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

Study Overview
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Brief Summary
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This study will collect effectiveness and safety data on JUVÉDERM VOLUX® Injectable Gel for Chin Enhancement in Chinese Adults based on real world data.

Detailed Description
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There will be 30 participants selected who undergo 3D imaging before and after JUVÉDERM VOLUX® treatment for digital analysis assessments. Up to 90 participants enrolled either prospectively prior to JUVÉDERM VOLUX® treatment or retrospectively after JUVÉDERM VOLUX® treatment.

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

Conditions
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Chin Retrusion

Intervention / Treatment
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* Device: JUVÉDERM VOLUX®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Participant has chin retrusion seeking chin enhancement who have received or plan to receive VOLUX chin treatment in Hainan Boao Super Hospital. Exclusion Criteria: History of hypersensitivity to lidocaine,HA, or Streptococcal protein History of tendency to develop hypertrophic scarring Untreated epilepsy or porphyria Current cutaneous inflammatory or infectious processes (eg, acne, herpes) in the treatment area Prior chin or jaw surgery, including cartilage grafts or implantation of any biomaterials Permanent filler, semi-permanent filler, or fat injected in the treatment area Temporary filler, other than VOLUX, injected in the treatment area within 12 months before enrollment Females who self-report current pregnancy or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1 JUVÉDERM VOLUX® with 3D Imaging<br>Treatment will be determined according to the physician's experience and Directions for Use. Cohort 1 will have follow-up on-site visits, including 3D imaging, at Months 1, 3, 6, and 12. | Device: JUVÉDERM VOLUX®<br>* JUVÉDERM VOLUX® injectable gel<br>|
| Cohort 2 JUVÉDERM VOLUX®<br>Treatment will be determined according to the physician's experience and Directions for Use. Cohort 2 will have follow-up on-site visits at Months 1 and 3 and follow-up telephone calls at Months 6 and 12. | Device: JUVÉDERM VOLUX®<br>* JUVÉDERM VOLUX® injectable gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle |  | Baseline, Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Responders based on the Investigator's Assessment of Improvement in the Chin and Jaw Area using the 5-point Global Aesthetic Improvement Scale (GAIS) | The Evaluating Investigator will assess the aesthetic improvement of the hands using the GAIS 5- point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. | Month 3 | 
| Percentage of Responders based on the Participant's Assessment of Improvement in the Chin and Jaw Area using the 5-point GAIS | Participant will assess the aesthetic improvement of the hands using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. | Month 3 | 
| The presence and severity of ISRs (Injection Site Response) at scheduled follow-up visits | The number of patients who experienced ISRs | Month 1, 3, 6, and 12 | 
| The number of Adverse Events (AEs) from physician observation and inquiry at scheduled follow-up visits | The number of patients who experienced AEs | Month 1, 3, 6, and 12 |