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
Related Papers Related Patents Related Grants Related Experts
All trials for Correction of Facial Wrinkles/Folds All trials for Facial Volume Enhancement All trials of Etermis 3 All trials of Etermis 4
-Summary
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.
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+Arms and interventions
- Etermis 3 (Device): 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
- Etermis 4 (Device): 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
+Outcome measures
Primary outcomes
- 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 outcomes
- 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]
+Eligibility
Sex: All, ages: 18 Years to any
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
+Locations (6)
| Facility | City | Country | Status |
|---|
| Merz Investigational Site #0490099 | Darmstadt | Germany | |
| Merz Investigational Site #0490095 | Hamburg | Germany | |
| Merz Investigational Site #0490345 | Hamburg | Germany | |
| Merz Investigational Site #0490309 | Kassel | Germany | |
| Merz Investigational Site #0490368 | München | Germany | |
| Merz Investigational Site #0490362 | Potsdam | Germany | |
+Investigators
- Merz Medical Expert, Study director, Merz Pharmaceuticals GmbH