Nasolabial Folds
Conditions
Brief summary
This clinical investigation is a randomized, evaluator-blind, active controlled, noninferiority study to evaluate the effectiveness and safety of Neuramis® Deep Lidocaine when compared with YVOIRE® Volume Plus.
Detailed description
Males or females between 18 and 75 years of age, who want to correct both NLFs with 3 or 4 points in the WSRS and who provided written informed consent are to be included in the investigation.
Interventions
DEVICEexperimental
Neuramis® Deep Lidocaine
DEVICEcomparator
YVOIRE® Volume Plus
Sponsors
Medy-Tox
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female, 18 to 75 years of age. 2. Subjects who desire correction of bilateral NLFs that are rated as 3 or 4 points on the WSRS.
Exclusion criteria
1. Subjects who have received anticoagulation, antiplatelet, or thrombolytic medications, anti inflammatory medications. 2. Subjects who had soft tissue augmentation, medium or deep peeling, or dermal photorejuvenation on the lower inferior orbital rim for wrinkle correction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WSRS improvement rate at Week 24 | Week 24 | WSRS improvement rate at Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of WSRS from Week 4, 12, 24, 36, and 52 | Week 4, 12, 24, 36, and 52 | Change of WSRS from Week 4, 12, 24, 36, and 52 |
| WSRS improvement rate on Week 4, 12, 36, and 52 | Week 4, 12, 36, and 52 | WSRS improvement rate on Week 4, 12, 36, and 52 |
| GAIS improvement rate on Week 4, 12, 24, 36, and 52 | Week 4, 12, 24, 36, and 52 | GAIS improvement rate on Week 4, 12, 24, 36, and 52 |
Countries
China
Outcome results
None listed