Volume Loss in the Infraorbital Hollow AreaNCT04594239
Evaluation of Effectiveness and Safety of Belotero Balance® (+) Lidocaine for Volume Augmentation of the Infraorbital Hollow
A study testing Belotero Balance (+) Lidocaine, needle and Belotero Balance (+) Lidocaine, cannula in people with Volume Loss in the Infraorbital Hollow Area, run by Merz North America, Inc. at 9 sites in 2 countries.
Trial summary
Confirm the effectiveness of Belotero Balance® (+) Lidocaine (BBL) injection for the correction of volume loss in the infraorbital hollow (IOH) area by demonstrating superiority to untreated control. Confirm the safety of BBL injection for the correction of volume loss in the IOH area. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Volume Loss in the Infraorbital Hollow Area
- What is being tested?
- Belotero Balance (+) Lidocaine, needle and Belotero Balance (+) Lidocaine, cannula
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 31 Aug 2020to 21 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is a candidate for bilateral IOH treatment.
- Has symmetrical right and left IOHs with the same MIHAS score of 2 or 3 (moderate or severe), as assessed live by the blinded evaluator.
Who cannot join
- Prior lower-eyelid surgery, including orbital or midface surgery, or a permanent implant or graft in the midfacial region that could interfere with effectiveness assessments.
- Previous treatment with fat injections or permanent and/or semi-permanent dermal fillers in the midfacial region.
- Previous lower-eyelid and/or malar-region treatments with any dermal fillers (e.g., collagen, hyaluronic acid (HA), calcium hydroxyapatite, poly L-lactic acid (PLLA)) within the past 24 months.
- Any other medical condition with the potential to interfere with the study outcome assessments or compromise subject safety.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
MetroDerm / Atlanta Center for Clinical Research, Merz Investigational Site #0010446
Atlanta, Georgia, 30342
Project Glammers, Merz Investigational Site #0010443
Brooklyn, New York, 11229
HKB Surgeons, Merz Investigational Site #0010447
Huntersville, North Carolina, 28078
The Center for Dermatology, Cosmetic & Laser Surgery, Merz Investigational Site #0010442
Mount Kisco, New York, 10549
Nashville Centre for Laser & Facial Surgery, Merz Investigational Site #0010353
Nashville, Tennessee, 37203
Art of Skin MD, Merz Investigational Site #0010444
Solana Beach, California, 92075
Moradi MD Face Beautiful Inc., Merz Investigational Site #0010358
Vista, California, 92083
Mariwalla Dermatology, Merz Investigational Site #0010445
West Islip, New York, 11795
Puerto Rico1 site
Jose Raul Montes Eyes and Facial Rejuvenation, Merz Investigational Site #0010436
San Juan, 00917
About this study
- Confirm the effectiveness of Belotero Balance® (+) Lidocaine (BBL) injection for the correction of volume loss in the infraorbital hollow (IOH) area by demonstrating superiority to untreated control.
- Confirm the safety of BBL injection for the correction of volume loss in the IOH area.
- Being tested
- Belotero Balance (+) Lidocaine, needle, Belotero Balance (+) Lidocaine, cannula, Untreated-control / delayed-treatment, needle, Untreated-control / delayed-treatment, cannulas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belotero Balance (+) Lidocaine, needleDevice
Injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using needles
Belotero Balance (+) Lidocaine, cannulaDevice
Injection of Belotero Balance (+) Lidocaine into the infraorbital hollows using cannulas
Untreated-control / delayed-treatment, needleDevice
Untreated-control, followed by delayed-treatment with Belotero Balance (+) Lidocaine (injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using needles)
Untreated-control / delayed-treatment, cannulasDevice
Untreated-control, followed by delayed-treatment with Belotero Balance (+) Lidocaine (injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using cannulas)
| Study group | Role | What they receive |
|---|---|---|
| Treatment, needle | Experimental | Not described Receives: Device: Belotero Balance (+) Lidocaine, needle |
| Treatment, cannula | Experimental | Not described Receives: Device: Belotero Balance (+) Lidocaine, cannula |
| Untreated-control / delayed-treatment, needle | Other | Not described Receives: Device: Untreated-control / delayed-treatment, needle |
| Untreated-control / delayed-treatment, cannula | Other | Not described Receives: Device: Untreated-control / delayed-treatment, cannulas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder Rate Based on Merz Infraorbital Hollow Assessment Scale (MIHAS) at Week 8
Responder rate was defined as percentage of subjects with treatment response at Week 8 on MIHAS, as assessed live by a blinded evaluator. Responders were defined as subjects who achieved greater than or equal to (>=) 1 grade improvement on both IOHs on the MIHAS. MIHAS (to assess infraorbital hollow) was a 5-point scale ranging as: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (extreme). A higher score indicated extreme signs of hollowing. This analysis was done using multiple imputation method to impute missing MIHAS scores. Percentage of subjects with response at Week 8 and corresponding confidence intervals were average values obtained from the multiple imputation approach.
