Infraorbital HollowingPhase 3NCT05088980
Study to Assess Effectiveness and Adverse Events of JUVEDERM VOLBELLA With Lidocaine Injection in Correcting Infraorbital Hollowing in Chinese Adult Participants
A Phase 3 study testing VOLBELLA with Lidocaine in people with Infraorbital Hollowing, run by Allergan at 7 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infraorbital Hollowing
- What is being tested?
- VOLBELLA with Lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 7 sitesChina
- Study dates
- 19 Oct 2021to 29 Nov 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Beijing Hospital /ID# 227588
Beijing, Beijing Municipality, 100730
Peking Union Medical College Hospital /ID# 227590
Beijing, Beijing Municipality, 100730
Nanjing Drum Tower Hospital /ID# 241042
Nanjing, Jiangsu, 210008
Zhongda Hospital Southeast University /ID# 241040
Nanjing, Jiangsu, 210009
The Affiliated Hospital of Qingdao University /ID# 227592
Qingdao, Shandong, 266000
Huashan Hospital, Fudan University /ID# 227591
Shanghai, Shanghai Municipality, 200040
Peking University First Hospital /ID# 227593
Xicheng District, Beijing Municipality, 100034
About this study
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
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.
Read more
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.
- Conditions
- Infraorbital Hollowing
- Being tested
- VOLBELLA with Lidocaine
- Keywords
- Infraorbital Hollowing, JUVEDERM VOLBELLA With Lidocaine, Lidocaine, VOLBELLA with Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VOLBELLA with LidocaineDevice
Also called JUVEDERM VOLBELLA with Lidocaine
Facial Injection
| Study group | Role | What they receive |
|---|---|---|
| VOLBELLA with Lidocaine | Experimental | Participants will receive VOLBELLA with Lidocaine on Day 1 and followed for 12 months. Receives: 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. Receives: Device: VOLBELLA with Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Month 3
Secondary outcomes (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).
Measured: 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).
Measured: 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.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start19 Oct 2021
- Primary completion29 Nov 2023
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infraorbital HollowingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ALLERGAN INC., Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088980
- Sponsor's protocol ID
- 1932-702-008
- Status last verified
- Nov 2024
- First submitted
- 11 Oct 2021
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05088980
- Acronym / sponsor ID
- 1932-702-008
- Conditions
- Infraorbital Hollowing
- Keywords
- Infraorbital Hollowing, JUVEDERM VOLBELLA With Lidocaine, Lidocaine, VOLBELLA with Lidocaine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VOLBELLA with Lidocaine | Experimental | Device: VOLBELLA with LidocaineParticipants will receive VOLBELLA with Lidocaine on Day 1 and followed for 12 months. |
| Control Group | Placebo comparator | Device: VOLBELLA with LidocaineParticipants will be followed for 3 months. Participants can opt to receive VOLBELLA with Lidocaine after 3 months and followed for 9 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VOLBELLA with LidocaineAlso: JUVEDERM VOLBELLA with LidocaineFacial Injection | Device | Control Group, VOLBELLA with Lidocaine |
Primary outcome
Percentage of Participants Achieving "Responder" Status for Evaluating Investigator's (EI) live assessment of AIHS
Time frame: Month 3
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).
3 secondary outcomes
Percentage of Participants Achieving "Responder" Status for EI's Assessment of GAIS
Time frame: Month 3
Percentage of Participants Achieving "Responder" Status for Participant's Assessment of GAIS
Time frame: Month 3
Change From Baseline of Overall Score in Participant Responses to FACE-Q Appraisal of Lower Eyelids Questionnaire
Time frame: Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Infraorbital Hollowing
Not yet recruitingPhase 2
Phase 2 Evaluation of Recombinant Human Platelet-Derived Growth Factor-BB (rhPDGF-BB) Injection for the Treatment of Infraorbital Hollowing
Infra-orbital Hollows, Skin Quality Improvement
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ALLERGAN INC. study director
Allergan
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VOLBELLA with Lidocaine in people with Infraorbital Hollowing, run by Allergan at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving "Responder" Status for Evaluating Investigator's (EI) live assessment of AIHS (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.