<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/NCT04414397</url>
  </required_header>
  <id_info>
    <org_study_id>1878-702-008</org_study_id>
    <nct_id>NCT04414397</nct_id>
  </id_info>
  <brief_title>A Study Evaluating JUVÉDERM VOLUMA® XC Injectable Gel for Correction of Temple Hollowing in Adult Participants Over 22 Years Old</brief_title>
  <official_title>A Multicenter, Evaluator-blinded, Randomized, Parallel-group, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Correction of Temple Hollowing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allergan</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>
      The objectives of this study are to evaluate the safety and effectiveness of Juvederm Voluma&#xD;
      XC injectable gel in adult participants seeking correction of temple hollowing&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 28, 2020</start_date>
  <completion_date type="Actual">October 17, 2022</completion_date>
  <primary_completion_date type="Actual">October 17, 2022</primary_completion_date>
  <phase>Phase 3</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participants with at Least a 1-Point Improvement (Decrease) in Temple as Assessed by the Evaluating Investigator (EI) using the Allergan Temple Hollowing Scale (ATHS)</measure>
    <time_frame>Change from Baseline to Month 3</time_frame>
    <description>The Evaluating Investigator will assess the participant's temple hollowing using the 5-point ATHS scale where: 0=convex, rounded temple to 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with Adverse Events</measure>
    <time_frame>From Day 1 to Day 395</time_frame>
    <description>An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study device.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants &quot;Improved &quot; or &quot;Much Improved&quot; on the Global Aesthetic Improvement Scale (GAIS) for the temple area as assessed by the Evaluating Investigator</measure>
    <time_frame>Month 3</time_frame>
    <description>The Evaluating Investigator will assess the 5-point GAIS where: 2=much improved, 1=improved, 0=no change, -1=worse and-2=much worse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants &quot;Improved &quot; or &quot;Much Improved&quot; on the Global Aesthetic Improvement Scale (GAIS) for the temple area as assessed by the participants</measure>
    <time_frame>Month 3</time_frame>
    <description>Participant will assess temple area using the 5-point GAIS where: 2=much improved, 1=improved, 0=no change, -1=worse and-2=much worse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline on FACE-Q Satisfaction with Facial Appearance questionnaire at Month 3</measure>
    <time_frame>Change from Baseline to Month 3</time_frame>
    <description>The participants responded to each item on the FACE-Q Satisfaction with Facial Appearance questionnaire using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, 4=Very Satisfied. The total score was transformed to a score of 0 (worst) to 100 (best) for comparison.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline to Month 3 on participants responses on FACE-Q Satisfaction with Temples questionnaire</measure>
    <time_frame>Change from Baseline to Month 3</time_frame>
    <description>The participants responded to each item on the FACE-Q Satisfaction with Temple questionnaire using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, 4=Very Satisfied. The total score was transformed to a score of 0 (worst) to 100 (best) for comparison.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">205</enrollment>
  <condition>Temple Hollowing</condition>
  <arm_group>
    <arm_group_label>JUVÉDERM VOLUMA® XC Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received JUVÉDERM VOLUMA® XC injectable gel treatment in both temples followed by an optional touch-up treatment 30 days later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No-treatment control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants received no treatment for 3 months and then received an optional delayed treatment with JUVÉDERM VOLUMA® XC and an optional touch-up treatment 30 days later.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>JUVÉDERM VOLUMA® XC</intervention_name>
    <description>JUVÉDERM VOLUMA® XC injectable gel</description>
    <arm_group_label>JUVÉDERM VOLUMA® XC Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No-treatment control</intervention_name>
    <description>Participants received no treatment for 3 months and then received an optional delayed treatment with JUVÉDERM VOLUMA® XC and an optional touch-up treatment 30 days later.</description>
    <arm_group_label>No-treatment control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants in general good health&#xD;
&#xD;
          -  Participants seeking improvement of temple hollowing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Temple hollowing due to trauma, congenital malformations, or lipodystrophy&#xD;
&#xD;
          -  Temporomandibular joint dysfunction or any other jaw issues&#xD;
&#xD;
          -  Recurrent temporal headaches such as temporal tendinitis migraine&#xD;
&#xD;
          -  Active autoimmune disease&#xD;
&#xD;
          -  History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA&#xD;
             products, or Streptococcal protein&#xD;
&#xD;
          -  Prior facial reconstructive surgeries, facelift, or browlift as well as surgeries on&#xD;
             the temple area (eg, biopsy)&#xD;
&#xD;
          -  Fat injection or permanent facial implants anywhere in the face&#xD;
&#xD;
          -  Semipermanent soft-tissue filler treatment in the temple or mid-face within 36 months&#xD;
             before enrollment&#xD;
&#xD;
          -  Temporary dermal filler injections above the subnasale within 24 months before&#xD;
             enrollment&#xD;
&#xD;
          -  Mesotherapy or cosmetic facial procedures above the subnasale within 6 months before&#xD;
             enrollment&#xD;
&#xD;
          -  Botulinum toxin treatment above the subnasale within 6 months before enrollment&#xD;
&#xD;
          -  Females who are pregnant, nursing, or planning a pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ALLERGAN INC.</last_name>
    <role>Study Director</role>
