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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
70
Upper face lifting
Mid-face and low-face lifting
Dr Jeanblanc
Aix-en-Provence, France
Dr Facchinetti
Cannes, France
Dr Converset-Viethel
Lyon, France
Dr Lemmel
Paris, France
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).
Time frame: Month 3
Percentages of responders for Global Aesthetic Improvement (GAIS) by the investigator
GAIS is a scale from 1 (worse) to 5 (very much improved)
Time frame: Month 3, Month 6, Month 12
Percentages of responders for Global Aesthetic Improvement (GAIS) by the subject
GAIS is a scale from 1 (worse) to 5 (very much improved)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Month 1
Number and percentages of skin reactions scored by the investigator
Skin reactions are scored as mild, moderate or severe
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Time frame: Month1, Month 3, Month 6, Month 12
Number and percentages of Adverse Events
Time frame: Month1, Month 3, Month 6, Month 12