<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/NCT03286283</url>
  </required_header>
  <id_info>
    <org_study_id>VP-1558</org_study_id>
    <nct_id>NCT03286283</nct_id>
  </id_info>
  <brief_title>The Use of J-Plasma® for Dermal Resurfacing</brief_title>
  <official_title>A Prospective, Multicenter, Single Arm Clinical Study Evaluating the Use of J-Plasma® for Dermal Resurfacing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Apyx Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Apyx Medical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the safety and effectiveness of J-Plasma in the reduction of facial&#xD;
      wrinkles and rhytides. It is a multi-center, single arm, evaluator-blind prospective study of&#xD;
      55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and&#xD;
      rhytides and will be conducted at up to 5 investigational centers in the United States. Each&#xD;
      study subject will receive one procedure with J-Plasma at enrollment. Follow-up will occur&#xD;
      immediately following the procedure, at 10 days, 1, 3, and 6 months after enrollment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study objective is to demonstrate the safety and efficacy of the J-Plasma system for use&#xD;
      in dermal skin resurfacing.&#xD;
&#xD;
      This is a multi-center, single arm, evaluator-blind prospective study of 55 study subjects&#xD;
      who are seeking a procedure to reduce the appearance of wrinkles and rhytides at up to 5&#xD;
      investigational centers in the United States.&#xD;
&#xD;
      Study subjects that meet study eligibility criteria and have provided informed consent will&#xD;
      be enrolled in the study. During the procedure, the investigators will use J-Plasma on&#xD;
      applicable facial zones to reduce wrinkles and rhytides.&#xD;
&#xD;
      Study subjects will be followed immediately following the procedure, at 10 days, 1, 3, and 6&#xD;
      months post-procedure for study assessments.&#xD;
&#xD;
      Study enrollment is expected to occur over 3-6 months. Imaging and study assessments will&#xD;
      continue through 6 months post-procedure. Total study duration is expected to be&#xD;
      approximately 9-12 months.&#xD;
&#xD;
      Primary study endpoints will be assessed at 3 months following the procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 22, 2018</start_date>
  <completion_date type="Actual">November 16, 2018</completion_date>
  <primary_completion_date type="Actual">August 20, 2018</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 multi-center, single arm, evaluator-blind prospective study of 55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and rhytides. Enrolled study subjects will receive one procedure with J-Plasma at enrollment. Wrinkle severity will be assessed using the Fitzpatrick Wrinkle and Elastosis Scale (FWS) at baseline and at each follow-up time point. Scores at each follow-up time point will be compared to the scores at baseline for each enrolled subject.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>This is a single-arm study in which investigators are not blinded. However, blinded Independent Photographic Reviewers (IPR) will be utilized to review all images (baseline and all follow-up time points) and assign FWS scores.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score</measure>
    <time_frame>Baseline to 3 months</time_frame>
    <description>The comparison of the proportion of subjects (i.e. percentage of treatment responders) with a ≥ 1-score improvement on the FWS at the 3-month visit, as compared to baseline as determined by at least 2 out of 3 blinded Independent Photographic Reviewers. Min=1, Max=9, where 1 is best and 9 is worst. The larger the difference between the baseline and 3 month scores, the greater the improvement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse Event Rate and Duration</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Adverse event rates, categorized by duration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With a ≥ 1-score Improvement on the Fitzpatrick Wrinkle and Elastosis Scale (FWS) and at Least an &quot;Improved&quot; Rating on the Modified Global Aesthetic Improvement Scale (GAIS) at the 3-month Visit.</measure>
    <time_frame>Baseline to 3 months</time_frame>
    <description>Assessment of modified Global Aesthetic Improvement Scale (GAIS) at the 3-month visit compared to baseline as assessed by the investigator. Scale ratings: &quot;Very much improved,&quot; &quot;Much improved,&quot; &quot;Improved,&quot; &quot;No change,&quot; &quot;Worse,&quot; &quot;Much worse,&quot; and &quot;Very much worse.&quot; An &quot;improvement&quot; on the modified GAIS includes &quot;Improved,&quot; &quot;Much improved,&quot; or &quot;Very much improved.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Pain and Discomfort</measure>
    <time_frame>Baseline to 3 months</time_frame>
    <description>The evaluation of the pain and discomfort after treatment as reported by the subject on a 10-point visual analog scale (VAS). Mean change in VAS from baseline to 3 months. 0 = best possible level of pain and discomfort, 10= worst possible level of pain and discomfort.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants With an Improvement on the FWS (as Scored by Independent Reviewers) and Modified GAIS Scale (as Scored by Participants) at 3 Months</measure>
    <time_frame>Baseline to 3 months</time_frame>
