Status:
COMPLETED
Evaluation of the Sensitivity of Merz Lips Fullness Assessment Scale Following Etermis 4® Treatment for Lips Volume Augmentation
Lead Sponsor:
Merz Pharmaceuticals GmbH
Conditions:
Subjects Desiring Lip Augmentation
Eligibility:
All Genders
18+ years
Phase:
NA
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 appearanc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2017
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03256942
Start Date
August 16 2017
End Date
November 17 2017
Last Update
May 23 2018
Active Locations (6)
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1
Dermatologische Privatpraxis, Merz Investigational Site #0490371
Munich, Bavaria, Germany, 80539
2
Dermatologie München-Neuhausen, Merz Investigational Site #0490372
Munich, Bavaria, Germany, 80636
3
Haut & Laserzentrum Potsdam, Merz Investigational Site #0490362
Potsdam, Brandenburg, Germany, 14467
4
Dermatologische Praxis, Merz Investigational Site #0490345
Hamburg, Hanse Stadt Hamburg, Germany, 22609