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/NCT05963204</url>
    </required_header>
    <id_info>
      <org_study_id>GLI.04.US.SL.023</org_study_id>
      <nct_id>NCT05963204</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Effects for Midface Improvement When Pairing a Biostimulator With a Skincare Regimen</brief_title>
    <official_title>A Randomized, Double-blinded, Split-face, Comparative Study to Evaluate the Synergistic Effects for Improving the Aging Midface When Pairing a Biostimulator With a Skincare Regimen</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Galderma R&amp;D</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Galderma R&amp;D</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>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        To assess skin structural change in midface after treatment with a biostimulator using&#xD;
        Line-Field Optical Coherence Tomography&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a randomized, double-blinded, split-face, comparative study.&#xD;
  &#xD;
        This study is designed to enroll and randomize approximately 20 subjects. All subjects are to&#xD;
        have midface volume loss and contour deficiency and facial photodamage.&#xD;
  &#xD;
        Eligible subjects are randomized to receive study skincare products for pre-conditioning, 2&#xD;
        weeks before Baseline. All subjects receive biostimulator treatment at the midface by the&#xD;
        Treating Investigator at Baseline. The method of injection is at the discretion of the&#xD;
        Treating Investigator. A sufficient amount of product is injected to achieve optimal&#xD;
        correction of the midface, in the opinion of the Treating Investigator.&#xD;
  &#xD;
        At the 6-week visit, after all study procedures for the visit are completed, treated subjects&#xD;
        received a second biostimulator treatment to achieve optimal aesthetic improvement. At the&#xD;
        12-week and 18-week visits, similar study procedures are performed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 7, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 19, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Structural change in midface post-treatment with a biostimulator compared to pre-treatment</measure>
      <time_frame>6 weeks and 18 weeks after Baseline</time_frame>
      <description>Percent change in collagen fiber density using Line-Field Confocal Optical Coherence Tomography at defined timepoints compared to baseline. Collagen density is defined as a number of fibers and is measured on each side of the midface.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Improvement in clinical grading score compared to pre-treatment</measure>
      <time_frame>Baseline, at 6 weeks, 12 weeks, and 18 weeks after Baseline</time_frame>
      <description>Percent change in skin parameters includes photodamage, roughness, radiance at defined timepoints compared to re-treatment. Each parameter is assessed by the Investigator on each side of the face using a 10-point Modified Griffiths' scale where 0 = none and 9 = severe.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subject satisfaction using a self-assessment questionnaire</measure>
      <time_frame>Baseline, at 6 weeks, 12 weeks, and 18 weeks after Baseline</time_frame>
      <description>Survey where subjects are asked about their satisfaction with treatment outcome on each half of their face. A 5-point subject satisfaction questionnaire with the following responses: strongly agree, agree, neither agree nor disagree, disagree, strongly disagree.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Photodamaged Skin</condition>
    <condition>Volume Deficiency of the Midface</condition>
    <arm_group>
      <arm_group_label>Biostimulator and Facial Moisturizer A</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Biostimulator is sterile dry powder poly L-lactic acid with sodium carboxymethylcellulose, non-pyrogenic mannitol. Mode of administration: injection. Dosage: at investigator's discretion for optimal outcome. Frequency and duration: injection at baseline and at week 6.&#xD;
  Facial Moisturizer A is a cream with active TriHex technology. Mode of administration: topical application. Frequency and duration: twice daily on half of the face for the entire study.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Biostimulator and Facial Moisturizer B</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Biostimulator is sterile dry powder poly L-lactic acid with sodium carboxymethylcellulose, non-pyrogenic mannitol. Mode of administration: injection. Dosage: at investigator's discretion for optimal outcome. Frequency and duration: injection at baseline and at week 6.&#xD;
  Facial Moisturizer B is a neutral, oil-free moisturizing lotion. Mode of administration: topical application. Frequency and duration: twice daily on half of the face for the entire study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Sculptra and Alastin Restorative Skin Complex</intervention_name>
      <description>Biostimulator and cosmetics</description>
      <arm_group_label>Biostimulator and Facial Moisturizer A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Sculptra and CeraVe Daily Moisturizing Lotion</intervention_name>
      <description>Biostimulator and cosmetics</description>
      <arm_group_label>Biostimulator and Facial Moisturizer B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subjects diagnosed with symmetrical, moderate-to-severe cheek wrinkles on each side of&#xD;
               the face as assessed via the Galderma Cheek Wrinkles Scale.&#xD;
  &#xD;
            -  Subjects with symmetrical, mild-to-severe photodamage at both sides of the midface.&#xD;
  &#xD;
            -  Subject who in the opinion of the treating investigator would need 2 biostimulator&#xD;
               treatments for optimal clinical outcomes.&#xD;
  &#xD;
            -  Ability of giving consent for participation in the study.&#xD;
  &#xD;
            -  Agreement to adhere to the procedures and requirements of the study and to report to&#xD;
               the institute on the day(s) and at the time(s) scheduled for the assessments.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subjects with asymmetrical severity or unidentical cheek wrinkle score between 2 sides&#xD;
               of the cheek.&#xD;
  &#xD;
            -  Asymmetrical severity photodamage score between 2 sides of the midface.&#xD;
  &#xD;
            -  Subjects with a history of allergy or hypersensitivity to any ingredient of the&#xD;
               treatment products.&#xD;
  &#xD;
            -  Previous tissue-augmenting therapy, contouring, or revitalization treatment in the&#xD;
               face, except lips.&#xD;
  &#xD;
            -  Previous treatment/procedure in the face in the previous 6 months that, in the&#xD;
               Investigator's opinion, would interfere with the study injections and/or study&#xD;
               assessments or exposed the study subject to undue risk by study participation, or&#xD;
               planning to undergo any of these procedures affecting the treatment area at any time&#xD;
               during the study.&#xD;
  &#xD;
            -  Subjects with any medical condition that, in the opinion of the Investigator, would&#xD;
               make the subject unsuitable for inclusion.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Orit Markowitz, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Markowitz Medical</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Thu Q Nguyen, PhD</last_name>
      <phone>817-961-5495</phone>
      <email>thu.nguyen@galderma.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Markowitz Medicals</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10128</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jennifer Yudkevich, CCRC</last_name>
        <phone>212-828-3120</phone>
        <email>jennifer@optiskinmedical.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 29, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mannitol</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05963204
  org study id: GLI.04.US.SL.023
  nct id: NCT05963204
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  To assess skin structural change in midface after treatment with a biostimulator using
        Line-Field Optical Coherence Tomography
  This is a randomized, double-blinded, split-face, comparative study.
  
