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

Subjects Desiring Lip Augmentation Clinical Trial

— ELISE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03256942
• Other study ID #: M900741002
• Status: Completed
• Phase: N/A
• Start date: August 16, 2017
• Est. completion date: November 17, 2017

Study information

• Verified date: November 2017
• Source: Merz Pharmaceuticals GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 17, 2017
• Est. primary completion date: November 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Subjects Desiring Lip Augmentation

Intervention

Device:
• Etermis 4®
Etermis 4® is a sterile non-pyrogenic physiological gel made of reticulated hyaluronic acid (HA) of non-animal origin.

Locations

Country	Name	City	State
Germany	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	Dermatologie München-Neuhausen, Merz Investigational Site #0490372	Munich	Bavaria
Germany	Dermatologische Privatpraxis, Merz Investigational Site #0490371	Munich	Bavaria
Germany	Haut & Laserzentrum Potsdam, Merz Investigational Site #0490362	Potsdam	Brandenburg

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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.	Week 4
Secondary	Change from baseline for treated and untreated lips at Visit 2 (Week 4) as assessed live by the blinded rater using MLFAS	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.	Week 4
Secondary	Agreement rate in treated subjects between MLFAS responders and Investigator Global Aesthetic Improvement Scale (Investigator-GAIS) responders at Visit 2 (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).	Week 4
Secondary	Agreement rate in treated subjects between MLFAS responders and FACE-Q Satisfaction with Lips responders at Visit 2 (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).	Week 4