<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/NCT03767972</url>
  </required_header>
  <id_info>
    <org_study_id>2017-4054</org_study_id>
    <nct_id>NCT03767972</nct_id>
  </id_info>
  <brief_title>Energy Devices for Rejuvenation</brief_title>
  <official_title>Energy Devices for Rejuvenation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Irvine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Irvine</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Non-ablative and ablative devices are the most commonly used minimally-invasive treatments&#xD;
      for skin rejuvenation. Current devices on the market for rejuvenation include the lasers such&#xD;
      as the Fraxel Restore, the Halo, the Helios III, the Pico, the ThermiVa and the DiVa which&#xD;
      have all been shown to have efficacy for the rejuvenation of the face, décolletage, hands and&#xD;
      vagina. In this study we propose to compare the efficacy and side effect profile of these&#xD;
      devices for skin rejuvenation of various areas of the body including the face, décolletage,&#xD;
      hands, trunk, upper and lower extremities, and vagina.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Anticipated">November 2021</completion_date>
  <primary_completion_date type="Anticipated">November 2021</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>
    <intervention_model_description>This is a prospective clinical trial to compare various energy-based devices for the rejuvenation of the face, neck/décolletage, hands, upper and lower extremities and vagina. Adults seeking rejuvenation of either the face, neck/décolletage, hands, upper and lower extremities, trunk and/or vagina will be treated with appropriate energy-based device(s) based on investigators' discretion. If patients' require rejuvenation of multiple areas, per investigator assessment, they will be allowed to get treatment in multiple areas. Patients will be followed for 3 months post-treatment to determine if the procedure was efficacious for rejuvenation of the area(s) treated.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Global Aesthetic Improvement Scale</measure>
    <time_frame>3 months</time_frame>
    <description>Patients will be followed for post-treatment using a patient and physician-reported 5-point likert scale (Global Aesthetic Improvement Scale) from 0=&quot;worse&quot; to 4=&quot;very much improved&quot;.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Rejuvenation</condition>
  <arm_group>
    <arm_group_label>Rejuvenation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adults requiring rejuvenation of either the face, neck/décolletage, hands, upper and lower extremities, trunk and/or vagina will receive energy-based treatment (Fraxel Restore, Helios III, PicoWay, Halo, ThermiVa or DiVa) based on the investigators' assessment and discretion. The treating physician will decide which energy-based device is best-suited to addressing the patients' aging concerns; although patient preference will be taken into account, ultimately the treating physician will be responsible for the correct assessment of patients' rejuvenation needs and use of appropriate energy-based devices for the final treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Energy-based device</intervention_name>
    <description>Patients will receive one treatment for rejuvenation using one or multiple energy-based devices based on investigator discretion.</description>
    <arm_group_label>Rejuvenation</arm_group_label>
    <other_name>Fraxel Restore, Helios III, PicoWay, Halo, ThermiVa, DiVa</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Exhibit skin aging and will benefit from skin rejuvenation treatment of the face,&#xD;
             neck/décolletage, trunk, hands, upper and lower extremities and/or vagina as&#xD;
             determined by the investigator/physician.&#xD;
&#xD;
          2. Subjects between the ages of 18-85 years old, at the time of consent.&#xD;
&#xD;
          3. Subjects may be male or female.&#xD;
&#xD;
          4. Subjects with Fitzpatrick Skin type I-III (Fraxel Restore, Helios III, Pico) or I-VI&#xD;
             (Halo, ThermiVa, DiVa).&#xD;
&#xD;
          5. Subjects must be able and willing to give written informed consent and to comply with&#xD;
             the requirements of this protocol. The consent form has been standardized in English.&#xD;
             For those patients who do not read and understand English, a consent form will be&#xD;
             standardized and provided in a language that they read and understand if possible.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Children and adolescents (less than 18 years old).&#xD;
&#xD;
          2. Subjects who are not willing or able to provide written consent.&#xD;
&#xD;
          3. Individuals with any significant medical history including skin disorders and eating&#xD;
             disorders as determined by the investigator/physician.&#xD;
