<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/NCT03774849</url>
  </required_header>
  <id_info>
    <org_study_id>PWY18010</org_study_id>
    <nct_id>NCT03774849</nct_id>
  </id_info>
  <brief_title>PicoWay™ 730 Resolve Fusion for Benign Pigmented Lesions and Wrinkles</brief_title>
  <official_title>Evaluation of the PicoWay™ Laser System With 730nm and Resolve™ Fusion Handpieces for Treatment of Benign Pigmented Lesions and Wrinkles</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Candela Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Candela Corporation</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of the PicoWay™ Laser System With 730nm and Resolve™ Fusion Handpieces for&#xD;
      Treatment of Benign Pigmented Lesions and Wrinkles.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will receive up to 4 study treatments with the PicoWay™ 730 nm laser wavelength,&#xD;
      PicoWay™1064nm fractional handpiece and/or PicoWay™ 1064nm fractional handpiece for treatment&#xD;
      of benign pigmented lesions or wrinkles. Subjects will return for three follow-up visit&#xD;
      evaluations 1-month, 2-months and 3-months post final study treatment. Primary efficacy&#xD;
      assessed by masked photographic evaluation. Optional biopsy collection for histological&#xD;
      analysis of laser tissue effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2018</start_date>
  <completion_date type="Actual">November 12, 2020</completion_date>
  <primary_completion_date type="Actual">November 12, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in wrinkles from baseline to 12 weeks post-study treatment assessed by blinded photographic evaluation using 9-Point Fitzpatrick Wrinkle Scale</measure>
    <time_frame>Baseline to 12-week follow-Up Visit</time_frame>
    <description>9-Point Fitzpatrick Wrinkle Scale (FWS)&#xD;
1=Fine Wrinkles to 9=Deep Wrinkles 1-3 Mild (fine textural changes with subtly accentuated skin lines) 4-6 Moderate (distinct papular elastosis [individual papules with yellow translucency under direct lighting] and dyschromia) 7-9 Severe (multipapular and confluent elastosis [thickened yellow and pallid] approaching or consistent with cutis rhomboidalis)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in benign pigmented lesions from baseline to 12 weeks post study treatment assessed by blinded photographic evaluation using a 5-Point Pigment Clearance Score</measure>
    <time_frame>Baseline to 12-week follow-Up Visit</time_frame>
    <description>5-Point Pigment Clearance Score 0 0% No improvement&#xD;
1-24% Trace to mild response&#xD;
25-49% Moderate response&#xD;
50-74% Good response&#xD;
75-100% Excellent response</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Benign Pigmented Lesions</condition>
  <condition>Facial Wrinkles</condition>
  <arm_group>
    <arm_group_label>Picoway™ 532nm fractional handpiece</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive up to four study treatments with the PicoWay™ 532nm fractional handpiece</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PicoWay™ 730nm wavelength</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PicoWay™ 730nm wavelength. Subjects will receive up to four study treatments with the PicoWay™ 730nm wavelength.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PicoWay ™1064nm fractional handpiece</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive up to four study treatments with the PicoWay™ 1064nm fractional handpiece</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PicoWay™ 532nm fractional handpiece</intervention_name>
    <description>PicoWay™ Laser System is picosecond 532/1064/785 laser</description>
    <arm_group_label>PicoWay™ 730nm wavelength</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PicoWay™ 730nm wavelength</intervention_name>
    <description>PicoWay™ Laser System is picosecond 532/1064/785 laser</description>
    <arm_group_label>Picoway™ 532nm fractional handpiece</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PicoWay™ 1064nm fractional handpiece</intervention_name>
    <description>PicoWay™ Laser System is picosecond 532/1064/785 laser</description>
    <arm_group_label>PicoWay ™1064nm fractional handpiece</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Willing to provide signed informed consent&#xD;
&#xD;
          2. Adults age 21 to 80&#xD;
&#xD;
          3. Fitzpatrick Skin Type (FST) I to VI&#xD;
&#xD;
          4. Presence of benign pigmented Lesions assessed at baseline as Pigment Severity Score&#xD;
             (PSS) of &quot;2&quot; or higher and/or wrinkles assessed at baseline as Fitzpatrick Wrinkle&#xD;
             Score (FWS) of &quot;2&quot; or higher&#xD;
&#xD;
          5. Willing to allow photographs and/or video to be taken of treated areas for the&#xD;
             purposes of this research study&#xD;
&#xD;
          6. Willing to abstain from any other procedures for treatment of benign pigmented lesions&#xD;
             or wrinkles in the laser treatment areas for the duration of the study including&#xD;
             surgery, light, laser, ultrasound or radiofrequency treatments&#xD;
&#xD;
          7. Willing to abstain from use of prescription cosmetic products for treatment of benign&#xD;
             pigmented lesions or wrinkles in the laser treatment areas for the duration of the&#xD;
             study including injections of neurotoxins or dermal fillers, skin lightening creams,&#xD;
             and wrinkle creams&#xD;
&#xD;
          8. Willingness to adhere to study treatment and follow-up visit schedules&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Pregnant, planning pregnancy or breast feeding&#xD;