        This study is designed to enroll and randomize approximately 20 subjects. All subjects are to
        have midface volume loss and contour deficiency and facial photodamage.
  
        Eligible subjects are randomized to receive study skincare products for pre-conditioning, 2
        weeks before Baseline. All subjects receive biostimulator treatment at the midface by the
        Treating Investigator at Baseline. The method of injection is at the discretion of the
        Treating Investigator. A sufficient amount of product is injected to achieve optimal
        correction of the midface, in the opinion of the Treating Investigator.
  
        At the 6-week visit, after all study procedures for the visit are completed, treated subjects
        received a second biostimulator treatment to achieve optimal aesthetic improvement. At the
        12-week and 18-week visits, similar study procedures are performed.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Structural change in midface post-treatment with a biostimulator compared to pre-treatment
  time frame: 6 weeks and 18 weeks after Baseline
  description: Percent change in collagen fiber density using Line-Field Confocal Optical Coherence Tomography at defined timepoints compared to baseline. Collagen density is defined as a number of fibers and is measured on each side of the midface.
  measure: Improvement in clinical grading score compared to pre-treatment
  time frame: Baseline, at 6 weeks, 12 weeks, and 18 weeks after Baseline
  description: Percent change in skin parameters includes photodamage, roughness, radiance at defined timepoints compared to re-treatment. Each parameter is assessed by the Investigator on each side of the face using a 10-point Modified Griffiths' scale where 0 = none and 9 = severe.
  measure: Subject satisfaction using a self-assessment questionnaire
  time frame: Baseline, at 6 weeks, 12 weeks, and 18 weeks after Baseline
  description: Survey where subjects are asked about their satisfaction with treatment outcome on each half of their face. A 5-point subject satisfaction questionnaire with the following responses: strongly agree, agree, neither agree nor disagree, disagree, strongly disagree.
  arm group label: Biostimulator and Facial Moisturizer A
  arm group type: Active Comparator
  description: Biostimulator is sterile dry powder poly L-lactic acid with sodium carboxymethylcellulose, non-pyrogenic mannitol. Mode of administration: injection. Dosage: at investigator's discretion for optimal outcome. Frequency and duration: injection at baseline and at week 6.
  Facial Moisturizer A is a cream with active TriHex technology. Mode of administration: topical application. Frequency and duration: twice daily on half of the face for the entire study.
  arm group label: Biostimulator and Facial Moisturizer B
  arm group type: Active Comparator
  description: Biostimulator is sterile dry powder poly L-lactic acid with sodium carboxymethylcellulose, non-pyrogenic mannitol. Mode of administration: injection. Dosage: at investigator's discretion for optimal outcome. Frequency and duration: injection at baseline and at week 6.
  Facial Moisturizer B is a neutral, oil-free moisturizing lotion. Mode of administration: topical application. Frequency and duration: twice daily on half of the face for the entire study.
  intervention type: Combination Product
  intervention name: Sculptra and Alastin Restorative Skin Complex
  description: Biostimulator and cosmetics
  arm group label: Biostimulator and Facial Moisturizer A
  intervention type: Combination Product
  intervention name: Sculptra and CeraVe Daily Moisturizing Lotion
  description: Biostimulator and cosmetics
  arm group label: Biostimulator and Facial Moisturizer B
  criteria: 
  gender: All
  minimum age: 22 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Orit Markowitz, MD
  role: Principal Investigator
  affiliation: Markowitz Medical
  last name: Thu Q Nguyen, PhD
  phone: 817-961-5495
  email: thu.nguyen@galderma.com
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Mannitol
  sharing ipd: No