Measured: Week 8
Secondary outcomes (5)
Percentage of Subjects With Global Aesthetic Improvement Scale (GAIS) Score at Week 8, as Assessed by the Treating Investigator
The GAIS is a 7-point scale ranging as +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse), as assessed by the investigator. An improvement on the GAIS was classified as "improved", "much improved", or "very much improved.
Measured: Week 8
Percentage of Subjects With GAIS Score at Week 8, as Assessed by the Subject
The GAIS is a 7-point scale ranging as +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse), as assessed by the subject. An improvement on the GAIS was classified as "improved", "much improved", or "very much improved.
Measured: Week 8
Change From Baseline in Rasch-Transformed Score for the Face-Q Satisfaction With Eyes at Week 8
The FACE-Q is a set of standardized patient-reported outcome scales for subjects undergoing facial cosmetic procedures. Subjects answered 7 questions of the FACE-Q satisfaction with eyes using a 4- point scale where: 1(very dissatisfied), 2 (somewhat dissatisfied), 3 (somewhat satisfied), 4 (very satisfied). The sum FACE-Q scores were Rasch-transformed and ranged from 0 to 100. Higher scores reflected a better outcome (greater satisfaction).
Measured: Baseline, Week 8
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Related to BBL
TEAEs are defined as adverse events (AEs) with onset or worsening on or after date and time of first dose of study treatment. A TEAE was considered to be "related" if a causal relationship between BBL and the TEAE is at least reasonably possible.
Measured: BBL Treatment (Needle and Cannula): Up to 80 weeks; Control/Delayed-treatment BBL (Needle and Cannula): Up to 56 weeks
Number of Subjects With Treatment-Emergent Serious Adverse Events (TESAEs) Related to BBL
TESAEs included TEAEs that resulted in death, required either inpatient hospitalization or the prolongation of hospitalization, were life-threatening, resulted in a persistent or significant disability/incapacity or resulted in a congenital anomaly/birth defect. A TESAE was considered to be "related" if a causal relationship between BBL and the TESAE is at least reasonably possible.
Measured: BBL Treatment (Needle and Cannula): Up to 80 weeks; Control/Delayed-treatment BBL (Needle and Cannula): Up to 56 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start31 Aug 2020
- Primary completion8 Apr 2021
- Study completion21 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Volume Loss in the Infraorbital Hollow AreaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merz Medical Expert, Study director, Merz North America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594239
- Sponsor's protocol ID
- M930121002
- Status last verified
- Jan 2024
- First submitted
- 13 Oct 2020
- Last updated
- 30 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness and Safety of Belotero Balance® (+) Lidocaine for Volume Augmentation of the Infraorbital Hollow
- ClinicalTrials.gov ID
- NCT04594239
- Acronym / sponsor ID
- M930121002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 8 Apr 2021 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Posted 30 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Confirm the effectiveness of Belotero Balance® (+) Lidocaine (BBL) injection for the correction of volume loss in the infraorbital hollow (IOH) area by demonstrating superiority to untreated control.
