<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/NCT01678482</url>
  </required_header>
  <id_info>
    <org_study_id>C1</org_study_id>
    <nct_id>NCT01678482</nct_id>
  </id_info>
  <brief_title>Clinical and Usability Study to Determine Safety and Efficacy of the Clear Device for Acne Treatment</brief_title>
  <official_title>Clinical and Usability Study to Determine Safety and Efficacy of the Clear Device for the Treatment of Mild to Moderate Inflammatory Acne.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Home Skinovations Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Home Skinovations Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a clinical research study to determine the ability of the Clear device to treat mild&#xD;
      to moderate inflammatory acne, and to determine if the average person is able to use the&#xD;
      device properly according to the labeling as describe in the operator manual.&#xD;
&#xD;
      The study involve treatments twice a week over 4 weeks total of 8 treatment sessions, in&#xD;
      which the subjects will be treating themselves with the Clear device, and 2 follow-up visits&#xD;
      to evaluate the results. The clinical result will be assessed by the investigator for&#xD;
      improvement in the acne condition. Treatment will be performed on the face of subjects&#xD;
      enrolled and who meet the inclusion criteria.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The subjects will be recruited if they are eligible to participate in the study according&#xD;
      with the device labeling presented at the doctor's office by printed ads. Subjects will be&#xD;
      given information about the Clear device according to its labeling. After reading the&#xD;
      information and labeling, it will be the subjects' decision if they understand the device&#xD;
      label information and if they want to participate in the study. The investigator will review&#xD;
      the inclusion / exclusion criteria with the subjects to ensure eligibility.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">April 2012</completion_date>
  <primary_completion_date type="Actual">April 2012</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acne lession count</measure>
    <time_frame>3 months post treatment</time_frame>
    <description>acne count post treatment compared to based line count</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Monitor Acne Lessions Count Reduction as Result of Usinfg the Device</condition>
  <arm_group>
    <arm_group_label>lession count reduction post treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A total of 50 subjects were included.&#xD;
The majority are female (62 %)&#xD;
At baseline the average number of lesions was 20.5±7.1, ranging from 6 to 36 lesions.&#xD;
All subjects demonstrated a reduction in lesion count.&#xD;
The average improvement after one month was 56.7%±8.9%, and remained similar also after 3 months 57.7%±9.4%.&#xD;
The percent of responders (with at least 40% of reduction) was 94% after 1 month and 96% after 3 months&#xD;
The Percent of responders is similar for males &amp; females and similar for cheeks &amp; front.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>light based device for treatment of acne</intervention_name>
    <arm_group_label>lession count reduction post treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Presence of mild to moderate acne.&#xD;
&#xD;
          2. Skin Type I to VI (Fitzpatrick).&#xD;
&#xD;
          3. Males or females who are 21-65 years old.&#xD;
&#xD;
          4. Willingness to follow the treatment schedule, post-treatment care and have photographs&#xD;
             taken.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pacemaker or internal defibrillator.&#xD;
&#xD;
          2. Permanent implant in the treated area, such as metal plates and screws or silicon,&#xD;
             unless deep enough in the bone.&#xD;
&#xD;
          3. Skin areas that have been injected with Botox/ Hyaluronic acid /collagen/fat&#xD;
             injections or other augmentation methods with bio-material during last 6 months.&#xD;
&#xD;
          4. Current or history of skin cancer, or any other type of cancer, or pre-malignant&#xD;
             moles.&#xD;
&#xD;
          5. Current severe medical conditions, such as heart and lung disorders.&#xD;
&#xD;
          6. Pregnant or breastfeeding.&#xD;
&#xD;
          7. Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use&#xD;
             of immunosuppressive medications.&#xD;
&#xD;
          8. History of diseases stimulated by heat, such as recurrent Herpes Simplex (cold sores)&#xD;
             in the treatment area, unless treated by following a preventive regime.&#xD;
&#xD;
          9. Poorly controlled endocrine disorders, such as diabetes or thyroid disorders.&#xD;
&#xD;
         10. Any active skin condition in the treatment area, such as sores, psoriasis, eczema, and&#xD;
             rash and rosacea.&#xD;
&#xD;
         11. History of skin disorders, keloids (excessive scarring), abnormal wound healing, as&#xD;
             well as very dry and fragile skin.&#xD;
&#xD;
         12. History of bleeding disorders, or use of anticoagulants in the last 10 days.&#xD;
&#xD;
         13. Any facial surgery performed within 12 months prior to treatment.&#xD;
&#xD;
         14. Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last 3&#xD;
             months.&#xD;
&#xD;
         15. Received treatment with light, laser, radiofrequency (RF), or other devices in the&#xD;
             treated area within 6 months.&#xD;
&#xD;
         16. Used isotretinoin (Accutane®) within 6 months prior to treatment.&#xD;
&#xD;
         17. Using of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing&#xD;
             agents) 1 week before and after each treatment session.&#xD;
&#xD;
         18. Subjects that are currently or have recently been treated with Alpha-Hydroxi Acids&#xD;
             (AHAs), Beta-Hydroxi Acids (BHAs), Retin-A®, topical retinoids or azelaic acid.&#xD;
&#xD;
         19. Subjects that have been on a steroid regimen within the past 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>SpaMedica</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5R3N8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>August 31, 2012</last_update_submitted>
  <last_update_submitted_qc>August 31, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acne, LED, blue light</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acne Vulgaris</mesh_term>
  </condition_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/NCT01678482
org study id: C1
nct id: NCT01678482
lead sponsor: 
has dmc: No
This is a clinical research study to determine the ability of the Clear device to treat mild
      to moderate inflammatory acne, and to determine if the average person is able to use the
      device properly according to the labeling as describe in the operator manual.

      The study involve treatments twice a week over 4 weeks total of 8 treatment sessions, in
      which the subjects will be treating themselves with the Clear device, and 2 follow-up visits
      to evaluate the results. The clinical result will be assessed by the investigator for
      improvement in the acne condition. Treatment will be performed on the face of subjects
      enrolled and who meet the inclusion criteria.
The subjects will be recruited if they are eligible to participate in the study according
      with the device labeling presented at the doctor's office by printed ads. Subjects will be
      given information about the Clear device according to its labeling. After reading the
      information and labeling, it will be the subjects' decision if they understand the device
      label information and if they want to participate in the study. The investigator will review
      the inclusion / exclusion criteria with the subjects to ensure eligibility.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Acne lession count
time frame: 3 months post treatment
description: acne count post treatment compared to based line count
arm group label: lession count reduction post treatment
arm group type: Experimental
description: A total of 50 subjects were included.
The majority are female (62 %)
At baseline the average number of lesions was 20.5±7.1, ranging from 6 to 36 lesions.
All subjects demonstrated a reduction in lesion count.
The average improvement after one month was 56.7%±8.9%, and remained similar also after 3 months 57.7%±9.4%.
The percent of responders (with at least 40% of reduction) was 94% after 1 month and 96% after 3 months
The Percent of responders is similar for males & females and similar for cheeks & front.
intervention type: Device
intervention name: light based device for treatment of acne
arm group label: lession count reduction post treatment
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Acne Vulgaris