<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/NCT03775031</url>
  </required_header>
  <id_info>
    <org_study_id>2018P001770</org_study_id>
    <nct_id>NCT03775031</nct_id>
  </id_info>
  <brief_title>Chemical Peels and Fractional Laser on IGF-1 Levels in Skin</brief_title>
  <official_title>Impact of Chemical Peels and Fractional Laser on IGF-1 Levels in Skin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</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>
      The purpose of this study is to evaluate the impact of fractional laser versus chemical peels&#xD;
      on IGF-1 levels in skin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed to assess the feasibility of using a fractional non ablative laser and&#xD;
      chemical peels to wound skin, and thereby elicit a change in IGF-1. Our hypothesis is that&#xD;
      fractional non ablative laser and a TCA chemical peel can induce similar effects as the&#xD;
      fractional ablative laser at three months. In other words, our theory is that these&#xD;
      approaches can stimulate the production of IGF-1 in older skin and restore UV damage repair&#xD;
      and response mechanisms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2019</start_date>
  <completion_date type="Anticipated">July 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2021</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>Single Group Assignment</intervention_model>
    <intervention_model_description>Randomized-Controlled (Subjects will serve as their own control)</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IGF-1 Levels</measure>
    <time_frame>3 months</time_frame>
    <description>To quantify IGF-1 levels in skin</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Skin Cancer</condition>
  <arm_group>
    <arm_group_label>Fraxel 1927nm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment setting for Fraxel 1927 nm: 20 mJ, Treatment level 8, 6 passes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fraxel 1550nm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment setting for Fraxel 1550 nm: 70 mJ, Treatment level 6, 6 passes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>25% TCA Peel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>25% TCA on 5 x 5 cm of sun exposed back</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patient serves as their own control</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fractional Laser and Chemical Peel</intervention_name>
    <description>Fractional 1927 nm Laser, Fractional 1550 nm Laser, and 25% TCA (trichloroacetic acid) peel</description>
    <arm_group_label>25% TCA Peel</arm_group_label>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Fraxel 1550nm</arm_group_label>
    <arm_group_label>Fraxel 1927nm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects &gt;55 years old&#xD;
&#xD;
          -  Fitzpatrick type I-II&#xD;
&#xD;
          -  Able to provide informed consent.&#xD;
&#xD;
          -  Cutaneous photodamage of 3 or above on the Larnier photodamage scale (see Appendix).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior laser or peel treatment in the area evaluated in the current study in the past&#xD;
             year.&#xD;
&#xD;
          -  Currently taking immunosuppressant medications known to interfere wound healing or&#xD;
             anti-inflammatory medications (such as NSAIDs, or steroids).&#xD;
&#xD;
          -  Subjects who have underlying diseases that could alter wound healing response (such as&#xD;
             Diabetes).&#xD;
&#xD;
          -  Currently taking insulin.&#xD;
&#xD;
          -  History of substance abuse, mental dysfunction, or other factors limiting ability to&#xD;
             cooperate with study.&#xD;
&#xD;
          -  History of abnormal scarring such as Keloids.&#xD;
&#xD;
          -  History of vitiligo.&#xD;
&#xD;
          -  Allergy or sensitivity or allergy to topical anesthesia&#xD;
&#xD;
          -  Inability to use sunscreen.&#xD;
&#xD;
          -  History of smoking in the last 10 years&#xD;
&#xD;
          -  Scar or prior surgery in the area of treatment.&#xD;
&#xD;
          -  Use of isotretinoin in the prior 6 months&#xD;
&#xD;
          -  Subjects who have bleeding disorders or who are taking anticoagulants&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Molly Wanner, MD</last_name>
    <phone>617-726-5066</phone>
    <email>mwanner@mgh.harvard.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Massachusetts General Hospital Clinical Unit for Research Trials and Outcomes in Skin</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Molly Wanner</last_name>
      <phone>617-726-5066</phone>
      <email>harvardskinstudies@partners.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>October 19, 2020</last_update_submitted>
  <last_update_submitted_qc>October 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Molly A. Wanner, MD</investigator_full_name>
    <investigator_title>Dermatologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Skin Neoplasms</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/NCT03775031
org study id: 2018P001770
nct id: NCT03775031
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the impact of fractional laser versus chemical peels
      on IGF-1 levels in skin.
This study is designed to assess the feasibility of using a fractional non ablative laser and
      chemical peels to wound skin, and thereby elicit a change in IGF-1. Our hypothesis is that
      fractional non ablative laser and a TCA chemical peel can induce similar effects as the
      fractional ablative laser at three months. In other words, our theory is that these
      approaches can stimulate the production of IGF-1 in older skin and restore UV damage repair
      and response mechanisms.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: Randomized-Controlled (Subjects will serve as their own control)
primary purpose: Prevention
masking: None (Open Label)
measure: IGF-1 Levels
time frame: 3 months
description: To quantify IGF-1 levels in skin
arm group label: Fraxel 1927nm
arm group type: Active Comparator
description: Treatment setting for Fraxel 1927 nm: 20 mJ, Treatment level 8, 6 passes
arm group label: Fraxel 1550nm
arm group type: Active Comparator
description: Treatment setting for Fraxel 1550 nm: 70 mJ, Treatment level 6, 6 passes
arm group label: 25% TCA Peel
arm group type: Active Comparator
description: 25% TCA on 5 x 5 cm of sun exposed back
arm group label: Control
arm group type: Placebo Comparator
description: Patient serves as their own control
intervention type: Device
intervention name: Fractional Laser and Chemical Peel
description: Fractional 1927 nm Laser, Fractional 1550 nm Laser, and 25% TCA (trichloroacetic acid) peel
arm group label: 25% TCA Peel
arm group label: Control
arm group label: Fraxel 1550nm
arm group label: Fraxel 1927nm
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Molly Wanner, MD
phone: 617-726-5066
email: mwanner@mgh.harvard.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Molly A. Wanner, MD
investigator title: Dermatologist
mesh term: Skin Neoplasms
sharing ipd: No