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/NCT06018987</url>
    </required_header>
    <id_info>
      <org_study_id>M21-833</org_study_id>
      <nct_id>NCT06018987</nct_id>
    </id_info>
    <brief_title>A Study to Assess Adverse Events and Effectiveness of HAC 20L Injections in Adult Participants for the Treatment of Nasolabial Folds</brief_title>
    <official_title>A Multicenter, Evaluator-blinded, Randomized, Delayed Treatment Control Group Study of the Safety and Effectiveness of HAC 20L for the Correction of Moderate to Severe Nasolabial Folds</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AbbVie</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AbbVie</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Nasolabial folds (NLF) are the two skin folds that run from each side of the nose to the&#xD;
        corners of the mouth. Prominent NLFs distort the contour of the midface, giving a fatigued&#xD;
        and aged appearance. Soft tissue fillers can be used to reduce the depth of NLFs and restore&#xD;
        a more youthful appearance. The purpose of this study is to evaluate how safe and effective&#xD;
        HAC 20L is in the correction of moderate to severe NLF in adult participants.&#xD;
  &#xD;
        HAC 20L is an investigational drug being developed for the treatment of NLF. There are 2&#xD;
        cohorts in this study. In each cohort participants are are assigned to either the treatment&#xD;
        group or no-treatment control group. There is a 1 in 3 chance that participants will be&#xD;
        assigned to the no-treatment control group. Around 255 adult participants with moderate to&#xD;
        severe NLF will be enrolled in the study at approximately 20 sites worldwide.&#xD;
  &#xD;
        Participants in the treatment group will receive an injection of HAC 20L to the NLF on Day 1&#xD;
        in Cohort 1 and Cohort 2 with the option of re-treatment after completion of Month 12 visit.&#xD;
        The control group will receive no treatment but will be offered an optional HAC 20L treatment&#xD;
        after 6 months.&#xD;
  &#xD;
        There may be higher treatment burden for participants in this trial compared to their&#xD;
        standard of care. Participants will attend regular visits during the study at a hospital or&#xD;
        clinic. The effect of the treatment will be examined by completing effectiveness&#xD;
        questionnaires by the subjects, evaluating investigator (EI) and central reviewers as well as&#xD;
        monitoring safety assessments such as vital signs, blood tests, injection site responses and&#xD;
        adverse events.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 5, 2023</start_date>
    <completion_date type="Anticipated">July 21, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 21, 2026</primary_completion_date>
    <phase>Phase 2/Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of Participants Achieving Responder Status Based on Evaluating Investigator's (EI's) Live Assessment of Nasolabial Folds (NLF) Severity using the Nasolabial Fold Severity Scale (NLFSS)</measure>
      <time_frame>Month 6</time_frame>
      <description>The NLFSS is a 5-point photonumeric scale used by the EI to assess the severity of each NFL where 0 = None and 4 = Extreme. A responder is defined as a participant who shows at least 1-point improvement on the NLFSS from baseline on both sides.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Adverse Events (AEs)</measure>
      <time_frame>Month 15</time_frame>
      <description>An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this device</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline on the Overall Score of FACE-Q-Appraisal of Lines: Nasolabial Folds Questionnaire</measure>
      <time_frame>Baseline to Month 6</time_frame>
      <description>The FACE Q-Appraisal of lines: Nasolabial Folds consists of 5 questions to assess how much the participants has been bothered by various aspects of NLFs in the past week where 1 = not at all and 4 = extremely.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants Achieving Responder Status Based on Evaluating Investigator's Assessment of Global Aesthetic Improvement on the NLF Area using the Global Aesthetic Improvement Scale (GAIS)</measure>
      <time_frame>Month 6</time_frame>
      <description>The GAIS will assess global aesthetic improvement of the NLF area by comparing the frontal and side view photographs taken at baseline where -2 = Much Worse and 2 = Much Improved. A responder is defined as achieving &quot;improved&quot; or &quot;much improved&quot;.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants Achieving Responder Status Based on Participant's Assessment of Global Aesthetic Improvement in the NLF Area Using the GAIS</measure>
      <time_frame>Month 6</time_frame>
      <description>The GAIS will assess global aesthetic improvement of the NLF area by comparing the frontal and side view photographs taken at baseline where -2 = Much Worse and 2 = Much Improved. A responder is defined as achieving &quot;improved&quot; or &quot;much improved&quot;.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">255</enrollment>
    <condition>Nasolabial Folds</condition>
    <arm_group>
