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A Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 on Lips and Perioral Area.
This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 Versus Comparator for Temporary Enhancement and Pouting of the Lips for Lip Augmentation and Correction of Perioral Area
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YVOIRE Y-Solution 360 | Experimental | Hyaluronic acid dermal filler |
|
| Juvéderm VOLBELLA | Active Comparator | Hyaluronic acid dermal filler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YVOIRE Y-Solution 360 | Device | Hyaluronic acid dermal filler |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change on the overall Lip Fullness Rating Scale (LFRS) from baseline to Week12. | To evaluate the performance of YVOIRE Y-Solution 360 on overall Lip 12 weeks after treatment, the mean change from baseline to 12 weeks will be measured using 5-point Lip Fullness Rating Scale (LFRS). LFRS Grades are 0 (None/Minimal), 1 (Mild), 2 (Moderate), 3 (Pronounced), and 4 (Very Pronounced). | 12 weeks from baseline |
| Responder rate calculated using Lip Fullness Rating Scale (LFRS) for overall lip at Week12. | To evaluate the performance of YVOIRE Y-Solution 360 on overall Lip 12 weeks after treatment, the responder rate defined as ≥ 1-point improvement on the 5-point Lip Fullness Rating Scale (LFRS) from baseline to 12 weeks will be calculated. | 12 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change on Lip Fullness Rating Scale (LFRS) from baseline to Week2, 4, 12 and 24. | To evaluate the performance of YVOIRE Y-Solution 360 at 2, 4, 12, and 24 weeks after treatment, the mean change from baseline to at 2, 4, 12, and 24 weeks will be measured using 5-point Lip Fullness Rating Scale (LFRS). | 2, 4, 12, 24 weeks from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tanja C. Fischer | Haut-und Lasercentrum Potsdam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haut-und Lasercentrum Potsdam | Potsdam | Germany |
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| Juvéderm VOLBELLA |
| Device |
Hyaluronic acid dermal filler |
|
| Responder rate on Lip Fullness Rating Scale (LFRS) from baseline to Week2, 4, 12 and 24. |
To evaluate the performance of YVOIRE Y-Solution 360 at 2, 4, 12, and 24 weeks after treatment, the responder rate (defined as at a least 1-point improvement) from baseline to at 2, 4, 12, and 24 weeks will be measured using 5-point Lip Fullness Rating Scale (LFRS). |
| 2, 4, 12, 24 weeks from baseline |
| Mean change on Vertical Perioral Lip lines Rating Scale - At rest(VPLRS) from baseline to Week2, 4, 12 and 24. | To evaluate the performance of YVOIRE Y-Solution 360 on perioral area at 2, 4, 12, and 24 weeks after treatment, the mean change from baseline to at 2, 4, 12, and 24 weeks will be measured using 5-point Vertical Perioral Lip lines Rating Scale - At rest (VPLRS). | 2, 4, 12, 24 weeks from baseline |
| Responder rate on Vertical Perioral Lip lines Rating Scale - At rest(VPLRS) from baseline to Week2, 4, 12 and 24. | To evaluate the performance of YVOIRE Y-Solution 360 on perioral area at 2, 4, 12, and 24 weeks after treatment, the responder rate (as at a least 1-point improvement) from baseline to at 2, 4, 12, and 24 weeks will be measured using 5-point Vertical Perioral Lip lines Rating Scale - At rest (VPLRS). | 2, 4, 12, 24 weeks from baseline |
| Global Aesthetic Improvement Scale (GAIS) evaluation by subject and investigator. | To measure the satisfaction of YVOIRE Y-Solution 360 the GAIS evaluation will be performed by subject and investigator. GAIS Grade are -2 (Much Worse), -1 (Worse), 0 (No change), 1 (Improved), and 2 (Much improved). | 2, 4, 12, 24 weeks from baseline |