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

Chin Retrusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04687046
• Other study ID #: 1868-705-008
• Status: Completed
• Start date: February 4, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: February 2023
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chin Retrusion

Intervention

Device:
• JUVÉDERM VOLUX®
JUVÉDERM VOLUX® injectable gel

Locations

Country	Name	City	State
China	Hainan Boao Super Hospital /ID# 235968	Qionghai	Hainan

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle		Baseline, Month 3
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   clinical study report synopsis