<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/NCT03039634</url>
  </required_header>
  <id_info>
    <org_study_id>SL-2016-01_FA</org_study_id>
    <nct_id>NCT03039634</nct_id>
  </id_info>
  <brief_title>Long-term Follow-up Study of Subjects Who Completed Clinical Studies 755.1100_FA, 810.1100_FA, or 1064.1100_FA</brief_title>
  <official_title>A Multicenter, Double-blind, Nontreatment, Long-term, Follow-up Study of Subjects Who Completed Clinical Studies 755.1100_FA, 810.1100_FA, or 1064.1100_FA of a Topical Silver Particle Solution Followed by Laser for the Treatment of Facial Acne Vulgaris</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sienna Labs</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sienna Labs</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the safety, effectiveness, and maintenance of effect of a novel topical&#xD;
      silver particle solution (Sienna 755.1100, 810.1100, or 1064.1100) used in conjunction with a&#xD;
      laser for the treatment of Acne Vulgaris.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2016</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">May 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Total lesion count by blinded investigator</measure>
    <time_frame>18 weeks post final treatment</time_frame>
    <description>Maintenance of effect by comparing lesion counts conducted at the exit visit of the predecessor study (ie, 12 weeks post-final treatment) and visit 2 of this study (ie, 18 weeks post-final treatment).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Total lesion count by blinded investigator</measure>
    <time_frame>24 weeks post final treatment</time_frame>
    <description>Maintenance of effect by comparing lesion counts conducted at the exit visit of the predecessor study (ie, 12 weeks post-final treatment) and visit 3 of this study (ie, 24 weeks post-final treatment).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety as assessed by number of adverse events</measure>
    <time_frame>up to 24 weeks post final treatment</time_frame>
    <description>Adverse events will be monitored throughout the study</description>
  </primary_outcome>
  <enrollment type="Actual">76</enrollment>
  <condition>Acne Vulgaris</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Up to 165 subjects will be considered for entry into the study. Subjects completing a&#xD;
        predecessor facial acne study (755.1100_FA, 810.1100_FA, or 1064.1100_FA) who meet all&#xD;
        study inclusion/exclusion criteria will be offered study participation. There will be no&#xD;
        treatments administered in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has participated in study 755.1100_FA, 810.1100_FA, or 1064.1100_FA and&#xD;
             fulfilled that study's exit criteria (ie, completion of the final visit [visit 7] of&#xD;
             that study).&#xD;
&#xD;
          -  Subject has followed predecessor study restrictions prior to study entry.&#xD;
&#xD;
          -  Subject is able to provide informed consent and Health Insurance Portability and&#xD;
             Accountability Act (HIPAA); minors will in addition have parent or legal guardian&#xD;
             provide consent.&#xD;
&#xD;
          -  Subject is willing to comply with the schedule, procedures, and restrictions of the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have had any treatments or conditions (eg, pregnancy or metabolic&#xD;
             disease) that may affect assessment of the safety or efficacy since enrollment in the&#xD;
             predecessor study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul Lizzul, MD</last_name>
    <role>Study Director</role>
    <affiliation>Sienna Biopharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85255</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33173</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hunt Valley</city>
        <state>Maryland</state>
        <zip>21030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Beverly</city>
        <state>Massachusetts</state>
        <zip>01915</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>92691</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Yardley</city>
        <state>Pennsylvania</state>
        <zip>19067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pflugerville</city>
        <state>Texas</state>
        <zip>78660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jordan</city>
        <state>Utah</state>
        <zip>84088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>February 28, 2019</last_update_submitted>
  <last_update_submitted_qc>February 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 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>
  <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/NCT03039634
org study id: SL-2016-01_FA
nct id: NCT03039634
lead sponsor: 
has dmc: No
This study evaluates the safety, effectiveness, and maintenance of effect of a novel topical
      silver particle solution (Sienna 755.1100, 810.1100, or 1064.1100) used in conjunction with a
      laser for the treatment of Acne Vulgaris.
observational model: Cohort
time perspective: Prospective
measure: Change in Total lesion count by blinded investigator
time frame: 18 weeks post final treatment
description: Maintenance of effect by comparing lesion counts conducted at the exit visit of the predecessor study (ie, 12 weeks post-final treatment) and visit 2 of this study (ie, 18 weeks post-final treatment).
measure: Change in Total lesion count by blinded investigator
time frame: 24 weeks post final treatment
description: Maintenance of effect by comparing lesion counts conducted at the exit visit of the predecessor study (ie, 12 weeks post-final treatment) and visit 3 of this study (ie, 24 weeks post-final treatment).
measure: Safety as assessed by number of adverse events
time frame: up to 24 weeks post final treatment
description: Adverse events will be monitored throughout the study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul Lizzul, MD
role: Study Director
affiliation: Sienna Biopharmaceuticals
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country: United States
responsible party type: Sponsor
mesh term: Acne Vulgaris
sharing ipd: No