Cheek Volume AugmentationBCheekNCT04886232
A Prospective, Multicenter, Randomized, Comparator-controlled, Evaluator-blinded Study to Evaluate the Safety and Effectiveness of VP1 Lido US for Volume Augmentation of the Cheek
A study testing VP1 Lido US and Restylane Lyft Lidocaine in people with Cheek Volume Augmentation, run by Merz North America, Inc. at 10 sites in Germany.
Trial summary
The primary objective of the study is to demonstrate non-inferiority of VP1 Lido US versus an approved hyaluronic acid dermal filler following deep (subdermal and/or supraperiosteal) injection of the cheek for volume augmentation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cheek Volume Augmentation
- What is being tested?
- VP1 Lido US and Restylane Lyft Lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 10 sitesGermany
- Study dates
- 25 May 2021to 16 May 2023
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a symmetrical rating of 2 (moderate) or 3 (severe) for right and left cheek on the Merz Cheeks Fullness Assessment Scale (MCFAS)
- Desires cheek augmentation to correct volume deficit in the midface and is willing to receive sufficient volume to achieve at least a 1-point improvement on the MCFAS
Who cannot join
- Skin or fat atrophy in the midfacial region other than that related to age.
- Subjects with body mass index of <18.5 or ≥30
- Acute inflammatory process or active infection at the injection site (e.g., acne, eczema, streptococcus infections), or history of chronic or recurrent infection or inflammation with the potential to interfere with the study results or increase the risk of AEs.
- Prior surgery, including midfacial plastic surgery, or has a permanent implant or graft in the midfacial region that could interfere with effectiveness assessments.
- Received midfacial region treatments with porcine-based collagen fillers or with RADIESSE® or with volumizing hyaluronic acid fillers such as but not limited to Juvéderm® Voluma, Restylane® Lyft within the past 24 months and/or with other HA fillers or mesotherapy within the past 12 months or plans to receive such treatments during participation in the study.
- Received facial dermal therapies (i.e., facial ablative or fractional laser, dermabrasion, chemical peels, non-invasive skin-tightening [e.g., Ultherapy®, Thermage®] and surgical procedures) in the midfacial region within the past 12 months or plans to receive them in the facial region during participation in the study.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
Hautmedizin Bad Soden, Merz Investigational Site #0490189
Bad Soden am Taunus, 65812
Rosenparkklinik, Merz Investigational Site #0490099
Darmstadt, 64297
Praxis für Hautkrankheiten, Merz Investigational Site #0490375
Drensteinfurt, 48317
Dermatologic Private Practive, Merz Investigational Site #0490381
Düsseldorf, 40212
Universität Hamburg, Merz Investigational Site #0490095
Hamburg, 20146
Dermatologic Private Practice, Merz Investigational Site #0490345
Hamburg, 22609
Private Clinic, Merz Investigational Site #0490284
Mannheim, 68161
Privatpraxis für Dermatologie und Ästhetik, Merz Investigational Site #0490371
München, 80539
Haut- und Lasercentrum Potsdam, Merz Investigational Site #0490362
Potsdam, 14467
Centroderm GmbH, Merz Investigational Site #0490367
Wuppertal, 42287
About this study
The primary objective of the study is to demonstrate non-inferiority of VP1 Lido US versus an approved hyaluronic acid dermal filler following deep (subdermal and/or supraperiosteal) injection of the cheek for volume augmentation.
- Conditions
- Cheek Volume Augmentation
- Being tested
- VP1 Lido US, Restylane Lyft Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VP1 Lido USDevice
Hyaluronic acid dermal filler containing lidocaine
Restylane Lyft LidocaineDevice
Hyaluronic acid dermal filler containing lidocaine
| Study group | Role | What they receive |
|---|---|---|
| VP1 Lido US - NC | Experimental | Injection to the left cheek via needle and to the right cheek via canula Receives: Device: VP1 Lido US |
| VP1 Lido US - CN | Experimental | Injection to the left cheek via canula and to the right cheek via needle Receives: Device: VP1 Lido US |
| Restylane Lyft Lidocaine - NC | Active comparator | Injection to the left cheek via needle and to the right cheek via canula Receives: Device: Restylane Lyft Lidocaine |
| Restylane Lyft Lidocaine - CN | Active comparator | Injection to the left cheek via canula and to the right cheek via needle Receives: Device: Restylane Lyft Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to Week 12 on the Merz Cheeks Fullness Assessment Scale (MCFAS)
The MCFAS is a 5-point ordinal rating
Measured: Baseline to week 12
Secondary outcomes (7)
Change from baseline to Week 12 on the MCFAS by injection type (cannula, needle)
Measured: Baseline to week 12
Treatment response rate where response is defined as a ≥ 1-point improvement on both cheeks when comparing the change from baseline to Week 12
Measured: Baseline to week 12
FACE-Q satisfaction with cheeks for treated subjects at baseline and Week 12
Measured: Week 12
Global Aesthetic Improvement Scale (GAIS) scores for treated subjects at Week 12, as completed by the treating investigator
Measured: Week 12
GAIS scores for treated subjects at Week 12, as completed by the subject
Measured: Week 12
Responder rates at Week 12, according to the MCFAS, as assessed by three blinded board-certified Independent Panel Reviewers (IPRs) using subject photographs
Measured: Week 12
Incidence of related serious or delayed onset adverse events (>21 days after treatment) following the first treatment including touch-up until Week 48
Measured: Baseline to week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start25 May 2021
- Primary completion25 Mar 2022
- Study completion16 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cheek Volume AugmentationStudies 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
- 202 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 Pharmaceuticals GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886232
- Sponsor's protocol ID
- M930061001
- Acronym
- BCheek
- Status last verified
- May 2023
- First submitted
- 10 May 2021
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Comparator-controlled, Evaluator-blinded Study to Evaluate the Safety and Effectiveness of VP1 Lido US for Volume Augmentation of the Cheek
- ClinicalTrials.gov ID
- NCT04886232
- Acronym / sponsor ID
- BCheek / M930061001
- Conditions
- Cheek Volume Augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 May 2021 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 16 May 2023 (actual)
- First posted
- 14 May 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.
