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

NCT04687046 | Completed

• 1 other identifier: 1868-705-008
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Chin Retrusion

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle

  Baseline, Month 3

Secondary Outcomes (4)

• 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

• Percentage of Responders based on the Participant's Assessment of Improvement in the Chin and Jaw Area using the 5-point GAIS

  Month 3

• The presence and severity of ISRs (Injection Site Response) at scheduled follow-up visits

  Month 1, 3, 6, and 12

• The number of Adverse Events (AEs) from physician observation and inquiry at scheduled follow-up visits

  Month 1, 3, 6, and 12

Study Arms (2)

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®

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®

Interventions

JUVÉDERM VOLUX® DEVICE

JUVÉDERM VOLUX® injectable gel

Cohort 1 JUVÉDERM VOLUX® with 3D Imaging; Cohort 2 JUVÉDERM VOLUX®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Participant has chin retrusion seeking chin enhancement who have received or plan to receive VOLUX chin treatment in Hainan Boao Super Hospital.

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Hainan Boao Super Hospital /ID# 235968

Qionghai, Hainan, 571434, China

Location

Related Links

• clinical study report synopsis

Study Officials

• ALLERGAN INC.

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 29, 2020
• Study Start: February 4, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

CN (1)