JUVÉDERM VOLUX® for Chin Retrusion in China

NCT04559984 | Completed Phase 3

• 1 other identifier: 1868-701-008
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 7

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM VOLUX® to correct moderate to severe chin retrusion in Chinese adults.

Conditions

Chin Retrusion

Outcome Measures

Primary Outcomes (1)

• Change from baseline in glabella-subnasale-pogonion (G-Sn-Pog) angle at Week 24

  The G-Sn-Pog angle is the angle formed by the point on the glabella, subnasale, and pogonion.

  Change from Baseline to Week 24

Secondary Outcomes (4)

• China (Allergan) Chin Retrusion Scale (CACRS) responder status based on the Evaluating Investigator's (EI) assessment of 2D images at Week 24

  Week 24

• Overall scores of Satisfaction with Chin module of the FACE-Q questionnaire at Week 24

  Week 24

• Responder status for participant and EI assessments of global aesthetic improvement in the chin and jaw area using the Global Aesthetic Improvement Scale (GAIS) at Week 24

  Week 24

• Number of patients experiencing one or more treatment emergent adverse events (TEAEs)

  Up to week 52

Study Arms (2)

JUVÉDERM VOLUX®

EXPERIMENTAL

Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with an optional touch-up treatment at week 4 if agreed upon by both the participant and Treating Investigator.

Device: JUVÉDERM VOLUX®

Control- No treatment

OTHER

No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period.

Device: JUVÉDERM VOLUX®

Interventions

JUVÉDERM VOLUX® DEVICE

JUVÉDERM VOLUX® injectable gel

Control- No treatment; JUVÉDERM VOLUX®

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 at least 18 years of age at the time of signing the ICF
• Male and female
• Participants of Chinese descent
• Participants seeking improvement of chin retrusion
• Chin retrusion (G-Sn-Pog angle of \< 172.5°) based on calculations of facial angle derived from digital images obtained using Canfield imaging equipment and software
• Has moderate to severe chin retrusion on the CACRS as determined by EI 2D image evaluation
• Has a reasonable goal for aesthetic improvement in chin retrusion and is able to achieve a 1-point improvement in CACRS score with study intervention in the judgment of TI
• Capable of giving signed informed consent as described in Appendix 10.1.3, which includes compliance with the requirements and restrictions listed in the ICF and in this 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

You may not qualify if:

• History of tendency to develop hypertrophic scarring
• History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA products, or streptococcal protein
• Active autoimmune disease
• Current cutaneous inflammatory or infectious processes (eg, acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion in the chin area (participants with a history of recurrent oral herpes are eligible if prophylactic antiviral/herpes medication is administered for 2 days before study intervention)
• Impaired cardiac conduction, impaired hepatic function, or impaired renal function according to the judgment of the TI based on medical history, laboratory testing results, and other clinical signs and symptoms
• Prior chin or jaw surgery, including cartilage grafts or implantation of any biomaterials
• Permanent dermal filler injected below the subnasale
• Semi-permanent dermal filler or fat injected below the subnasale within 36 months before enrollment
• Temporary dermal filler injected below the subnasale within 12 months before enrollment
• Orthodontics procedures within 12 months before enrollment
• Botulinum toxin treatment in the chin area within 6 months before enrollment
• Mesotherapy or cosmetic facial procedures (eg, face-lift, brow lift, facial reconstructive surgery, laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures) below the subnasale within 6 months before enrollment
• Current enrollment in an investigational drug or device study or participation in such a study within 30 days before enrollment
• Abnormal and clinically significant results according to the TI or designee, on hematology, clinical chemistry, or urinalysis
• Females who are pregnant, nursing, or planning a pregnancy during the study

Sponsors & Collaborators

• Allergan: lead

Study Sites (7)

Plastic Surgery Hospital(Institute), Cams, Pumc /ID# 224441

Beijing, Beijing Municipality, 100144, China

Location

Beijing Hospital /ID# 224440

Beijing, Beijing Municipality, 100730, China

Location

Nanfang Hospital of Southern Medical University /ID# 224442

Guangzhou, Guangdong, 510515, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 224444

Wuhan, Hubei, 430022, China

Location

Nanjing Drum Tower Hospital /ID# 224439

Nanjing, Jiangsu, 210008, China

Location

Peking University International Hospital /ID# 224438

Beijing, 102206, China

Location

Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine /ID# 224445

Shanghai, 200011, China

Location

Related Links

• clinical study report synopsis

Study Officials

• ALLERGAN INC.

  Allergan

  STUDY DIRECTOR

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: September 17, 2020
• First Posted: September 23, 2020
• Study Start: October 15, 2020
• Primary Completion: August 26, 2022
• Study Completion: August 26, 2022
• Last Updated: August 21, 2023

Record last verified: 2023-08

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: 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/

Locations

CN (7)