<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/NCT03228641</url>
  </required_header>
  <id_info>
    <org_study_id>700-00001</org_study_id>
    <nct_id>NCT03228641</nct_id>
  </id_info>
  <brief_title>Evaluation of Safety and Efficacy of Micro-coring Device for Treatment of Facial Wrinkles and Skin Laxity</brief_title>
  <acronym>AIS</acronym>
  <official_title>A Prospective, Multi-center, Randomized Pilot Study for the Safety and Efficacy of a GEN II Micro-coring Device for the Treatment of Wrinkles and Skin Laxity in the Pre-auricular Area and Mid to Lower Face</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cytrellis Biosystems, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cytrellis Biosystems, Inc.</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>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A pilot study is designed to evaluate safety and efficacy of the Micro-Coring (MC) technology&#xD;
      for treatment of facial wrinkles. MC device employs hollow coring needles that enable safe,&#xD;
      rapid, and effective full-thickness small skin cores (200-500 microns in diameter) removal&#xD;
      initiating a skin repair process through formation of new collagen and elastin fibers (skin&#xD;
      rejuvenation).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multi-center, randomized, single blind, bilateral paired study&#xD;
      evaluating the safety, tolerability and preliminary effectiveness of a micro-coring device&#xD;
      for removal of excess skin using 2 needle gauges (22G, 24G,) at densities (percent of skin&#xD;
      removed per 1cm2) of 2.5-10% in subjects with mid- and lower- face skin laxity manifested by&#xD;
      moderate-to-severe mid and lower cheek wrinkles, deepening of the nasolabial folds at rest;&#xD;
      prominence of marionette lines at rest; downturn of the oral commissures at rest, sagging of&#xD;
      the skin at the jawline at rest. Subjects are blinded to needle gauge and density.&#xD;
&#xD;
      There will be two cohorts of subjects: one group of subjects will receive a single treatment&#xD;
      and the second - multiple treatments. All subjects will be followed for 180 days with several&#xD;
      intermediate visits at 3, 7, 30, 60, and 90-days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2016</start_date>
  <completion_date type="Actual">April 30, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>subject is blinded to the needle gauge and density of treatment</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>improvement in wrinkle appearance</measure>
    <time_frame>60 and 90 days</time_frame>
    <description>One grade or better improvement in score on Wrinkle Severity Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>improvement in skin laxity</measure>
    <time_frame>up to 180 days</time_frame>
    <description>One grade or better improvement in score on Laxity Scale</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Wrinkle</condition>
  <condition>Facial and Neck Skin Laxity</condition>
  <arm_group>
    <arm_group_label>micro-excisional skin removal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Facial and neck wrinkles will be treated with micro-excisional skin removal</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>micro-excisional skin removal with coring needle</intervention_name>
    <arm_group_label>micro-excisional skin removal</arm_group_label>
    <other_name>micro-coring, micro-excisional skin removal</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fitzpatrick Skin Type 1, 2, or 3 as assessed by Investigator&#xD;
&#xD;
          -  One or more of the following conditions assessed by Investigator using provided&#xD;
             Severity Scales:&#xD;
&#xD;
               -  Nasolabial fold severity at rest ≥2 and ≤4;&#xD;
&#xD;
               -  Marionette line prominence at rest ≥2 and ≤4;&#xD;
&#xD;
               -  Oral commissure drooping at rest ≥2 and ≤4;&#xD;
&#xD;
               -  Jawline sagging at rest ≥2 and ≤4 .&#xD;
&#xD;
               -  Moderate-to-Severe wrinkles at rest at least in one of the following areas - the&#xD;
                  upper lip, chin and cheeks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lesions suspicious for any malignancy or the presence of actinic keratosis, melasma,&#xD;
             vitiligo, cutaneous papules/nodules or active inflammatory lesions in the areas to be&#xD;
             treated&#xD;
&#xD;
          -  History of keloid formation or hypertrophic scarring&#xD;
&#xD;
          -  History of trauma or surgery to the treatment areas in the past 6 months&#xD;
&#xD;
          -  Scar present in the areas to be treated&#xD;
&#xD;
          -  Silicone or synthetic material injections in the areas to be treated&#xD;
&#xD;
          -  Injection of FDA-approved dermal fillers in the past two years&#xD;
&#xD;
          -  Injection of fat in the past year&#xD;
&#xD;
          -  History of treatment with dermabrasion, ablative laser, or radiofrequency in the past&#xD;
             year&#xD;
&#xD;
          -  History of treatment with non-ablative laser in the past 6 months&#xD;
&#xD;
          -  History of treatment with botulinum toxin injections in the areas to be treated within&#xD;
             the prior 6 months&#xD;
&#xD;
          -  Active smokers (0.5 pack/day) or having quit within 3 months prior to treatment&#xD;
&#xD;
          -  Active, chronic, or recurrent infection&#xD;
&#xD;
          -  History of compromised immune system or currently being treated with immunosuppressive&#xD;
             agents&#xD;
&#xD;
          -  History of sensitivity to analgesic agents, Aquaphor®, topical or local anesthetics&#xD;
             (e.g., lidocaine, benzocaine, procaine) or chlorhexidine, povidone-iodine or&#xD;
             epinephrine&#xD;
&#xD;
          -  Excessive sun exposure and use of tanning beds or tanning creams within 30 days prior&#xD;
             to treatment&#xD;
&#xD;
          -  Treatment with aspirin or other blood thinning agents within 14 days prior to&#xD;
             treatment&#xD;
&#xD;
          -  History or presence of any clinically significant bleeding disorder&#xD;
&#xD;
          -  Co-morbid condition that in the Investigator's opinion could limit ability to&#xD;
             participate in the study or to comply with follow-up requirements&#xD;
&#xD;
          -  History of drug and/or alcohol abuse&#xD;
&#xD;
          -  Any issue that, at the discretion of the Investigator, would interfere with assessment&#xD;
             of safety or efficacy or compromise the subject's ability to undergo study procedures&#xD;
             or give informed consent&#xD;
&#xD;
          -  Treatment with an investigational device or agent within 30 days before treatment or&#xD;
             during the study period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michail M Pankratov, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Senior Vice President of Clinical &amp; Regulatory Affairs</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Patricia E Krantz</last_name>
    <role>Study Director</role>
    <affiliation>Director of Clinical Operations</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Laser &amp; Skin Center of Northern CA</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SkinCare Physicians</name>
      <address>
        <city>Chestnut Hill</city>
        <state>Massachusetts</state>
        <zip>02467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laser &amp; Skin Surgery Center of NY</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nashville Center for Laser &amp; Facial Surgery</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr A Jay Burns Cosmetic Surgery</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Fernandes JR, Samayoa JC, Broelsch GF, McCormack MC, Nicholls AM, Randolph MA, Mihm MC, Austen WG Jr. Micro-mechanical fractional skin rejuvenation. Plast Reconstr Surg. 2013 Feb;131(2):216-223. doi: 10.1097/PRS.0b013e3182789afa.</citation>
    <PMID>23357983</PMID>
  </results_reference>
  <results_reference>
    <citation>Russe E, Purschke M, Farinelli WA, Wang Y, Doukas AG, Limpiangkanan W, Sakamoto FH, Tam J, Wechselberger G, Anderson RR. Micro-fractional, directional skin tightening: A porcine model. Lasers Surg Med. 2016 Mar;48(3):264-9. doi: 10.1002/lsm.22444. Epub 2015 Dec 2.</citation>
    <PMID>26627306</PMID>
  </results_reference>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>February 14, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>June 7, 2018</last_update_submitted>
  <last_update_submitted_qc>June 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>skin rejuvenation</keyword>
  <keyword>wrinkle removal</keyword>
  <keyword>skin laxity reduction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cutis Laxa</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Clinical data analysis will be summarized in the Clinical Study Report and later submitted for publication in the peer-reviewed journal</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03228641
org study id: 700-00001
nct id: NCT03228641
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
A pilot study is designed to evaluate safety and efficacy of the Micro-Coring (MC) technology
      for treatment of facial wrinkles. MC device employs hollow coring needles that enable safe,
      rapid, and effective full-thickness small skin cores (200-500 microns in diameter) removal
      initiating a skin repair process through formation of new collagen and elastin fibers (skin
      rejuvenation).
This is a prospective, multi-center, randomized, single blind, bilateral paired study
      evaluating the safety, tolerability and preliminary effectiveness of a micro-coring device
      for removal of excess skin using 2 needle gauges (22G, 24G,) at densities (percent of skin
      removed per 1cm2) of 2.5-10% in subjects with mid- and lower- face skin laxity manifested by
      moderate-to-severe mid and lower cheek wrinkles, deepening of the nasolabial folds at rest;
      prominence of marionette lines at rest; downturn of the oral commissures at rest, sagging of
      the skin at the jawline at rest. Subjects are blinded to needle gauge and density.

      There will be two cohorts of subjects: one group of subjects will receive a single treatment
      and the second - multiple treatments. All subjects will be followed for 180 days with several
      intermediate visits at 3, 7, 30, 60, and 90-days.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: subject is blinded to the needle gauge and density of treatment
measure: improvement in wrinkle appearance
time frame: 60 and 90 days
description: One grade or better improvement in score on Wrinkle Severity Scale
measure: improvement in skin laxity
time frame: up to 180 days
description: One grade or better improvement in score on Laxity Scale
arm group label: micro-excisional skin removal
arm group type: Experimental
description: Facial and neck wrinkles will be treated with micro-excisional skin removal
intervention type: Device
intervention name: micro-excisional skin removal with coring needle
arm group label: micro-excisional skin removal
other name: micro-coring, micro-excisional skin removal
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michail M Pankratov, MD, PhD
role: Study Director
affiliation: Senior Vice President of Clinical & Regulatory Affairs
last name: Patricia E Krantz
role: Study Director
affiliation: Director of Clinical Operations
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Fernandes JR, Samayoa JC, Broelsch GF, McCormack MC, Nicholls AM, Randolph MA, Mihm MC, Austen WG Jr. Micro-mechanical fractional skin rejuvenation. Plast Reconstr Surg. 2013 Feb;131(2):216-223. doi: 10.1097/PRS.0b013e3182789afa.
PMID: 23357983
citation: Russe E, Purschke M, Farinelli WA, Wang Y, Doukas AG, Limpiangkanan W, Sakamoto FH, Tam J, Wechselberger G, Anderson RR. Micro-fractional, directional skin tightening: A porcine model. Lasers Surg Med. 2016 Mar;48(3):264-9. doi: 10.1002/lsm.22444. Epub 2015 Dec 2.
PMID: 26627306
responsible party type: Sponsor
mesh term: Cutis Laxa
sharing ipd: No
ipd description: Clinical data analysis will be summarized in the Clinical Study Report and later submitted for publication in the peer-reviewed journal