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

Not Applicable

Completed

• Conditions: Subjects Desiring Lip Augmentation
• Interventions: Device: Etermis 4®

• Registration Number: NCT03256942
• Lead Sponsor: Merz Pharmaceuticals GmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-16
• Study First Submitted: 2017-08-17
• Study First Submitted QC: 2017-08-21
• Study First Posted: 2017-08-22
• Status Verified: 2017-11
• Primary Completion: 2017-11-17
• Study Completion: 2017-11-17
• Last Update Submitted: 2018-05-22
• Last Update Posted: 2018-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Etermis 4® Treatment	Etermis 4®	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.

Primary Outcome Measures

Name	Time	Method
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).	Week 4	Response is defined as ≥ 1-point improvement on both the upper and lower lips compared to baseline. Upper and lower lips are to be assessed separately.; The MLFAS is a 5-point scale ranging from 0 (very thin) to 4 (very full). A positive number change from baseline indicates improvement.

Secondary Outcome Measures

Name	Time	Method
Agreement rate in treated subjects between MLFAS responders and FACE-Q Satisfaction with Lips responders at Visit 2 (week 4).	Week 4	Agreement for a subject is reached if he/she is a responder for both MLFAS and FACE-Q Satisfaction with Lips or he/she is a non-responder for both MLFAS and FACE-Q Satisfaction with Lips. MLFAS is assessed by a blinded rater. MLFAS response is defined as ≥ 1-point improvement on both the upper and lower lips compared to baseline. FACE-Q Satisfaction with Lips is assessed by the treated subject at baseline and at Visit 2. FACE-Q Satisfaction with Lips response is defined as a positive change in the FACE-Q score.; The MLFAS is a 5-point scale ranging from 0 (very thin) to 4 (very full). A positive number change from baseline indicates improvement. FACE-Q scores are derived from a questionaire of 10 questions relating to the satisfaction with lips appearance. Answers range from 1 (very dissatisfied) to 4 (very satisfied).
Change from baseline for treated and untreated lips at Visit 2 (Week 4) as assessed live by the blinded rater using MLFAS	Week 4	Upper and lower lips are to be assessed separately. The MLFAS is a 5-point scale ranging from 0 (very thin) to 4 (very full). A positive number change from baseline indicates improvement.
Agreement rate in treated subjects between MLFAS responders and Investigator Global Aesthetic Improvement Scale (Investigator-GAIS) responders at Visit 2 (Week 4).	Week 4	Agreement for a subject is reached if he/she is a responder for both MLFAS and Investigator-GAIS or he/she is a non-responder for both MLFAS and Investigator-GAIS. GAIS response is defined as at least a "+1 improved" rating on the Investigator -GAIS.; The MLFAS is a 5-point scale ranging from 0 (very thin) to 4 (very full). A positive number change from baseline indicates improvement. The Investigator-GAIS is a 7-point scale ranging from -3 (very much worse) to +4 (very much improved).

Trial Locations

Locations (6)

Dermatologische Praxis, Merz Investigational Site #0490345; 🇩🇪 Hamburg, Hanse Stadt Hamburg, Germany

Universität Hamburg, FB Chemie und Molekularbiologie, Merz Investigational Site #0490095; 🇩🇪 Hamburg, Germany

DRK Kliniken Nordhessen, Merz Investigational Site #0490309; 🇩🇪 Kassel, Hessen, Germany

Haut & Laserzentrum Potsdam, Merz Investigational Site #0490362; 🇩🇪 Potsdam, Brandenburg, Germany

Dermatologische Privatpraxis, Merz Investigational Site #0490371; 🇩🇪 Munich, Bavaria, Germany

Dermatologie München-Neuhausen, Merz Investigational Site #0490372; 🇩🇪 Munich, Bavaria, Germany