<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/NCT04466527</url>
  </required_header>
  <id_info>
    <org_study_id>2020P000838</org_study_id>
    <nct_id>NCT04466527</nct_id>
  </id_info>
  <brief_title>Laser Treatment of Moderate to Severe Acne Vulgaris</brief_title>
  <official_title>Laser Treatment for the Clinical Improvement of Acne Vulgaris: A Self-Controlled Trial</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>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, we are enrolling subjects with moderate to severe acne vulgaris and&#xD;
      investigating the use of a commercially available laser in treating acne.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 20, 2021</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2023</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>Changes in Physician's Global Assessment (PGA) of Acne Severity</measure>
    <time_frame>Change in PGA score between baseline visit and post procedural visit</time_frame>
    <description>The physician will score the acne vulgaris based on the Physician's Global Assessment (PGA) scale. A score of 0 indicates that residual hyperpigmentation and erythema may be present; a score of 1 indicates that there are a few scattered comedones and a few small papules; a score of 3 indicates that more than half of the face is involved, that there are many comedones, papules, and pustules, and that one nodule may be present; a score of 4 indicates that the entire face is involved, covered with comedones, numerous papules and pustules, and a few nodules and cysts. The change in PGA score will be recorded at each of the 4 study visits, for up to</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">22</enrollment>
  <condition>Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this arm will undergo laser treatment on their active acne vulgaris lesions. Subjects will serve as their own control.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laser Intervention</intervention_name>
    <description>Subjects with undergo laser exposure of their active acne vulgaris.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject must be able and willing to provide written informed consent and comply with&#xD;
             the requirements of the study protocol;&#xD;
&#xD;
          2. In good general health, based on answers provided during the screening visit;&#xD;
&#xD;
          3. Subject must be able to read and understand English;&#xD;
&#xD;
          4. Any gender and any Fitzpatrick skin type;&#xD;
&#xD;
          5. Ages 18 through 40;&#xD;
&#xD;
          6. Subjects must have moderate to severe nodular active facial acne vulgaris (PGA 3 or 4)&#xD;
&#xD;
          7. Willing to sun protect treated area for the duration of enrollment in the study and 1&#xD;
             year after treatment;&#xD;
&#xD;
          8. Subjects must be ineligible for or have declined standard of care treatments (e.g.&#xD;
             oral isotretinoin therapy).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participation in another investigational drug or device clinical trial in the past 30&#xD;
             days;&#xD;
&#xD;
          2. Currently undergoing or wish to begin or continue topical treatments;&#xD;
&#xD;
          3. Are pregnant or lactating;&#xD;
&#xD;
          4. History of allergic reaction to topical anesthesia;&#xD;
&#xD;
          5. Subjects may not have undergone oral isotretinoin therapy within the past 12 months;&#xD;
&#xD;
          6. Currently take oral antibiotic or oral therapy for acne;&#xD;
&#xD;
          7. History of keloidal or hypertrophic scarring;&#xD;
&#xD;
          8. Laser treatment in past six months;&#xD;
&#xD;
          9. History of poor wound healing;&#xD;
&#xD;
         10. Clinically significant abnormal findings or conditions which might, in the opinion of&#xD;
             the Investigator, interfere with study evaluations or pose a risk to subject safety&#xD;
             during the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dieter Manstein, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Neera Nathan, MD, MSHS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MGH Clinical Unit for Research Trials &amp; Outcomes in Skin</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>April 21, 2023</last_update_submitted>
  <last_update_submitted_qc>April 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Dieter Manstein, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Acne</keyword>
  <keyword>Acne Vulgaris</keyword>
  <keyword>Laser</keyword>
  <keyword>Cystic Acne</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acne Vulgaris</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/NCT04466527
org study id: 2020P000838
nct id: NCT04466527
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
In this study, we are enrolling subjects with moderate to severe acne vulgaris and
      investigating the use of a commercially available laser in treating acne.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in Physician's Global Assessment (PGA) of Acne Severity
time frame: Change in PGA score between baseline visit and post procedural visit
description: The physician will score the acne vulgaris based on the Physician's Global Assessment (PGA) scale. A score of 0 indicates that residual hyperpigmentation and erythema may be present; a score of 1 indicates that there are a few scattered comedones and a few small papules; a score of 3 indicates that more than half of the face is involved, that there are many comedones, papules, and pustules, and that one nodule may be present; a score of 4 indicates that the entire face is involved, covered with comedones, numerous papules and pustules, and a few nodules and cysts. The change in PGA score will be recorded at each of the 4 study visits, for up to
arm group label: Treatment
arm group type: Experimental
description: Subjects in this arm will undergo laser treatment on their active acne vulgaris lesions. Subjects will serve as their own control.
intervention type: Device
intervention name: Laser Intervention
description: Subjects with undergo laser exposure of their active acne vulgaris.
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dieter Manstein, MD, PhD
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Neera Nathan, MD, MSHS
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Dieter Manstein, MD
investigator title: Principal Investigator
mesh term: Acne Vulgaris
sharing ipd: No