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

Allergan

Status: Completed

Conditions: Chin Retrusion

Treatments: Device: JUVÉDERM VOLUX®

Study type: Observational

Funder types: Industry

Identifiers

NCT04687046

1868-705-008

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

90 participants in 2 patient groups

Cohort 1 JUVÉDERM VOLUX® with 3D Imaging

Description:

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.

Treatment:

Device: JUVÉDERM VOLUX®

Cohort 2 JUVÉDERM VOLUX®

Description:

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.

Treatment:

Device: JUVÉDERM VOLUX®