      <arm_group_label>Cohort 1: Treatment Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive subdermal injection of HAC20L to the nasolabial folds on Day 1 followed by an optional touch-up treatment on Day 30 if applicable. Participants will then be eligible to receive optional repeat treatment at Month 12 if applicable.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 1: Control Group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants will not receive treatment for 6 months and then will be offered an optional delayed treatment of HAC 20L after completion of of Month 6 visit with an optional touch-up treatment offered 30 days after delayed treatment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 2: Treatment Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive subdermal injection of HAC20L to the nasolabial folds on Day 1 followed by an optional touch-up treatment on Day 30 if applicable. Participants will then be eligible to receive optional repeat treatment at Month 12 if applicable.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 2: Control Group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants will not receive treatment for 6 months and then will be offered an optional delayed treatment of HAC 20L after completion of of Month 6 visit with an optional touch-up treatment offered 30 days after delayed treatment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No-Treatment Control</intervention_name>
      <description>Participants will not receive treatment for 6 months and then will be offered an optional delayed treatment of HAC 20L after completion of of Month 6 visit with an optional touch-up treatment offered 30 days after delayed treatment.</description>
      <arm_group_label>Cohort 1: Control Group</arm_group_label>
      <arm_group_label>Cohort 2: Control Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>HAC 20L</intervention_name>
      <description>Subdermal Injections</description>
      <arm_group_label>Cohort 1: Treatment Group</arm_group_label>
      <arm_group_label>Cohort 2: Treatment Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Has moderate or severe NLFs (NLFSS score 2 or 3) on each NLF based on EI's live&#xD;
               assessment (both NLFs must qualify and need to have the same score)&#xD;
  &#xD;
            -  General good health, in the opinion of the TI, and no known current COVID 19 disease&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Atrophic skin in the facial area that makes it unsuitable for injection&#xD;
  &#xD;
            -  History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA&#xD;
               products, bovine or porcine collagen products, Streptococcal protein or any other&#xD;
               incipient&#xD;
  &#xD;
            -  Fat injection or permanent implants (e.g., polymethylmethacrylate, silicone,&#xD;
               polytetrafluoroethylene) anywhere in the face, or is planning to be implanted with any&#xD;
               of these products at any time during the study.&#xD;
  &#xD;
            -  Received semipermanent soft-tissue filler treatment (e.g., calcium hydroxyapatite,&#xD;
               poly-L-lactic acid) in the face below the orbital rim within 24 months before&#xD;
               enrollment, or is planning to be implanted with any of these products at any time&#xD;
               during the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>ABBVIE INC.</last_name>
      <role>Study Director</role>
      <affiliation>AbbVie</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>ABBVIE CALL CENTER</last_name>
      <phone>844-663-3742</phone>
      <email>abbvieclinicaltrials@abbvie.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Privatpraxis Dr. Hilton &amp; Partner /ID# 231401</name>
        <address>
          <city>Duesseldorf</city>
          <state>Nordrhein-Westfalen</state>
          <zip>40212</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <link>
      <url>https://www.abbvieclinicaltrials.com/study/?id=M21-833</url>
      <description>Related Info</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>HAC 20L</keyword>
    <keyword>AGN-8010</keyword>
    <keyword>Nasolabial Folds</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/</ipd_time_frame>
      <ipd_access_criteria>Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/</ipd_access_criteria>
      <ipd_url>https://vivli.org/ourmember/abbvie/</ipd_url>
    </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/NCT06018987
  org study id: M21-833
  nct id: NCT06018987
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Nasolabial folds (NLF) are the two skin folds that run from each side of the nose to the
        corners of the mouth. Prominent NLFs distort the contour of the midface, giving a fatigued
        and aged appearance. Soft tissue fillers can be used to reduce the depth of NLFs and restore
        a more youthful appearance. The purpose of this study is to evaluate how safe and effective
        HAC 20L is in the correction of moderate to severe NLF in adult participants.
  
        HAC 20L is an investigational drug being developed for the treatment of NLF. There are 2
        cohorts in this study. In each cohort participants are are assigned to either the treatment
        group or no-treatment control group. There is a 1 in 3 chance that participants will be
        assigned to the no-treatment control group. Around 255 adult participants with moderate to
        severe NLF will be enrolled in the study at approximately 20 sites worldwide.
  
        Participants in the treatment group will receive an injection of HAC 20L to the NLF on Day 1
        in Cohort 1 and Cohort 2 with the option of re-treatment after completion of Month 12 visit.
