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

NCT04886232 | Completed

• 1 other identifier: M930061001
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Cheek Volume Augmentation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (4)

VP1 Lido US - NC

EXPERIMENTAL

Injection to the left cheek via needle and to the right cheek via canula

Device: VP1 Lido US

VP1 Lido US - CN

EXPERIMENTAL

Injection to the left cheek via canula and to the right cheek via needle

Device: VP1 Lido US

Restylane Lyft Lidocaine - NC

ACTIVE COMPARATOR

Injection to the left cheek via needle and to the right cheek via canula

Device: Restylane Lyft Lidocaine

Restylane Lyft Lidocaine - CN

ACTIVE COMPARATOR

Injection to the left cheek via canula and to the right cheek via needle

Device: Restylane Lyft Lidocaine

Interventions

VP1 Lido US DEVICE

Hyaluronic acid dermal filler containing lidocaine

VP1 Lido US - CN; VP1 Lido US - NC

Restylane Lyft Lidocaine DEVICE

Hyaluronic acid dermal filler containing lidocaine

Restylane Lyft Lidocaine - CN; Restylane Lyft Lidocaine - NC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merz North America, Inc.: lead

Study Sites (10)

Hautmedizin Bad Soden, Merz Investigational Site #0490189

Bad Soden am Taunus, 65812, Germany

Location

Rosenparkklinik, Merz Investigational Site #0490099

Darmstadt, 64297, Germany

Location

Praxis für Hautkrankheiten, Merz Investigational Site #0490375

Drensteinfurt, 48317, Germany

Location

Dermatologic Private Practive, Merz Investigational Site #0490381

Düsseldorf, 40212, Germany

Location

Universität Hamburg, Merz Investigational Site #0490095

Hamburg, 20146, Germany

Location

Dermatologic Private Practice, Merz Investigational Site #0490345

Hamburg, 22609, Germany

Location

Private Clinic, Merz Investigational Site #0490284

Mannheim, 68161, Germany

Location

Privatpraxis für Dermatologie und Ästhetik, Merz Investigational Site #0490371

München, 80539, Germany

Location

Haut- und Lasercentrum Potsdam, Merz Investigational Site #0490362

Potsdam, 14467, Germany

Location

Centroderm GmbH, Merz Investigational Site #0490367

Wuppertal, 42287, Germany

Location

Study Officials

• Merz Medical Expert

  Merz Pharmaceuticals GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 14, 2021
• Study Start: May 25, 2021
• Primary Completion: March 25, 2022
• Study Completion: May 16, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (10)