JUVÉDERM VOLUX® for Chin Retrusion in China

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2022-08-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of JUVÉDERM VOLUX® Injectable Gel for Chin Enhancement in Chinese Adults Using Real-World Evidence

NCT04687046

Chin Retrusion

COMPLETED

Safety and Effectiveness of JUVÉDERM® VOLBELLA® With Lidocaine for Lip Enhancement in Chinese Adults

NCT03519204

Lip Enhancement

COMPLETED NA

A Study to Assess Adverse Events and Effectiveness of Intradermally Injected JUVÉDERM® VOLITE™ Gel Filler in Adult Participants in China With Fine Lines Around the Mouth

NCT05454033

Perioral Lines

COMPLETED PHASE3

A Safety and Effectiveness Study of JUVÉDERM VOLUMA® XC Injectable Gel for Chin Augmentation

NCT02833077

Chin Retrusion

COMPLETED NA

Study of the Safety and Effectiveness of JUVÉDERM VOLUX™ XC Injectable Gel for Restoring Jawline Definition

NCT03712137

Jawline Definition

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chin Retrusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

JUVÉDERM VOLUX®

Intervention Type DEVICE

JUVÉDERM VOLUX® injectable gel

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.

Group Type OTHER

JUVÉDERM VOLUX®

Intervention Type DEVICE

JUVÉDERM VOLUX® injectable gel

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

JUVÉDERM VOLUX®

JUVÉDERM VOLUX® injectable gel

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No