xml: <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/NCT06032286</url>
    </required_header>
    <id_info>
      <org_study_id>ASIRC_SSMS_07-14-23</org_study_id>
      <nct_id>NCT06032286</nct_id>
    </id_info>
    <brief_title>Evaluation of Efficacy and Safety of the Skinstylus Sterilock Microneedling System for the Treatment of Facial Wrinkles</brief_title>
    <official_title>Evaluation of Efficacy and Safety of the Skinstylus Sterilock Microneedling System for the Treatment of Facial Wrinkles</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beauty Health</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Beauty Health</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_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        To assess the efficacy and safety of the Skin stylus Sterilock microneedling system in&#xD;
        reducing the appearance of facial wrinkles.This study is intended to be a single arm study.&#xD;
        Suitable subjects who meet all inclusion criteria and consented will undergo 4 microneedling&#xD;
        sessions at baseline and days 30, 60 and 90.&#xD;
  &#xD;
        Subjects will be assessed at days 90, 120 and finally at day 150 by a physician utilizing the&#xD;
        wrinkle grading scale developed by Lemperle (2001) and skin laxity and texture using a&#xD;
        modified Alexiandes Armenakas (2010) grading scale.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is intended to be a single arm study. Suitable subjects who meet all inclusion&#xD;
        criteria and consented will undergo 4 microneedling sessions at baseline and days 30, 60 and&#xD;
        90.&#xD;
  &#xD;
        Subjects will be assessed at days 90, 120 and finally at day 150 by a physician utilizing the&#xD;
        wrinkle grading scale developed by Lemperle (2001) and skin laxity and texture using a&#xD;
        modified Alexiandes Armenakas (2010) grading scale.&#xD;
  &#xD;
        Physicians will grade treatment response on days, 90, 120 and finally on day 150 using a&#xD;
        Global Aesthetic Improvement Scale (GAIS) Standard photography will be recorded at baseline&#xD;
        and days 30, 60, 90, 120 and finally at day 150.&#xD;
  &#xD;
        Subjects will complete diaries including self-assessment of treatment response, side effects&#xD;
        &amp; downtime up to 7 days post treatment.&#xD;
  &#xD;
        Subjects will assess treatment response on days 90, 120 and finally on day 150 using a&#xD;
        Subject Global Aesthetic Improvement Scale (SGAIS).&#xD;
  &#xD;
        Subjects will assess treatment response and satisfaction at baseline and day 150 using the&#xD;
        Facial Appearance, Health-Related Quality of Life and Adverse Effects (FACE-Q3) Patient&#xD;
        reported outcome measure (PROM).&#xD;
  &#xD;
        The number, type and severity of adverse events will be recorded during the duration of the&#xD;
        study period.&#xD;
  &#xD;
        At the end of the study period, photography will be assessed by three blinded physicians&#xD;
        using the wrinkle grading scale developed by Lemperle (2001)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 8, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2024</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>Single group, all subjects will receive intervention.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Wrinkle improvement</measure>
      <time_frame>120 and 150 days after the first treatment</time_frame>
      <description>Mean improvement over baseline of one grade for wrinkles utilizing the Lemperle (2001) grading scale scores of the periorbital, cheek folds and glabellar lines 120 and 150 days after the first treatment.&#xD;
  The Lemperle Wrinkle Grading Scale, is used to assess the severity of facial wrinkles.&#xD;
  The scale divides the face into distinct facial areas (horizontal forehead lines, glabellar frown lines, periorbital lines, preauricular lines, cheek folds, nasolabial folds, upper lip lines, corner of mouth line, marionette lines and chin crease). Each area is classified 0-5, (0-No wrinkles, 5-Very deep wrinkles).&#xD;
  Lemperle G, Holmes RE, Cohen SR, Lemperle SM. A classification of facial wrinkles. Plast Reconstr Surg. 2001;108(6):1735-1750.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Texture and laxity</measure>
      <time_frame>120 and 150 days after the first treatment</time_frame>