    <description>Fitzpatrick Wrinkle and Elastosis Scale (FWS) ≥ 1-score improvement and ≥ 75% agreement with at least an &quot;improved&quot; rating by the subject on the modified Global Aesthetic Improvement Scale (GAIS) at 3 months compared to baseline. FWS Scale: Min=1, Max=9, where 1 is best and 9 is worst. The larger the difference between the baseline and 3 month scores, the greater the improvement. Modified GAIS Scale ratings: &quot;Very much improved,&quot; &quot;Much improved,&quot; &quot;Improved,&quot; &quot;No change,&quot; &quot;Worse,&quot; &quot;Much worse,&quot; and &quot;Very much worse.&quot; An &quot;improvement&quot; on the modified GAIS includes &quot;Improved,&quot; &quot;Much improved,&quot; or &quot;Very much improved.&quot;</description>
  </other_outcome>
  <other_outcome>
    <measure>Mean Change in Fitzpatrick Wrinkle and Elastosis Scale (FWS) From Baseline to 3-month Follow-up Visit</measure>
    <time_frame>Baseline to 3 months</time_frame>
    <description>Magnitude of improvement measured by the mean change in Fitzpatrick Wrinkle and Elastosis Scale (FWS) from baseline to 3-month visit. Scale of 1 to 9 where 1 represents the lowest severity of wrinkles and 9 represents the greatest severity of wrinkles. Negative change value represents aesthetic improvement.</description>
  </other_outcome>
  <other_outcome>
    <measure>Study Subject Satisfaction at 3-month Visit</measure>
    <time_frame>3 Months</time_frame>
    <description>Evaluation of the subject satisfaction as reported by the subject on a visual analog scale (VAS). VAS scale ranges 0-10, 0 = best possible level of satisfaction, 10= worst possible level of satisfaction</description>
  </other_outcome>
  <other_outcome>
    <measure>Achievement of Re-epithelialization - 10 Days</measure>
    <time_frame>10 Days</time_frame>
    <description>Achievement of re-epithelialization by facial zone and across facial zones after treatment</description>
  </other_outcome>
  <other_outcome>
    <measure>Achievement of Re-epithelialization - 1 Month</measure>
    <time_frame>1 Month</time_frame>
    <description>Achievement of re-epithelialization by facial zone and across facial zones after treatment</description>
  </other_outcome>
  <other_outcome>
    <measure>Achievement of Re-epithelialization - 3 Months</measure>
    <time_frame>3 Months</time_frame>
    <description>Achievement of re-epithelialization by facial zone and across facial zones after treatment</description>
  </other_outcome>
  <other_outcome>
    <measure>Mean Duration for Study Subject to Feel Comfortable in Public After Treatment</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Mean duration for study subject to feel comfortable in public after treatment as reported by the subject</description>
  </other_outcome>
  <other_outcome>
    <measure>Study Subject - Pain/Discomfort Daily 10-point Visual Analog Scale (VAS) Pre-procedure, Post-procedure, and Daily Through the 10 Day Follow-up Visit (10d FUV Visit Window: 9-14 Days)</measure>
    <time_frame>Pre-procedure, post-procedure and Daily through 10 Day Follow-up Visit, approximately 9-14 days</time_frame>
    <description>Daily 10-point Visual Analog Scale (VAS) pain assessments following treatment through the 10 day follow-up visit by diary day with a change from the VAS pain score at baseline. The 10 day follow-up visit window was 9-14 days. Not all participants recorded their VAS score every day on the daily diary; daily diary was collected from each participant at their 10 day follow-up visit (visit window: 9-14 days).</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of Subjects With Correct Identification of 3-month Images</measure>
    <time_frame>Baseline to 3 months</time_frame>
    <description>The proportion of subjects (i.e. percentage of treatment responders) with correct identification of 3-month images, in comparison to baseline, as determined by at least 2 out of 3 blinded Independent Photographic Reviewers.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Facial Wrinkles</condition>
  <condition>Rhytides</condition>
  <arm_group>
    <arm_group_label>J-Plasma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each study subject will receive one procedure with J-Plasma at enrollment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>J-Plasma</intervention_name>
    <description>Dermal resurfacing procedure with J-Plasma.</description>
    <arm_group_label>J-Plasma</arm_group_label>
    <other_name>Cold Helium Plasma</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female subjects ≥30 years of age.&#xD;
&#xD;
          2. Subject is seeking improvement of facial appearance by reducing facial wrinkles and&#xD;
             rhytides.&#xD;
&#xD;
          3. Subject with a facial wrinkle score rating of at least 2 on the FWS as determined by&#xD;
             the investigator.&#xD;
&#xD;
          4. Subject with a Fitzpatrick Skin Scale score ≤III.&#xD;
&#xD;
          5. Subject is willing and able to provide written informed consent.&#xD;
&#xD;
          6. Subject is willing and able to comply with protocol requirements, including obtaining&#xD;
             study-required images/photos and assessments, and returning for follow-up visits.&#xD;
&#xD;
          7. Subject is willing to release rights to study Sponsor for the use of the photos,&#xD;
             including in potential publication.&#xD;
&#xD;
          8. Subject is willing to abstain from other facial cosmetic procedures through the 6&#xD;
             month follow-up visit; examples include, but are not limited to, laser or chemical&#xD;
             re-surfacing, dermabrasion, neuromodulator and/or filler injections, aesthetic facial&#xD;
