<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/NCT04429607</url>
  </required_header>
  <id_info>
    <org_study_id>STU00211739</org_study_id>
    <nct_id>NCT04429607</nct_id>
  </id_info>
  <brief_title>Treatment of Sebaceous Hyperplasia With PDL and Nd:YAG Versus Erbium:YAG: A Randomized Controlled Trial</brief_title>
  <official_title>Treatment of Sebaceous Hyperplasia With PDL and Nd:YAG Versus Erbium:YAG: A Randomized Controlled Trial</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>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare treatment of sebaceous hyperplasia with pulsed dye&#xD;
      laser (PDL) plus neodymium doped yttrium aluminum garnet laser (Nd:YAG) versus erbium doped&#xD;
      yttrium aluminum garnet (erbium:YAG) laser versus electrodesiccation and curettage (ED&amp;C).&#xD;
&#xD;
      This is a randomized clinical trial. Approximately 18 participants will enrolled. Each&#xD;
      participant will have their sebaceous hyperplasia lesions randomized to receive either&#xD;
      Erbium:YAG, PDL plus Nd:YAG, or ED&amp;C treatment. Solitary lesions will be randomized to a&#xD;
      group, thus, a patient may receive all three treatments, each on different lesions. Lesions&#xD;
      will be treated twice, 2-6 weeks after the first treatment. Lesion size and count will be&#xD;
      measured before treatment and at follow-up 4-12 weeks after the first treatment. This study&#xD;
      is a pilot study designed to determine the feasibility of these procedures.&#xD;
&#xD;
      Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion&#xD;
      criteria will be considered for enrollment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">December 2023</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <phase>Phase 2</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in size of sebaceous hyperplasia</measure>
    <time_frame>4-12 weeks</time_frame>
    <description>Change in size of sebaceous hyperplasia from baseline to 4-12 weeks after first treatment by measuring length and width in mm of each lesion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in sebaceous hyperplasia lesion count</measure>
    <time_frame>4-12 weeks</time_frame>
    <description>Change in sebaceous hyperplasia lesion count from baseline to 4-12 weeks after first treatment</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Sebaceous Hyperplasia</condition>
  <arm_group>
    <arm_group_label>Erbium:YAG Laser</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Solitary lesions will be randomized to a group, thus, a patient may receive all three treatments, each on different lesions. Patients will undergo two total treatment sessions at 2-6 week intervals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PDL plus Nd:YAG</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Solitary lesions will be randomized to a group, thus, a patient may receive all three treatments, each on different lesions. Patients will undergo two total treatment sessions at 2-6 week intervals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ED&amp;C treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Solitary lesions will be randomized to a group, thus, a patient may receive all three treatments, each on different lesions. Patients will undergo two total treatment sessions at 2-6 week intervals.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Erbium:YAG Laser</intervention_name>
    <description>Erbium:YAG 2940nm will be performed using single spot, multiple pulses on lesions.</description>
    <arm_group_label>Erbium:YAG Laser</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pulsed Dye Laser</intervention_name>
    <description>PDL will be performed using settings of 6-10 J/s2 on lesions.</description>
    <arm_group_label>PDL plus Nd:YAG</arm_group_label>
    <other_name>PDL</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nd:YAG Laser</intervention_name>
    <description>Nd:YAG 1064nm will be performed using settings of 60-110 J/s2 on lesions.</description>
    <arm_group_label>PDL plus Nd:YAG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Electrodessication and curettage</intervention_name>
    <description>Electrodessication and curettage will be performed using an epilating needle, followed by curettage on lesions.</description>
    <arm_group_label>ED&amp;C treatment</arm_group_label>
    <other_name>ED&amp;C</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ≥18 years of age&#xD;
&#xD;
          2. Receiving cosmetic treatment for sebaceous hyperplasia&#xD;
&#xD;
          3. In good general health as assessed by the investigator&#xD;
&#xD;
          4. Participants must have the ability to understand and the willingness to sign a written&#xD;
             informed consent prior to registration on study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient pregnant or nursing&#xD;
&#xD;
          2. Patient with history of poor wound healing that would result in hypertrophic scar or&#xD;
             keloid at the discretion of the physician&#xD;
&#xD;
          3. Patient with recent sun exposure that would result in pigment changes at the&#xD;
             discretion of the physician&#xD;
&#xD;
          4. Subject unwilling to sign an IRB approved consent form&#xD;
&#xD;
          5. Participants who are unable to communicate or cooperate with the investigator due to&#xD;
             language problems, poor mental development, or impaired cerebral function are not&#xD;
             eligible&#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>
  <overall_contact>
    <last_name>Alejandra Onate, M.S.</last_name>
    <phone>312-695-6647</phone>
    <email>onate@northwestern.edu</email>
  </overall_contact>
  <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>
    <contact>
      <last_name>Alejandra Onate, M.S.</last_name>
      <phone>312-695-6647</phone>
      <email>onate@northwestern.edu</email>
    </contact>
    <investigator>
      <last_name>Murad Alam, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</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 of Dermatology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperplasia</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/NCT04429607
org study id: STU00211739
nct id: NCT04429607
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this study is to compare treatment of sebaceous hyperplasia with pulsed dye
      laser (PDL) plus neodymium doped yttrium aluminum garnet laser (Nd:YAG) versus erbium doped
      yttrium aluminum garnet (erbium:YAG) laser versus electrodesiccation and curettage (ED&C).

      This is a randomized clinical trial. Approximately 18 participants will enrolled. Each
      participant will have their sebaceous hyperplasia lesions randomized to receive either
      Erbium:YAG, PDL plus Nd:YAG, or ED&C treatment. Solitary lesions will be randomized to a
      group, thus, a patient may receive all three treatments, each on different lesions. Lesions
      will be treated twice, 2-6 weeks after the first treatment. Lesion size and count will be
      measured before treatment and at follow-up 4-12 weeks after the first treatment. This study
      is a pilot study designed to determine the feasibility of these procedures.

      Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion
      criteria will be considered for enrollment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in size of sebaceous hyperplasia
time frame: 4-12 weeks
description: Change in size of sebaceous hyperplasia from baseline to 4-12 weeks after first treatment by measuring length and width in mm of each lesion.
measure: Change in sebaceous hyperplasia lesion count
time frame: 4-12 weeks
description: Change in sebaceous hyperplasia lesion count from baseline to 4-12 weeks after first treatment
arm group label: Erbium:YAG Laser
arm group type: Active Comparator
description: Solitary lesions will be randomized to a group, thus, a patient may receive all three treatments, each on different lesions. Patients will undergo two total treatment sessions at 2-6 week intervals.
arm group label: PDL plus Nd:YAG
arm group type: Active Comparator
description: Solitary lesions will be randomized to a group, thus, a patient may receive all three treatments, each on different lesions. Patients will undergo two total treatment sessions at 2-6 week intervals.
arm group label: ED&C treatment
arm group type: Active Comparator
description: Solitary lesions will be randomized to a group, thus, a patient may receive all three treatments, each on different lesions. Patients will undergo two total treatment sessions at 2-6 week intervals.
intervention type: Device
intervention name: Erbium:YAG Laser
description: Erbium:YAG 2940nm will be performed using single spot, multiple pulses on lesions.
arm group label: Erbium:YAG Laser
intervention type: Device
intervention name: Pulsed Dye Laser
description: PDL will be performed using settings of 6-10 J/s2 on lesions.
arm group label: PDL plus Nd:YAG
other name: PDL
intervention type: Device
intervention name: Nd:YAG Laser
description: Nd:YAG 1064nm will be performed using settings of 60-110 J/s2 on lesions.
arm group label: PDL plus Nd:YAG
intervention type: Procedure
intervention name: Electrodessication and curettage
description: Electrodessication and curettage will be performed using an epilating needle, followed by curettage on lesions.
arm group label: ED&C treatment
other name: ED&C
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
last name: Alejandra Onate, M.S.
phone: 312-695-6647
email: onate@northwestern.edu
facility: 
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Murad Alam
investigator title: Professor of Dermatology
mesh term: Hyperplasia
sharing ipd: No