Status:
COMPLETED
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
Lead Sponsor:
Merz North America, Inc.
Conditions:
Cheek Volume Augmentation
Eligibility:
All Genders
18-70 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2023
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT04886232
Start Date
May 25 2021
End Date
May 16 2023
Last Update
May 24 2023
Active Locations (10)
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1
Hautmedizin Bad Soden, Merz Investigational Site #0490189
Bad Soden am Taunus, Germany, 65812
2
Rosenparkklinik, Merz Investigational Site #0490099
Darmstadt, Germany, 64297
3
Praxis für Hautkrankheiten, Merz Investigational Site #0490375
Drensteinfurt, Germany, 48317
4
Dermatologic Private Practive, Merz Investigational Site #0490381
Düsseldorf, Germany, 40212