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NCT Number: NCT04687046

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

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

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Key information

Conditions

Chin Retrusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hainan Boao Super Hospital /ID# 235968

Qionghai, Hainan, 571434, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JUVÉDERM VOLUX®

Device

JUVÉDERM VOLUX® injectable gel

Primary outcomes

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

    Time frame: Baseline, Month 3

Secondary outcomes

  1. 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)

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: Month 1, 3, 6, and 12

    The number of patients who experienced ISRs

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

    Time frame: Month 1, 3, 6, and 12

    The number of patients who experienced AEs

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 29, 2020
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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