<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/NCT01705860</url>
  </required_header>
  <id_info>
    <org_study_id>017-101-09-032</org_study_id>
    <nct_id>NCT01705860</nct_id>
  </id_info>
  <brief_title>Long Term Follow Up to Determine the Effects of Collagenase SANTYL Ointment on Scar Formation</brief_title>
  <official_title>A Long Term Follow-Up to Study 017-101-09-001: Effect of Collagenase Santyl® Ointment vs. Placebo on Healing and Scarring Characteristics of 600um Dermatome Wounds</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Healthpoint</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Healthpoint</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study will evaluate the long term effects on scar formation for dermatome-induced&#xD;
      skin wounds treated with Collagenase Santyl® Ointment or vehicle (white petrolatum ointment)&#xD;
      alone. The previous study, 017-101-09-001, utilized a small, experimental, cutaneous wound to&#xD;
      evaluate both time to complete wound closure and quality of the resulting scar when&#xD;
      Collagenase Santyl® Ointment was used to treat the wound.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Scar Assessment</measure>
    <time_frame>1 Day</time_frame>
    <description>Vancouver Scar Scale assessment of dermatome wounds previously treated with Santyl Ointment or White Petrolatum</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Scar Quality</measure>
    <time_frame>1 Day</time_frame>
    <description>Quality of scars over time will be assessed with the BTC-2000 instrument assessment</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">12</enrollment>
  <condition>Follow up to Acute Wound Scar Study</condition>
  <arm_group>
    <arm_group_label>Assessment</arm_group_label>
    <description>All subjects will receive same assessments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Santyl</intervention_name>
    <arm_group_label>Assessment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy adult volunteers who were previously treated in study 017-101-09-001 with&#xD;
        Collagenase Santyl Ointment and Vehicle (white petrolatum ointment).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects will be considered qualified for enrollment if they participated in the&#xD;
             Collagenase Santyl® Ointment Study 017 101-09-001 and provide written informed&#xD;
             consent.&#xD;
&#xD;
          -  The informed consent document must be read, signed, and dated by the suubject before&#xD;
             conducting any study procedures or exams. In addition, the informed consent document&#xD;
             must be signed and dated by the individual who consents the subject. A photocopy of&#xD;
             the signed informed consent document must be provided to the subject and the original&#xD;
             signed document placed in the subject's chart.&#xD;
&#xD;
          -  Subject participated in the 017-101-09-001 study and received at least one application&#xD;
             of a test article, whether Collagenase Santyl® Ointment or White Petrolatum.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  N/A&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Herbert B Slade, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Healthpoint</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shai Rozen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas Southwestern Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>April 11, 2013</last_update_submitted>
  <last_update_submitted_qc>April 11, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 15, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Collagen, collagenase, scar</keyword>
  <pending_results>
    <submitted>September 13, 2016</submitted>
    <returned>October 31, 2016</returned>
  </pending_results>
  <!-- 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/NCT01705860
org study id: 017-101-09-032
nct id: NCT01705860
lead sponsor: 
has dmc: No
The present study will evaluate the long term effects on scar formation for dermatome-induced
      skin wounds treated with Collagenase Santyl® Ointment or vehicle (white petrolatum ointment)
      alone. The previous study, 017-101-09-001, utilized a small, experimental, cutaneous wound to
      evaluate both time to complete wound closure and quality of the resulting scar when
      Collagenase Santyl® Ointment was used to treat the wound.
time perspective: Prospective
measure: Scar Assessment
time frame: 1 Day
description: Vancouver Scar Scale assessment of dermatome wounds previously treated with Santyl Ointment or White Petrolatum
measure: Scar Quality
time frame: 1 Day
description: Quality of scars over time will be assessed with the BTC-2000 instrument assessment
arm group label: Assessment
description: All subjects will receive same assessments.
intervention type: Biological
intervention name: Santyl
arm group label: Assessment
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Herbert B Slade, MD
role: Study Chair
affiliation: Healthpoint
last name: Shai Rozen, MD
role: Principal Investigator
affiliation: University of Texas Southwestern Medical Center
facility: 
country: United States
responsible party type: Sponsor
submitted: September 13, 2016
returned: October 31, 2016