A Study Evaluating JUVÉDERM® VOLUMA® XC Injectable Gel for Correction of Temple Hollowing in Adult Participants ≥ 22 Years Old

• ClinicalTrials.gov Identifier: NCT04414397
• Recruitment Status: Completed
• First Posted: June 4, 2020
• Results First Posted: April 25, 2024
• Last Update Posted: April 25, 2024
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

Tracking Information

• First Submitted Date: May 29, 2020
• First Posted Date: June 4, 2020
• Results First Submitted Date: March 29, 2024
• Results First Posted Date: April 25, 2024
• Last Update Posted Date: April 25, 2024
• Actual Study Start Date: May 28, 2020
• Actual Primary Completion Date: October 17, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 29, 2024)

• Percentage of Participants With ≥ 1-grade Improvement From Baseline in the Validated Allergan Temple Hollowing Scale (ATHS) Based on Evaluating Investigator (EI) Assessment at Month 3 [ Time Frame: Baseline, Month 3 (Control Period) ]
  The Evaluating Investigator assessed the participant's temple hollowing using the 5-point ATHS scale where 0=convex, rounded temple and 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement.
• Number of Participants With Adverse Events [ Time Frame: From the time of informed consent until the participant exited the study, up to 13 months after their initial/touch-up treatment, and up to 6 months after the maintenance treatment ]
  An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant whether or not it is related to the investigational product. The investigator assesses the relationship of each event to the use of the investigational product. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first use of the investigational product.

Original Primary Outcome Measures (submitted: May 29, 2020)

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 ]

The Evaluating Investigator will assess the participant's temple hollowing using the ATHS 5-point scale where: 0=convex, rounded temple to 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement.

Current Secondary Outcome Measures (submitted: March 29, 2024)

• Percentage of Participants With a Score of "Improved " or "Much Improved" on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Evaluating Investigator (EI) at Month 3 [ Time Frame: Month 3 (Control Period) ]
  The Evaluating Investigator assessed the participant's temple area using the 5-point GAIS where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
• Percentage of Participants With a Score of "Improved" or "Much Improved" on the Global Aesthetic Improvement Scale (GAIS) for the Temple Area as Assessed by the Participants at Month 3 [ Time Frame: Month 3 (Control Period) ]
  Participants assessed their temple area using the 5-point GAIS where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
• Change From Baseline on FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 3 [ Time Frame: Baseline, Month 3 (Control Period) ]
  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, and 4=Very Satisfied. The total score was transformed to a score of 0 (worst) to 100 (best) for comparison. A positive change from Baseline indicates improvement.
• Change From Baseline to Month 3 on Participants Responses on FACE-Q Satisfaction With Temples Questionnaire [ Time Frame: Baseline, Month 3 (Control Period) ]
  The participants responded to each item on the FACE-Q Satisfaction with Temples 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. A positive change from Baseline indicates improvement.

Original Secondary Outcome Measures (submitted: May 29, 2020)

• Participants "Improved" or "Much Improved" as assessed by the Evaluating Investigator using the Global Aesthetic Improvement Scale (GAIS) [ Time Frame: Month 3 ]
  The Evaluating Investigator will assess the participant's temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and-2=much worse.
• Participants "Improved" or "Much Improved" as self-asssed by participant using the Global Aesthetic Improvement Scale (GAIS) [ Time Frame: Month 3 ]
  Participant will assess temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and-2=much worse.
• Change from baseline on FACE-Q Satisfaction with Facial Appearance questionnaire at Month 3 [ Time Frame: Change from Baseline to Month 3 ]
  10-item questionnaire assessing satisfaction with various aspects of facial appearance. Participants respond to each item as: 1 Very Dissatisfied, 2 Somewhat Dissatisfied, 3 Somewhat Satisfied, 4 Very Satisfied
• Change from baseline to Month 3 on participants responses on FACE-Q Satisfaction with Temples questionnaire [ Time Frame: Change from Baseline to Month 3 ]
  Multiple item questionnaire assessing satisfaction with various aspects of the temples. Participants respond to each item as: 1 Very Dissatisfied, 2 Somewhat Dissatisfied, 3 Somewhat Satisfied, 4 Very Satisfied

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study Evaluating JUVÉDERM® VOLUMA® XC Injectable Gel for Correction of Temple Hollowing in Adult Participants ≥ 22 Years Old
• 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
• Brief Summary: 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
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Temple Hollowing

Intervention

• Device: JUVÉDERM® VOLUMA® XC
  JUVÉDERM® VOLUMA® XC injectable gel
• Other: No-treatment control
  Participants received no treatment for 3 months during the Control Period.

Study Arms

• No Treatment then JUVÉDERM® VOLUMA® XC
  Participants received no treatment for 3 months during the Control Period. They either exited the study at Month 3 or received an optional treatment with JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Post-Control Period and an optional touch-up treatment 30 days later. Participants did not receive any treatment during the Maintenance Treatment Period.
  Interventions:

  • Device: JUVÉDERM® VOLUMA® XC
  • Other: No-treatment control
• Experimental: JUVÉDERM® VOLUMA® XC
  Participants received JUVÉDERM® VOLUMA® XC injectable gel treatment in both temples during the Control Period followed by an optional touch-up treatment 30 days later. Participants exited the study at Month 13 or received an optional maintenance treatment and were followed for 6 months during the Maintenance Treatment Period.
  Intervention: Device: JUVÉDERM® VOLUMA® XC

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 26, 2021): 205
• Original Estimated Enrollment (submitted: May 29, 2020): 213
• Actual Study Completion Date: October 17, 2022
• Actual Primary Completion Date: October 17, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Participants in general good health
• Participants seeking improvement of temple hollowing

Exclusion Criteria:

• Temple hollowing due to trauma, congenital malformations, or lipodystrophy
• Temporomandibular joint dysfunction or any other jaw issues
• Recurrent temporal headaches such as temporal tendinitis migraine
• Active autoimmune disease
• History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA products, or Streptococcal protein
• Prior facial reconstructive surgeries, facelift, or browlift as well as surgeries on the temple area (eg, biopsy)
• Fat injection or permanent facial implants anywhere in the face
• Semipermanent soft-tissue filler treatment in the temple or mid-face within 36 months before enrollment
• Temporary dermal filler injections above the subnasale within 24 months before enrollment
• Mesotherapy or cosmetic facial procedures above the subnasale within 6 months before enrollment
• Botulinum toxin treatment above the subnasale within 6 months before enrollment
• Females who are pregnant, nursing, or planning a pregnancy

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 22 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Puerto Rico, United States

Administrative Information

• NCT Number: NCT04414397
• Other Study ID Numbers: 1878-702-008
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan 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.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• 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/
• URL: https://vivli.org/ourmember/abbvie/

• Current Responsible Party: Allergan
• Original Responsible Party: Same as current
• Current Study Sponsor: Allergan
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: ALLERGAN, INC.; Allergan

• PRS Account: Allergan
• Verification Date: March 2024