CClinicalTrials.gg
CompletedNCT04559984Updated Aug 21, 2023

JUVÉDERM VOLUX® for Chin Retrusion in China

A Phase 3 interventional study of JUVÉDERM VOLUX® in Chin Retrusion, sponsored by Allergan. Completed at 7 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-21.

Sponsored by Allergan · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chin Retrusion
03

In context

Lead sponsor

Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • Tattoos, piercings or scars that would interfere with study visual assessments and 3D measurements of chin area in the judgment of TI
  • Trauma to the chin or has residual deficiencies, congenital deformities, or scarring which would impact the trial data evaluation in the judgment of TI
  • Menstruation at the time of study intervention (study intervention may be delayed as necessary to accommodate menstrual period cessation)
  • The participant has a condition or is in a situation which, in the TI's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    JUVÉDERM VOLUX®

    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®

  • Other
    Control- No treatment

    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

  • DeviceJUVÉDERM VOLUX®

    JUVÉDERM VOLUX® injectable gel

06

What researchers measure

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.

    Time frame: Change from Baseline to Week 24

Secondary outcomes

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

    The CACRS is a validated 5-point ordinal scale developed by Allergan to grade the severity of chin retrusion. The scale ranges from 0=none to 4=severe.

    Time frame: Week 24

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

    The subject will assess satisfaction using the 10 items on the Satisfaction with Chin FACE-Q.

    Time frame: Week 24

  3. 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

    The GAIS is a 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.

    Time frame: Week 24

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

    The number of patients who experienced one or more TEAEs

    Time frame: Up to week 52

07

Study locations

7 sites
  • Plastic Surgery Hospital(Institute), Cams, Pumc /ID# 224441
    Beijing, Beijing 100144, China
  • Beijing Hospital /ID# 224440
    Beijing, Beijing 100730, China
  • Nanfang Hospital of Southern Medical University /ID# 224442
    Guangzhou, Guangdong 510515, China
  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 224444
    Wuhan, Hubei 430022, China
  • Nanjing Drum Tower Hospital /ID# 224439
    Nanjing, Jiangsu 210008, China
  • Peking University International Hospital /ID# 224438
    Beijing, 102206, China
  • Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine /ID# 224445
    Shanghai, 200011, China
08

References and documents

Individual participant data

Plan to share: Yes — 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 information: Study protocol, Sap, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04559984
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
Sep 23, 2020
Start date
Oct 15, 2020
Primary completion
Aug 26, 2022
Completion
Aug 26, 2022
Last update
Aug 21, 2023

Study contacts

ALLERGAN INC.
study director · Allergan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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