<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/NCT03825315</url>
  </required_header>
  <id_info>
    <org_study_id>1820201</org_study_id>
    <nct_id>NCT03825315</nct_id>
  </id_info>
  <brief_title>DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis</brief_title>
  <official_title>A Phase II, Prospective, Randomized, Double-Blind, Multi-center, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Revance Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Revance Therapeutics, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, double-blind, placebo-controlled, parallel group, multi-center trial of&#xD;
      a single administration of DaxibotulinumtoxinA (DAXI) (high-dose; low-dose) for injection&#xD;
      versus placebo for the management of Plantar Fasciitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately 150 subjects, recruited from approximately 20 study centers in the United&#xD;
      States (US) will be randomized to DAXI (HIGH-dose; LOW-dose) or placebo group, respectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 31, 2018</start_date>
  <completion_date type="Actual">June 4, 2020</completion_date>
  <primary_completion_date type="Actual">June 4, 2020</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>Subjects will be randomly assigned to 1 of 3 treatment groups: DAXI for injection LOW dose, DAXI for injection HIGH dose, Placebo</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double Blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in the Numeric Pain Rating Scale (NPRS) score</measure>
    <time_frame>Week 8</time_frame>
    <description>Change from baseline in the Numeric Pain Rating Scale (NPRS) score (Scale Range: 0 {No pain} to 10 {Worst pain imaginable})</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Foot Function Index (FFI)</measure>
    <time_frame>All post treatment time points (approximately 6 months)</time_frame>
    <description>Change from baseline in Foot Function Index (FFI) (Pain Sub-Scale Range: 0 {No pain} to 10 {Worst pain imaginable}, Disability Sub-Scale Range: 0 {No difficulty} to 10 {So difficult unable to do so}, Activity Limitation Sub-Scale Range: 0 {None of the time} to 10 {All of the time})</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Moderate improvement on the Clinical Global Impression of Change (CGIC)</measure>
    <time_frame>All post treatment time points (approximately 6 months)</time_frame>
    <description>Proportion of subjects with improvement on the Clinical Global Impression of Change (CGIC) over time</description>
  </other_outcome>
  <other_outcome>
    <measure>Improvement on the the Patient Global Impression of Change (PGIC)</measure>
    <time_frame>All post treatment time points (approximately 6 months)</time_frame>
    <description>Proportion of subjects with improvement on the Patient Global Impression of Change (PGIC) over time</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">155</enrollment>
  <condition>Plantar Fasciitis</condition>
  <arm_group>
    <arm_group_label>DAXI for Injection: LOW Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LOW Dose Group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DAXI for Injection: HIGH Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HIGH Dose Group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>DAXI for Injection: LOW Dose</intervention_name>
    <description>DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.</description>
    <arm_group_label>DAXI for Injection: LOW Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>DAXI for Injection: HIGH Dose</intervention_name>
    <description>DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.</description>
    <arm_group_label>DAXI for Injection: HIGH Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo is a sterile lyophilized product consisting of inactive ingredients without the neurotoxin to be reconstituted with sterile, non-preserved 0.9% sodium chloride solution.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent, including authorization to release health information.&#xD;
&#xD;
          -  Male or female subjects 18 to 65 years of age with diagnosis of unilateral plantar&#xD;
             fasciitis.&#xD;
&#xD;
          -  Persistent heel pain.&#xD;
&#xD;
          -  Women of child bearing potential must have a negative pregnancy test at Screening and&#xD;
             Injection Visits and must use an effective method of contraception during the course&#xD;
             of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous injection of botulinum toxin in the lower extremities or feet.&#xD;
&#xD;
          -  Previously suffered a partial or full thickness tear or surgery of the plantar fascia&#xD;
             within the 5 years preceding participation in the investigation.&#xD;
&#xD;
          -  Pregnant, nursing, or planning a pregnancy during the study.&#xD;
&#xD;
          -  Current enrollment in an investigational drug or device study or participation in such&#xD;
             a study within the last 30 days prior to first visit.&#xD;
&#xD;
          -  Any condition or situation which, in the Investigator's opinion, puts the subject at&#xD;
             significant risk, could confound the trial results, or may interfere significantly&#xD;
             with the subject's participation in the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roman Rubio, MD</last_name>
    <role>Study Director</role>
    <affiliation>Revance Therapeutics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aung Foot Health Clinic</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sacramento Foot and Ankle Center, Inc</name>
      <address>
        <city>Carmichael</city>
        <state>California</state>
        <zip>95608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bay Area Foot Care</name>
      <address>
        <city>Castro Valley</city>
        <state>California</state>