The primary objective of the study is to demonstrate non-inferiority of VP1 Lido US versus an approved hyaluronic acid dermal filler following deep (subdermal and/or supraperiosteal) injection of the cheek for volume augmentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VP1 Lido US - NC | Experimental | Device: VP1 Lido USInjection to the left cheek via needle and to the right cheek via canula |
| VP1 Lido US - CN | Experimental | Device: VP1 Lido USInjection to the left cheek via canula and to the right cheek via needle |
| Restylane Lyft Lidocaine - NC | Active comparator | Device: Restylane Lyft LidocaineInjection to the left cheek via needle and to the right cheek via canula |
| Restylane Lyft Lidocaine - CN | Active comparator | Device: Restylane Lyft LidocaineInjection to the left cheek via canula and to the right cheek via needle |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Has a symmetrical rating of 2 (moderate) or 3 (severe) for right and left cheek on the Merz Cheeks Fullness Assessment Scale (MCFAS)
- Desires cheek augmentation to correct volume deficit in the midface and is willing to receive sufficient volume to achieve at least a 1-point improvement on the MCFAS
Key exclusion criteria (6 listed)
- Skin or fat atrophy in the midfacial region other than that related to age.
- Subjects with body mass index of <18.5 or ≥30
- Acute inflammatory process or active infection at the injection site (e.g., acne, eczema, streptococcus infections), or history of chronic or recurrent infection or inflammation with the potential to interfere with the study results or increase the risk of AEs.
- Prior surgery, including midfacial plastic surgery, or has a permanent implant or graft in the midfacial region that could interfere with effectiveness assessments.
- Received midfacial region treatments with porcine-based collagen fillers or with RADIESSE® or with volumizing hyaluronic acid fillers such as but not limited to Juvéderm® Voluma, Restylane® Lyft within the past 24 months and/or with other HA fillers or mesotherapy within the past 12 months or plans to receive such treatments during participation in the study.
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 |
|---|---|---|
| VP1 Lido USHyaluronic acid dermal filler containing lidocaine | Device | VP1 Lido US - CN, VP1 Lido US - NC |
| Restylane Lyft LidocaineHyaluronic acid dermal filler containing lidocaine | Device | Restylane Lyft Lidocaine - CN, Restylane Lyft Lidocaine - NC |
Primary outcome
Change from baseline to Week 12 on the Merz Cheeks Fullness Assessment Scale (MCFAS)
Time frame: Baseline to week 12
The MCFAS is a 5-point ordinal rating
7 secondary outcomes
Change from baseline to Week 12 on the MCFAS by injection type (cannula, needle)
Time frame: Baseline to week 12
Treatment response rate where response is defined as a ≥ 1-point improvement on both cheeks when comparing the change from baseline to Week 12
Time frame: Baseline to week 12
FACE-Q satisfaction with cheeks for treated subjects at baseline and Week 12
Time frame: Week 12
Global Aesthetic Improvement Scale (GAIS) scores for treated subjects at Week 12, as completed by the treating investigator
Time frame: Week 12
GAIS scores for treated subjects at Week 12, as completed by the subject
Time frame: Week 12
Responder rates at Week 12, according to the MCFAS, as assessed by three blinded board-certified Independent Panel Reviewers (IPRs) using subject photographs
Time frame: Week 12
Incidence of related serious or delayed onset adverse events (>21 days after treatment) following the first treatment including touch-up until Week 48
Time frame: Baseline to week 48
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 24 May 2023.
- Individual participant dataSharing planned: No
Related trials for Cheek Volume Augmentation
Active, not recruiting
Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling
Dermal Fillers, Cheek Augmentation
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 Pharmaceuticals GmbH
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VP1 Lido US and Restylane Lyft Lidocaine in people with Cheek Volume Augmentation, run by Merz North America, Inc. at 10 sites in Germany.
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 6 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 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. 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?
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?
Change from baseline to Week 12 on the Merz Cheeks Fullness Assessment Scale (MCFAS) (time frame: Baseline to week 12). 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 24 May 2023.