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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
JUVÉDERM VOLUX® injectable gel
Plastic Surgery Hospital(Institute), Cams, Pumc /ID# 224441
Beijing, Beijing Municipality, China
Beijing Hospital /ID# 224440
Beijing, Beijing Municipality, China
Nanfang Hospital of Southern Medical University /ID# 224442
Guangzhou, Guangdong, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 224444
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.
Time frame: Change from Baseline to Week 24
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.
Time frame: Week 24
Overall scores of Satisfaction with Chin module of the FACE-Q questionnaire at Week 24
The subject will assess satisfaction using the 10 items on the Satisfaction with Chin FACE-Q.
Time frame: 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.
Time frame: Week 24
Number of patients experiencing one or more treatment emergent adverse events (TEAEs)
The number of patients who experienced one or more TEAEs
Time frame: Up to week 52
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Wuhan, Hubei, China
Nanjing Drum Tower Hospital /ID# 224439
Nanjing, Jiangsu, China
Peking University International Hospital /ID# 224438
Beijing, China
Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine /ID# 224445
Shanghai, China