<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/NCT03284021</url>
  </required_header>
  <id_info>
    <org_study_id>STU00205107</org_study_id>
    <nct_id>NCT03284021</nct_id>
  </id_info>
  <brief_title>Fraxel Laser for Alopecia</brief_title>
  <official_title>A Pilot Study on 1550 nm Fractional Erbium-glass Laser for Alopecia Treatment</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>
    <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 pilot study to evaluate the effect of the 1550 nm fractional erbium-glass laser in&#xD;
      patients with nonscarring alopecias. Participants currently living in the Chicago&#xD;
      metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.&#xD;
      Participants will receive 5 sessions of laser, 30 days apart, to the area of alopecia on the&#xD;
      scalp. Follow-up is at 150 days.&#xD;
&#xD;
      This study was a pilot study designed to determine feasibility of this procedure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The study did not start.&#xD;
  </why_stopped>
  <start_date type="Anticipated">April 24, 2019</start_date>
  <completion_date type="Anticipated">April 24, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 24, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical change of alopecia from baseline to 150 days.</measure>
    <time_frame>Baseline and 150 Days</time_frame>
    <description>Outcome assessors will measure clinical change using the Jaeschke scale, a 15 point scale that describes how worse or better the condition is.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Alopecia</condition>
  <arm_group>
    <arm_group_label>Fraxel laser</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fractional erbium-glass 1550 nm laser</intervention_name>
    <description>The fractional erbium-glass 1550 nm laser will be applied to the previously 100 cm2 determined area of the scalp with the following parameters: 5-10 mm tip, 5-10 mJ, pulse energy 500-1500 MTZ/cm2 density, one to twopasses, static mode.</description>
    <arm_group_label>Fraxel laser</arm_group_label>
    <other_name>Fraxel RE:STORE</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females ≥ 18 years old&#xD;
&#xD;
          2. Subjects are in good health as judged by the investigator.&#xD;
&#xD;
          3. Diagnosed by a dermatologist with mild to moderate androgenetic alopecia or alopecia&#xD;
             areata.&#xD;
&#xD;
          4. Subject is seeking treatment for alopecia.&#xD;
&#xD;
          5. Subject has never previously used finasteride or minoxidil or has consistently used&#xD;
             finasteride or minoxidil for at least 1 year.&#xD;
&#xD;
          6. Subjects who are willing and have the ability to understand and provide informed&#xD;
             consent for participation in the study and are able to communicate with the&#xD;
             investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Evidence of another skin condition affecting the treatment area that would interfere&#xD;
             with clinical assessments.&#xD;
&#xD;
          2. Subjects who are unwilling to avoid initiating treatment with minoxidil or finasteride&#xD;
             for the duration of the study; or in subjects who have been treated with minoxidil or&#xD;
             finasteride for at least 1 year, unwilling to avoid changes in the dosing regimen of&#xD;
             these medications for the duration of the study.&#xD;
&#xD;
          3. Willing to refrain from washing hair or using hair product 24 hours before and after&#xD;
             treatment visits&#xD;
&#xD;
          4. History of recurrent facial or labial herpes simplex infection&#xD;
&#xD;
          5. History of hypertrophic scars or keloids&#xD;
&#xD;
          6. Subjects who have any requirement for the use of local or systemic steroids or other&#xD;
             immunosuppressive agent&#xD;
&#xD;
          7. Pregnant or breast feeding&#xD;
&#xD;
          8. Uncooperative patients or patients with neurological disorders who are incapable of&#xD;
             following directions or who are predictably unwilling to return for follow-up&#xD;
             examinations.&#xD;
&#xD;
          9. Subjects who are unable to understand the protocol or give informed consent.&#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 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 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</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</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alopecia</mesh_term>
    <mesh_term>Alopecia Areata</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/NCT03284021
org study id: STU00205107
nct id: NCT03284021
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a pilot study to evaluate the effect of the 1550 nm fractional erbium-glass laser in
      patients with nonscarring alopecias. Participants currently living in the Chicago
      metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.
      Participants will receive 5 sessions of laser, 30 days apart, to the area of alopecia on the
      scalp. Follow-up is at 150 days.

      This study was a pilot study designed to determine feasibility of this procedure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical change of alopecia from baseline to 150 days.
time frame: Baseline and 150 Days
description: Outcome assessors will measure clinical change using the Jaeschke scale, a 15 point scale that describes how worse or better the condition is.
arm group label: Fraxel laser
arm group type: Other
intervention type: Device
intervention name: Fractional erbium-glass 1550 nm laser
description: The fractional erbium-glass 1550 nm laser will be applied to the previously 100 cm2 determined area of the scalp with the following parameters: 5-10 mm tip, 5-10 mJ, pulse energy 500-1500 MTZ/cm2 density, one to twopasses, static mode.
arm group label: Fraxel laser
other name: Fraxel RE:STORE
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
mesh term: Alopecia
mesh term: Alopecia Areata
sharing ipd: No