             surgery, etc.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject with a Fitzpatrick Skin Scale score &gt;III.&#xD;
&#xD;
          2. Subject is pregnant or lactating.&#xD;
&#xD;
          3. Active HSV-1 or diabetes mellitus.&#xD;
&#xD;
          4. Active cut, wound, or infection on the skin of the face.&#xD;
&#xD;
          5. Subject has used, within the past 30 days, Accutane or any medication that can cause&#xD;
             dermal hypersensitivity.&#xD;
&#xD;
          6. Subject has a history of autoimmune disease.&#xD;
&#xD;
          7. Subject with a bleeding disorder or who is on blood thinning medication that may be at&#xD;
             risk for bleeding.&#xD;
&#xD;
          8. Subject has a known adverse reaction to anesthetics.&#xD;
&#xD;
          9. Subjects with active skin disease of the facial area or known connective tissue&#xD;
             disease.&#xD;
&#xD;
         10. Subjects with known susceptibility to keloid formation or hypertrophic scarring.&#xD;
&#xD;
         11. Subjects with present cancerous or pre-cancerous lesions in the area to be treated.&#xD;
&#xD;
         12. Subject who, for any reason, suspects that they will not be able to complete the&#xD;
             prescribed follow-up assessment(s);&#xD;
&#xD;
         13. Subject has had concurrent therapy that, in the investigator's opinion, would&#xD;
             interfere with the evaluation of the safety and efficacy of the study treatment&#xD;
             method.&#xD;
&#xD;
         14. Subject is not willing to release rights to study Sponsor for the use of the photos,&#xD;
             including in potential publication.&#xD;
&#xD;
         15. Subject is enrolled in another investigational (drug or device) clinical trial that&#xD;
             can interfere with this study's assessments.&#xD;
&#xD;
         16. Subject has undergone a facelift procedure or received facial injections within the&#xD;
             past year.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cindy Ponce, BS(ACS)</last_name>
    <role>Study Director</role>
    <affiliation>Apyx Medical (formerly Bovie Medical Corporation)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Miami Plastic Surgery</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Integrated Aesthetics</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Dermatology, Vein &amp; Research Center</name>
      <address>
        <city>Alpharetta</city>
        <state>Georgia</state>
        <zip>30022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>September 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <results_first_submitted>May 28, 2019</results_first_submitted>
  <results_first_submitted_qc>July 31, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 7, 2019</results_first_posted>
  <last_update_submitted>July 21, 2022</last_update_submitted>
  <last_update_submitted_qc>July 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rhytides</keyword>
  <keyword>Wrinkle Reduction</keyword>
  <keyword>J-Plasma</keyword>
  <keyword>Dermal Resurfacing</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The Sponsor does not plan to make individual participant data (IPD) available to other researchers.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT03286283/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 28, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT03286283/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>All participants who were enrolled were assigned to a/the treatment group.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>J-Plasma</title>
          <description>Each study subject will receive one procedure with J-Plasma at enrollment.&#xD;
J-Plasma: Dermal resurfacing procedure with J-Plasma.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>J-Plasma</title>
          <description>Each study subject received one procedure with J-Plasma at enrollment.&#xD;
J-Plasma: Dermal resurfacing procedure with J-Plasma.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="55"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Adults 30 years of age or older who provided informed consent and who met the inclusion/exclusion criteria.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.5" lower_limit="31" upper_limit="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Race/Ethnicity are not mutually exclusive categories.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>American Indian/Alaskan Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score</title>
          <description>Participants' Average Fitzpatrick Wrinkle and Elastosis Scale (FWS) score at baseline as determined by Independent Photographic Reviewers; the FWS is a scale of 1 to 9 where 9 represents the highest severity of wrinkles and rhytides and 1 represents the lowest severity of wrinkles and rhytides.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Baseline FWS Score = 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline FWS Score = 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline FWS Score = 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline FWS Score = 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline FWS Score = 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline FWS Score = 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline FWS Score = 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline FWS Score = 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline FWS Score = 9</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Improvement in Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score</title>