&#xD;
          2. Allergy to topical or injectable lidocaine or similar medications&#xD;
&#xD;
          3. Allergy to topical steroid or similar medications&#xD;
&#xD;
          4. Unprotected sun exposure in the six weeks prior to enrollment, or active tan in the&#xD;
             laser treatment area&#xD;
&#xD;
          5. History of melanoma in the intended treatment area&#xD;
&#xD;
          6. History of keloid or hypertrophic scar formation&#xD;
&#xD;
          7. Use of topical or systemic retinoid therapy during the past six (6) months&#xD;
&#xD;
          8. Use of neurotoxins in the intended treatment area within the past three (3) months or&#xD;
             throughout the duration of the study&#xD;
&#xD;
          9. Use of dermal fillers in the intended treatment area within the last six (6) months or&#xD;
             throughout the duration of the study&#xD;
&#xD;
         10. Severe immunosuppression resulting from medications and/or a medical condition that&#xD;
             could impair healing after treatment.&#xD;
&#xD;
         11. Open wound or infection in the intended treatment area&#xD;
&#xD;
         12. History of light induced seizure disorders&#xD;
&#xD;
         13. Dermatologic and/or cosmetic procedures in the intended treatment area(s) during the&#xD;
             past six months&#xD;
&#xD;
         14. The subject is not suitable, in the opinion of the clinician, for participation in the&#xD;
             study due to medical or other reasons that could compromise the study integrity or&#xD;
             subject safety&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph Lowery</last_name>
    <role>Study Director</role>
    <affiliation>Director of Clinical Affairs, Candela Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Syneron Candela Institute for Excellence</name>
      <address>
        <city>Wayland</city>
        <state>Massachusetts</state>
        <zip>01778</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>August 5, 2021</last_update_submitted>
  <last_update_submitted_qc>August 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>March 17, 2023</submitted>
    <returned>April 10, 2023</returned>
    <submitted>July 13, 2023</submitted>
    <returned>August 2, 2023</returned>
    <submitted>August 29, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03774849
org study id: PWY18010
nct id: NCT03774849
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
Evaluation of the PicoWay™ Laser System With 730nm and Resolve™ Fusion Handpieces for
      Treatment of Benign Pigmented Lesions and Wrinkles.
Subjects will receive up to 4 study treatments with the PicoWay™ 730 nm laser wavelength,
      PicoWay™1064nm fractional handpiece and/or PicoWay™ 1064nm fractional handpiece for treatment
      of benign pigmented lesions or wrinkles. Subjects will return for three follow-up visit
      evaluations 1-month, 2-months and 3-months post final study treatment. Primary efficacy
      assessed by masked photographic evaluation. Optional biopsy collection for histological
      analysis of laser tissue effects.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in wrinkles from baseline to 12 weeks post-study treatment assessed by blinded photographic evaluation using 9-Point Fitzpatrick Wrinkle Scale
time frame: Baseline to 12-week follow-Up Visit
description: 9-Point Fitzpatrick Wrinkle Scale (FWS)
1=Fine Wrinkles to 9=Deep Wrinkles 1-3 Mild (fine textural changes with subtly accentuated skin lines) 4-6 Moderate (distinct papular elastosis [individual papules with yellow translucency under direct lighting] and dyschromia) 7-9 Severe (multipapular and confluent elastosis [thickened yellow and pallid] approaching or consistent with cutis rhomboidalis)
measure: Change in benign pigmented lesions from baseline to 12 weeks post study treatment assessed by blinded photographic evaluation using a 5-Point Pigment Clearance Score
time frame: Baseline to 12-week follow-Up Visit
description: 5-Point Pigment Clearance Score 0 0% No improvement
1-24% Trace to mild response
25-49% Moderate response
50-74% Good response
75-100% Excellent response
arm group label: Picoway™ 532nm fractional handpiece
arm group type: Experimental
description: Subjects will receive up to four study treatments with the PicoWay™ 532nm fractional handpiece
arm group label: PicoWay™ 730nm wavelength
arm group type: Experimental
description: PicoWay™ 730nm wavelength. Subjects will receive up to four study treatments with the PicoWay™ 730nm wavelength.
arm group label: PicoWay ™1064nm fractional handpiece
arm group type: Experimental
description: Subjects will receive up to four study treatments with the PicoWay™ 1064nm fractional handpiece
intervention type: Device
intervention name: PicoWay™ 532nm fractional handpiece
description: PicoWay™ Laser System is picosecond 532/1064/785 laser
arm group label: PicoWay™ 730nm wavelength
intervention type: Device
intervention name: PicoWay™ 730nm wavelength
description: PicoWay™ Laser System is picosecond 532/1064/785 laser
arm group label: Picoway™ 532nm fractional handpiece
intervention type: Device
intervention name: PicoWay™ 1064nm fractional handpiece
description: PicoWay™ Laser System is picosecond 532/1064/785 laser
arm group label: PicoWay ™1064nm fractional handpiece
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: No
last name: Joseph Lowery
role: Study Director
affiliation: Director of Clinical Affairs, Candela Corporation
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
submitted: March 17, 2023
returned: April 10, 2023
submitted: July 13, 2023
returned: August 2, 2023
submitted: August 29, 2023