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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
202
Hyaluronic acid dermal filler containing lidocaine
Hyaluronic acid dermal filler containing lidocaine
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
Change from baseline to Week 12 on the Merz Cheeks Fullness Assessment Scale (MCFAS)
The MCFAS is a 5-point ordinal rating
Time frame: Baseline to week 12
Change from baseline to Week 12 on the MCFAS by injection type (cannula, needle)
Time frame: Baseline to week 12
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
FACE-Q satisfaction with cheeks for treated subjects at baseline and Week 12
Time frame: Week 12
Global Aesthetic Improvement Scale (GAIS) scores for treated subjects at Week 12, as completed by the treating investigator
Time frame: Week 12
GAIS scores for treated subjects at Week 12, as completed by the subject
Time frame: Week 12
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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