NCT04210258

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 154 (actual)
• Sponsor: Merz Pharmaceuticals GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Correction of Facial Wrinkles/Folds
• Facial Volume Enhancement

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-12-27
• Completion: 2017-12-27
• First posted: 2019-12-24
• Last updated: 2020-01-02

Locations

6 sites across 1 country: Germany