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

Primary Purpose

Subjects Desiring Lip Augmentation

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Etermis 4®
Sponsored by
Merz Pharmaceuticals GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subjects Desiring Lip Augmentation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Dermatologische Privatpraxis, Merz Investigational Site #0490371
  • Dermatologie München-Neuhausen, Merz Investigational Site #0490372
  • Haut & Laserzentrum Potsdam, Merz Investigational Site #0490362
  • Dermatologische Praxis, Merz Investigational Site #0490345
  • DRK Kliniken Nordhessen, Merz Investigational Site #0490309
  • Universität Hamburg, FB Chemie und Molekularbiologie, Merz Investigational Site #0490095

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Etermis 4® Treatment

No Treatment

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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).

Full Information

First Posted
August 17, 2017
Last Updated
May 22, 2018
Sponsor
Merz Pharmaceuticals GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT03256942
Brief Title
Evaluation of the Sensitivity of Merz Lips Fullness Assessment Scale Following Etermis 4® Treatment for Lips Volume Augmentation
Acronym
ELISE
Official Title
Evaluation of the Sensitivity of Merz Lips Fullness Assessment Scale Following Etermis 4® Treatment for Lips Volume Augmentation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
August 16, 2017 (Actual)
Primary Completion Date
November 17, 2017 (Actual)
Study Completion Date
November 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merz Pharmaceuticals GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjects Desiring Lip Augmentation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Etermis 4® Treatment
Arm Type
Experimental
Arm 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.
Arm Title
No Treatment
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Etermis 4®
Intervention Description
Etermis 4® is a sterile non-pyrogenic physiological gel made of reticulated hyaluronic acid (HA) of non-animal origin.
Primary Outcome Measure Information:
Title
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).
Description
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.
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Change from baseline for treated and untreated lips at Visit 2 (Week 4) as assessed live by the blinded rater using MLFAS
Description
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.
Time Frame
Week 4
Title
Agreement rate in treated subjects between MLFAS responders and Investigator Global Aesthetic Improvement Scale (Investigator-GAIS) responders at Visit 2 (Week 4).
Description
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).
Time Frame
Week 4
Title
Agreement rate in treated subjects between MLFAS responders and FACE-Q Satisfaction with Lips responders at Visit 2 (week 4).
Description
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).
Time Frame
Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merz Medical Expert
Organizational Affiliation
Merz Pharmaceuticals GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Dermatologische Privatpraxis, Merz Investigational Site #0490371
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80539
Country
Germany
Facility Name
Dermatologie München-Neuhausen, Merz Investigational Site #0490372
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80636
Country
Germany
Facility Name
Haut & Laserzentrum Potsdam, Merz Investigational Site #0490362
City
Potsdam
State/Province
Brandenburg
ZIP/Postal Code
14467
Country
Germany
Facility Name
Dermatologische Praxis, Merz Investigational Site #0490345
City
Hamburg
State/Province
Hanse Stadt Hamburg
ZIP/Postal Code
22609
Country
Germany
Facility Name
DRK Kliniken Nordhessen, Merz Investigational Site #0490309
City
Kassel
State/Province
Hessen
ZIP/Postal Code
34121
Country
Germany
Facility Name
Universität Hamburg, FB Chemie und Molekularbiologie, Merz Investigational Site #0490095
City
Hamburg
ZIP/Postal Code
20146
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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

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