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

Merz Pharmaceuticals

Status: Completed

Conditions: Subjects Desiring Lip Augmentation

Treatments: Device: Etermis 4®

Study type: Interventional

Funder types: Industry

Identifiers

NCT03256942

M900741002

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

75 participants in 2 patient groups

Etermis 4® Treatment

Experimental group

Description:

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.

Treatment:

Device: Etermis 4®

No Treatment

No Intervention group