<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/NCT01688063</url>
  </required_header>
  <id_info>
    <org_study_id>STU49554</org_study_id>
    <nct_id>NCT01688063</nct_id>
  </id_info>
  <brief_title>Skin Elasticity Measurements of the Face and Surgical Scars Stratified by Age and Skin Type</brief_title>
  <official_title>A Pilot Study of Skin Elasticity Measurements of the Face and Surgical Scars Stratified by Age and Skin Type</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 primary objective of Part A is to compare the change in elasticity measurements at&#xD;
      baseline and at 3 months between subjects who have had a resurfacing or tightening procedure&#xD;
      and those who have not. The secondary objective for Part A is to develop baseline elasticity&#xD;
      scores for ages 18-35, 36-50, and 51-65 and for Fitzpatrick skin types I-II, III-IV, and&#xD;
      V-VI. The primary objective of Part B is to compare the age of the scar and surrounding&#xD;
      tissue with the elasticity measurements.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Skin elasticity measurement of participant's scars</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Difference in skin elasticity measurements will be compared between subjects of varying ages at different anatomical sites: scarred sites, forehead, cheeks, mandible, and inner arm.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">35</enrollment>
  <condition>Skin Scarring</condition>
  <condition>Skin Elasticity</condition>
  <arm_group>
    <arm_group_label>Part A: 3 Arms</arm_group_label>
    <description>Subjects will be recruited and enrolled to fill one of three Arms. The first Arm will include 25 subjects who are scheduled to receive resurfacing or tightening procedures AS STANDARD OF CARE (CO2 resurfacing or tightening procedure (1 treatment), radiofrequency (2 tx), Fraxel ( 2 tx), or PDL. These subjects will have baseline elasticity measurements recorded on their face and right forearm before their procedures, and follow up measurements will be repeated 3 months following their last treatment. The second Arm will include 25 subjects who are not scheduled to receive any cosmetic procedures but who agree to return for repeated measurements 3 months following the first. Baseline elasticity measurements will be recorded from subjects' face and right forearm and subjects will return in 3 months for follow-up measurements. The third Arm will include the remaining 50 subjects; these subjects will have the elasticity measurements performed only once on their face and forearm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B</arm_group_label>
    <description>The study population in the second cohort will consist of 250 subjects who have a surgical scar &gt;2 cm in length. Subjects enrolled will have three elasticity measurements performed in one study visit. Elasticity will be measured directly in the center of the scar, 3cm perpendicular to the center of the scar, and 3cm in line from one end of the scar (Appendix 2).</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Up to 350 subjects who meet the inclusion/exclusion criteria for either study Part A, Part&#xD;
        B or both will be consented and enrolled with the goal of having 100 subjects complete Part&#xD;
        A and 250 subjects complete Part B. Subjects will be recruited from the Dermatology Clinic&#xD;
        at Northwestern University and other Northwestern University clinics.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Part A:&#xD;
&#xD;
          -  Subject is 18-65 years of age&#xD;
&#xD;
          -  Subject scheduled to have resurfacing or tightening procedure done as Standard of Care&#xD;
             (Arm 1, 25 subjects).&#xD;
&#xD;
          -  The subject 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;
        Part B:&#xD;
&#xD;
          -  Subject is 18 and over&#xD;
&#xD;
          -  Subject has a linear surgical scar that is &gt; 2cm.&#xD;
&#xD;
          -  The subject 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;
        Part A, Group 1:&#xD;
&#xD;
        -Subject is planning on having a cosmetic procedure done to their face during the 3 months&#xD;
        they are participating in the study (Arm 2, 25 subjects).&#xD;
&#xD;
        Parts A and B:&#xD;
&#xD;
          -  Under 18 years of age&#xD;
&#xD;
          -  Pregnancy or Lactation&#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>February 2023</verification_date>
  <study_first_submitted>August 15, 2011</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>February 17, 2023</last_update_submitted>
  <last_update_submitted_qc>February 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</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>
  <keyword>Skin Elasticity</keyword>
  <keyword>Scar Elasticity</keyword>
  <keyword>Cutometer</keyword>
  <keyword>Dermal Torque Meter</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cicatrix</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/NCT01688063
org study id: STU49554
nct id: NCT01688063
lead sponsor: 
has dmc: Yes
The primary objective of Part A is to compare the change in elasticity measurements at
      baseline and at 3 months between subjects who have had a resurfacing or tightening procedure
      and those who have not. The secondary objective for Part A is to develop baseline elasticity
      scores for ages 18-35, 36-50, and 51-65 and for Fitzpatrick skin types I-II, III-IV, and
      V-VI. The primary objective of Part B is to compare the age of the scar and surrounding
      tissue with the elasticity measurements.
observational model: Cohort
time perspective: Retrospective
measure: Skin elasticity measurement of participant's scars
time frame: up to 3 months
description: Difference in skin elasticity measurements will be compared between subjects of varying ages at different anatomical sites: scarred sites, forehead, cheeks, mandible, and inner arm.
arm group label: Part A: 3 Arms
description: Subjects will be recruited and enrolled to fill one of three Arms. The first Arm will include 25 subjects who are scheduled to receive resurfacing or tightening procedures AS STANDARD OF CARE (CO2 resurfacing or tightening procedure (1 treatment), radiofrequency (2 tx), Fraxel ( 2 tx), or PDL. These subjects will have baseline elasticity measurements recorded on their face and right forearm before their procedures, and follow up measurements will be repeated 3 months following their last treatment. The second Arm will include 25 subjects who are not scheduled to receive any cosmetic procedures but who agree to return for repeated measurements 3 months following the first. Baseline elasticity measurements will be recorded from subjects' face and right forearm and subjects will return in 3 months for follow-up measurements. The third Arm will include the remaining 50 subjects; these subjects will have the elasticity measurements performed only once on their face and forearm.
arm group label: Part B
description: The study population in the second cohort will consist of 250 subjects who have a surgical scar >2 cm in length. Subjects enrolled will have three elasticity measurements performed in one study visit. Elasticity will be measured directly in the center of the scar, 3cm perpendicular to the center of the scar, and 3cm in line from one end of the scar (Appendix 2).
study pop: 
sampling method: Non-Probability Sample
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: Cicatrix