Aged appearance is often caused by an infraorbital hollowing, which is characterized as a sunken appearance of the eye that results in the casting of a dark shadow over the nasal lower eyelid, giving a fatigued appearance. This study will assess how safe and effective JUVEDERM VOLBELLA with Lidocaine is in correcting infraorbital hollowing in adult participants in China. VOLBELLA with Lidocaine is an investigational product being developed for the correction of infraorbital hollowing. Participants are randomly assigned to 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 on 4 chance that participants will be assigned to control group. Around 160 adult participants seeking correction of infraorbital hollowing will be enrolled at approximately 8 sites across China. Participants in treatment group will receive VOLBELLA with Lidocaine injections on Day 1 and followed for 12 months. Participants in control group are followed for 3 months. Participants in Control group can opt to receive VOLBELLA with Lidocaine injection after completion of 3 months and followed for 9 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
160
Facial Injection
Beijing Hospital /ID# 227588
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital /ID# 227590
Beijing, Beijing Municipality, China
Peking University First Hospital /ID# 227593
Xicheng District, Beijing Municipality, China
Nanjing Drum Tower Hospital /ID# 241042
Nanjing, Jiangsu, China
Zhongda Hospital Southeast University /ID# 241040
Nanjing, Jiangsu, China
The Affiliated Hospital of Qingdao University /ID# 227592
Qingdao, Shandong, China
Huashan Hospital, Fudan University /ID# 227591
Shanghai, Shanghai Municipality, China
Percentage of Participants Achieving "Responder" Status for Evaluating Investigator's (EI) live assessment of AIHS
A "responder" is a participant with at least 1- grade improvement on the Allergan Infraorbital Hollows Scale (AIHS) in both infraorbital areas. AIHS is a 5-point ordinal scale developed by Allergan to grade the severity of infraorbital hollowing (0 = None, 4 = Extreme).
Time frame: Month 3
Percentage of Participants Achieving "Responder" Status for EI's Assessment of GAIS
A "responder" is a participant who shows improvement in the overall aesthetic assessment in the infraorbital area using Global Aesthetic Improvement Scale (GAIS).
Time frame: Month 3
Percentage of Participants Achieving "Responder" Status for Participant's Assessment of GAIS
A "responder" is a participant who shows improvement in the overall aesthetic assessment in the infraorbital area using Global Aesthetic Improvement Scale (GAIS).
Time frame: Month 3
Change From Baseline of Overall Score in Participant Responses to FACE-Q Appraisal of Lower Eyelids Questionnaire
In the FACE-Q Appraisal of Lower Eyelids questionnaire, the responses to the 7 items will be summed and converted to a Rasch-transformed score that ranges from 0 to 100.
Time frame: Month 3
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