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

Merz Pharmaceuticals GmbH154 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

154

Conditions

Correction of Facial Wrinkles/Folds Facial Volume Enhancement

Interventions

Etermis 3DEVICE

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 4DEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Merz Investigational Site #0490099

Darmstadt, Germany

Merz Investigational Site #0490095

Hamburg, Germany

Merz Investigational Site #0490345

Hamburg, Germany

Merz Investigational Site #0490309

Kassel, Germany

Outcomes

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"

Time frame: 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"

Time frame: 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"

Time frame: 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"

Time frame: 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"

Time frame: 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

Time frame: 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"

Time frame: Baseline up to month 12-13

Data from ClinicalTrials.gov

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