<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/NCT03793348</url>
  </required_header>
  <id_info>
    <org_study_id>AIS 700-00052</org_study_id>
    <nct_id>NCT03793348</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles</brief_title>
  <official_title>A Prospective, Multi-center, Pivotal Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Moderate to Severe Facial Wrinkles</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>
      Study evaluating the efficacy of a micro coring device for the treatment of moderate to&#xD;
      severe check wrinkles&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Up to 35 subjects who meet the inclusion/exclusion criteria will be treated. All subjects&#xD;
      will be monitored for a period of 90 days post treatment.&#xD;
&#xD;
      Study results will be assessed with the following:&#xD;
&#xD;
        -  Lemperle Scale&#xD;
&#xD;
        -  Investigator GAIS Scale&#xD;
&#xD;
        -  Subject Satisfaction Scale&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 12, 2018</start_date>
  <completion_date type="Anticipated">August 21, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale</measure>
    <time_frame>90 day post treatment</time_frame>
    <description>A mean change of 1 point or greater reduction in cheek wrinkle severity at 90 days post treatment using the Lemperle Wrinkle Severity Scale, as assessed by (3) blinded Independent Reviewers Lemperle Scale:&#xD;
No wrinkles =0 Just perceptible wrinkles =1 Shallow wrinkles=2 Moderately deep wrinkles=3 Deep wrinkles, well-defined edges =4 Very deep wrinkles, redundant fold=5</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess aesthetic improvement using Global Aesthetic Improvement Scale</measure>
    <time_frame>90 day post treatment</time_frame>
    <description>Overall aesthetic improvement level per Principal Investigator at 90 days compared to baseline on the Global Aesthetic Improvement Scale.&#xD;
Very Much Improved (Optimal cosmetic result)=3 Much Improved (Marked improvement from the initial condition, but not completely optimal)=2 No Change (The appearance is essentially the same as baseline)=0 Worse (The appearance is worse than the original condition)= -1 Much Worse (Marked worsening in appearance from the initial condition)= - 2 Very Much Worse (Obvious worsening in appearance from the initial condition)=- 3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess aesthetic improvement using Subject Satisfaction Scale</measure>
    <time_frame>90 day post treatment</time_frame>
    <description>Satisfaction with the aesthetic appearance of the treatment area per Subject Satisfaction Scale compared to baseline.&#xD;
Extremely dissatisfied=0 Somewhat dissatisfied=1 Slightly dissatisfied=2 Neither satisfied or dissatisfied=3 Slightly satisfied=4 Somewhat satisfied=5 Extremely satisfied=6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess aesthetic improvement in wrinkles using OCT images (optional)</measure>
    <time_frame>Baseline to Day 90 post treatment</time_frame>
    <description>Assessment of improvement using OCT images with Vista software to determine wrinkle depth reduction, comparing pre-treatment depth to post treatment depth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess efficacy results using Canfield Software,, by comparing the changes in wrinkles at baseline and 90 days post treatment.</measure>
    <time_frame>Baseline to Day 90 post treatment</time_frame>
    <description>Validated Canfield software comparing baseline wrinkles to day 90 follow up wrinkles via automated photo analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess safety profile by recording of adverse events</measure>
    <time_frame>Adverse events will be recorded immediately treatment, Day 1, Day 7, Day 30, Day 60 and Day 90 post treatment. Ad hoc assessment can occur upon subject report of AE.</time_frame>
    <description>The incidence and severity of systemic and local adverse events will be recorded by the PI at all visits and a 14 day diary completed by each subject will also be collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess safety profile by reviewing completed 14 day subject diary for potential side effects.</measure>
    <time_frame>For 14 days post treatment</time_frame>
    <description>14 day diary completed by each subject will record potential side effects, level of severity (mild = 1; moderate = 2; severe = 3), and end date of the potential side effects.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">35</enrollment>
  <condition>Wrinkle</condition>
  <arm_group>
    <arm_group_label>Micro-exisional skin removal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Micro-coring of skin on the facial and neck areas will be conducted in one treatment and followed for 90 days post treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MCD</intervention_name>
    <description>Micro coring skin removal with automated coring device</description>
    <arm_group_label>Micro-exisional skin removal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females 40-70 years of age&#xD;
&#xD;
          -  Fitzpatrick Skin Type I to IV as judged by the Investigator&#xD;
&#xD;
          -  Cheek areas are at least a score of 3 using the Lemperle Wrinkle Assessment Scale as&#xD;
             judged by the Investigator&#xD;
&#xD;
          -  Able to provide written informed consent, understand and willing to comply with all&#xD;
             study related procedures and follow-up visits.&#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 injections in the areas to be treated&#xD;
&#xD;
          -  Injection of dermal fillers, fat or botulinum toxin, as well as any minimally&#xD;
             invasive/invasive medical device for skin treatment, in the study treatment areas,&#xD;
             within the past 6 months (i.e., dermabrasion, laser, RF devices)&#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;
          -  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 participate in the study&#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>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Laser and Skin Surgery Center of Northern California</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>AboutSkin Research, LLC</name>
      <address>
        <city>Greenwood Village</city>
        <state>Colorado</state>
        <zip>80111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Audrey Langhorst</last_name>
      <phone>303-756-7546</phone>
      <email>research@aboutskinderm.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Miami Dermatology &amp; Laser Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33173</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Laser and Skin Surgery of New York</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Moreno</last_name>
      <phone>212-686-7306</phone>
      <email>research@laserskinsurgery.com</email>
    </contact>
    <investigator>
      <last_name>Roy Geronemus</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Office of Brian Biesman, M.D.</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dallas Plastic Surgery Institute</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Casey Martin</last_name>
      <phone>214-823-1978</phone>
      <email>Casey.Martin@dpsi.org</email>
    </contact>
    <investigator>
      <last_name>Jay Burns</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>January 2, 2019</last_update_submitted>
  <last_update_submitted_qc>January 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>facial wrinkles</keyword>
  <keyword>skin laxity</keyword>
  <keyword>sagging skin</keyword>
  <!-- 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/NCT03793348
org study id: AIS 700-00052
nct id: NCT03793348
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
Study evaluating the efficacy of a micro coring device for the treatment of moderate to
      severe check wrinkles
Up to 35 subjects who meet the inclusion/exclusion criteria will be treated. All subjects
      will be monitored for a period of 90 days post treatment.

