Clinical trial NCT03256942: Evaluation of the Sensitivity of Merz Lips Fullness Assessment Scale Following Etermis 4® Treatment for Lips Volume Augmentation
Official title: Evaluation of the Sensitivity of Merz Lips Fullness Assessment Scale Following Etermis 4® Treatment for Lips Volume Augmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjects Desiring Lip Augmentation
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2017-08-22
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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).
timeFrame: Week 4
Secondary outcomes:
measure: Change from baseline for treated and untreated lips at Visit 2 (Week 4) as assessed live by the blinded rater using MLFAS
timeFrame: Week 4
measure: Agreement rate in treated subjects between MLFAS responders and Investigator Global Aesthetic Improvement Scale (Investigator-GAIS) responders at Visit 2 (Week 4).
timeFrame: Week 4
measure: Agreement rate in treated subjects between MLFAS responders and FACE-Q Satisfaction with Lips responders at Visit 2 (week 4).
timeFrame: Week 4
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Dermatologische Privatpraxis, Merz Investigational Site #0490371
state: Bavaria
city: Munich
country: Germany
facility: Dermatologie München-Neuhausen, Merz Investigational Site #0490372
state: Bavaria
city: Potsdam
country: Germany
facility: Haut & Laserzentrum Potsdam, Merz Investigational Site #0490362
state: Brandenburg
city: Hamburg
country: Germany
facility: Dermatologische Praxis, Merz Investigational Site #0490345
state: Hanse Stadt Hamburg
city: Kassel
country: Germany
facility: DRK Kliniken Nordhessen, Merz Investigational Site #0490309
state: Hessen
city: Hamburg
country: Germany
facility: Universität Hamburg, FB Chemie und Molekularbiologie, Merz Investigational Site #0490095
Study officials:
affiliation: Merz Pharmaceuticals GmbH
name: Merz Medical Expert
role: STUDY_DIRECTOR
References: