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Primary objective:
- To evaluate the sensitivity of the Merz Lip Fullness Assessment Scale (MLFAS).
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etermis 4® Treatment | Experimental | 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. |
|
| No Treatment | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etermis 4® | Device | Etermis 4® is a sterile non-pyrogenic physiological gel made of reticulated hyaluronic acid (HA) of non-animal origin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merz Medical Expert | Merz Pharmaceuticals GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatologische Privatpraxis, Merz Investigational Site #0490371 | Munich | Bavaria | 80539 | Germany | ||
| Dermatologie München-Neuhausen, Merz Investigational Site #0490372 |
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| 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 |
| 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 |
| Munich |
| Bavaria |
| 80636 |
| Germany |
| Haut & Laserzentrum Potsdam, Merz Investigational Site #0490362 | Potsdam | Brandenburg | 14467 | Germany |
| Dermatologische Praxis, Merz Investigational Site #0490345 | Hamburg | Hanse Stadt Hamburg | 22609 | Germany |
| DRK Kliniken Nordhessen, Merz Investigational Site #0490309 | Kassel | Hesse | 34121 | Germany |
| Universität Hamburg, FB Chemie und Molekularbiologie, Merz Investigational Site #0490095 | Hamburg | 20146 | Germany |