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This study will investigate the non-inferiority of Belotero® Basic versus Juvéderm® Ultra 3 in the treatment of nasolabial folds
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic Acid Filler - Medical Device | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic Acid Filler | Device | The dosage is individualized depending on the depth of the NLF. The goal is to achieve optimal correction of both NLF with single implantations of Belotero® Basic and Juvéderm® Ultra 3 respectively. Each subject will be injected with Belotero® Basic and Lidocaine containing Juvéderm® Ultra 3 according to a split-face design. The allocation of fillers to the side of the face will be randomized. The randomization method is block-wise with a ratio 1:1 to the groups Belotero® Basic left and Juvéderm® Ultra 3 right, Belotero® Basic right and Juvéderm® Ultra 3 left. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects reporting an equal or better outcome for the side of face treated with Belotero® Basic compared to the side of face treated with Juvéderm® Ultra 3 at V4 on the validated Wrinkle Severity Rating Scale II | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall intra-individual change at V2 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation | Week 0 | |
| Overall intra-individual change at V3 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clemens Acker, Dr. | Merz Pharmaceuticals GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Praxisklinik Kaiserplatz | Frankfurt am Main | 60311 | Germany |
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| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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|
| 2 Weeks |
| Overall intra-individual change at V4 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation | 4 Weeks |
| Overall absolute score change at V2 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation assessed by photo rating of one independent rater | Week 0 |
| Overall absolute score change at V3 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation assessed by photo rating of one independent rater | 2 Weeks |
| Overall absolute score change at V4 post implantation in the validated Wrinkle Severity Rating Scale II compared to V2 pre implantation assessed by photo rating of one independent rater | 4 Weeks |
| Proportion of overall responders i.e. at least 1 point improvement in the validated Wrinkle Severity Rating Scale II(WSRS II) at V4, based on the intra-individual change in WSRS II compared to baseline before implantation, V2 pre implantation | 4 Weeks |
| Assessment of Global aesthetic improvement [GAIS] by the investigator and subject V2 post implantation and V4 | 4 Weeks |
| Overall GAIS by photo rating of an individual rater V2 post implantation and V4 | 4 Weeks |
| Subject Satisfaction Questionnaire results at V2 pre and post implantation | Week 0 |
| Subject Satisfaction Questionnaire results at V3 | 2 Weeks |
| Subject Satisfaction Questionnaire results at V4 | 4 Weeks |
| Global assessment of subject comfort at V2 post implantation by the investigator and the subject. | Week 0 |
| Global assessment of subject comfort at V3 by the investigator and the subject | 2 Weeks |
| Global assessment of subject comfort at V4 by the investigator and the subject | 4 Weeks |
| Proportion of subjects feeling the implant at V2 post implantation | Week 0 |
| Proportion of subjects feeling the implant at V3. | 2 Weeks |
| Proportion of subjects feeling the implant at V4 | 4 Weeks |
| Proportion of subjects recommending Belotero® Basic only or Juvéderm® Ultra 3 only or both at V4 | 4 Weeks |