<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/NCT02218788</url>
  </required_header>
  <id_info>
    <org_study_id>Hydroxytite p100:2013</org_study_id>
    <nct_id>NCT02218788</nct_id>
  </id_info>
  <brief_title>Injectable Filler for Facial Soft Tissue Augmentation</brief_title>
  <official_title>An Open-label, Retrospective, Postmarketing Study of Safety and Performance of Hydroxytite, a Calcium Hydroxyapatite Based Filler for Facial Soft Tissue Augmentation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Panaxia Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Panaxia Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and performance of Hydroxytite in all&#xD;
      subjects who have received sub dermal or deep dermal injections.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2013</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">November 2017</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To assess the safety of Hydroxytite (Crystalys) in subjects who received subdermal or deep-dermal injections</measure>
    <time_frame>6 months</time_frame>
    <description>Adverse events or Serious adverse events, Injection site reactions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Performance</measure>
    <time_frame>6 months</time_frame>
    <description>To give a score, using the LRS, to Hydroxytite treatment compared to patient's baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance</measure>
    <time_frame>6 months</time_frame>
    <description>To give a score, using the Global Aesthetic Improvement Scale (GAIS), to Hydroxytite treatment compared to patient's baseline</description>
  </secondary_outcome>
  <enrollment type="Actual">218</enrollment>
  <condition>Wrinkles</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients treated with Hydroxytite, above the age of 18&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is over 18 years of age&#xD;
&#xD;
          -  Patient received Hydroxytite injection(s).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Patient declines to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>July 31, 2019</last_update_submitted>
  <last_update_submitted_qc>July 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nasolabial folds</keyword>
  <keyword>Marionette lines</keyword>
  <keyword>Cheek bones</keyword>
  <keyword>Jaw lines</keyword>
  <!-- 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/NCT02218788
org study id: Hydroxytite p100:2013
nct id: NCT02218788
lead sponsor: 
has dmc: No
The purpose of this study is to assess the safety and performance of Hydroxytite in all
      subjects who have received sub dermal or deep dermal injections.
observational model: Cohort
time perspective: Retrospective
measure: To assess the safety of Hydroxytite (Crystalys) in subjects who received subdermal or deep-dermal injections
time frame: 6 months
description: Adverse events or Serious adverse events, Injection site reactions.
measure: Performance
time frame: 6 months
description: To give a score, using the LRS, to Hydroxytite treatment compared to patient's baseline
measure: Performance
time frame: 6 months
description: To give a score, using the Global Aesthetic Improvement Scale (GAIS), to Hydroxytite treatment compared to patient's baseline
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor