<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/NCT02246465</url>
  </required_header>
  <id_info>
    <org_study_id>RXI-109-1402</org_study_id>
    <nct_id>NCT02246465</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Revised Hypertrophic Scars</brief_title>
  <official_title>An Open-Label, Multi-Center, Prospective, Within-Subject Controlled, Phase 2a Study to Evaluate the Effectiveness and Safety of RXI 109 on the Outcome of Scar Revision Surgery for Hypertrophic Scars in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RXi Pharmaceuticals, Corp.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RXi Pharmaceuticals, Corp.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effectiveness of RXI-109 in reducing the&#xD;
      recurrence of hypertrophic scar formation following elective revision of a pre-existing&#xD;
      hypertrophic scar.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reducing the recurrence of hypertrophic scar after scar revision surgery</measure>
    <time_frame>9 months</time_frame>
    <description>To evaluate the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective scar revision surgery by review of photographic results and Patient and Observer Scar Assessment Scales.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety evaluation of RXI-109</measure>
    <time_frame>9 months</time_frame>
    <description>To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after elective revision of a hypertrophic scar</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Hypertrophic Scar</condition>
  <arm_group>
    <arm_group_label>RXI-109</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RXI-109 dosed at the site of the revised hypertrophic scar</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RXI-109</intervention_name>
    <arm_group_label>RXI-109</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults, 21-55 years of age&#xD;
&#xD;
          -  General good health&#xD;
&#xD;
          -  Previous surgery or injury resulting in a hypertrophic scar&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Scars on the face or front of neck may not be included in the trial&#xD;
&#xD;
          -  Use of tobacco or nicotine-containing products&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pamela Pavco, PhD</last_name>
    <role>Study Director</role>
    <affiliation>RXi Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lake Worth</city>
        <state>Florida</state>
        <zip>33461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Huntersville</city>
        <state>North Carolina</state>
        <zip>28028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Pedro Sula</city>
        <zip>21104</zip>
        <country>Honduras</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Honduras</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>February 21, 2018</last_update_submitted>
  <last_update_submitted_qc>February 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hypertrophic scar</keyword>
  <keyword>Cicatrix</keyword>
  <keyword>Scar prevention</keyword>
  <keyword>Scar revision</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertrophy</mesh_term>
    <mesh_term>Cicatrix, Hypertrophic</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/NCT02246465
org study id: RXI-109-1402
nct id: NCT02246465
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine the effectiveness of RXI-109 in reducing the
      recurrence of hypertrophic scar formation following elective revision of a pre-existing
      hypertrophic scar.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Reducing the recurrence of hypertrophic scar after scar revision surgery
time frame: 9 months
description: To evaluate the effectiveness of RXI-109 in reducing the recurrence of hypertrophic scar formation following elective scar revision surgery by review of photographic results and Patient and Observer Scar Assessment Scales.
measure: Safety evaluation of RXI-109
time frame: 9 months
description: To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after elective revision of a hypertrophic scar
arm group label: RXI-109
arm group type: Experimental
description: RXI-109 dosed at the site of the revised hypertrophic scar
intervention type: Drug
intervention name: RXI-109
arm group label: RXI-109
criteria: 
gender: All
minimum age: 21 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pamela Pavco, PhD
role: Study Director
affiliation: RXi Pharmaceuticals
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Honduras
country: United States
responsible party type: Sponsor
mesh term: Hypertrophy
mesh term: Cicatrix, Hypertrophic