Clinical trial NCT05088980: Study to Assess Effectiveness and Adverse Events of JUVEDERM VOLBELLA With Lidocaine Injection in Correcting Infraorbital Hollowing in Chinese Adult Participants
Official title: A Multicenter, Evaluator-blinded, Randomized, No-treatment Controlled Study to Evaluate the Safety and Effectiveness of JUVÉDERM VOLBELLA With Lidocaine Injectable Gel for Correction of Infraorbital Hollowing in Chinese Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infraorbital Hollowing
Keywords: Infraorbital Hollowing
JUVEDERM VOLBELLA With Lidocaine
Lidocaine
VOLBELLA with Lidocaine
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2021-10-22
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Participants seeking improvement of infraorbital hollowing.
* Has Moderate or Severe infraorbital hollowing (grade 2 or 3 on the AIHS) for each eye as assessed by the evaluating investigator (i.e., both eyes must qualify but do not need to have the same score).
* Treating Investigator (TI) considers the participant's anatomy to be amenable to improvement to an Allergan Infraorbital Hollows Scale (AIHS) grade of 0 or 1 (None or Minimal).
* Participant must be in good health as determined by medical history, vital signs an TI's judgment, including no known active pandemic infection.
* Able, as assessed by the TI, and willing to follow study instructions (including compliance with the safety diary) and likely to complete all required study visits.
* Able to complete effectiveness self-assessments without the use of glasses (contact lens use is acceptable if they will be used for all participant self-assessments).

Exclusion Criteria:

* Has experienced trauma to the infraorbital area within 12 months before enrollment or has residual deficiencies, deformities, or scarring in the periorbital or cheek areas.
* Has active or recurrent inflammation or infection in either eye.
* Has active autoimmune disease.
* Has history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid (HA) products, or Streptococcal protein.
* Has received botulinum toxin treatment above the subnasale within 9 months before enrollment.
* Has changes in use of over-the-counter or prescription oral or topical, anti-wrinkle products above the subnasale within 30 days before enrollment.
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
* Has tattoos, piercings, or scars that would interfere with visual assessment of the infraorbital hollows.
* TI's discretion based on participant's safety and/or study integrity (the participant has a condition or is in a situation that, in the TI's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study, such as clinically significant abnormal lab testing results as judged by TI).
* Directly or indirectly involved in the conduct and administration of this study as an investigator, subinvestigator, study coordinator, or other study staff member; employee of the sponsor; first-degree family member, significant other, or relative residing with one of the above persons involved directly or indirectly in the study; or enrolled in the study at another clinical site.

Primary outcomes:
measure: Percentage of Participants Achieving "Responder" Status for Evaluating Investigator's (EI) live assessment of AIHS
timeFrame: Month 3
Secondary outcomes:
measure: Percentage of Participants Achieving "Responder" Status for EI's Assessment of GAIS
timeFrame: Month 3
measure: Percentage of Participants Achieving "Responder" Status for Participant's Assessment of GAIS
timeFrame: Month 3
measure: Change From Baseline of Overall Score in Participant Responses to FACE-Q Appraisal of Lower Eyelids Questionnaire
timeFrame: Month 3
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital /ID# 227588
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital /ID# 227590
state: Beijing
city: Xicheng District
country: China
facility: Peking University First Hospital /ID# 227593
state: Beijing
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital /ID# 241042
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University /ID# 241040
state: Jiangsu
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University /ID# 227592
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University /ID# 227591
state: Shanghai
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References: