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)
Status
Completed
Conditions
Cheek Volume Augmentation
Treatments
Device: VP1 Lido US
Device: Restylane Lyft Lidocaine
Details and patient eligibility
About
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.
Enrollment
202 patients
Sex
All
Ages
18 to 70 years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Single Blind
202 participants in 4 patient groups
VP1 Lido US - NC
Experimental group
Description:
Injection to the left cheek via needle and to the right cheek via canula
Treatment:
Device: VP1 Lido US
VP1 Lido US - CN
Experimental group
Description:
Injection to the left cheek via canula and to the right cheek via needle
Treatment:
Device: VP1 Lido US
Restylane Lyft Lidocaine - NC
Active Comparator group
Description:
Injection to the left cheek via needle and to the right cheek via canula
Treatment:
Device: Restylane Lyft Lidocaine
Restylane Lyft Lidocaine - CN
Active Comparator group
Description:
Injection to the left cheek via canula and to the right cheek via needle
Treatment:
Device: Restylane Lyft Lidocaine
Trial contacts and locations
10
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Data sourced from clinicaltrials.gov
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