        The control group will receive no treatment but will be offered an optional HAC 20L treatment
        after 6 months.
  
        There may be higher treatment burden for participants in this trial compared to their
        standard of care. Participants will attend regular visits during the study at a hospital or
        clinic. The effect of the treatment will be examined by completing effectiveness
        questionnaires by the subjects, evaluating investigator (EI) and central reviewers as well as
        monitoring safety assessments such as vital signs, blood tests, injection site responses and
        adverse events.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Percentage of Participants Achieving Responder Status Based on Evaluating Investigator's (EI's) Live Assessment of Nasolabial Folds (NLF) Severity using the Nasolabial Fold Severity Scale (NLFSS)
  time frame: Month 6
  description: The NLFSS is a 5-point photonumeric scale used by the EI to assess the severity of each NFL where 0 = None and 4 = Extreme. A responder is defined as a participant who shows at least 1-point improvement on the NLFSS from baseline on both sides.
  measure: Number of Participants with Adverse Events (AEs)
  time frame: Month 15
  description: An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this device
  measure: Change from Baseline on the Overall Score of FACE-Q-Appraisal of Lines: Nasolabial Folds Questionnaire
  time frame: Baseline to Month 6
  description: The FACE Q-Appraisal of lines: Nasolabial Folds consists of 5 questions to assess how much the participants has been bothered by various aspects of NLFs in the past week where 1 = not at all and 4 = extremely.
  measure: Percentage of Participants Achieving Responder Status Based on Evaluating Investigator's Assessment of Global Aesthetic Improvement on the NLF Area using the Global Aesthetic Improvement Scale (GAIS)
  time frame: Month 6
  description: The GAIS will assess global aesthetic improvement of the NLF area by comparing the frontal and side view photographs taken at baseline where -2 = Much Worse and 2 = Much Improved. A responder is defined as achieving "improved" or "much improved".
  measure: Percentage of Participants Achieving Responder Status Based on Participant's Assessment of Global Aesthetic Improvement in the NLF Area Using the GAIS
  time frame: Month 6
  description: The GAIS will assess global aesthetic improvement of the NLF area by comparing the frontal and side view photographs taken at baseline where -2 = Much Worse and 2 = Much Improved. A responder is defined as achieving "improved" or "much improved".
  arm group label: Cohort 1: Treatment Group
  arm group type: Experimental
  description: Participants will receive subdermal injection of HAC20L to the nasolabial folds on Day 1 followed by an optional touch-up treatment on Day 30 if applicable. Participants will then be eligible to receive optional repeat treatment at Month 12 if applicable.
  arm group label: Cohort 1: Control Group
  arm group type: Other
  description: Participants will not receive treatment for 6 months and then will be offered an optional delayed treatment of HAC 20L after completion of of Month 6 visit with an optional touch-up treatment offered 30 days after delayed treatment.
  arm group label: Cohort 2: Treatment Group
  arm group type: Experimental
  description: Participants will receive subdermal injection of HAC20L to the nasolabial folds on Day 1 followed by an optional touch-up treatment on Day 30 if applicable. Participants will then be eligible to receive optional repeat treatment at Month 12 if applicable.
  arm group label: Cohort 2: Control Group
  arm group type: Other
  description: Participants will not receive treatment for 6 months and then will be offered an optional delayed treatment of HAC 20L after completion of of Month 6 visit with an optional touch-up treatment offered 30 days after delayed treatment.
  intervention type: Other
  intervention name: No-Treatment Control
  description: Participants will not receive treatment for 6 months and then will be offered an optional delayed treatment of HAC 20L after completion of of Month 6 visit with an optional touch-up treatment offered 30 days after delayed treatment.
  arm group label: Cohort 1: Control Group
  arm group label: Cohort 2: Control Group
  intervention type: Device
  intervention name: HAC 20L
  description: Subdermal Injections
  arm group label: Cohort 1: Treatment Group
  arm group label: Cohort 2: Treatment Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: ABBVIE INC.
  role: Study Director
  affiliation: AbbVie
  last name: ABBVIE CALL CENTER
  phone: 844-663-3742
  email: abbvieclinicaltrials@abbvie.com
  facility: 
  status: Recruiting
  country: Germany
  url: https://www.abbvieclinicaltrials.com/study/?id=M21-833
  description: Related Info
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
  ipd access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
  ipd url: https://vivli.org/ourmember/abbvie/