Chin Retrusion
Conditions
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.
Interventions
DEVICEJUVÉDERM VOLUX®
JUVÉDERM VOLUX® injectable gel
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle | Baseline, Month 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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 |
| 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 |
Countries
China
Outcome results
None listed