        <description>The comparison of the proportion of subjects (i.e. percentage of treatment responders) with a ≥ 1-score improvement on the FWS at the 3-month visit, as compared to baseline as determined by at least 2 out of 3 blinded Independent Photographic Reviewers. Min=1, Max=9, where 1 is best and 9 is worst. The larger the difference between the baseline and 3 month scores, the greater the improvement.</description>
        <time_frame>Baseline to 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>J-Plasma</title>
            <description>Each study subject received one procedure with J-Plasma at enrollment.&#xD;
J-Plasma: Dermal resurfacing procedure with J-Plasma.</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score</title>
          <description>The comparison of the proportion of subjects (i.e. percentage of treatment responders) with a ≥ 1-score improvement on the FWS at the 3-month visit, as compared to baseline as determined by at least 2 out of 3 blinded Independent Photographic Reviewers. Min=1, Max=9, where 1 is best and 9 is worst. The larger the difference between the baseline and 3 month scores, the greater the improvement.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Adverse Event Rate and Duration</title>
        <description>Adverse event rates, categorized by duration</description>
        <time_frame>Up to 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>J-Plasma</title>
            <description>Each study subject received one procedure with J-Plasma at enrollment.&#xD;
J-Plasma: Dermal resurfacing procedure with J-Plasma.</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Event Rate and Duration</title>
          <description>Adverse event rates, categorized by duration</description>
          <units>percentage of adverse events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percentage of Serious Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of Adverse Events Resolved in 7 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage Adverse Events Resolved in 14 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With a ≥ 1-score Improvement on the Fitzpatrick Wrinkle and Elastosis Scale (FWS) and at Least an &quot;Improved&quot; Rating on the Modified Global Aesthetic Improvement Scale (GAIS) at the 3-month Visit.</title>
        <description>Assessment of modified Global Aesthetic Improvement Scale (GAIS) at the 3-month visit compared to baseline as assessed by the investigator. Scale ratings: &quot;Very much improved,&quot; &quot;Much improved,&quot; &quot;Improved,&quot; &quot;No change,&quot; &quot;Worse,&quot; &quot;Much worse,&quot; and &quot;Very much worse.&quot; An &quot;improvement&quot; on the modified GAIS includes &quot;Improved,&quot; &quot;Much improved,&quot; or &quot;Very much improved.&quot;</description>
        <time_frame>Baseline to 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>J-Plasma</title>
            <description>Each study subject received one procedure with J-Plasma at enrollment.&#xD;
J-Plasma: Dermal resurfacing procedure with J-Plasma.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a ≥ 1-score Improvement on the Fitzpatrick Wrinkle and Elastosis Scale (FWS) and at Least an &quot;Improved&quot; Rating on the Modified Global Aesthetic Improvement Scale (GAIS) at the 3-month Visit.</title>
          <description>Assessment of modified Global Aesthetic Improvement Scale (GAIS) at the 3-month visit compared to baseline as assessed by the investigator. Scale ratings: &quot;Very much improved,&quot; &quot;Much improved,&quot; &quot;Improved,&quot; &quot;No change,&quot; &quot;Worse,&quot; &quot;Much worse,&quot; and &quot;Very much worse.&quot; An &quot;improvement&quot; on the modified GAIS includes &quot;Improved,&quot; &quot;Much improved,&quot; or &quot;Very much improved.&quot;</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Evaluation of Pain and Discomfort</title>
        <description>The evaluation of the pain and discomfort after treatment as reported by the subject on a 10-point visual analog scale (VAS). Mean change in VAS from baseline to 3 months. 0 = best possible level of pain and discomfort, 10= worst possible level of pain and discomfort.</description>
        <time_frame>Baseline to 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>J-Plasma</title>
            <description>Each study subject received one procedure with J-Plasma at enrollment.&#xD;
J-Plasma: Dermal resurfacing procedure with J-Plasma.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of Pain and Discomfort</title>
          <description>The evaluation of the pain and discomfort after treatment as reported by the subject on a 10-point visual analog scale (VAS). Mean change in VAS from baseline to 3 months. 0 = best possible level of pain and discomfort, 10= worst possible level of pain and discomfort.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.8" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With an Improvement on the FWS (as Scored by Independent Reviewers) and Modified GAIS Scale (as Scored by Participants) at 3 Months</title>
        <description>Fitzpatrick Wrinkle and Elastosis Scale (FWS) ≥ 1-score improvement and ≥ 75% agreement with at least an &quot;improved&quot; rating by the subject on the modified Global Aesthetic Improvement Scale (GAIS) at 3 months compared to baseline. FWS Scale: Min=1, Max=9, where 1 is best and 9 is worst. The larger the difference between the baseline and 3 month scores, the greater the improvement. Modified GAIS Scale ratings: &quot;Very much improved,&quot; &quot;Much improved,&quot; &quot;Improved,&quot; &quot;No change,&quot; &quot;Worse,&quot; &quot;Much worse,&quot; and &quot;Very much worse.&quot; An &quot;improvement&quot; on the modified GAIS includes &quot;Improved,&quot; &quot;Much improved,&quot; or &quot;Very much improved.&quot;</description>
