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

Completed

• Conditions: Facial Volume Enhancement; Correction of Facial Wrinkles/Folds

• Registration Number: NCT04210258
• Lead Sponsor: Merz Pharmaceuticals GmbH

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-01
• Primary Completion: 2017-12-27
• Study Completion: 2017-12-27
• Status Verified: 2019-12
• Study First Submitted: 2019-12-17
• Study First Submitted QC: 2019-12-23
• Study First Posted: 2019-12-24
• Last Update Submitted: 2019-12-27
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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
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
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
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

Trial Locations

Locations (6)

Merz Investigational Site #0490099; 🇩🇪 Darmstadt, Germany

Merz Investigational Site #0490095; 🇩🇪 Hamburg, Germany

Merz Investigational Site #0490345; 🇩🇪 Hamburg, Germany

Merz Investigational Site #0490368; 🇩🇪 München, Germany

Merz Investigational Site #0490362; 🇩🇪 Potsdam, Germany

Merz Investigational Site #0490309; 🇩🇪 Kassel, Germany