CompletedNot Applicable

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

Germany75 participantsStarted 2017-08-16

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Trial details

NCT IDNCT03256942

SponsorMerz Pharmaceuticals GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-11-17

View on ClinicalTrials.gov More Subjects Desiring Lip Augmentation trials