        <zip>94546</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Coast Foot and Ankle</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>92648</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foot and Ankle Clinic</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bay Area Foot Care</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Foot and Ankle Foundation</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LA Podiatry Group</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Podiatry 1st</name>
      <address>
        <city>Belleville</city>
        <state>Illinois</state>
        <zip>62226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rosalind Franklin University of Medicine &amp; Science</name>
      <address>
        <city>North Chicago</city>
        <state>Illinois</state>
        <zip>60064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansas Institute of Research</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66211-1358</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Foot &amp; Ankle Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Research International</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Texas Institute of Neurology and Headache</name>
      <address>
        <city>Frisco</city>
        <state>Texas</state>
        <zip>75034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hermann Drive Research Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Futuro Clinical Trials, LLC</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Strash Foot and Ankle Care</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Podiatry Group of South Texas</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78295</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Foot and Ankle, LLC</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wasatch Clinical Research</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <disposition_first_submitted>February 11, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>February 11, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">February 12, 2021</disposition_first_posted>
  <last_update_submitted>February 11, 2021</last_update_submitted>
  <last_update_submitted_qc>February 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>DAXI for injection,</keyword>
  <keyword>Plantar Fasciitis,</keyword>
  <keyword>Heel Pain,</keyword>
  <keyword>BotulinumtoxinA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fasciitis</mesh_term>
    <mesh_term>Fasciitis, Plantar</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>June 2, 2023</submitted>
    <returned>June 26, 2023</returned>
    <submitted>August 24, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03825315
org study id: 1820201
nct id: NCT03825315
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, double-blind, placebo-controlled, parallel group, multi-center trial of
      a single administration of DaxibotulinumtoxinA (DAXI) (high-dose; low-dose) for injection
      versus placebo for the management of Plantar Fasciitis.
Approximately 150 subjects, recruited from approximately 20 study centers in the United
      States (US) will be randomized to DAXI (HIGH-dose; LOW-dose) or placebo group, respectively.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects will be randomly assigned to 1 of 3 treatment groups: DAXI for injection LOW dose, DAXI for injection HIGH dose, Placebo
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double Blinded
measure: Change from baseline in the Numeric Pain Rating Scale (NPRS) score
time frame: Week 8
description: Change from baseline in the Numeric Pain Rating Scale (NPRS) score (Scale Range: 0 {No pain} to 10 {Worst pain imaginable})
measure: Change from baseline in Foot Function Index (FFI)
time frame: All post treatment time points (approximately 6 months)
description: Change from baseline in Foot Function Index (FFI) (Pain Sub-Scale Range: 0 {No pain} to 10 {Worst pain imaginable}, Disability Sub-Scale Range: 0 {No difficulty} to 10 {So difficult unable to do so}, Activity Limitation Sub-Scale Range: 0 {None of the time} to 10 {All of the time})
measure: Moderate improvement on the Clinical Global Impression of Change (CGIC)
time frame: All post treatment time points (approximately 6 months)
description: Proportion of subjects with improvement on the Clinical Global Impression of Change (CGIC) over time
measure: Improvement on the the Patient Global Impression of Change (PGIC)
time frame: All post treatment time points (approximately 6 months)
description: Proportion of subjects with improvement on the Patient Global Impression of Change (PGIC) over time
arm group label: DAXI for Injection: LOW Dose
arm group type: Experimental
description: LOW Dose Group
arm group label: DAXI for Injection: HIGH Dose
arm group type: Experimental
description: HIGH Dose Group
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo Group.
intervention type: Biological
intervention name: DAXI for Injection: LOW Dose
description: DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.
arm group label: DAXI for Injection: LOW Dose
intervention type: Other
intervention name: DAXI for Injection: HIGH Dose
description: DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.
arm group label: DAXI for Injection: HIGH Dose
intervention type: Other
intervention name: Placebo
description: Placebo is a sterile lyophilized product consisting of inactive ingredients without the neurotoxin to be reconstituted with sterile, non-preserved 0.9% sodium chloride solution.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Roman Rubio, MD
role: Study Director
affiliation: Revance Therapeutics, Inc.
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country: United States
responsible party type: Sponsor
mesh term: Fasciitis
mesh term: Fasciitis, Plantar
sharing ipd: No
submitted: June 2, 2023
returned: June 26, 2023
submitted: August 24, 2023