NCT05088980

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

October 19, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2023

Completed
Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

2.1 years

First QC Date

October 11, 2021

Last Update Submit

November 21, 2024

Conditions

Infraorbital Hollowing

Keywords

Infraorbital HollowingJUVEDERM VOLBELLA With LidocaineLidocaineVOLBELLA with Lidocaine

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Percentage of Participants Achieving "Responder" Status for EI's Assessment of GAIS

    Month 3

  • Percentage of Participants Achieving "Responder" Status for Participant's Assessment of GAIS

    Month 3

  • Change From Baseline of Overall Score in Participant Responses to FACE-Q Appraisal of Lower Eyelids Questionnaire

    Month 3

Study Arms (2)

VOLBELLA with Lidocaine

EXPERIMENTAL

Participants will receive VOLBELLA with Lidocaine on Day 1 and followed for 12 months.

Device: VOLBELLA with Lidocaine

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.

Device: VOLBELLA with Lidocaine

Interventions

VOLBELLA with LidocaineDEVICE

Facial Injection

Also known as: JUVEDERM VOLBELLA with Lidocaine
Control GroupVOLBELLA with Lidocaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Beijing Hospital /ID# 227588

Beijing, Beijing Municipality, 100730, China

Location

Peking Union Medical College Hospital /ID# 227590

Beijing, Beijing Municipality, 100730, China

Location

Peking University First Hospital /ID# 227593

Xicheng District, Beijing Municipality, 100034, China

Location

Nanjing Drum Tower Hospital /ID# 241042

Nanjing, Jiangsu, 210008, China

Location

Zhongda Hospital Southeast University /ID# 241040

Nanjing, Jiangsu, 210009, China

Location

The Affiliated Hospital of Qingdao University /ID# 227592

Qingdao, Shandong, 266000, China

Location

Huashan Hospital, Fudan University /ID# 227591

Shanghai, Shanghai Municipality, 200040, China

Location

Related Links

Study Officials

  • ALLERGAN INC.

    Allergan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2021

First Posted

October 22, 2021

Study Start

October 19, 2021

Primary Completion

November 29, 2023

Study Completion

November 29, 2023

Last Updated

November 25, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access Criteria
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/
More information

Locations

CN(7)