Correction of Facial Wrinkles/Folds Clinical Trial
— POMETOfficial 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
| NCT number | NCT04210258 |
| Other study ID # | M900991001 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 1, 2016 |
| Est. completion date | December 27, 2017 |
| Verified date | December 2019 |
| Source | Merz Pharmaceuticals GmbH |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 154 |
| Est. completion date | December 27, 2017 |
| Est. primary completion date | December 27, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Merz Investigational Site #0490099 | Darmstadt | |
| Germany | Merz Investigational Site #0490095 | Hamburg | |
| Germany | Merz Investigational Site #0490345 | Hamburg | |
| Germany | Merz Investigational Site #0490309 | Kassel | |
| Germany | Merz Investigational Site #0490368 | München | |
| Germany | Merz Investigational Site #0490362 | Potsdam |
| Lead Sponsor | Collaborator |
|---|---|
| Merz Pharmaceuticals GmbH |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | ||
| Primary | 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 | ||
| Primary | 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 | ||
| Primary | 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 | ||
| Primary | 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 | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 |