      <description>Mean improvement over baseline of one grade for skin laxity and texture 120 and 150 days after the first treatment using a scale developed by Alexiandes Armenakas This is a modified texture and laxity grading scale adapted from the complete grading scale developed by Alexiandes Armenakas (2010). The scale is an 8 point descriptive scale (0-4, with 0.4 increments). Where 0 is no visible evidence of skin laxity or texture and 4 is severe skin laxity and skin roughness (texture)</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Adverse events</measure>
      <time_frame>150 days</time_frame>
      <description>Incidence and degree of (adverse events) side effects</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">49</enrollment>
    <condition>Subjects Displaying Facial Ageing</condition>
    <arm_group>
      <arm_group_label>Microneedling</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>4 microneedling sessions at baseline and days 30, 60 and 90.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Skinstylus microneedling device</intervention_name>
      <description>Microneedling, also known as percutaneous collagen induction (PCI), is a minimally invasive technique where small needles create microscopic wounds in the skin inducing collagen formation.</description>
      <arm_group_label>Microneedling</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy male &amp; females; 35 to 75 years of age with signs of facial aging.&#xD;
  &#xD;
            -  Fitzpatrick I-VI phototype skin types.&#xD;
  &#xD;
            -  Volunteers with wrinkle grading of 1 to 4 according to Lemperle (2001) wrinkle grading&#xD;
               scale.&#xD;
  &#xD;
            -  Volunteers with a laxity grading of 1-3.5 according to Alexiandes Armenakas (2010)&#xD;
               grading scale.&#xD;
  &#xD;
            -  Written informed consent is given.&#xD;
  &#xD;
            -  Females of childbearing potential (FOCBP) and females who are premenses must be&#xD;
               willing to practice effective contraception for the duration of the study. (Effective&#xD;
               contraception is defined as stabilized on oral contraceptive for at least 3 months,&#xD;
               intrauterine device, condom with spermicide, diaphragm with spermicide, implant,&#xD;
               NuvaRing, injection, transdermal patch or abstinence.)&#xD;
  &#xD;
            -  Females on birth control pills must have taken the same type of pill for at least 3&#xD;
               months prior to entering the study and must not change type during the study.&#xD;
  &#xD;
            -  Those who have used birth control pills in the past must have discontinued usage at&#xD;
               least 3 months prior to the start of the study.&#xD;
  &#xD;
            -  Volunteers agree NOT to use any topical agents containing active ingredients such as&#xD;
               retinol, glycolic acid in the treatment area, during the study period.&#xD;
  &#xD;
            -  Volunteers agree NOT to undergo any aesthetic treatments (such as Botox, fillers,&#xD;
               microdermabrasion, laser surfacing etc.) in the treatment area, during the study&#xD;
               period.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Volunteers have used a topical anti-aging product containing active ingredients within&#xD;
               4 weeks of commencing the study.&#xD;
  &#xD;
            -  Volunteers suffer from Hemophilia or other clotting/bleeding disorders.&#xD;
  &#xD;
            -  Volunteers taking anticoagulant therapy, e.g., warfarin, heparin.&#xD;
  &#xD;
            -  Volunteers who have used aspirin continuously in the last 2 weeks.&#xD;
  &#xD;
            -  Volunteers with active acne vulgaris of the face.&#xD;
  &#xD;
            -  Volunteers who have stopped taking birth control pills within the last 3 months.&#xD;
  &#xD;
            -  Volunteers suffer from uncontrolled diabetes mellitus.&#xD;
  &#xD;
            -  Volunteers with known malignancy and/or undergoing chemotherapy, radiotherapy, or high&#xD;
               doses of corticosteroids.&#xD;
  &#xD;
            -  Volunteers suffer from keloid scars, Human Papilloma virus (HPV) or birth marks in the&#xD;
               treatment area.&#xD;
  &#xD;
            -  Volunteers have a tendency for keloid scar formation.&#xD;
  &#xD;
            -  Volunteers suffer from eczema or skin rashes in the treatment area.&#xD;
  &#xD;
            -  Volunteers suffer from systemic infections such as hepatitis.&#xD;
  &#xD;
            -  Volunteers have known allergy to topical/local anesthetics.&#xD;
  &#xD;
            -  Volunteers have continuously used high dose NSAIDs for the last 2 weeks.&#xD;
  &#xD;
            -  Volunteers have undergone plastic surgery in the treatment area within the last 6&#xD;
               months.&#xD;
  &#xD;
            -  Volunteers have undergone filler injections in the treatment area within the last 6&#xD;
