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

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

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

Study Overview

• Status: Completed
• Conditions: Chin Retrusion
• Intervention / Treatment: Device: JUVÉDERM VOLUX®

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• China
  • Hainan
    • Qionghai, Hainan, China, 571434
      • Hainan Boao Super Hospital /ID# 235968

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All participants receive VOLUX treatment at Hainan Boao Super Hospital, with screening and follow-up visits at Hainan Boao Super Hospital or another hospital.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1 JUVÉDERM VOLUX® with 3D Imaging; 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®; JUVÉDERM VOLUX® injectable gel
Cohort 2 JUVÉDERM VOLUX®; 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®; JUVÉDERM VOLUX® injectable gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: December 2, 2020
• First Submitted That Met QC Criteria: December 23, 2020
• First Posted (Actual): December 29, 2020

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1868-705-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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