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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

154 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-01

Study Completion Date

2017-12-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Correction of Facial Wrinkles/Folds Facial Volume Enhancement

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Etermis 3

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

Intervention Type DEVICE

Etermis 4

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No