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
NCT ID: NCT04886232
Last Updated: 2023-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
202 participants
INTERVENTIONAL
2021-05-25
2023-05-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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VP1 Lido US - NC
Injection to the left cheek via needle and to the right cheek via canula
VP1 Lido US
Hyaluronic acid dermal filler containing lidocaine
VP1 Lido US - CN
Injection to the left cheek via canula and to the right cheek via needle
VP1 Lido US
Hyaluronic acid dermal filler containing lidocaine
Restylane Lyft Lidocaine - NC
Injection to the left cheek via needle and to the right cheek via canula
Restylane Lyft Lidocaine
Hyaluronic acid dermal filler containing lidocaine
Restylane Lyft Lidocaine - CN
Injection to the left cheek via canula and to the right cheek via needle
Restylane Lyft Lidocaine
Hyaluronic acid dermal filler containing lidocaine
Interventions
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VP1 Lido US
Hyaluronic acid dermal filler containing lidocaine
Restylane Lyft Lidocaine
Hyaluronic acid dermal filler containing lidocaine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Merz North America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Merz Medical Expert
Role: STUDY_DIRECTOR
Merz Pharmaceuticals GmbH
Locations
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Hautmedizin Bad Soden, Merz Investigational Site #0490189
Bad Soden am Taunus, , Germany
Rosenparkklinik, Merz Investigational Site #0490099
Darmstadt, , Germany
Praxis für Hautkrankheiten, Merz Investigational Site #0490375
Drensteinfurt, , Germany
Dermatologic Private Practive, Merz Investigational Site #0490381
Düsseldorf, , Germany
Universität Hamburg, Merz Investigational Site #0490095
Hamburg, , Germany
Dermatologic Private Practice, Merz Investigational Site #0490345
Hamburg, , Germany
Private Clinic, Merz Investigational Site #0490284
Mannheim, , Germany
Privatpraxis für Dermatologie und Ästhetik, Merz Investigational Site #0490371
München, , Germany
Haut- und Lasercentrum Potsdam, Merz Investigational Site #0490362
Potsdam, , Germany
Centroderm GmbH, Merz Investigational Site #0490367
Wuppertal, , Germany
Countries
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Other Identifiers
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M930061001
Identifier Type: -
Identifier Source: org_study_id
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