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

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

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

Study Overview

• Status: Completed
• Conditions: Temple Hollowing
• Intervention / Treatment: Device: JUVÉDERM® VOLUMA® XC; Other: No-treatment control

• Study Type: Interventional
• Enrollment (Actual): 205
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00917
    • Jose Raul Montes Eyes & Facial Rejuvenation-Torre Medica Aux /ID# 232706
• United States
  • California
    • Los Angeles, California, United States, 90069
      • Skin Care and Laser Physicians of Beverly Hills /ID# 232967
    • Newport Beach, California, United States, 92663
      • Steve Yoelin MD Medical Associate Inc /ID# 232956
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Steven Fagien MD PA /ID# 232807
    • Bradenton, Florida, United States, 34209
      • Bradenton Dermatologist /ID# 232822
    • Coral Gables, Florida, United States, 33134
      • Hevia Cosmetic Dermatology /ID# 232824
    • Miami, Florida, United States, 33137-3254
      • Skin and Cancer Associates, LLP /ID# 232923
    • West Palm Beach, Florida, United States, 33401-2712
      • Research Institute of the Southeast, LLC /ID# 233144
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Delricht Research /ID# 233142
  • Maryland
    • Glenn Dale, Maryland, United States, 20769-9182
      • Callender Center for Clinical Research /ID# 233167
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Skincare Physicians /ID# 233054
  • New York
    • Latham, New York, United States, 12110
      • Williams Plastic Surgery Specialists /ID# 232789
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517-9901
      • Aesthetic Solutions /ID# 232953
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • The Practice of Brian S. Biesman MD PLLC /ID# 232662
  • Texas
    • Dallas, Texas, United States, 75231
      • Dallas Plastic Surgery Institute /ID# 232971

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: JUVÉDERM® VOLUMA® XC; JUVÉDERM® VOLUMA® XC injectable gel; Other: No-treatment control; Participants received no treatment for 3 months during the Control Period.
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.	Device: JUVÉDERM® VOLUMA® XC; JUVÉDERM® VOLUMA® XC injectable gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Baseline, Month 3 (Control Period)
Number of Participants With Adverse Events	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.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Month 3 (Control Period)
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	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.	Month 3 (Control Period)
Change From Baseline on FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 3	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.	Baseline, Month 3 (Control Period)
Change From Baseline to Month 3 on Participants Responses on FACE-Q Satisfaction With Temples Questionnaire	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.	Baseline, Month 3 (Control Period)

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: ALLERGAN, INC., Allergan

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2020
• Primary Completion (Actual): October 17, 2022
• Study Completion (Actual): October 17, 2022

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: May 29, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Estimated): April 25, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1878-702-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing 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 Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• 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