Evaluation of the Sensitivity of Merz Lips Fullness Assessment Scale Following Etermis 4® Treatment for Lips Volume Augmentation

Evaluation of the Sensitivity of Merz Lips Fullness Assessment Scale Following Etermis 4® Treatment for Lips Volume Augmentation

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.

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.