        <time_frame>Baseline to 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>J-Plasma</title>
            <description>Each study subject received one procedure with J-Plasma at enrollment.&#xD;
J-Plasma: Dermal resurfacing procedure with J-Plasma.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Improvement on the FWS (as Scored by Independent Reviewers) and Modified GAIS Scale (as Scored by Participants) at 3 Months</title>
          <description>Fitzpatrick Wrinkle and Elastosis Scale (FWS) ≥ 1-score improvement and ≥ 75% agreement with at least an &quot;improved&quot; rating by the subject on the modified Global Aesthetic Improvement Scale (GAIS) at 3 months compared to baseline. FWS Scale: Min=1, Max=9, where 1 is best and 9 is worst. The larger the difference between the baseline and 3 month scores, the greater the improvement. Modified GAIS Scale ratings: &quot;Very much improved,&quot; &quot;Much improved,&quot; &quot;Improved,&quot; &quot;No change,&quot; &quot;Worse,&quot; &quot;Much worse,&quot; and &quot;Very much worse.&quot; An &quot;improvement&quot; on the modified GAIS includes &quot;Improved,&quot; &quot;Much improved,&quot; or &quot;Very much improved.&quot;</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Mean Change in Fitzpatrick Wrinkle and Elastosis Scale (FWS) From Baseline to 3-month Follow-up Visit</title>
        <description>Magnitude of improvement measured by the mean change in Fitzpatrick Wrinkle and Elastosis Scale (FWS) from baseline to 3-month visit. Scale of 1 to 9 where 1 represents the lowest severity of wrinkles and 9 represents the greatest severity of wrinkles. Negative change value represents aesthetic improvement.</description>
        <time_frame>Baseline to 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>J-Plasma</title>
            <description>Each study subject received one procedure with J-Plasma at enrollment.&#xD;
J-Plasma: Dermal resurfacing procedure with J-Plasma.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Fitzpatrick Wrinkle and Elastosis Scale (FWS) From Baseline to 3-month Follow-up Visit</title>
          <description>Magnitude of improvement measured by the mean change in Fitzpatrick Wrinkle and Elastosis Scale (FWS) from baseline to 3-month visit. Scale of 1 to 9 where 1 represents the lowest severity of wrinkles and 9 represents the greatest severity of wrinkles. Negative change value represents aesthetic improvement.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.13" spread="1.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Study Subject Satisfaction at 3-month Visit</title>
        <description>Evaluation of the subject satisfaction as reported by the subject on a visual analog scale (VAS). VAS scale ranges 0-10, 0 = best possible level of satisfaction, 10= worst possible level of satisfaction</description>
        <time_frame>3 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>J-Plasma</title>
            <description>Each study subject received one procedure with J-Plasma at enrollment.&#xD;
J-Plasma: Dermal resurfacing procedure with J-Plasma.</description>
          </group>
        </group_list>
        <measure>
          <title>Study Subject Satisfaction at 3-month Visit</title>
          <description>Evaluation of the subject satisfaction as reported by the subject on a visual analog scale (VAS). VAS scale ranges 0-10, 0 = best possible level of satisfaction, 10= worst possible level of satisfaction</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Achievement of Re-epithelialization - 10 Days</title>
        <description>Achievement of re-epithelialization by facial zone and across facial zones after treatment</description>
        <time_frame>10 Days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>J-Plasma</title>
            <description>Each study subject received one procedure with J-Plasma at enrollment.&#xD;
J-Plasma: Dermal resurfacing procedure with J-Plasma.</description>
          </group>
        </group_list>
        <measure>
          <title>Achievement of Re-epithelialization - 10 Days</title>
          <description>Achievement of re-epithelialization by facial zone and across facial zones after treatment</description>
          <units>percentage of re-epithelialization</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.8" spread="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Achievement of Re-epithelialization - 1 Month</title>
        <description>Achievement of re-epithelialization by facial zone and across facial zones after treatment</description>
        <time_frame>1 Month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>J-Plasma</title>
            <description>Each study subject received one procedure with J-Plasma at enrollment.&#xD;
J-Plasma: Dermal resurfacing procedure with J-Plasma.</description>
          </group>
        </group_list>
        <measure>
          <title>Achievement of Re-epithelialization - 1 Month</title>
          <description>Achievement of re-epithelialization by facial zone and across facial zones after treatment</description>
          <units>percentage of re-epithelialization</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Achievement of Re-epithelialization - 3 Months</title>
        <description>Achievement of re-epithelialization by facial zone and across facial zones after treatment</description>
