NCT03256942

Brief Summary

Primary objective: \- To evaluate the sensitivity of the Merz Lip Fullness Assessment Scale (MLFAS). Secondary objectives:

  • To evaluate the clinical aesthetic improvement outcome in lips appearance four weeks after Etermis 4® injection.
  • To evaluate safety/tolerability of Etermis 4® treatment in lips.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 17, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 22, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2017

Completed
Last Updated

May 23, 2018

Status Verified

November 1, 2017

Enrollment Period

3 months

First QC Date

August 17, 2017

Last Update Submit

May 22, 2018

Conditions

Subjects Desiring Lip Augmentation

Outcome Measures

Primary Outcomes (1)

  • Responder rate for treated and for untreated lips at Visit 2 (Week 4), as assessed live by the blinded rater using the Merz Lip Fullness Assessment Scale (MLFAS).

    Response is defined as ≥ 1-point improvement on both the upper and lower lips compared to baseline. Upper and lower lips are to be assessed separately. The MLFAS is a 5-point scale ranging from 0 (very thin) to 4 (very full). A positive number change from baseline indicates improvement.

    Week 4

Secondary Outcomes (3)

  • Change from baseline for treated and untreated lips at Visit 2 (Week 4) as assessed live by the blinded rater using MLFAS

    Week 4

  • Agreement rate in treated subjects between MLFAS responders and Investigator Global Aesthetic Improvement Scale (Investigator-GAIS) responders at Visit 2 (Week 4).

    Week 4

  • Agreement rate in treated subjects between MLFAS responders and FACE-Q Satisfaction with Lips responders at Visit 2 (week 4).

    Week 4

Study Arms (2)

Etermis 4® Treatment

EXPERIMENTAL

Etermis 4® will be applied according to the method of administration described in the current version of the Instructions for Use (IFU) until optimal cosmetic result is obtained at the discretion of the treating investigator. Single injection session, injections into the lips.

Device: Etermis 4®

No Treatment

NO INTERVENTION

Interventions

Etermis 4®DEVICE

Etermis 4® is a sterile non-pyrogenic physiological gel made of reticulated hyaluronic acid (HA) of non-animal origin.

Etermis 4® Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male or female study subjects with thin to medium lips volume (grade 1 to 2 on MLFAS), seeking for hyaluronic acid (HA) for lips volume augmentation in ≥1-point improvement on the MLFAS on both the upper and lower lips and fulfilling the criteria listed in the Instruction for Use (IFU) of the Study Medical Device to be injected.

You may not qualify if:

  • Subjects with a medical condition and/or medication according to current IFU which is contra indicated for HA filler treatment, or prior facial surgeries or surgical permanent implants, lips augmentation treatment or other aesthetic procedure in the face that could interfere with performance assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Dermatologische Privatpraxis, Merz Investigational Site #0490371

Munich, Bavaria, 80539, Germany

Location

Dermatologie München-Neuhausen, Merz Investigational Site #0490372

Munich, Bavaria, 80636, Germany

Location

Haut & Laserzentrum Potsdam, Merz Investigational Site #0490362

Potsdam, Brandenburg, 14467, Germany

Location

Dermatologische Praxis, Merz Investigational Site #0490345

Hamburg, Hanse Stadt Hamburg, 22609, Germany

Location

DRK Kliniken Nordhessen, Merz Investigational Site #0490309

Kassel, Hesse, 34121, Germany

Location

Universität Hamburg, FB Chemie und Molekularbiologie, Merz Investigational Site #0490095

Hamburg, 20146, Germany

Location

Study Officials

  • Merz Medical Expert

    Merz Pharmaceuticals GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2017

First Posted

August 22, 2017

Study Start

August 16, 2017

Primary Completion

November 17, 2017

Study Completion

November 17, 2017

Last Updated

May 23, 2018

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(6)