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This study will collect effectiveness and safety data on JUVÉDERM VOLUX® Injectable Gel for Chin Enhancement in Chinese Adults based on real world data.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JUVÉDERM VOLUX® | Device | JUVÉDERM VOLUX® injectable gel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the Glabella-Subnasale-Pogonion (G-Sn-Pog) Angle | Baseline, Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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All participants receive VOLUX treatment at Hainan Boao Super Hospital, with screening and follow-up visits at Hainan Boao Super Hospital or another hospital.
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| Name | Affiliation | Role |
|---|---|---|
| ALLERGAN INC. | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hainan Boao Super Hospital /ID# 235968 | Qionghai | Hainan | 571434 | China |
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| 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 |
| 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 |
| 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 |