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| Name | Class |
|---|---|
| Eurofins Laboratoire Dermscan | UNKNOWN |
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The aim of this study is to compare two models of the Nobel Lift range (PDO sutures) with similar PDO devices available on the market, in a split-face comparative study. Each thread model will be used in one indication: upper face (eyebrow lift) or mid-face and lower-face.
Aesthetic efficacy of the devices will be evaluated and compared with the Global Aesthetic Improvement Scale (GAIS), jowl laxity scale, subjective evaluation of the patient and photographs during a 12-months period. Safety of the devices and procedures will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Noble Lift threads | Experimental |
| |
| Croquis threads | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eyebrow lift | Device | Upper face lifting |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Global Aesthetic Improvement (GAIS) by the investigator between both products | Non-inferiority of Noble Lift® threads in comparison with Croquis® thread, in terms of GAIS mean score on Month 3, assessed by an independent blinded investigator on photos (in global and for each indication). GAIS is a scale from 1 (worse) to 5 (very much improved). | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentages of responders for Global Aesthetic Improvement (GAIS) by the investigator | GAIS is a scale from 1 (worse) to 5 (very much improved) | Month 3, Month 6, Month 12 |
| Percentages of responders for Global Aesthetic Improvement (GAIS) by the subject |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Audrey Natalizio | Contact | +33 4 72 82 36 56 | audrey.natalizio@cpt.eurofinseu.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Jeanblanc | Aix-en-Provence | France |
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Hemi-face, intra-individual study
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| Jaw lift |
| Device |
Mid-face and low-face lifting |
|
GAIS is a scale from 1 (worse) to 5 (very much improved) |
| Month 3, Month 6, Month 12 |
| Change from baseline of Facial Laxity Rating Scale (FLRS) score | FLRS is a scale from 1 (mild laxity) to 9 (severe laxity) | Month 3, Month 6, Month 12 |
| Percentages of subjects satisfied with the intervention using a subjective evaluation questionnaire | Answers are evaluated from 1 (very dissatisfied) to 5 (very satisfied) | Month 3, Month 6, Month 12 |
| Number and percentages of immediate and early skin reactions collected by the subject | Skin reactions are scored as mild, moderate or severe | Month 1 |
| Number and percentages of skin reactions scored by the investigator | Skin reactions are scored as mild, moderate or severe | Month1, Month 3, Month 6, Month 12 |
| Number and percentages of Adverse Events | Month1, Month 3, Month 6, Month 12 |
| Dr Facchinetti | Cannes | France |
|
| Dr Converset-Viethel | Lyon | France |
|
| Dr Lemmel | Paris | France |
|