JUVÉDERM VOLUX® for Chin Retrusion in China

August 16, 2023 updated by: Allergan

A Randomized, Multicenter, "No-Treatment" Control Study to Evaluate the Safety and Effectiveness of JUVÉDERM VOLUX® Injectable Gel for the Enhancement of the Chin to Correct Moderate to Severe Retrusion in Chinese Adults

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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®
JUVÉDERM VOLUX® injectable gel
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®
JUVÉDERM VOLUX® injectable gel

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in glabella-subnasale-pogonion (G-Sn-Pog) angle at Week 24
Time Frame: Change from Baseline to 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
China (Allergan) Chin Retrusion Scale (CACRS) responder status based on the Evaluating Investigator's (EI) assessment of 2D images at Week 24
Time Frame: 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.
Week 24
Overall scores of Satisfaction with Chin module of the FACE-Q questionnaire at Week 24
Time Frame: Week 24
The subject will assess satisfaction using the 10 items on the Satisfaction with Chin FACE-Q.
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
Time Frame: Week 24
The GAIS is a 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
Week 24
Number of patients experiencing one or more treatment emergent adverse events (TEAEs)
Time Frame: Up to week 52
The number of patients who experienced one or more TEAEs
Up to week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ALLERGAN INC., Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 26, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 26, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1868-701-008

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

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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