    <affiliation>Allergan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Skin Care and Laser Physicians of Beverly Hills /ID# 232967</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Steve Yoelin MD Medical Assoc. Inc /ID# 232956</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663-3311</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Steven Fagien MD PA /ID# 232807</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33431</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bradenton Dermatologist /ID# 232822</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hevia Cosmetic Dermatology /ID# 232824</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skin and Cancer Associates, LLP /ID# 232923</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33137-3254</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Institute of the Southeast, LLC /ID# 233144</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33401-2712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delricht Research /ID# 233142</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Callender Center for Clinical Research /ID# 233167</name>
      <address>
        <city>Glenn Dale</city>
        <state>Maryland</state>
        <zip>20769-9182</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skincare Physicians /ID# 233054</name>
      <address>
        <city>Chestnut Hill</city>
        <state>Massachusetts</state>
        <zip>02467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Williams Plastic Surgery Specialists /ID# 232789</name>
      <address>
        <city>Latham</city>
        <state>New York</state>
        <zip>12110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aesthetic Solutions /ID# 232953</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27517-9901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Practice of Brian S. Biesman MD PLLC /ID# 232662</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dallas Plastic Surgery Institute /ID# 232971</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jose Raul Montes Eyes &amp; Facial Rejuvenation-Torre Medica Aux /ID# 232706</name>
      <address>
        <city>San Juan</city>
        <zip>00917</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.abbvieclinicaltrials.com/study/?id=1878-702-008</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <disposition_first_submitted>July 25, 2023</disposition_first_submitted>
  <disposition_first_submitted_qc>July 25, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">July 27, 2023</disposition_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 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>
  <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, but a results disposition has been submitted           -->
</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/NCT04414397
org study id: 1878-702-008
nct id: NCT04414397
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The objectives of this study are to evaluate the safety and effectiveness of Juvederm Voluma
      XC injectable gel in adult participants seeking correction of temple hollowing
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Participants with at Least a 1-Point Improvement (Decrease) in Temple as Assessed by the Evaluating Investigator (EI) using the Allergan Temple Hollowing Scale (ATHS)
time frame: Change from Baseline to Month 3
description: The Evaluating Investigator will assess the participant's temple hollowing using the 5-point ATHS scale where: 0=convex, rounded temple to 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement.
measure: Number of Participants with Adverse Events
time frame: From Day 1 to Day 395
description: An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study device.
measure: Percentage of Participants "Improved " or "Much Improved" on the Global Aesthetic Improvement Scale (GAIS) for the temple area as assessed by the Evaluating Investigator
time frame: Month 3
description: The Evaluating Investigator will assess the 5-point GAIS where: 2=much improved, 1=improved, 0=no change, -1=worse and-2=much worse.
measure: Percentage of participants "Improved " or "Much Improved" on the Global Aesthetic Improvement Scale (GAIS) for the temple area as assessed by the participants
time frame: Month 3
description: Participant will assess temple area using the 5-point GAIS where: 2=much improved, 1=improved, 0=no change, -1=worse and-2=much worse.
measure: Change from baseline on FACE-Q Satisfaction with Facial Appearance questionnaire at Month 3
time frame: Change from Baseline to Month 3
description: The participants responded to each item on the FACE-Q Satisfaction with Facial Appearance questionnaire using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, 4=Very Satisfied. The total score was transformed to a score of 0 (worst) to 100 (best) for comparison.
measure: Change from baseline to Month 3 on participants responses on FACE-Q Satisfaction with Temples questionnaire
time frame: Change from Baseline to Month 3
description: The participants responded to each item on the FACE-Q Satisfaction with Temple questionnaire using a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, 4=Very Satisfied. The total score was transformed to a score of 0 (worst) to 100 (best) for comparison.
arm group label: JUVÉDERM VOLUMA® XC Treatment
arm group type: Experimental
description: Participants received JUVÉDERM VOLUMA® XC injectable gel treatment in both temples followed by an optional touch-up treatment 30 days later.
arm group label: No-treatment control
arm group type: Other
description: Participants received no treatment for 3 months and then received an optional delayed treatment with JUVÉDERM VOLUMA® XC and an optional touch-up treatment 30 days later.
intervention type: Device
intervention name: JUVÉDERM VOLUMA® XC
description: JUVÉDERM VOLUMA® XC injectable gel
arm group label: JUVÉDERM VOLUMA® XC Treatment
intervention type: Other
intervention name: No-treatment control
description: Participants received no treatment for 3 months and then received an optional delayed treatment with JUVÉDERM VOLUMA® XC and an optional touch-up treatment 30 days later.
arm group label: No-treatment control
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: ALLERGAN INC.
role: Study Director
affiliation: Allergan
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Puerto Rico
country: United States
url: https://www.abbvieclinicaltrials.com/study/?id=1878-702-008
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/