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Correction of Facial Wrinkles/FoldsPOMETNCT04210258

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

An observational study of Correction of Facial Wrinkles/Folds and Facial Volume Enhancement, run by Merz Pharmaceuticals GmbH at 6 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Etermis 3 and Etermis 4
Type of treatment
Medical device
How many people
154 participants
Where
6 sitesGermany
Study dates
1 Jun 2016to 27 Dec 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Germany6 sites

  • Merz Investigational Site #0490099

    Darmstadt, 64283

  • Merz Investigational Site #0490095

    Hamburg, 20146

  • Merz Investigational Site #0490345

    Hamburg, 22609

  • Merz Investigational Site #0490309

    Kassel, 34121

  • Merz Investigational Site #0490368

    München, 80333

  • Merz Investigational Site #0490362

    Potsdam, 14467

Other trials in Germany

About this study

Official title: 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

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.

Being tested
Etermis 3, Etermis 4

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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"

    Measured: Baseline to month 6-7

  2. 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"

    Measured: Baseline to month 3-4

  3. 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"

    Measured: Baseline to month 6-7

  4. 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"

    Measured: Baseline to month 6-7

  5. 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"

    Measured: Baseline to month 3-4

Secondary outcomes (5)

  1. 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

    Measured: Baseline up to month 12-13

  2. 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"

    Measured: Baseline up to month 12-13

  3. 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"

    Measured: Baseline up to month 12-13

  4. 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.

    Measured: Baseline up to month 12-13

  5. 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.

    Measured: Baseline up to month 12-13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2019
  2. Study start1 Jun 2016
  3. Primary completion27 Dec 2017
  4. Study completion27 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04210258
Sponsor's protocol ID
M900991001
Acronym
POMET
Status last verified
Dec 2019
First submitted
17 Dec 2019
Last updated
2 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Correction of Facial Wrinkles/Folds and Facial Volume Enhancement, run by Merz Pharmaceuticals GmbH at 6 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04210258.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.

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