<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/NCT04447963</url>
  </required_header>
  <id_info>
    <org_study_id>BTL-785F_WRI</org_study_id>
    <nct_id>NCT04447963</nct_id>
  </id_info>
  <brief_title>Evaluation of Safety and Efficacy of the BTL-785F Device for Non-invasive Reduction of Wrinkles</brief_title>
  <official_title>Evaluation of Safety and Efficacy of the BTL-785F Device for Non-invasive Reduction of Wrinkles</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BTL Industries Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BTL Industries Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the clinical safety and the performance of the BTL-785F system&#xD;
      equipped with BTL-785-2 applicator for non-invasive treatment of facial wrinkles.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will evaluate the clinical safety and the performance of the BTL-785F system&#xD;
      equipped with BTL-785-2 applicator for non-invasive treatment of facial wrinkles. The study&#xD;
      is a multicenter single-arm, open-label, interventional study. The subjects will be enrolled&#xD;
      and assigned into one experimental study arm. The subjects will be required to complete three&#xD;
      (3) treatment visits and two follow-up visits. At every treatment visit after the first,&#xD;
      prior to the procedure, the participants will be assessed for adverse effects resulting from&#xD;
      the previous treatment(s) with the BTL-785F device.&#xD;
&#xD;
      Safety measures will include documentation of adverse events (AE) during and after the&#xD;
      procedures.&#xD;
&#xD;
      Follow-ups visits at 3 months and 6 months after the final treatment will be held.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Actual">June 28, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assess reduction of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale</measure>
    <time_frame>3 months</time_frame>
    <description>Gathering of clinical evidence that the Device is able to achieve reduction of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale. The primary efficacy outcome measure is a statistically significant reduction of at least 1.0 score in the average score of Fitzpatrick Wrinkle and Elastosis Scale score according to at least 2 out of 3 blinded dermatologists at 3-months follow-up compared to baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess safety profile by recording of adverse events</measure>
    <time_frame>7 months</time_frame>
    <description>All AEs including local and systemic reactions not meeting the criteria for &quot;serious adverse events&quot; will be captured on the appropriate CRF. Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed only by those with the training and authority to make a diagnosis, which would include MD, DDS, DMD, PA, Nurse Practitioner or DO), and time of resolution/stabilization of the event. All AEs occurring during the study must be documented appropriately regardless of relationship to study device. All AEs will be followed to adequate resolution.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess subjects' satisfaction with the treatment using Subject Satisfaction Questionnaire</measure>
    <time_frame>6 months</time_frame>
    <description>Every subject who completed the treatment will be asked to fill in the Satisfaction Questionnaire at the 3 months follow-up and the 6 months follow-up. This evaluation should reflect overall satisfaction with the results compared to therapy comfort, experienced pain, duration, and application convenience.&#xD;
Subjects will be asked: &quot;Overall how are you satisfied with the therapy?&quot; 1 = very satisfied; 2 = satisfied; 3 = neither/nor; 4 = unsatisfied; 5 = very unsatisfied.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Wrinkle</condition>
  <arm_group>
    <arm_group_label>Non-invasive treatment of wrinkles and rhytids</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects will be enrolled and assigned into one experimental study arm. The subjects will be required to complete three (3) treatment visits and two follow-up visits.&#xD;
At the baseline visit health status will be assessed and, if needed, additional tests will be performed. Inclusion and exclusion criteria will be verified and informed consent will be signed.&#xD;
The treatment administration phase consists of three (3) treatment visits, delivered 1 week apart.&#xD;
At every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the BTL-785F device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Non-invasive treatment of facial wrinkles</intervention_name>
    <description>Application of radiofrequency field which provides controlled heating to the skin.Therapeutic effect is observed when the tissue temperature reaches 40-45 degrees Celsius.</description>
    <arm_group_label>Non-invasive treatment of wrinkles and rhytids</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female subjects over 21 years of age seeking treatment and reduction&#xD;
             of facial wrinkles&#xD;
&#xD;
          -  Subjects should be able understand the investigative nature of the treatment, the&#xD;
             possible benefits and side effects, and must sign the Informed Consent Form&#xD;
&#xD;
          -  Presence of clearly visible wrinkles in the treated area when the face is relaxed as&#xD;
             deemed appropriate by the Investigator&#xD;
&#xD;
          -  Subjects willing and able to abstain from partaking in any facial treatments other&#xD;
             than the study procedure during study participation&#xD;
&#xD;
          -  Willingness to comply with study instructions, to return to the clinic for the&#xD;
             required visits, and to have photographs of their face taken&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bacterial or viral infection, acute inflammations&#xD;
&#xD;
          -  Impaired immune system&#xD;
&#xD;
          -  Isotretinoin in the past 12 months&#xD;
&#xD;
          -  Skin related autoimmune diseases&#xD;
&#xD;
          -  Radiation therapy and/or chemotherapy&#xD;
&#xD;
          -  Poor healing and unhealed wounds in the treatment area&#xD;
&#xD;
          -  Metal implants&#xD;
&#xD;
          -  Permanent implant in the treated area&#xD;
&#xD;
          -  Pacemaker or internal defibrillator, or any other active electrical implant anywhere&#xD;
             in the body&#xD;
&#xD;
          -  Facial dermabrasion, facial resurfacing, or deep chemical peeling in the treatment&#xD;
             area within 6 months prior to the treatment&#xD;
