<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/NCT01677221</url>
  </required_header>
  <id_info>
    <org_study_id>Acleara-01</org_study_id>
    <nct_id>NCT01677221</nct_id>
  </id_info>
  <brief_title>Effects of Acleara Needle Insert on Acne</brief_title>
  <official_title>A Clinical Trial Investigating the Effects of Acleara Needle Insert on Acne Vulgaris</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Theravant Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Theravant Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective, open-label study will be conducted in 15 healthy subjects per clinical site&#xD;
      ages 14 or older who meet the inclusion/exclusion criteria. Each subject may have up to 5&#xD;
      lesions treated on the face, chest or back with the Acleara insert. Subjects will receive up&#xD;
      to 3 follow up visits and evaluated for improvement in acne lesions and monitored for any&#xD;
      adverse events.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 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>Subject assessment of reduction in acne lesion size</measure>
    <time_frame>24-72 hours, 1-2 weeks, 1 month</time_frame>
    <description>Percentage range of lesion reduction</description>
  </primary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Acne Vulgaris</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Acleara Acne Treatment System</intervention_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects &gt;14 years of age&#xD;
&#xD;
          -  Subject has mild to moderate acne vulgaris on the face, chest or back.&#xD;
&#xD;
          -  Subject has one or more inflammatory acne lesions on face, chest or back.&#xD;
&#xD;
          -  Willingness to participate in the study&#xD;
&#xD;
          -  Informed consent agreement signed by the subject&#xD;
&#xD;
          -  Willingness to follow the treatment schedule and post treatment care requirements&#xD;
&#xD;
          -  Willingness to remain on current acne therapy as directed by the Investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has an infection or other dermatologic condition (aside from acne) in the area&#xD;
             to be treated&#xD;
&#xD;
          -  Subject is immunosuppressed&#xD;
&#xD;
          -  Subject is unable to comply with treatment or follow-up visits&#xD;
&#xD;
          -  Any other condition or laboratory value that would, in the professional opinion of the&#xD;
             investigator, potentially affect the subject's response or the integrity of the data&#xD;
             or would pose an unacceptable risk to the subject.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Charles County Dermatology Associates</name>
      <address>
        <city>White Plains</city>
        <state>Maryland</state>
        <zip>20695-3064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bellaire Dermatology Associates</name>
      <address>
        <city>Bellaire</city>
        <state>Texas</state>
        <zip>77401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>January 9, 2013</last_update_submitted>
  <last_update_submitted_qc>January 9, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acne</keyword>
  <keyword>inflammatory acne</keyword>
  <keyword>intense pulsed light</keyword>
  <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>Benzoyl Peroxide</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>May 12, 2015</submitted>
    <returned>May 29, 2015</returned>
  </pending_results>
  <!-- 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/NCT01677221
org study id: Acleara-01
nct id: NCT01677221
lead sponsor: 
has dmc: No
This prospective, open-label study will be conducted in 15 healthy subjects per clinical site
      ages 14 or older who meet the inclusion/exclusion criteria. Each subject may have up to 5
      lesions treated on the face, chest or back with the Acleara insert. Subjects will receive up
      to 3 follow up visits and evaluated for improvement in acne lesions and monitored for any
      adverse events.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Subject assessment of reduction in acne lesion size
time frame: 24-72 hours, 1-2 weeks, 1 month
description: Percentage range of lesion reduction
intervention type: Device
intervention name: Acleara Acne Treatment System
criteria: 
gender: All
minimum age: 14 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Acne Vulgaris
mesh term: Benzoyl Peroxide
submitted: May 12, 2015
returned: May 29, 2015