&#xD;
          4. Subjects on any substances affecting blood coagulation (including but not limited to&#xD;
             aspirin and other non-steroid anti-inflammatory drugs, warfarin, vitamin E, fish oil,&#xD;
             heparin, low-molecular weight heparin, novel anti-coagulants).&#xD;
&#xD;
          5. Subjects with known blood coagulopathies.&#xD;
&#xD;
          6. Subjects with a compromise of local blood supply (including but not limited to recent&#xD;
             surgery, severe scarring, autoimmune diseases involving the face, neck/décolletage,&#xD;
             trunk, hands or lower extremities such as lupus, morphea, sarcoid or mixed connective&#xD;
             tissue disease) (dependent on their treatment group).&#xD;
&#xD;
          7. Subjects who have received energy-based rejuvenation treatment of the face,&#xD;
             neck/décolletage, trunk, hands, upper and lower extremities, and/or vagina within the&#xD;
             past 3 months (dependent on the area they are planning to treat).&#xD;
&#xD;
          8. Subjects who meet any of the contraindication criteria listed in the product&#xD;
             information for the device the subject will be treated with.&#xD;
&#xD;
          9. Subjects who are self-reported to be currently pregnant or lactating at the time of&#xD;
             treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California, Irvine, Dermatology Clinical Research Center</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92697</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>April 14, 2021</last_update_submitted>
  <last_update_submitted_qc>April 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Irvine</investigator_affiliation>
    <investigator_full_name>Katerina Yale, MD</investigator_full_name>
    <investigator_title>Clincial Research Fellow, Department of Dermatology</investigator_title>
  </responsible_party>
  <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/NCT03767972
org study id: 2017-4054
nct id: NCT03767972
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Non-ablative and ablative devices are the most commonly used minimally-invasive treatments
      for skin rejuvenation. Current devices on the market for rejuvenation include the lasers such
      as the Fraxel Restore, the Halo, the Helios III, the Pico, the ThermiVa and the DiVa which
      have all been shown to have efficacy for the rejuvenation of the face, décolletage, hands and
      vagina. In this study we propose to compare the efficacy and side effect profile of these
      devices for skin rejuvenation of various areas of the body including the face, décolletage,
      hands, trunk, upper and lower extremities, and vagina.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is a prospective clinical trial to compare various energy-based devices for the rejuvenation of the face, neck/décolletage, hands, upper and lower extremities and vagina. Adults seeking rejuvenation of either the face, neck/décolletage, hands, upper and lower extremities, trunk and/or vagina will be treated with appropriate energy-based device(s) based on investigators' discretion. If patients' require rejuvenation of multiple areas, per investigator assessment, they will be allowed to get treatment in multiple areas. Patients will be followed for 3 months post-treatment to determine if the procedure was efficacious for rejuvenation of the area(s) treated.
primary purpose: Treatment
masking: None (Open Label)
measure: Global Aesthetic Improvement Scale
time frame: 3 months
description: Patients will be followed for post-treatment using a patient and physician-reported 5-point likert scale (Global Aesthetic Improvement Scale) from 0="worse" to 4="very much improved".
arm group label: Rejuvenation
arm group type: Experimental
description: Adults requiring rejuvenation of either the face, neck/décolletage, hands, upper and lower extremities, trunk and/or vagina will receive energy-based treatment (Fraxel Restore, Helios III, PicoWay, Halo, ThermiVa or DiVa) based on the investigators' assessment and discretion. The treating physician will decide which energy-based device is best-suited to addressing the patients' aging concerns; although patient preference will be taken into account, ultimately the treating physician will be responsible for the correct assessment of patients' rejuvenation needs and use of appropriate energy-based devices for the final treatment.
intervention type: Device
intervention name: Energy-based device
description: Patients will receive one treatment for rejuvenation using one or multiple energy-based devices based on investigator discretion.
arm group label: Rejuvenation
other name: Fraxel Restore, Helios III, PicoWay, Halo, ThermiVa, DiVa
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Irvine
investigator full name: Katerina Yale, MD
investigator title: Clincial Research Fellow, Department of Dermatology
sharing ipd: No