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

NCT04891419 | Completed Phase 3 Results FDA Device

• 1 other identifier: 1878-701-008
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Temple Hollowing

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events

  An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug and no more than 30 days after the last dose of the study drug.

  Up to 14 Months

• 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

Secondary Outcomes (4)

• Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Temples Questionnaire at Month 6

  Change from Baseline to Month 6

• Change From Baseline on Rasch Transformed Score of FACE-Q Satisfaction With Facial Appearance Questionnaire at Month 6

  Change from baseline to Month 6

• Participants "Improved" or "Much Improved" as Self-assessed by Participant Using the Global Aesthetic Improvement Scale (GAIS)

  Month 6

• Participants "Improved" or "Much Improved" as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS)

  Month 6

Study Arms (2)

JUVÉDERM® VOLUMA® with Lidocaine

EXPERIMENTAL

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

Control- No treatment

NO INTERVENTION

No treatment is administered. Optional treatment at month 6.

Interventions

JUVÉDERM® VOLUMA® with Lidocaine DEVICE

JUVÉDERM® VOLUMA® with Lidocaine injectable gel

JUVÉDERM® VOLUMA® with Lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allergan: lead

Study Sites (8)

China-Japan Friendship Hospital /ID# 241680

Beijing, Beijing Municipality, 100029, China

Location

Beijing Hospital /ID# 233582

Beijing, Beijing Municipality, 100730, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 233602

Wuhan, Hubei, 430022, China

Location

Nanjing Drum Tower Hospital /ID# 233607

Nanjing, Jiangsu, 210008, China

Location

Zhongda Hospital Southeast University /ID# 233604

Nanjing, Jiangsu, 210009, China

Location

Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine /ID# 233571

Shanghai, Shanghai Municipality, 200011, China

Location

Shanghai Sixth People's Hospital /ID# 233568

Shanghai, Shanghai Municipality, 200233, China

Location

Peking University International Hospital /ID# 242166

Beijing, 102206, China

Location

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ALLERGAN, INC.

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 18, 2021
• Study Start: July 20, 2021
• Primary Completion: November 22, 2023
• Study Completion: November 22, 2023
• Last Updated: December 12, 2024
• Results First Posted: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

CN (8)