafe or that would interfere&#xD;
             with study treatment and assessment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clear Dermatology &amp; Aesthetics Center</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85255</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laser &amp; Skin Surgery Center of Northern California</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Dermatology &amp; Laser Surgery</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95819</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Dermatology &amp; Laser Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33173</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spencer Dermatology</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33716</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gwinnett Dermatology, PC</name>
      <address>
        <city>Snellville</city>
        <state>Georgia</state>
        <zip>30078</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Dermatology Institute-DuPage Medical Group</name>
      <address>
        <city>Naperville</city>
        <state>Illinois</state>
        <zip>60563</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shideler Clinical Research Center</name>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <zip>46032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maryland Laser, Skin &amp; Vein Institute</name>
      <address>
        <city>Hunt Valley</city>
        <state>Maryland</state>
        <zip>21030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clarkston Skin Research</name>
      <address>
        <city>Clarkston</city>
        <state>Michigan</state>
        <zip>48346</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James Q Del Rosso, DO, LLC</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skin Laser &amp; Surgery Specialists of NY &amp; NJ</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology, Laser &amp; Vein Specialists of the Carolinas</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn State Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yardley Dermatology Associates</name>
      <address>
        <city>Yardley</city>
        <state>Pennsylvania</state>
        <zip>19067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology &amp; Laser Center of Charleston</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Clinical Research Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Institute for Clinical Research</name>
      <address>
        <city>Pflugerville</city>
        <state>Texas</state>
        <zip>78660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spokane Dermatology Clinic</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>92204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <disposition_first_submitted>September 5, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>September 8, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">September 18, 2017</disposition_first_posted>
  <last_update_submitted>September 8, 2017</last_update_submitted>
  <last_update_submitted_qc>September 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 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, but a results disposition has been submitted           -->
</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/NCT02217228
org study id: SEB-0121
secondary id: IDE #G120273
nct id: NCT02217228
lead sponsor: 
has dmc: No
Prospective, randomized multicenter study to examine the safety and effectiveness of Sebacia
      microparticles with or without laser in the treatment of moderate to moderately-severe
      inflammatory acne vulgaris
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Mean percent change in inflammatory lesion count from Baseline to Week 12
time frame: Week 12
measure: Number of of adverse events
time frame: Screening to 12 Weeks
measure: Mean absolute change in inflammatory lesion count from Baseline to Week 12
time frame: Week 12
measure: Success by Investigator's Global Assessment at Week 12 (defined as 2-point decrease from Baseline IGA)
time frame: Week 12
arm group label: Sebacia microparticles and laser
arm group type: Experimental
description: Gold microparticle suspension + laser treatment x 3 over the course of two weeks
arm group label: Vehicle suspension and laser
arm group type: Experimental
description: Vehicle suspension + laser treatment x 3 over the course of two weeks
arm group label: Sebacia microparticles without laser
arm group type: Experimental
description: Gold microparticle suspension treatment x 3 over the course of two weeks
intervention type: Device
intervention name: Sebacia microparticles and laser
arm group label: Sebacia microparticles and laser
intervention type: Device
intervention name: Vehicle suspension and laser
arm group label: Vehicle suspension and laser
intervention type: Device
intervention name: Sebacia microparticles without laser
arm group label: Sebacia microparticles without laser
criteria: 
gender: All
minimum age: 15 Years
maximum age: 35 Years
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Acne Vulgaris