<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/NCT03306628</url>
  </required_header>
  <id_info>
    <org_study_id>17-01153</org_study_id>
    <nct_id>NCT03306628</nct_id>
  </id_info>
  <brief_title>Early Carbon Dioxide Laser Therapy for Alleviation of Incisional Scar Burden</brief_title>
  <official_title>Early Carbon Dioxide Laser Therapy for Alleviation of Incisional Scar Burden</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, randomized pilot study of patients who will undergo either early or&#xD;
      late incisional laser therapy after breast reduction surgery to alleviate scar burden at NYU&#xD;
      Langone Medical Center. The purpose of this study is to see how well carbon dioxide (CO2)&#xD;
      laser therapy works at preventing scar formation after surgery.CO2 laser therapy is currently&#xD;
      being used by dermatologists and plastic surgeons to help with scarring after acne and to&#xD;
      rejuvenate the face; its benefits are now being explored by medical professionals in&#xD;
      dermatology and cosmetic surgery to prevent scarring after surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Dr. Hazen is no longer full-time faculty / was not able to find an appropriate PI to take over&#xD;
    study.&#xD;
  </why_stopped>
  <start_date type="Actual">November 15, 2017</start_date>
  <completion_date type="Anticipated">August 26, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 26, 2019</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Vancouver Scar Scale Score</measure>
    <time_frame>1 Week to Post Laser 1-Year</time_frame>
    <description>Total of score of each measure below:&#xD;
Pigmentation (0-2) Normal 0 Hypopigmentation 1 Hyperpigmentation 2&#xD;
Vascularity (0-3) Normal 0 Pink 1 Red 2 Purple 3&#xD;
Pliability (0-5) Normal 0 Supple 1 Yielding 2 Firm 3 Banding 4 Contracture 5&#xD;
Height (0-3) Normal (flat) 0 0-2 mm 1 2-5 mm 2 &gt;5 mm 3</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Skin Scarring</condition>
  <arm_group>
    <arm_group_label>Early Laser Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>a group which will receive laser therapy to one breast incision at the first post-operative visit</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Late Laser Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>a group which will receive laser therapy to one breast incision 6 weeks after surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CO2 Laser Administration</intervention_name>
    <description>The CO2 fractional laser system will be applied at a pulse energy setting of 50 millijoules and a density of 100 spots/cm2 on one of the breast incisions (either one week after surgery or six weeks after surgery, depending on the randomization group).</description>
    <arm_group_label>Early Laser Therapy</arm_group_label>
    <arm_group_label>Late Laser Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of all ethnic origins will be considered, although certain ethnic groups will&#xD;
             be preferentially excluded more than others such as black and South Asian patients due&#xD;
             to our exclusion criteria related to darker skin individuals (see below).&#xD;
&#xD;
          -  Patients undergoing bilateral breast reduction surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Males will be excluded from this study as male patients rarely undergo breast&#xD;
             reduction surgery. When males do undergo breast reduction surgery for gynecomastia, it&#xD;
             is often unilateral, and is performed with several techniques and incision types that&#xD;
             are not typical employed during female breast reduction. Thus, for this study, only&#xD;
             female patients will be considered (see below).&#xD;
&#xD;
          -  Any patient enrolled in this study who shows evidence of delayed wound healing,&#xD;
             dehiscence, or post operative infection at the first post operative visit will be&#xD;
             excluded&#xD;
&#xD;
          -  Patients with darker skin (Fitzpatrick IV and above), which is a well-known&#xD;
             contraindication to laser therapy&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Patients who have had prior breast surgery&#xD;
&#xD;
          -  Patients who have had prior chest/breast irradiation&#xD;
&#xD;
          -  Patients with the following diseases which interferes with wound healing: prior&#xD;
             hypertrophic scarring/keloids, type I or type II Diabetes Mellitus, autoimmune&#xD;
             diseases/collagen vascular diseases&#xD;
&#xD;
          -  Patients who are active smokers&#xD;
&#xD;
          -  Patients using blood thinners that cannot be stopped&#xD;
&#xD;
          -  Patients who have used aspirin within a week of the procedure date&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexes Hazen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>January 2, 2020</last_update_submitted>
  <last_update_submitted_qc>January 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Skin Scarring</keyword>
  <keyword>keloids</keyword>
  <keyword>hypertrophic scars</keyword>
  <keyword>CO2 laser therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cicatrix</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03306628
org study id: 17-01153
nct id: NCT03306628
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective, randomized pilot study of patients who will undergo either early or
      late incisional laser therapy after breast reduction surgery to alleviate scar burden at NYU
      Langone Medical Center. The purpose of this study is to see how well carbon dioxide (CO2)
      laser therapy works at preventing scar formation after surgery.CO2 laser therapy is currently
      being used by dermatologists and plastic surgeons to help with scarring after acne and to
      rejuvenate the face; its benefits are now being explored by medical professionals in
      dermatology and cosmetic surgery to prevent scarring after surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in Vancouver Scar Scale Score
time frame: 1 Week to Post Laser 1-Year
description: Total of score of each measure below:
Pigmentation (0-2) Normal 0 Hypopigmentation 1 Hyperpigmentation 2
Vascularity (0-3) Normal 0 Pink 1 Red 2 Purple 3
Pliability (0-5) Normal 0 Supple 1 Yielding 2 Firm 3 Banding 4 Contracture 5
Height (0-3) Normal (flat) 0 0-2 mm 1 2-5 mm 2 >5 mm 3
arm group label: Early Laser Therapy
arm group type: Experimental
description: a group which will receive laser therapy to one breast incision at the first post-operative visit
arm group label: Late Laser Therapy
arm group type: Experimental
description: a group which will receive laser therapy to one breast incision 6 weeks after surgery
intervention type: Other
intervention name: CO2 Laser Administration
description: The CO2 fractional laser system will be applied at a pulse energy setting of 50 millijoules and a density of 100 spots/cm2 on one of the breast incisions (either one week after surgery or six weeks after surgery, depending on the randomization group).
arm group label: Early Laser Therapy
arm group label: Late Laser Therapy
criteria: 
gender: Female
gender based: Yes
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: No
last name: Alexes Hazen, MD
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cicatrix
sharing ipd: No