Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A 48-week, single-center, randomized, patient & evaluator-blind, matched pairs, active-controlled, non-inferiority, confirmatory design
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Device - UNIVELO Sub-Q | Experimental | UNIVELO Sub-Q |
|
| Comparator Device - Restylane Sub-Q | Active Comparator | Restylane Sub-Q |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UNIVELO Sub-Q 2mL | Device | Test device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Wrinkle Severity Rating Scale (WSRS) | Measure severity of wrinkle from score of 1 (no visible fold) to 5 (extremely deep and long folds) | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wrinkle Severity Rating Scale (WSRS) | Measure severity of wrinkle from score of 1 (no visible fold) to 5 (extremely deep and long folds) | 8 weeks, 16 weeks, 36 weeks, 48 weeks |
| Global Aesthetic Improvement Scale (GAIS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Restylane Sub-Q 2mL |
| Device |
Comparator Device |
|
Measure improvement status of wrinkle from score of -1 (worse) to 3 (very much improved)
| 8 weeks, 16 weeks, 24 weeks, 36 weeks, 48 weeks |