Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cheek Volume Augmentation
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-14
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline to Week 12 on the Merz Cheeks Fullness Assessment Scale (MCFAS)
timeFrame: Baseline to week 12
Secondary outcomes:
measure: Change from baseline to Week 12 on the MCFAS by injection type (cannula, needle)
timeFrame: Baseline to week 12
measure: Treatment response rate where response is defined as a ≥ 1-point improvement on both cheeks when comparing the change from baseline to Week 12
timeFrame: Baseline to week 12
measure: FACE-Q satisfaction with cheeks for treated subjects at baseline and Week 12
timeFrame: Week 12
measure: Global Aesthetic Improvement Scale (GAIS) scores for treated subjects at Week 12, as completed by the treating investigator
timeFrame: Week 12
measure: GAIS scores for treated subjects at Week 12, as completed by the subject
timeFrame: Week 12
measure: Responder rates at Week 12, according to the MCFAS, as assessed by three blinded board-certified Independent Panel Reviewers (IPRs) using subject photographs
timeFrame: Week 12
measure: Incidence of related serious or delayed onset adverse events (>21 days after treatment) following the first treatment including touch-up until Week 48
timeFrame: Baseline to week 48
Other outcomes:
Locations:
city: Bad Soden am Taunus
country: Germany
facility: Hautmedizin Bad Soden, Merz Investigational Site #0490189
city: Darmstadt
country: Germany
facility: Rosenparkklinik, Merz Investigational Site #0490099
city: Drensteinfurt
country: Germany
facility: Praxis für Hautkrankheiten, Merz Investigational Site #0490375
city: Düsseldorf
country: Germany
facility: Dermatologic Private Practive, Merz Investigational Site #0490381
city: Hamburg
country: Germany
facility: Universität Hamburg, Merz Investigational Site #0490095
city: Hamburg
country: Germany
facility: Dermatologic Private Practice, Merz Investigational Site #0490345
city: Mannheim
country: Germany
facility: Private Clinic, Merz Investigational Site #0490284
city: München
country: Germany
facility: Privatpraxis für Dermatologie und Ästhetik, Merz Investigational Site #0490371
city: Potsdam
country: Germany
facility: Haut- und Lasercentrum Potsdam, Merz Investigational Site #0490362
city: Wuppertal
country: Germany
facility: Centroderm GmbH, Merz Investigational Site #0490367
Study officials:
affiliation: Merz Pharmaceuticals GmbH
name: Merz Medical Expert
role: STUDY_DIRECTOR
References: