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

Merz Pharmaceuticals

Status: Completed

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

Treatments: Device: Etermis 4; Device: Etermis 3

Study type: Observational

Funder types: Industry

Identifiers

NCT04210258

M900991001

Details and patient eligibility

About

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.

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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