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

Completed

• Conditions: Chin Retrusion
• Interventions: Device: JUVÉDERM VOLUX®

• Registration Number: NCT04687046
• Lead Sponsor: Allergan

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-29
• Study Start: 2021-02-04
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1 JUVÉDERM VOLUX® with 3D Imaging	JUVÉDERM VOLUX®	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.
Cohort 2 JUVÉDERM VOLUX®	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle	Baseline, Month 3

Secondary Outcome Measures

Name	Time	Method
Percentage of Responders based on the Participant's Assessment of Improvement in the Chin and Jaw Area using the 5-point GAIS	Month 3	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.
The number of Adverse Events (AEs) from physician observation and inquiry at scheduled follow-up visits	Month 1, 3, 6, and 12	The number of patients who experienced AEs
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)	Month 3	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.
The presence and severity of ISRs (Injection Site Response) at scheduled follow-up visits	Month 1, 3, 6, and 12	The number of patients who experienced ISRs

Trial Locations

Locations (1)

Hainan Boao Super Hospital /ID# 235968; 🇨🇳 Qionghai, Hainan, China