&#xD;
          -  Current or history of skin cancer, or current condition of any other type of cancer,&#xD;
             or pre-malignant moles&#xD;
&#xD;
          -  History of any type of cancer&#xD;
&#xD;
          -  Active collagen diseases&#xD;
&#xD;
          -  Cardiovascular diseases (such as vascular diseases, peripheral arterial disease,&#xD;
             thrombophlebitis and thrombosis)&#xD;
&#xD;
          -  Pregnancy/nursing or IVF procedure&#xD;
&#xD;
          -  History of bleeding coagulopathies, use of anticoagulants&#xD;
&#xD;
          -  Any active condition in the treatment area, such as sores, psoriasis, eczema, rash and&#xD;
             rosacea&#xD;
&#xD;
          -  Any surgical procedure in the treatment area within the last three months or before&#xD;
             complete healing&#xD;
&#xD;
          -  Poorly controlled endocrine disorders, such as diabetes&#xD;
&#xD;
          -  Acute neuralgia and neuropathy&#xD;
&#xD;
          -  Kidney or liver failure&#xD;
&#xD;
          -  Sensitivity disorders in the treatment area&#xD;
&#xD;
          -  Varicose veins, pronounced edemas&#xD;
&#xD;
          -  Prior use of dermal fillers, botulinum toxin, lasers, etc. therapies in the treated&#xD;
             area that can influence the study results at the investigator discretion&#xD;
&#xD;
          -  Unwillingness/inability to not change their usual cosmetics and especially not to use&#xD;
             ani-aging or anti-wrinkles products in the treated area during the duration of the&#xD;
             study including the follow-up period&#xD;
&#xD;
          -  Unwillingness/inability to abstain from cosmetic procedures in the treated area at&#xD;
             least 15 days before every examination with the facial image analysis system VISIA&#xD;
&#xD;
          -  Any other disease or condition (e.g. eye disease) at the investigator discretion that&#xD;
             may pose risk to the patient or compromise the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Evgeni Hristozov, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dermatologist</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dermatological center &quot;Lege Artis&quot;</name>
      <address>
        <city>Stara Zagora</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>November 9, 2021</last_update_submitted>
  <last_update_submitted_qc>November 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT04447963
org study id: BTL-785F_WRI
nct id: NCT04447963
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study will evaluate the clinical safety and the performance of the BTL-785F system
      equipped with BTL-785-2 applicator for non-invasive treatment of facial wrinkles.
This study will evaluate the clinical safety and the performance of the BTL-785F system
      equipped with BTL-785-2 applicator for non-invasive treatment of facial wrinkles. The study
      is a multicenter single-arm, open-label, interventional study. The subjects will be enrolled
      and assigned into one experimental study arm. The subjects will be required to complete three
      (3) treatment visits and two follow-up visits. At every treatment visit after the first,
      prior to the procedure, the participants will be assessed for adverse effects resulting from
      the previous treatment(s) with the BTL-785F device.

      Safety measures will include documentation of adverse events (AE) during and after the
      procedures.

      Follow-ups visits at 3 months and 6 months after the final treatment will be held.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Assess reduction of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale
time frame: 3 months
description: Gathering of clinical evidence that the Device is able to achieve reduction of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale. The primary efficacy outcome measure is a statistically significant reduction of at least 1.0 score in the average score of Fitzpatrick Wrinkle and Elastosis Scale score according to at least 2 out of 3 blinded dermatologists at 3-months follow-up compared to baseline.
measure: Assess safety profile by recording of adverse events
time frame: 7 months
description: All AEs including local and systemic reactions not meeting the criteria for "serious adverse events" will be captured on the appropriate CRF. Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed only by those with the training and authority to make a diagnosis, which would include MD, DDS, DMD, PA, Nurse Practitioner or DO), and time of resolution/stabilization of the event. All AEs occurring during the study must be documented appropriately regardless of relationship to study device. All AEs will be followed to adequate resolution.
measure: Assess subjects' satisfaction with the treatment using Subject Satisfaction Questionnaire
time frame: 6 months
description: Every subject who completed the treatment will be asked to fill in the Satisfaction Questionnaire at the 3 months follow-up and the 6 months follow-up. This evaluation should reflect overall satisfaction with the results compared to therapy comfort, experienced pain, duration, and application convenience.
Subjects will be asked: "Overall how are you satisfied with the therapy?" 1 = very satisfied; 2 = satisfied; 3 = neither/nor; 4 = unsatisfied; 5 = very unsatisfied.
arm group label: Non-invasive treatment of wrinkles and rhytids
arm group type: Experimental
description: The subjects will be enrolled and assigned into one experimental study arm. The subjects will be required to complete three (3) treatment visits and two follow-up visits.
At the baseline visit health status will be assessed and, if needed, additional tests will be performed. Inclusion and exclusion criteria will be verified and informed consent will be signed.
The treatment administration phase consists of three (3) treatment visits, delivered 1 week apart.
At every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the BTL-785F device.
intervention type: Device
intervention name: Non-invasive treatment of facial wrinkles
description: Application of radiofrequency field which provides controlled heating to the skin.Therapeutic effect is observed when the tissue temperature reaches 40-45 degrees Celsius.
arm group label: Non-invasive treatment of wrinkles and rhytids
criteria: 
gender: All
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Evgeni Hristozov, MD
role: Principal Investigator
affiliation: Dermatologist
facility: 
country: Bulgaria
responsible party type: Sponsor
sharing ipd: No