<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/NCT03818555</url>
  </required_header>
  <id_info>
    <org_study_id>SEB-0550</org_study_id>
    <nct_id>NCT03818555</nct_id>
  </id_info>
  <brief_title>Sebacia Postmarket Study of Real-World Use</brief_title>
  <official_title>A Prospective, Multicenter, Postmarket Study of Sebacia Microparticles Treatment in Patients Using Topical Acne Products for Mild to Moderate 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_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postmarket study of Sebacia Microparticles treatment during adoption into clinical use for&#xD;
      patients with mild to moderate inflammatory acne vulgaris.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Inflammatory Lesion Count</measure>
    <time_frame>Months 2, 3, 6, 9 and 12</time_frame>
    <description>Percent change in number of inflammatory lesions from baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Investigator's Global Assessment</measure>
    <time_frame>Months 2, 3, 6, 9 and 12</time_frame>
    <description>Percent of subjects clear (IGA 0) or almost clear (IGA 1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician's Overall Assessment of Improvement</measure>
    <time_frame>Months 2, 3, 6, 9 and 12</time_frame>
    <description>Categorical improvement from baseline (worse, no change, minimal, moderate, marked, complete)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">125</enrollment>
  <condition>Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>Sebacia Microparticles Treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sebacia Microparticles Treatment</intervention_name>
    <description>Sebacia Microparticles procedure involving microparticles and 1064 nm laser. Three treatment procedures over a two-week period.</description>
    <arm_group_label>Sebacia Microparticles Treatment</arm_group_label>
    <other_name>Sebacia treatment, Microparticles and Nd:Yag laser treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mild to moderate facial inflammatory acne vulgaris (IGA 2 or 3)&#xD;
&#xD;
          -  Between 10 and 50 papules/pustules&#xD;
&#xD;
          -  Fitzpatrick skin phototype I, II or III&#xD;
&#xD;
          -  Able to provide informed consent and comply with study schedule and other requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Moderately severe or severe acne vulgaris (IGA 4 or 5)&#xD;
&#xD;
          -  Nodulocystic acne, significant scarring or excoriation&#xD;
&#xD;
          -  Requires oral retinoid, antibiotic or corticosteroid for acne&#xD;
&#xD;
          -  New or fluctuating hormone or hormone-regulating therapy&#xD;
&#xD;
          -  Photosensitivity or allergy to gold&#xD;
&#xD;
          -  Medical or mental health condition that would pose a risk to patient or impair&#xD;
             treatment and evaluation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>VP, Clinical &amp; Regulatory Affairs</last_name>
    <role>Study Director</role>
    <affiliation>Sebacia, Inc.</affiliation>
  </overall_official>
  <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>Dermatology Institute of Boston</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02116</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 - Central</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Institute for Clinical Research - Pflugerville</name>
      <address>
        <city>Pflugerville</city>
        <state>Texas</state>
        <zip>78660</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>Company Website</description>
  </link>
  <link>
    <url>http://www.acneclinicalstudy.com</url>
    <description>Study Website</description>
  </link>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>October 24, 2020</last_update_submitted>
  <last_update_submitted_qc>October 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2020</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03818555
org study id: SEB-0550
nct id: NCT03818555
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Postmarket study of Sebacia Microparticles treatment during adoption into clinical use for
      patients with mild to moderate inflammatory acne vulgaris.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Inflammatory Lesion Count
time frame: Months 2, 3, 6, 9 and 12
description: Percent change in number of inflammatory lesions from baseline
measure: Investigator's Global Assessment
time frame: Months 2, 3, 6, 9 and 12
description: Percent of subjects clear (IGA 0) or almost clear (IGA 1)
measure: Physician's Overall Assessment of Improvement
time frame: Months 2, 3, 6, 9 and 12
description: Categorical improvement from baseline (worse, no change, minimal, moderate, marked, complete)
arm group label: Sebacia Microparticles Treatment
arm group type: Other
intervention type: Other
intervention name: Sebacia Microparticles Treatment
description: Sebacia Microparticles procedure involving microparticles and 1064 nm laser. Three treatment procedures over a two-week period.
arm group label: Sebacia Microparticles Treatment
other name: Sebacia treatment, Microparticles and Nd:Yag laser treatment
criteria: 
gender: All
minimum age: 12 Years
maximum age: 45 Years
healthy volunteers: No
last name: VP, Clinical & Regulatory Affairs
role: Study Director
affiliation: Sebacia, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.sebacia.com
description: Company Website
url: http://www.acneclinicalstudy.com
description: Study Website
responsible party type: Sponsor
mesh term: Acne Vulgaris
sharing ipd: No