<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/NCT01662349</url>
  </required_header>
  <id_info>
    <org_study_id>MOE - 121</org_study_id>
    <nct_id>NCT01662349</nct_id>
  </id_info>
  <brief_title>Safety Study of Plasma Treatment System to Treat Back Acne</brief_title>
  <official_title>A Single Center, Pilot Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Plasma Treatment System in Treating Back Acne</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Moe Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Moe Medical Devices</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety of treating human skin with atmospheric&#xD;
      plasma and get an initial evaluation of the efficacy of this treatment for acne.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was stopped due to other research priorities.&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</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>Change in number of reported adverse events</measure>
    <time_frame>Change from Baseline to 1 month post-treatment</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>Plasma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Plasma applied to back for up to 20 minutes, twice/week for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MOE Antimicrobial Plasma Treatment System</intervention_name>
    <description>Plasma applied to back for up to 20 minutes, twice/week for 4 weeks</description>
    <arm_group_label>Plasma</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and non-pregnant, non-nursing females age 18-40 years old.&#xD;
&#xD;
          2. Presence of clinically-evident back acne.&#xD;
&#xD;
          3. Minimum of 20 non-inflammatory lesions (open and closed comedones)&#xD;
&#xD;
          4. Minimum of 30 total lesions (sum of inflammatory and non-inflammatory)&#xD;
&#xD;
          5. Subject must have measurable sebum production.&#xD;
&#xD;
          6. Subjects must be in generally good health.&#xD;
&#xD;
          7. Must be able and willing to comply with the requirements of the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any nodulo-cystic lesions at Baseline&#xD;
&#xD;
          2. Pregnancy or breast feeding&#xD;
&#xD;
          3. Use of acne devices or systemic therapy with antibiotics within four months prior to&#xD;
             start and throughout the duration of the study&#xD;
&#xD;
          4. Intake of any oral retinoids within four months prior to study start and throughout&#xD;
             the duration of the study&#xD;
&#xD;
          5. Topical use of topical retinoids within two weeks prior to study start and throughout&#xD;
             the duration of the study&#xD;
&#xD;
          6. Topical use of antibiotics, steroids and/or other non-retinoid topical acne products&#xD;
             within two weeks prior to study start and throughout the duration of the study&#xD;
&#xD;
          7. Use of an experimental drug or device within 30 days prior to study start;&#xD;
&#xD;
          8. Intake of hormonal therapy within 3 months prior to study start&#xD;
&#xD;
          9. Use of topical products on the back containing glycolic or other acids, masks, washes&#xD;
             or soaps containing benzoyl peroxide or salicylic acid, non mild cleansers or&#xD;
             moisturizers containing retinol, salicylic or α- or β-hydroxy acids.&#xD;
&#xD;
         10. Concomitant use of mega-doses of certain vitamins, such as vitamin D (&gt;2000IU QD)&#xD;
             vitamin B12, haloperidol, halogens such as iodide and bromide, lithium, hydantoin and&#xD;
             phenobarbital.&#xD;
&#xD;
         11. Procedures on the skin of the back such as chemical or laser peel, microdermabrasion,&#xD;
             photodynamic therapy) within the past 2 weeks or during the study.&#xD;
&#xD;
         12. History or evidence of other skin conditions or diseases that may require concurrent&#xD;
             therapy or may interfere with the evaluation of the study medication&#xD;
&#xD;
         13. Any significant medical conditions that could confound the interpretation of the study&#xD;
             results.&#xD;
&#xD;
         14. History of/or current skin cancer cancer&#xD;
&#xD;
         15. Use of tanning booths, sun lamps within the past 2 weeks or during the study&#xD;
&#xD;
         16. Any metallic implants or prostheses in the vicinity of the treatment site (such as&#xD;
             shoulders, back, spine, pacemakers, etc.).&#xD;
&#xD;
         17. Any known photosensitivity disorders felt by the investigators to preclude safe&#xD;
             inclusion in the study.&#xD;
&#xD;
         18. History of significant post-inflammatory hyperpigmentation at the sites of acne&#xD;
             lesions.&#xD;
&#xD;
         19. History of or is currently immunocompromised.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexandra B. Kimball, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Partners Healthcare System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Unit for Research Trials and Outcomes in Skin (CURTIS)</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>September 2017</verification_date>
  <study_first_submitted>August 2, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acne Vulgaris</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Infective Agents</mesh_term>
    <mesh_term>Anti-Bacterial Agents</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01662349
org study id: MOE - 121
nct id: NCT01662349
lead sponsor: 
The purpose of this study is to evaluate the safety of treating human skin with atmospheric
      plasma and get an initial evaluation of the efficacy of this treatment for acne.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in number of reported adverse events
time frame: Change from Baseline to 1 month post-treatment
arm group label: Plasma
arm group type: Experimental
description: Plasma applied to back for up to 20 minutes, twice/week for 4 weeks
intervention type: Device
intervention name: MOE Antimicrobial Plasma Treatment System
description: Plasma applied to back for up to 20 minutes, twice/week for 4 weeks
arm group label: Plasma
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Alexandra B. Kimball, MD
role: Principal Investigator
affiliation: Partners Healthcare System
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acne Vulgaris
mesh term: Anti-Infective Agents
mesh term: Anti-Bacterial Agents