               months.&#xD;
  &#xD;
            -  Volunteers have received Botox or other neuromodulators injections in the treatment&#xD;
               area within the last 6 months.&#xD;
  &#xD;
            -  Females who are pregnant, breast-feeding or who wish to become pregnant during the&#xD;
               study period.&#xD;
  &#xD;
            -  Enrolled in another clinical trial during the same study period.&#xD;
  &#xD;
            -  Volunteer has a planned hospital admission and/or surgical procedure for an illness or&#xD;
               disease which existed before enrolment into the clinical trial, and which may&#xD;
               interfere with the course or outcome of the study.&#xD;
  &#xD;
            -  Volunteering has medical or psychological condition(s) associated with a risk of poor&#xD;
               protocol compliance (e.g., alcoholism or drug abuse).&#xD;
  &#xD;
            -  Volunteer is undergoing or is likely to undergo other treatments.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>35 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Juan Velasquez, phD</last_name>
      <phone>5624768861</phone>
      <email>jvelasquez@hydrafacial.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ablon Skin Institute</name>
        <address>
          <city>Manhattan Beach</city>
          <state>California</state>
          <zip>90266</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Shelley Joyce</last_name>
        <phone>310-727-3376</phone>
        <email>shelley@abloninstitute.com</email>
      </contact>
      <contact_backup>
        <last_name>Riham Farid</last_name>
        <phone>310 727-3376</phone>
        <email>riham@abloninstitute.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>West Dermatology Research Center</name>
        <address>
          <city>San Diego</city>
          <state>California</state>
          <zip>92121</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sabrina Fabi, MD, FAAD, FAACS</last_name>
        <phone>(858) 657-1004</phone>
        <email>sgfabi@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Freia Canals</last_name>
        <phone>(858) 657-1004</phone>
        <email>freia.canals@westderm.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Lemperle G, Holmes RE, Cohen SR, Lemperle SM. A classification of facial wrinkles. Plast Reconstr Surg. 2001 Nov;108(6):1735-50; discussion 1751-2. doi: 10.1097/00006534-200111000-00048.</citation>
      <PMID>11711957</PMID>
    </reference>
    <reference>
      <citation>Alexiades-Armenakas M. A quantitative and comprehensive grading scale for rhytides, laxity, and photoaging. J Drugs Dermatol. 2006 Sep;5(8):808-9. No abstract available.</citation>
      <PMID>16989197</PMID>
    </reference>
    <reference>
      <citation>Pusic AL, Klassen AF, Scott AM, Cano SJ. Development and psychometric evaluation of the FACE-Q satisfaction with appearance scale: a new patient-reported outcome instrument for facial aesthetics patients. Clin Plast Surg. 2013 Apr;40(2):249-60. doi: 10.1016/j.cps.2012.12.001.</citation>
      <PMID>23506765</PMID>
    </reference>
    <reference>
      <citation>Orentreich DS, Orentreich N. Subcutaneous incisionless (subcision) surgery for the correction of depressed scars and wrinkles. Dermatol Surg. 1995 Jun;21(6):543-9. doi: 10.1111/j.1524-4725.1995.tb00259.x.</citation>
      <PMID>7773602</PMID>
    </reference>
    <reference>
      <citation>Alster TS, Graham PM. Microneedling: A Review and Practical Guide. Dermatol Surg. 2018 Mar;44(3):397-404. doi: 10.1097/DSS.0000000000001248.</citation>
      <PMID>28796657</PMID>
    </reference>
    <results_reference>
      <citation>Ablon G. Safety and Effectiveness of an Automated Microneedling Device in Improving the Signs of Aging Skin. J Clin Aesthet Dermatol. 2018 Aug;11(8):29-34. Epub 2018 Aug 1.</citation>
      <PMID>30214664</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Wrinkles</keyword>
    <keyword>Facial ageing</keyword>
    <keyword>Micro needling</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Facies</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Plan for data to be published in peer reviewed journal</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06032286
  org study id: ASIRC_SSMS_07-14-23
  nct id: NCT06032286
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  To assess the efficacy and safety of the Skin stylus Sterilock microneedling system in
        reducing the appearance of facial wrinkles.This study is intended to be a single arm study.
        Suitable subjects who meet all inclusion criteria and consented will undergo 4 microneedling
        sessions at baseline and days 30, 60 and 90.
  