        <time_frame>3 Months</time_frame>
        <population>Data were not collected at 3 months since all subjects had reported 100% re-epithelization prior to 3 months.</population>
        <group_list>
          <group group_id="O1">
            <title>J-Plasma</title>
            <description>Each study subject received one procedure with J-Plasma at enrollment.&#xD;
J-Plasma: Dermal resurfacing procedure with J-Plasma.</description>
          </group>
        </group_list>
        <measure>
          <title>Achievement of Re-epithelialization - 3 Months</title>
          <description>Achievement of re-epithelialization by facial zone and across facial zones after treatment</description>
          <population>Data were not collected at 3 months since all subjects had reported 100% re-epithelization prior to 3 months.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Mean Duration for Study Subject to Feel Comfortable in Public After Treatment</title>
        <description>Mean duration for study subject to feel comfortable in public after treatment as reported by the subject</description>
        <time_frame>Up to 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>J-Plasma</title>
            <description>Each study subject received one procedure with J-Plasma at enrollment.&#xD;
J-Plasma: Dermal resurfacing procedure with J-Plasma.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Duration for Study Subject to Feel Comfortable in Public After Treatment</title>
          <description>Mean duration for study subject to feel comfortable in public after treatment as reported by the subject</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Study Subject - Pain/Discomfort Daily 10-point Visual Analog Scale (VAS) Pre-procedure, Post-procedure, and Daily Through the 10 Day Follow-up Visit (10d FUV Visit Window: 9-14 Days)</title>
        <description>Daily 10-point Visual Analog Scale (VAS) pain assessments following treatment through the 10 day follow-up visit by diary day with a change from the VAS pain score at baseline. The 10 day follow-up visit window was 9-14 days. Not all participants recorded their VAS score every day on the daily diary; daily diary was collected from each participant at their 10 day follow-up visit (visit window: 9-14 days).</description>
        <time_frame>Pre-procedure, post-procedure and Daily through 10 Day Follow-up Visit, approximately 9-14 days</time_frame>
        <population>Pain scores on the Visual Analog Scale (VAS) were recorded on a daily diary and analyzed out to the 10 day follow-up visit, with a visit window of 9-14 days. Not all participants recorded a VAS score for each day on the daily diary. Participants' diaries were collected at their 10 day follow-up visit.</population>
        <group_list>
          <group group_id="O1">
            <title>J-Plasma</title>
            <description>Each study subject received one procedure with J-Plasma at enrollment.&#xD;
J-Plasma: Dermal resurfacing procedure with J-Plasma.</description>
          </group>
        </group_list>
        <measure>
          <title>Study Subject - Pain/Discomfort Daily 10-point Visual Analog Scale (VAS) Pre-procedure, Post-procedure, and Daily Through the 10 Day Follow-up Visit (10d FUV Visit Window: 9-14 Days)</title>
          <description>Daily 10-point Visual Analog Scale (VAS) pain assessments following treatment through the 10 day follow-up visit by diary day with a change from the VAS pain score at baseline. The 10 day follow-up visit window was 9-14 days. Not all participants recorded their VAS score every day on the daily diary; daily diary was collected from each participant at their 10 day follow-up visit (visit window: 9-14 days).</description>
          <population>Pain scores on the Visual Analog Scale (VAS) were recorded on a daily diary and analyzed out to the 10 day follow-up visit, with a visit window of 9-14 days. Not all participants recorded a VAS score for each day on the daily diary. Participants' diaries were collected at their 10 day follow-up visit.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-procedure 10-point Visual Analog Scale (VAS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Immediately Post-Procedure 10-point Visual Analog</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 0 10-point Visual Analog Scale (VAS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 10-point Visual Analog Scale (VAS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2 10-point Visual Analog Scale (VAS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3 10-point Visual Analog Scale (VAS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4 10-point Visual Analog Scale (VAS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5 10-point Visual Analog Scale (VAS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6 10-point Visual Analog Scale (VAS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 10-point Visual Analog Scale (VAS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8 10-point Visual Analog Scale (VAS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 9 10-point Visual Analog Scale (VAS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10 10-point Visual Analog Scale (VAS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11 10-point Visual Analog Scale (VAS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12 10-point Visual Analog Scale (VAS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13 10-point Visual Analog Scale (VAS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 10-point Visual Analog Scale (VAS)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Proportion of Subjects With Correct Identification of 3-month Images</title>
        <description>The proportion of subjects (i.e. percentage of treatment responders) with correct identification of 3-month images, in comparison to baseline, as determined by at least 2 out of 3 blinded Independent Photographic Reviewers.</description>
        <time_frame>Baseline to 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>J-Plasma</title>
            <description>Each study subject received one procedure with J-Plasma at enrollment.&#xD;
J-Plasma: Dermal resurfacing procedure with J-Plasma.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With Correct Identification of 3-month Images</title>
          <description>The proportion of subjects (i.e. percentage of treatment responders) with correct identification of 3-month images, in comparison to baseline, as determined by at least 2 out of 3 blinded Independent Photographic Reviewers.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Through 6 month follow-up visit for all enrolled subjects.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>J-Plasma</title>
          <description>Each study subject received one procedure with J-Plasma at enrollment.&#xD;
J-Plasma: Dermal resurfacing procedure with J-Plasma.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Hypersensitivity to the treatment (resulting in erythema, swelling, induration, and/or urticaria)</sub_title>
                <counts group_id="E1" events="29" subjects_affected="26" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Itching</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Post-inflammatory hyperpigmentation</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Prolonged wound healing</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Sensitivity to topical care</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Shawn Roman/Vice President of Research and Development</name_or_title>
      <organization>Apyx Medical (formerly Bovie Medical Corporation)</organization>
      <phone>1-727-384-2323</phone>
      <email>shawn.roman@apyxmedical.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03286283
org study id: VP-1558
nct id: NCT03286283
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
This study evaluates the safety and effectiveness of J-Plasma in the reduction of facial
      wrinkles and rhytides. It is a multi-center, single arm, evaluator-blind prospective study of
      55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and
      rhytides and will be conducted at up to 5 investigational centers in the United States. Each
      study subject will receive one procedure with J-Plasma at enrollment. Follow-up will occur
      immediately following the procedure, at 10 days, 1, 3, and 6 months after enrollment.
The study objective is to demonstrate the safety and efficacy of the J-Plasma system for use
      in dermal skin resurfacing.

      This is a multi-center, single arm, evaluator-blind prospective study of 55 study subjects
      who are seeking a procedure to reduce the appearance of wrinkles and rhytides at up to 5
      investigational centers in the United States.

      Study subjects that meet study eligibility criteria and have provided informed consent will
      be enrolled in the study. During the procedure, the investigators will use J-Plasma on
      applicable facial zones to reduce wrinkles and rhytides.

      Study subjects will be followed immediately following the procedure, at 10 days, 1, 3, and 6
      months post-procedure for study assessments.

      Study enrollment is expected to occur over 3-6 months. Imaging and study assessments will
      continue through 6 months post-procedure. Total study duration is expected to be
      approximately 9-12 months.

      Primary study endpoints will be assessed at 3 months following the procedure.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is a multi-center, single arm, evaluator-blind prospective study of 55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and rhytides. Enrolled study subjects will receive one procedure with J-Plasma at enrollment. Wrinkle severity will be assessed using the Fitzpatrick Wrinkle and Elastosis Scale (FWS) at baseline and at each follow-up time point. Scores at each follow-up time point will be compared to the scores at baseline for each enrolled subject.
primary purpose: Treatment
masking: None (Open Label)
masking description: This is a single-arm study in which investigators are not blinded. However, blinded Independent Photographic Reviewers (IPR) will be utilized to review all images (baseline and all follow-up time points) and assign FWS scores.
measure: Improvement in Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score
time frame: Baseline to 3 months
description: The comparison of the proportion of subjects (i.e. percentage of treatment responders) with a ≥ 1-score improvement on the FWS at the 3-month visit, as compared to baseline as determined by at least 2 out of 3 blinded Independent Photographic Reviewers. Min=1, Max=9, where 1 is best and 9 is worst. The larger the difference between the baseline and 3 month scores, the greater the improvement.
measure: Adverse Event Rate and Duration
time frame: Up to 3 months
description: Adverse event rates, categorized by duration
measure: Number of Participants With a ≥ 1-score Improvement on the Fitzpatrick Wrinkle and Elastosis Scale (FWS) and at Least an "Improved" Rating on the Modified Global Aesthetic Improvement Scale (GAIS) at the 3-month Visit.
time frame: Baseline to 3 months
description: Assessment of modified Global Aesthetic Improvement Scale (GAIS) at the 3-month visit compared to baseline as assessed by the investigator. Scale ratings: "Very much improved," "Much improved," "Improved," "No change," "Worse," "Much worse," and "Very much worse." An "improvement" on the modified GAIS includes "Improved," "Much improved," or "Very much improved."
measure: Evaluation of Pain and Discomfort
time frame: Baseline to 3 months
description: The evaluation of the pain and discomfort after treatment as reported by the subject on a 10-point visual analog scale (VAS). Mean change in VAS from baseline to 3 months. 0 = best possible level of pain and discomfort, 10= worst possible level of pain and discomfort.
measure: Number of Participants With an Improvement on the FWS (as Scored by Independent Reviewers) and Modified GAIS Scale (as Scored by Participants) at 3 Months
time frame: Baseline to 3 months
description: Fitzpatrick Wrinkle and Elastosis Scale (FWS) ≥ 1-score improvement and ≥ 75% agreement with at least an "improved" rating by the subject on the modified Global Aesthetic Improvement Scale (GAIS) at 3 months compared to baseline. FWS Scale: Min=1, Max=9, where 1 is best and 9 is worst. The larger the difference between the baseline and 3 month scores, the greater the improvement. Modified GAIS Scale ratings: "Very much improved," "Much improved," "Improved," "No change," "Worse," "Much worse," and "Very much worse." An "improvement" on the modified GAIS includes "Improved," "Much improved," or "Very much improved."
measure: Mean Change in Fitzpatrick Wrinkle and Elastosis Scale (FWS) From Baseline to 3-month Follow-up Visit
time frame: Baseline to 3 months
description: Magnitude of improvement measured by the mean change in Fitzpatrick Wrinkle and Elastosis Scale (FWS) from baseline to 3-month visit. Scale of 1 to 9 where 1 represents the lowest severity of wrinkles and 9 represents the greatest severity of wrinkles. Negative change value represents aesthetic improvement.
measure: Study Subject Satisfaction at 3-month Visit
time frame: 3 Months
description: Evaluation of the subject satisfaction as reported by the subject on a visual analog scale (VAS). VAS scale ranges 0-10, 0 = best possible level of satisfaction, 10= worst possible level of satisfaction
measure: Achievement of Re-epithelialization - 10 Days
time frame: 10 Days
description: Achievement of re-epithelialization by facial zone and across facial zones after treatment
measure: Achievement of Re-epithelialization - 1 Month
time frame: 1 Month
description: Achievement of re-epithelialization by facial zone and across facial zones after treatment
measure: Achievement of Re-epithelialization - 3 Months
time frame: 3 Months
description: Achievement of re-epithelialization by facial zone and across facial zones after treatment
measure: Mean Duration for Study Subject to Feel Comfortable in Public After Treatment
time frame: Up to 3 months
description: Mean duration for study subject to feel comfortable in public after treatment as reported by the subject
measure: Study Subject - Pain/Discomfort Daily 10-point Visual Analog Scale (VAS) Pre-procedure, Post-procedure, and Daily Through the 10 Day Follow-up Visit (10d FUV Visit Window: 9-14 Days)
time frame: Pre-procedure, post-procedure and Daily through 10 Day Follow-up Visit, approximately 9-14 days
description: Daily 10-point Visual Analog Scale (VAS) pain assessments following treatment through the 10 day follow-up visit by diary day with a change from the VAS pain score at baseline. The 10 day follow-up visit window was 9-14 days. Not all participants recorded their VAS score every day on the daily diary; daily diary was collected from each participant at their 10 day follow-up visit (visit window: 9-14 days).
measure: Proportion of Subjects With Correct Identification of 3-month Images
time frame: Baseline to 3 months
description: The proportion of subjects (i.e. percentage of treatment responders) with correct identification of 3-month images, in comparison to baseline, as determined by at least 2 out of 3 blinded Independent Photographic Reviewers.
arm group label: J-Plasma
arm group type: Experimental
description: Each study subject will receive one procedure with J-Plasma at enrollment.
intervention type: Device
intervention name: J-Plasma
description: Dermal resurfacing procedure with J-Plasma.
arm group label: J-Plasma
other name: Cold Helium Plasma
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: Cindy Ponce, BS(ACS)
role: Study Director
affiliation: Apyx Medical (formerly Bovie Medical Corporation)
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
ipd description: The Sponsor does not plan to make individual participant data (IPD) available to other researchers.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 