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 (BCheek)

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 Overview

• Status: Completed
• Conditions: Cheek Volume Augmentation
• Intervention / Treatment: Device: VP1 Lido US; Device: Restylane Lyft Lidocaine

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad Soden am Taunus, Germany, 65812
    • Hautmedizin Bad Soden, Merz Investigational Site #0490189
  • Darmstadt, Germany, 64297
    • Rosenparkklinik, Merz Investigational Site #0490099
  • Drensteinfurt, Germany, 48317
    • Praxis für Hautkrankheiten, Merz Investigational Site #0490375
  • Düsseldorf, Germany, 40212
    • Dermatologic Private Practive, Merz Investigational Site #0490381
  • Hamburg, Germany, 20146
    • Universität Hamburg, Merz Investigational Site #0490095
  • Hamburg, Germany, 22609
    • Dermatologic Private Practice, Merz Investigational Site #0490345
  • Mannheim, Germany, 68161
    • Private Clinic, Merz Investigational Site #0490284
  • München, Germany, 80539
    • Privatpraxis für Dermatologie und Ästhetik, Merz Investigational Site #0490371
  • Potsdam, Germany, 14467
    • Haut- und Lasercentrum Potsdam, Merz Investigational Site #0490362
  • Wuppertal, Germany, 42287
    • Centroderm GmbH, Merz Investigational Site #0490367

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VP1 Lido US - NC; Injection to the left cheek via needle and to the right cheek via canula	Device: VP1 Lido US; Hyaluronic acid dermal filler containing lidocaine
Experimental: VP1 Lido US - CN; Injection to the left cheek via canula and to the right cheek via needle	Device: VP1 Lido US; Hyaluronic acid dermal filler containing lidocaine
Active Comparator: Restylane Lyft Lidocaine - NC; Injection to the left cheek via needle and to the right cheek via canula	Device: Restylane Lyft Lidocaine; Hyaluronic acid dermal filler containing lidocaine
Active Comparator: Restylane Lyft Lidocaine - CN; Injection to the left cheek via canula and to the right cheek via needle	Device: Restylane Lyft Lidocaine; Hyaluronic acid dermal filler containing lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to Week 12 on the Merz Cheeks Fullness Assessment Scale (MCFAS)	The MCFAS is a 5-point ordinal rating	Baseline to week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to Week 12 on the MCFAS by injection type (cannula, needle)	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	Baseline to week 12
FACE-Q satisfaction with cheeks for treated subjects at baseline and Week 12	Week 12
Global Aesthetic Improvement Scale (GAIS) scores for treated subjects at Week 12, as completed by the treating investigator	Week 12
GAIS scores for treated subjects at Week 12, as completed by the subject	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	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	Baseline to week 48

Collaborators and Investigators

• Sponsor: Merz North America, Inc.
• Investigators: Study Director: Merz Medical Expert, Merz Pharmaceuticals GmbH

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2021
• Primary Completion (Actual): March 25, 2022
• Study Completion (Actual): May 16, 2023

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 10, 2021
• First Posted (Actual): May 14, 2021

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: M930061001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No