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

NCT04210258 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 154

Last updated 2020-01-02

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Merz Pharmaceuticals GmbH

    lead INDUSTRY

Principal Investigators

  • Merz Medical Expert · Merz Pharmaceuticals GmbH

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-01
Primary Completion
2017-12-27
Completion
2017-12-27

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04210258 on ClinicalTrials.gov