Clinical trial NCT04210258: Post-Market Clinical Follow-up Performance and Safety Study of Etermis 3 and 4 in the Face
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Correction of Facial Wrinkles/Folds
Facial Volume Enhancement
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2019-12-24
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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)

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.


Eligibility criteria: 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

Primary outcomes:
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"
timeFrame: Baseline to month 6-7
measure: 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"
timeFrame: Baseline to month 3-4
measure: 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"
timeFrame: Baseline to month 6-7
measure: 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"
timeFrame: Baseline to month 6-7
measure: 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"
timeFrame: Baseline to month 3-4
Secondary outcomes:
measure: 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
timeFrame: Baseline up to month 12-13
measure: 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"
timeFrame: Baseline up to month 12-13
measure: 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"
timeFrame: Baseline up to month 12-13
measure: 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.
timeFrame: Baseline up to month 12-13
measure: 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.
timeFrame: Baseline up to month 12-13
Other outcomes:
Locations:
city: Darmstadt
country: Germany
facility: Merz Investigational Site #0490099
city: Hamburg
country: Germany
facility: Merz Investigational Site #0490095
city: Hamburg
country: Germany
facility: Merz Investigational Site #0490345
city: Kassel
country: Germany
facility: Merz Investigational Site #0490309
city: München
country: Germany
facility: Merz Investigational Site #0490368
city: Potsdam
country: Germany
facility: Merz Investigational Site #0490362
Study officials:
affiliation: Merz Pharmaceuticals GmbH
name: Merz Medical Expert
role: STUDY_DIRECTOR
References: