<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/NCT03303170</url>
  </required_header>
  <id_info>
    <org_study_id>SEB-0493</org_study_id>
    <nct_id>NCT03303170</nct_id>
  </id_info>
  <brief_title>Non-Significant Risk Study of Sebacia Microparticles in the Treatment of Facial Acne Vulgaris</brief_title>
  <official_title>A Prospective, Multicenter, Randomized, Controlled, Evaluator-Blinded Study of the Safety and Effectiveness of Sebacia Microparticles as an Accessory to 1064 nm Nd:Yag Laser in the Treatment of Facial 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, randomized, controlled, parallel group clinical study with blinded assessment&#xD;
      evaluating Sebacia Microparticles (SM) with Nd:Yag laser in facial inflammatory acne vulgaris&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 25, 2017</start_date>
  <completion_date type="Actual">April 10, 2018</completion_date>
  <primary_completion_date type="Actual">April 10, 2018</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 number of inflammatory acne lesions</measure>
    <time_frame>Week 12</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">168</enrollment>
  <condition>Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>Sebacia Microparticles</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Nd:Yag Laser</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sebacia Microparticles</intervention_name>
    <description>Topical microparticle suspension</description>
    <arm_group_label>Sebacia Microparticles</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nd:Yag Laser</intervention_name>
    <description>Laser delivering 1064 nm wavelength light</description>
    <arm_group_label>Nd:Yag Laser</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mild to moderate acne vulgaris&#xD;
&#xD;
          -  At least 15 inflammatory acne lesions&#xD;
&#xD;
          -  Skin phototype I - III&#xD;
&#xD;
          -  Able to understand and comply with study requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe acne vulgaris&#xD;
&#xD;
          -  Nodulocystic acne&#xD;
&#xD;
          -  Ongoing use of medications and/or treatments for acne&#xD;
&#xD;
          -  New hormone regimen (used for less than 12 weeks)&#xD;
&#xD;
          -  Significant medical or mental health condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>45 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>Scripps Health</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92121</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>Meridian Clinical Research</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MediSearch Clinical Trials</name>
      <address>
        <city>Saint Joseph</city>
        <state>Missouri</state>
        <zip>64506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology, Laser &amp; Vein Institute</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research Associates</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>International Clinical Research</name>
      <address>
        <city>Murfreesboro</city>
        <state>Tennessee</state>
        <zip>37130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Institute for Clinical Research</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Center for Skin Research</name>
      <address>
        <city>Katy</city>
        <state>Texas</state>
        <zip>77494</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Clinical Research</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.sebacia.com</url>
    <description>Sponsor Website</description>
  </link>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <disposition_first_submitted>October 2, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>October 2, 2019</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">October 14, 2019</disposition_first_posted>
  <last_update_submitted>October 2, 2019</last_update_submitted>
  <last_update_submitted_qc>October 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2019</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/NCT03303170
org study id: SEB-0493
nct id: NCT03303170
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
Prospective, randomized, controlled, parallel group clinical study with blinded assessment
      evaluating Sebacia Microparticles (SM) with Nd:Yag laser in facial inflammatory acne vulgaris
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in number of inflammatory acne lesions
time frame: Week 12
arm group label: Sebacia Microparticles
arm group type: Experimental
arm group label: Nd:Yag Laser
arm group type: Active Comparator
intervention type: Device
intervention name: Sebacia Microparticles
description: Topical microparticle suspension
arm group label: Sebacia Microparticles
intervention type: Device
intervention name: Nd:Yag Laser
description: Laser delivering 1064 nm wavelength light
arm group label: Nd:Yag Laser
criteria: 
gender: All
minimum age: 12 Years
maximum age: 45 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.sebacia.com
description: Sponsor Website
responsible party type: Sponsor
mesh term: Acne Vulgaris