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The objective of this study is to evaluate the safety and effectiveness of JUVÉDERM VOLUX® to correct moderate to severe chin retrusion in Chinese adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JUVÉDERM VOLUX® | Experimental | Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with an optional touch-up treatment at week 4 if agreed upon by both the participant and Treating Investigator. |
|
| Control- No treatment | Other | No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JUVÉDERM VOLUX® | Device | JUVÉDERM VOLUX® injectable gel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in glabella-subnasale-pogonion (G-Sn-Pog) angle at Week 24 | The G-Sn-Pog angle is the angle formed by the point on the glabella, subnasale, and pogonion. | Change from Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| China (Allergan) Chin Retrusion Scale (CACRS) responder status based on the Evaluating Investigator's (EI) assessment of 2D images at Week 24 | The CACRS is a validated 5-point ordinal scale developed by Allergan to grade the severity of chin retrusion. The scale ranges from 0=none to 4=severe. | Week 24 |
| Overall scores of Satisfaction with Chin module of the FACE-Q questionnaire at Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ALLERGAN INC. | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Plastic Surgery Hospital(Institute), Cams, Pumc /ID# 224441 | Beijing | Beijing Municipality | 100144 | China | ||
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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The subject will assess satisfaction using the 10 items on the Satisfaction with Chin FACE-Q. |
| Week 24 |
| Responder status for participant and EI assessments of global aesthetic improvement in the chin and jaw area using the Global Aesthetic Improvement Scale (GAIS) at Week 24 | The GAIS is a 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. | Week 24 |
| Number of patients experiencing one or more treatment emergent adverse events (TEAEs) | The number of patients who experienced one or more TEAEs | Up to week 52 |
| Beijing Hospital /ID# 224440 |
| Beijing |
| Beijing Municipality |
| 100730 |
| China |
| Nanfang Hospital of Southern Medical University /ID# 224442 | Guangzhou | Guangdong | 510515 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 224444 | Wuhan | Hubei | 430022 | China |
| Nanjing Drum Tower Hospital /ID# 224439 | Nanjing | Jiangsu | 210008 | China |
| Peking University International Hospital /ID# 224438 | Beijing | 102206 | China |
| Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine /ID# 224445 | Shanghai | 200011 | China |