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OpenTrials
Completed

NCT Number: NCT04886232

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

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.

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Key information

Conditions

Cheek Volume Augmentation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hautmedizin Bad Soden, Merz Investigational Site #0490189, Bad Soden am Taunus, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VP1 Lido US

Device

Hyaluronic acid dermal filler containing lidocaine

Restylane Lyft Lidocaine

Device

Hyaluronic acid dermal filler containing lidocaine

Primary outcomes

  1. 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

Secondary outcomes

  1. Change from baseline to Week 12 on the MCFAS by injection type (cannula, needle)

    Time frame: Baseline to week 12

  2. 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

  3. FACE-Q satisfaction with cheeks for treated subjects at baseline and Week 12

    Time frame: Week 12

  4. Global Aesthetic Improvement Scale (GAIS) scores for treated subjects at Week 12, as completed by the treating investigator

    Time frame: Week 12

  5. GAIS scores for treated subjects at Week 12, as completed by the subject

    Time frame: Week 12

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Merz North America, Inc.

Industry

Registry information

Acronym: BCheek

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
May 14, 2021
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.