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

NCT04210258 — Completed, 154 participants, Merz Pharmaceuticals GmbH

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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

RegistryNCT04210258, acronym POMET
StatusCompleted
Study typeObservational
Enrollment154 (Actual)
SponsorMerz Pharmaceuticals GmbH (Industry)
ConditionsCorrection of Facial Wrinkles/Folds, Facial Volume Enhancement
InterventionsEtermis 3, Etermis 4 (Device)
Datesstart 2016-06-01, primary completion 2017-12-27, completion 2017-12-27, first posted 2019-12-24, last updated 2020-01-02
Locations6 sites in Germany

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)

FacilityCityCountryStatus
Merz Investigational Site #0490099DarmstadtGermany
Merz Investigational Site #0490095HamburgGermany
Merz Investigational Site #0490345HamburgGermany
Merz Investigational Site #0490309KasselGermany
Merz Investigational Site #0490368MünchenGermany
Merz Investigational Site #0490362PotsdamGermany

+Investigators

  • Merz Medical Expert, Study director, Merz Pharmaceuticals GmbH