Post-Market Clinical Follow-up Performance and Safety Study of Etermis 3 and 4 in the Face

Study Overview
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Brief Summary
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To confirm the clinical performance of Etermis 3 and Etermis 4 based on the blinded investigator´s assessments on the respective Merz Aesthetics Scales from day 0 (D0) pre-injection to month 6/7 (depending on touch up) visit for nasolabial folds and marionette lines and from D0 pre-injection to month 3/4 (depending on touch up) visit for upper and lower lip fullness.

Official Title
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Open Label Multicenter Evaluator-blinded Post-market Clinical Follow-up (PMCF) Study to Confirm Performance and Safety of Etermis 3 and 4 in the Treatment of Moderate and Severe Wrinkles/Folds as Well as Facial Volume Enhancement

Conditions
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Correction of Facial Wrinkles/Folds, Facial Volume Enhancement

Intervention / Treatment
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* Device: Etermis 3
* Device: Etermis 4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects seeking hyaluronic acid dermal filler treatment to redefine/volumize/correct at least two of the indicated facial areas: Nasolabial folds Marionette lines Upper and lower lip fullness Exclusion Criteria: Subjects that have already been injected with non-resorbable filler, or that have recently been treated with any dermal filler in the region to be treated in the study Subjects with known sensitivity to hyaluronic acid-based products

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Etermis 3|Cross-linked hyaluronic dermal filler. Treatment and follow-up according to standard of care and instruction of use for filling facial moderate wrinkles (marionette lines) and/or to increase lip volume|
|Device: Etermis 4|Cross-linked hyaluronic dermal filler. Treatment and follow-up according to standard of care and instruction of use for filling deep and severe volume loss (nasolabial folds and/or marionette lines) and/or to increase lip volume|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate for marionette lines after treatment with Etermis 3 based on the blinded Investigator's opinion on the Merz Aesthetics Scale Marionette lines- At Rest |  | Baseline to month 6-7 | 
| Responder rate for lips after treatment with Etermis 3 based on the blinded Investigator's opinion on the Merz Aesthetics Scale Upper and lower lip fullness - At Rest |  | Baseline to month 3-4 | 
| Responder rate for NLFs after treatment with Etermis 4 based on the blinded Investigator's opinion on the Merz Aesthetics Scale Nasolabial folds- At Rest |  | Baseline to month 6-7 | 
| Responder rate for marionette lines after treatment with Etermis 4 based on the blinded Investigator's opinion on the Merz Aesthetics Scale Marionette lines- At Rest |  | Baseline to month 6-7 | 
| Responder rate for lips after treatment with Etermis 4 based on the blinded Investigator's opinion on the Merz Aesthetics Scale Upper and lower lip fullness - At Rest |  | Baseline to month 3-4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of blinded Investigator's assessment of marionette lines, per product from D0 pre-injection to M1 visit (before touch-up), to M2, to M3/M4, to M6/M7, to M9/M10, and to M12/M13 according to the Merz Aesthetics Scale Marionette lines - At Rest |  | Baseline up to month 12-13 | 
| Change of blinded Investigator's assessment of lip volume, per product from D0 pre-injection to M1 visit (before touch-up), to M2, to M3/M4, to M6/M7, to M9/M10, and to M12/M13 according to Merz Aesthetics Scale Upper and Lower lip fullness - At Rest |  | Baseline up to month 12-13 | 
| Change of blinded Investigator's assessment of nasolabial folds, per product from D0 pre-injection to M1 visit (before touch-up), to M2, to M3/M4, to M6/M7, to M9/M10, and to M12/M13 according to the Merz Aesthetics Scale Nasolabial folds - At Rest |  | Baseline up to month 12-13 | 
| Subject's satisfaction on the global impression of changes scale (GICS) from D0 pre-injection photos to M1 visit pre-optional touch-ups, M2 visit if applicable, M3/M4, M6/M7 visit, M9/M10 visit and to M12/M13 visit. |  | Baseline up to month 12-13 | 
| Blinded Investigator's global opinion on clinical performance on the global aesthetic improvement scale (GAIS) from D0 pre-injection photos to M1 visit pre-optional touch-ups, M2 visit if applicable, M3/M4, M6/M7 visit, M9/M10 visit and to M12/M13 visit. |  | Baseline up to month 12-13 |