JUVÉDERM® VOLUMA® With Lidocaine for Correction of Temple Hollowing in Chinese Population

A Multicenter, Evaluator-blinded, Randomized, No-treatment Controlled Study to Evaluate the Safety and Effectiveness of JUVÉDERM® VOLUMA® With Lidocaine for Correction of Temple Hollowing in Chinese Population

The objectives of this study are to evaluate the safety and effectiveness of JUVÉDERM®VOLUMA® with Lidocaine injectable gel in adult Chinese population seeking correction of temple hollowing.

Study Overview

• Status: Completed
• Conditions: Temple Hollowing
• Intervention / Treatment: Device: JUVÉDERM® VOLUMA® with Lidocaine

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100029
    • China-Japan Friendship Hosp /ID# 241680
  • Beijing, China, 102206
    • Peking University International Hospital /ID# 242166
  • Shanghai, China, 200011
    • Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine /ID# 233571
  • Beijing
    • Beijing, Beijing, China, 100730
      • Beijing Hospital /ID# 233582
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 233602
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital /ID# 233607
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital Southeast University /ID# 233604
  • Shanghai
    • Shanghai, Shanghai, China, 200233
      • Shanghai Sixth People's Hospital /ID# 233568

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant must be 18 or over, at the time of signing the ICF
• Participants seeking improvement of temple hollowing
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the protocol
• Written informed consent from the participant has been obtained prior to any study-related procedures
• Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable
• Is able to complete effectiveness self-assessments without the use of glasses (contact lens use is acceptable if they will be used for all participant self-assessments)

Exclusion Criteria:

• Temple hollowing due to trauma, congenital malformations, or lipodystrophy, either congenital or acquired
• Has experienced trauma to the temple area within 6 months before enrollment or has residual deficiencies, deformities, or scarring
• Temporal arteritis or history of temporal arteritis
• Temporomandibular joint dysfunction or any other jaw issues
• Recurrent temporal headaches such as temporal tendinitis migraine
• Active or recurrent inflammation or infection in either eye
• Tendency to develop hypertrophic scarring
• Active autoimmune disease
• History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA products, or Streptococcal protein
• Current cutaneous or mucosal inflammatory or infectious processes (e.g. acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion, above the subnasal
• 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 12 months before enrollment
• Mesotherapy or cosmetic facial procedures above the subnasale within 6 months before enrollment (examples of mesotherapy or cosmetic facial procedures are laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures.
• Injections in the nasolabial fold are acceptable only if done at least 3 months prior to enrollment
• Botulinum toxin treatment above the subnasale within 6 months before enrollment
• Has braces or other orthodontics
• Not eligible for this study if participants have begun using any new over the counter or prescription oral or tropical, anti-wrinkle products above the subnasale within 30 days before enrollment. Participants who have been on a regimen of such products for at least 30 days are eligible for the study if they intend to continue their regimen throughout the study
• Is on a regimen of anti-coagulation therapy (eg, warfarin, clopidogrel)
• Has tattoos, piercings, facial hair, or scars above and including the subnasale that would interfere with visual assessment of the temple
• Females who are pregnant, nursing, or planning a pregnancy
• Plans a significant weight change (more than 10% of body weight) during the study

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
Experimental: JUVÉDERM® VOLUMA® with Lidocaine; Participants will be treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel in temple. Participants are eligible for touch up treatment	Device: JUVÉDERM® VOLUMA® with Lidocaine; JUVÉDERM® VOLUMA® with Lidocaine injectable gel
No Intervention: Control- No treatment; No treatment is administered. Optional treatment at month 6.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	Change from Baseline to Month 6
Number of Participants with Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.	Up to 14 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline on FACE-Q Satisfaction with Facial Appearance questionnaire at Month 6	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 6
Change from baseline on FACE-Q Satisfaction with Temples questionnaire at Month 6	16-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 6
Participants "Improved" or "Much Improved" as self-assessed by participant using the Global Aesthetic Improvement Scale (GAIS)	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.	Month 6
Participants "Improved" or "Much Improved" as assessed by the Evaluating Investigator using the Global Aesthetic Improvement Scale (GAIS)	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.	Month 6

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2021
• Primary Completion (Actual): November 22, 2023
• Study Completion (Actual): November 22, 2023

Study Registration Dates

• First Submitted: May 14, 2021
• First Submitted That Met QC Criteria: May 14, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 1878-701-008

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