<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/NCT01701440</url>
  </required_header>
  <id_info>
    <org_study_id>0310-0017</org_study_id>
    <nct_id>NCT01701440</nct_id>
  </id_info>
  <brief_title>Efficacy Study for Magnetic Induction to Treat Wrinkles</brief_title>
  <official_title>Radiofrequency Magnetic Induction Device for Use In Dermatologic Procedures for the Non-Invasive Treatment of Wrinkles and Rhytides</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rocky Mountain Biosystems, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rocky Mountain Biosystems, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study we propose to test the Biofusionary Bebe in order to reduce skin laxity and&#xD;
      improve contour and cosmesis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">July 2013</completion_date>
  <primary_completion_date type="Anticipated">July 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>Improvement in cosmesis</measure>
    <time_frame>1 month</time_frame>
    <description>Improvement in cosmesis will be assessed by scoring photographs taken before and 1 month after treatment. Circumference changes will be measured and compared</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in cosmesis</measure>
    <time_frame>3 months</time_frame>
    <description>Improvement in cosmesis will be assessed by scoring photographs taken before and at 3 months after treatment. Circumference changes will be measured and compared.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Wrinkles and Rhytides</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biofusionary Bebe</intervention_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        The inclusion criteria for the study are:&#xD;
&#xD;
          -  Male or female 21 to 65 years old,&#xD;
&#xD;
          -  Clinically appreciable skin laxity on the abdomen (including flank), face, neck, hips,&#xD;
             thighs, upper arms &amp; buttocks as determined by the study investigator,&#xD;
&#xD;
          -  For females, post-menopausal, surgically sterilized, or using a medically accepted&#xD;
             form of birth control for at least 3 months prior to the study,&#xD;
&#xD;
          -  Apparently healthy,&#xD;
&#xD;
          -  Informed consent signed by the subject.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The exclusion criteria for the study are:&#xD;
&#xD;
          -  History of skin hypersensitivity,&#xD;
&#xD;
          -  Current skin disorder (e.g. keloid scarring) or infection (e.g., herpes simplex) in&#xD;
             the treatment area,&#xD;
&#xD;
          -  Subjects with pacemakers, internal defibrillators or electronically, magnetically, and&#xD;
             mechanically activated implants,&#xD;
&#xD;
          -  Subjects with implanted medical prostheses (such as clips, pins or plates) proximal to&#xD;
             the treatment site,&#xD;
&#xD;
          -  The current or recent use (within the past 12 months) of isotretinoin,&#xD;
&#xD;
          -  Pregnancy,&#xD;
&#xD;
          -  Infectious diseases (such as HIV) present,&#xD;
&#xD;
          -  Are a tobacco smoker,&#xD;
&#xD;
          -  Insulin dependent diabetic subjects,&#xD;
&#xD;
          -  Oxygen dependent subjects,&#xD;
&#xD;
          -  Subjects with severe chronic illness, scleroderma, or lupus,&#xD;
&#xD;
          -  Subjects with open sores or scars in the treatment region, or&#xD;
&#xD;
          -  Subjects with ischemia in the treatment region.&#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>
  <overall_official>
    <last_name>Jerome Garden, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Physicians Laser and Dermatology Institute of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Physicians Laser and Dermatolgy Institute of Chicago,LLC</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>October 10, 2012</last_update_submitted>
  <last_update_submitted_qc>October 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 11, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01701440
org study id: 0310-0017
nct id: NCT01701440
lead sponsor: 
has dmc: No
In this study we propose to test the Biofusionary Bebe in order to reduce skin laxity and
      improve contour and cosmesis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement in cosmesis
time frame: 1 month
description: Improvement in cosmesis will be assessed by scoring photographs taken before and 1 month after treatment. Circumference changes will be measured and compared
measure: Improvement in cosmesis
time frame: 3 months
description: Improvement in cosmesis will be assessed by scoring photographs taken before and at 3 months after treatment. Circumference changes will be measured and compared.
intervention type: Device
intervention name: Biofusionary Bebe
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jerome Garden, MD
role: Principal Investigator
affiliation: Physicians Laser and Dermatology Institute of Chicago
facility: 
country: United States
responsible party type: Sponsor