- Confirm the safety of BBL injection for the correction of volume loss in the IOH area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment, needle | Experimental | Device: Belotero Balance (+) Lidocaine, needle |
| Treatment, cannula | Experimental | Device: Belotero Balance (+) Lidocaine, cannula |
| Untreated-control / delayed-treatment, needle | Other | Device: Untreated-control / delayed-treatment, needle |
| Untreated-control / delayed-treatment, cannula | Other | Device: Untreated-control / delayed-treatment, cannulas |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Is a candidate for bilateral IOH treatment.
- Has symmetrical right and left IOHs with the same MIHAS score of 2 or 3 (moderate or severe), as assessed live by the blinded evaluator.
Key exclusion criteria (4 listed)
- Prior lower-eyelid surgery, including orbital or midface surgery, or a permanent implant or graft in the midfacial region that could interfere with effectiveness assessments.
- Previous treatment with fat injections or permanent and/or semi-permanent dermal fillers in the midfacial region.
- Previous lower-eyelid and/or malar-region treatments with any dermal fillers (e.g., collagen, hyaluronic acid (HA), calcium hydroxyapatite, poly L-lactic acid (PLLA)) within the past 24 months.
- Any other medical condition with the potential to interfere with the study outcome assessments or compromise subject safety.
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 |
|---|---|---|
| Belotero Balance (+) Lidocaine, needleInjection of Belotero Balance (+) Lidocaine to the infraorbital hollows using needles | Device | Treatment, needle |
| Belotero Balance (+) Lidocaine, cannulaInjection of Belotero Balance (+) Lidocaine into the infraorbital hollows using cannulas | Device | Treatment, cannula |
| Untreated-control / delayed-treatment, needleUntreated-control, followed by delayed-treatment with Belotero Balance (+) Lidocaine (injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using needles) | Device | Untreated-control / delayed-treatment, needle |
| Untreated-control / delayed-treatment, cannulasUntreated-control, followed by delayed-treatment with Belotero Balance (+) Lidocaine (injection of Belotero Balance (+) Lidocaine to the infraorbital hollows using cannulas) | Device | Untreated-control / delayed-treatment, cannula |
Primary outcome
Responder Rate Based on Merz Infraorbital Hollow Assessment Scale (MIHAS) at Week 8
Time frame: Week 8
Responder rate was defined as percentage of subjects with treatment response at Week 8 on MIHAS, as assessed live by a blinded evaluator. Responders were defined as subjects who achieved greater than or equal to (>=) 1 grade improvement on both IOHs on the MIHAS. MIHAS (to assess infraorbital hollow) was a 5-point scale ranging as: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (extreme). A higher score indicated extreme signs of hollowing. This analysis was done using multiple imputation method to impute missing MIHAS scores. Percentage of subjects with response at Week 8 and corresponding confidence intervals were average values obtained from the multiple imputation approach.
5 secondary outcomes
Percentage of Subjects With Global Aesthetic Improvement Scale (GAIS) Score at Week 8, as Assessed by the Treating Investigator
Time frame: Week 8
Percentage of Subjects With GAIS Score at Week 8, as Assessed by the Subject
Time frame: Week 8
Change From Baseline in Rasch-Transformed Score for the Face-Q Satisfaction With Eyes at Week 8
Time frame: Baseline, Week 8
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Related to BBL
Time frame: BBL Treatment (Needle and Cannula): Up to 80 weeks; Control/Delayed-treatment BBL (Needle and Cannula): Up to 56 weeks
Number of Subjects With Treatment-Emergent Serious Adverse Events (TESAEs) Related to BBL
Time frame: BBL Treatment (Needle and Cannula): Up to 80 weeks; Control/Delayed-treatment BBL (Needle and Cannula): Up to 56 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Merz Medical Expert study director
Merz North America, Inc.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Belotero Balance (+) Lidocaine, needle and Belotero Balance (+) Lidocaine, cannula in people with Volume Loss in the Infraorbital Hollow Area, run by Merz North America, Inc. at 9 sites in 2 countries.
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 2 inclusion and 4 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 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Puerto Rico. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Responder Rate Based on Merz Infraorbital Hollow Assessment Scale (MIHAS) at Week 8 (time frame: Week 8). 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 30 Jan 2024.