<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/NCT01704209</url>
  </required_header>
  <id_info>
    <org_study_id>STU67333</org_study_id>
    <nct_id>NCT01704209</nct_id>
  </id_info>
  <brief_title>Collagen Injections for the Treatment of Acne Scars and Wrinkles</brief_title>
  <official_title>Pilot Study of Autologous Fibroblast Injection for Acne Scars, Forehead Lines, Lip Lines, Horizontal Neck Lines, and Static Crow's Feet</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find out if autologous (your own) fibroblast injections are&#xD;
      effective for the treatment of acne scars and wrinkles.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Company stopped making product for cosmetic use. All consented subjects withdrew before any&#xD;
    study interventions were performed.&#xD;
  </why_stopped>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline of rater's comparisons at 6 months</measure>
    <time_frame>Basline and 6 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Acne Scars</condition>
  <condition>Wrinkles</condition>
  <arm_group>
    <arm_group_label>Fibroblast Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The fibroblast treatment will be randomly injected into one side of the face.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The vehicle will be injected randomly to the other side of the face.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fibroblast Treatment</intervention_name>
    <arm_group_label>Fibroblast Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Vehicle</intervention_name>
    <arm_group_label>Vehicle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 or over&#xD;
&#xD;
          -  Bilateral acne scars or have moderate to severe wrinkles&#xD;
&#xD;
          -  Subjects in good health&#xD;
&#xD;
          -  Subjects has the willingness and the ability to understand and provide informed&#xD;
             consent for the use of their tissue and communicate with the investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years of age&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  recent Accutane use in the past 6 months&#xD;
&#xD;
          -  prone to hypertrophic and keloidal scarring&#xD;
&#xD;
          -  have excessively redundant skin in the treatment area or wrinkles longer than 20 cm&#xD;
             total&#xD;
&#xD;
          -  have a history of autoimmune disorders, organ transplantation, cancer not in&#xD;
             remission, active or chronic skin disease&#xD;
&#xD;
          -  have a history of basal-cell carcinoma&#xD;
&#xD;
          -  have previously received autologous fibroblast treatment&#xD;
&#xD;
          -  have undergone any confounding therapy in the lower two-thirds of the face within 1&#xD;
             year or any investigational treatment within 30 days.&#xD;
&#xD;
          -  have an allergy to collagen, bovine products, local anesthetics, gentamicin, or&#xD;
             amphotericin B&#xD;
&#xD;
          -  subjects who are unable to understand the protocol or to give informed consent&#xD;
&#xD;
          -  subjects with mental illness&#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>
  <overall_official>
    <last_name>Murad Alam, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University Feinberg School of Medicine, Department of Dermatology</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>December 2, 2021</last_update_submitted>
  <last_update_submitted_qc>December 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Murad Alam</investigator_full_name>
    <investigator_title>Professor in Dermatology, Otolaryngology- Head and Neck Surgery and Surgery-Organ Transplantation</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acne Vulgaris</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/NCT01704209
org study id: STU67333
nct id: NCT01704209
lead sponsor: 
has dmc: Yes
The purpose of this study is to find out if autologous (your own) fibroblast injections are
      effective for the treatment of acne scars and wrinkles.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change from baseline of rater's comparisons at 6 months
time frame: Basline and 6 months
arm group label: Fibroblast Treatment
arm group type: Experimental
description: The fibroblast treatment will be randomly injected into one side of the face.
arm group label: Vehicle
arm group type: Placebo Comparator
description: The vehicle will be injected randomly to the other side of the face.
intervention type: Drug
intervention name: Fibroblast Treatment
arm group label: Fibroblast Treatment
intervention type: Procedure
intervention name: Vehicle
arm group label: Vehicle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Murad Alam, MD
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Murad Alam
investigator title: Professor in Dermatology, Otolaryngology- Head and Neck Surgery and Surgery-Organ Transplantation
mesh term: Acne Vulgaris