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

NCT04210258 | Completed

• 1 other identifier: M900991001
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 6

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.

Conditions

Correction of Facial Wrinkles/Folds; Facial Volume Enhancement

Outcome Measures

Primary Outcomes (5)

• 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

• 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

Secondary Outcomes (5)

• 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

• 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

• 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

• 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

Interventions

Etermis 3 DEVICE

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 4 DEVICE

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy male and female subjects seeking hyaluronic acid dermal filler treatment to redefine/volumize/correct at least two of the indicated facial areas (NLFs, marionette lines, upper and lower lips)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merz Pharmaceuticals GmbH: lead

Study Sites (6)

Merz Investigational Site #0490099

Darmstadt, 64283, Germany

Location

Merz Investigational Site #0490095

Hamburg, 20146, Germany

Location

Merz Investigational Site #0490345

Hamburg, 22609, Germany

Location

Merz Investigational Site #0490309

Kassel, 34121, Germany

Location

Merz Investigational Site #0490368

München, 80333, Germany

Location

Merz Investigational Site #0490362

Potsdam, 14467, Germany

Location

Study Officials

• Merz Medical Expert

  Merz Pharmaceuticals GmbH

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 24, 2019
• Study Start: June 1, 2016
• Primary Completion: December 27, 2017
• Study Completion: December 27, 2017
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6)