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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VOLBELLA with Lidocaine | Experimental | Participants will receive VOLBELLA with Lidocaine on Day 1 and followed for 12 months. |
|
| Control Group | Placebo Comparator | Participants will be followed for 3 months. Participants can opt to receive VOLBELLA with Lidocaine after 3 months and followed for 9 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VOLBELLA with Lidocaine | Device | Facial Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Month 3 |
| Percentage of Participants Achieving "Responder" Status for Participant's Assessment of GAIS |
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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 |
|---|---|---|---|---|---|---|
| Beijing Hospital /ID# 227588 | Beijing | Beijing Municipality | 100730 | China | ||
| Peking Union Medical College Hospital /ID# 227590 |
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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A "responder" is a participant who shows improvement in the overall aesthetic assessment in the infraorbital area using Global Aesthetic Improvement Scale (GAIS). |
| 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. | Month 3 |
| Beijing |
| Beijing Municipality |
| 100730 |
| China |
| Peking University First Hospital /ID# 227593 | Xicheng District | Beijing Municipality | 100034 | China |
| Nanjing Drum Tower Hospital /ID# 241042 | Nanjing | Jiangsu | 210008 | China |
| Zhongda Hospital Southeast University /ID# 241040 | Nanjing | Jiangsu | 210009 | China |
| The Affiliated Hospital of Qingdao University /ID# 227592 | Qingdao | Shandong | 266000 | China |
| Huashan Hospital, Fudan University /ID# 227591 | Shanghai | Shanghai Municipality | 200040 | China |