        Subjects will be assessed at days 90, 120 and finally at day 150 by a physician utilizing the
        wrinkle grading scale developed by Lemperle (2001) and skin laxity and texture using a
        modified Alexiandes Armenakas (2010) grading scale.
  This study is intended to be a single arm study. Suitable subjects who meet all inclusion
        criteria and consented will undergo 4 microneedling sessions at baseline and days 30, 60 and
        90.
  
        Subjects will be assessed at days 90, 120 and finally at day 150 by a physician utilizing the
        wrinkle grading scale developed by Lemperle (2001) and skin laxity and texture using a
        modified Alexiandes Armenakas (2010) grading scale.
  
        Physicians will grade treatment response on days, 90, 120 and finally on day 150 using a
        Global Aesthetic Improvement Scale (GAIS) Standard photography will be recorded at baseline
        and days 30, 60, 90, 120 and finally at day 150.
  
        Subjects will complete diaries including self-assessment of treatment response, side effects
        & downtime up to 7 days post treatment.
  
        Subjects will assess treatment response on days 90, 120 and finally on day 150 using a
        Subject Global Aesthetic Improvement Scale (SGAIS).
  
        Subjects will assess treatment response and satisfaction at baseline and day 150 using the
        Facial Appearance, Health-Related Quality of Life and Adverse Effects (FACE-Q3) Patient
        reported outcome measure (PROM).
  
        The number, type and severity of adverse events will be recorded during the duration of the
        study period.
  
        At the end of the study period, photography will be assessed by three blinded physicians
        using the wrinkle grading scale developed by Lemperle (2001)
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Single group, all subjects will receive intervention.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Wrinkle improvement
  time frame: 120 and 150 days after the first treatment
  description: Mean improvement over baseline of one grade for wrinkles utilizing the Lemperle (2001) grading scale scores of the periorbital, cheek folds and glabellar lines 120 and 150 days after the first treatment.
  The Lemperle Wrinkle Grading Scale, is used to assess the severity of facial wrinkles.
  The scale divides the face into distinct facial areas (horizontal forehead lines, glabellar frown lines, periorbital lines, preauricular lines, cheek folds, nasolabial folds, upper lip lines, corner of mouth line, marionette lines and chin crease). Each area is classified 0-5, (0-No wrinkles, 5-Very deep wrinkles).
  Lemperle G, Holmes RE, Cohen SR, Lemperle SM. A classification of facial wrinkles. Plast Reconstr Surg. 2001;108(6):1735-1750.
  measure: Texture and laxity
  time frame: 120 and 150 days after the first treatment
  description: Mean improvement over baseline of one grade for skin laxity and texture 120 and 150 days after the first treatment using a scale developed by Alexiandes Armenakas This is a modified texture and laxity grading scale adapted from the complete grading scale developed by Alexiandes Armenakas (2010). The scale is an 8 point descriptive scale (0-4, with 0.4 increments). Where 0 is no visible evidence of skin laxity or texture and 4 is severe skin laxity and skin roughness (texture)
  measure: Adverse events
  time frame: 150 days
  description: Incidence and degree of (adverse events) side effects
  arm group label: Microneedling
  arm group type: Experimental
  description: 4 microneedling sessions at baseline and days 30, 60 and 90.
  intervention type: Device
  intervention name: Skinstylus microneedling device
  description: Microneedling, also known as percutaneous collagen induction (PCI), is a minimally invasive technique where small needles create microscopic wounds in the skin inducing collagen formation.
  arm group label: Microneedling
  criteria: 
  gender: All
  minimum age: 35 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Juan Velasquez, phD
  phone: 5624768861
  email: jvelasquez@hydrafacial.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  citation: Lemperle G, Holmes RE, Cohen SR, Lemperle SM. A classification of facial wrinkles. Plast Reconstr Surg. 2001 Nov;108(6):1735-50; discussion 1751-2. doi: 10.1097/00006534-200111000-00048.
  PMID: 11711957
  citation: Alexiades-Armenakas M. A quantitative and comprehensive grading scale for rhytides, laxity, and photoaging. J Drugs Dermatol. 2006 Sep;5(8):808-9. No abstract available.
  PMID: 16989197
  citation: Pusic AL, Klassen AF, Scott AM, Cano SJ. Development and psychometric evaluation of the FACE-Q satisfaction with appearance scale: a new patient-reported outcome instrument for facial aesthetics patients. Clin Plast Surg. 2013 Apr;40(2):249-60. doi: 10.1016/j.cps.2012.12.001.
  PMID: 23506765
  citation: Orentreich DS, Orentreich N. Subcutaneous incisionless (subcision) surgery for the correction of depressed scars and wrinkles. Dermatol Surg. 1995 Jun;21(6):543-9. doi: 10.1111/j.1524-4725.1995.tb00259.x.
  PMID: 7773602
  citation: Alster TS, Graham PM. Microneedling: A Review and Practical Guide. Dermatol Surg. 2018 Mar;44(3):397-404. doi: 10.1097/DSS.0000000000001248.
  PMID: 28796657
  citation: Ablon G. Safety and Effectiveness of an Automated Microneedling Device in Improving the Signs of Aging Skin. J Clin Aesthet Dermatol. 2018 Aug;11(8):29-34. Epub 2018 Aug 1.
  PMID: 30214664
  responsible party type: Sponsor
  mesh term: Facies
  sharing ipd: No
  ipd description: Plan for data to be published in peer reviewed journal