A Study to Evaluate the Performance and Safety of YVOIRE volume plus for Temporary Improvement of Mid-face Volume
This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate the Performance and Safety of YVOIRE volume plus versus Restylane Lyft with Lidocaine for Temporary Improvement of Mid-face Volume.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
105
Hyaluronic acid dermal filler
Hyaluronic acid dermal filler
LG Chem investigational site 01
Munich, Germany
Non-inferiority of YVOIRE volume plus versus Restylane Lyft with Lidocaine
To demonstrate non-inferiority of YVOIRE volume plus versus Restylane Lyft with Lidocaine in the improvement of mid face volume by comparing the mean change from Baseline in the Mid Face Volume Loss Rating Scale (MFVLRS) at 24 weeks after the final treatment
Time frame: 24 weeks from baseline
Responder rate of YVOIRE volume plus
To confirm performance of YVOIRE volume plus by the responder rate (defined as at least 1-point improvement from Baseline) at 24 weeks after the final treatment
Time frame: 24 weeks from baseline
Mean Change of Mid Face Volume Loss Rating Scale (MFVLRS)
To compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on the MFVLRS
Time frame: 4, 8, 12, 52 weeks from baseline
Responder rate of YVOIRE volume plus
To confirm performance of YVOIRE volume plus by the responder rate (defined as at least 1-point improvement from Baseline) at 24 weeks after the final treatment
Time frame: 4, 8, 12, 52 weeks from baseline
Mean Score of Mid Face Volume Loss Rating Scale (MFVLRS)
o compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on the MFVLRS
Time frame: 4, 8, 12, 24, 52 weeks from baseline
The mean scores of the GAIS
To compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on Global Aesthetic Improvement Scale (GAIS)
Time frame: 4, 8, 12, 24, 52 weeks from baseline
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Mean change in mid-face volume
To compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on the three dimensional (3-D) photograph measurement
Time frame: 24 weeks from baseline