      Study results will be assessed with the following:

        -  Lemperle Scale

        -  Investigator GAIS Scale

        -  Subject Satisfaction Scale
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale
time frame: 90 day post treatment
description: A mean change of 1 point or greater reduction in cheek wrinkle severity at 90 days post treatment using the Lemperle Wrinkle Severity Scale, as assessed by (3) blinded Independent Reviewers Lemperle Scale:
No wrinkles =0 Just perceptible wrinkles =1 Shallow wrinkles=2 Moderately deep wrinkles=3 Deep wrinkles, well-defined edges =4 Very deep wrinkles, redundant fold=5
measure: Assess aesthetic improvement using Global Aesthetic Improvement Scale
time frame: 90 day post treatment
description: Overall aesthetic improvement level per Principal Investigator at 90 days compared to baseline on the Global Aesthetic Improvement Scale.
Very Much Improved (Optimal cosmetic result)=3 Much Improved (Marked improvement from the initial condition, but not completely optimal)=2 No Change (The appearance is essentially the same as baseline)=0 Worse (The appearance is worse than the original condition)= -1 Much Worse (Marked worsening in appearance from the initial condition)= - 2 Very Much Worse (Obvious worsening in appearance from the initial condition)=- 3
measure: Assess aesthetic improvement using Subject Satisfaction Scale
time frame: 90 day post treatment
description: Satisfaction with the aesthetic appearance of the treatment area per Subject Satisfaction Scale compared to baseline.
Extremely dissatisfied=0 Somewhat dissatisfied=1 Slightly dissatisfied=2 Neither satisfied or dissatisfied=3 Slightly satisfied=4 Somewhat satisfied=5 Extremely satisfied=6
measure: Assess aesthetic improvement in wrinkles using OCT images (optional)
time frame: Baseline to Day 90 post treatment
description: Assessment of improvement using OCT images with Vista software to determine wrinkle depth reduction, comparing pre-treatment depth to post treatment depth.
measure: Assess efficacy results using Canfield Software,, by comparing the changes in wrinkles at baseline and 90 days post treatment.
time frame: Baseline to Day 90 post treatment
description: Validated Canfield software comparing baseline wrinkles to day 90 follow up wrinkles via automated photo analysis.
measure: Assess safety profile by recording of adverse events
time frame: Adverse events will be recorded immediately treatment, Day 1, Day 7, Day 30, Day 60 and Day 90 post treatment. Ad hoc assessment can occur upon subject report of AE.
description: The incidence and severity of systemic and local adverse events will be recorded by the PI at all visits and a 14 day diary completed by each subject will also be collected.
measure: Assess safety profile by reviewing completed 14 day subject diary for potential side effects.
time frame: For 14 days post treatment
description: 14 day diary completed by each subject will record potential side effects, level of severity (mild = 1; moderate = 2; severe = 3), and end date of the potential side effects.
arm group label: Micro-exisional skin removal
arm group type: Experimental
description: Micro-coring of skin on the facial and neck areas will be conducted in one treatment and followed for 90 days post treatment.
intervention type: Device
intervention name: MCD
description: Micro coring skin removal with automated coring device
arm group label: Micro-exisional skin removal
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Active, not recruiting
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor