clinical study to evaluate safety and effectiveness of noble lift® lifting threads

Conditions: Aesthetic

Summary: 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.


Eligibility criteria:
inclusion criteria: * bmi comprised between 18.5 and 30 * no ongoing or planned diet. * group 1: requiring an aesthetic treatment of upper face with resorbable threads. * group 2: subject requiring an aesthetic treatment of mid-face and lower-face with resorbable threads * subject with dense and not too thin skin. exclusion criteria: * pregnant or nursing woman or planning a pregnancy during the study; * suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study result and/or subject safety, especially cardiac disorder, non-controlled high blood pressure, diabetes, panic disorders, depression, active auto-immune disease, cold, high fever,... * suffering from malnutrition. * acute inflammatory process or infection, or history of chronic or recurrent infection or inflammation with the potential to interfere with the study results or increase the risk of adverse events. * wound healing disorder or with a disorder that may impact wound healing such as connective tissue or immunosuppressive disorder. * history of precancerous lesions/skin malignancies. * active skin disease within 6 months of study entry. * scars, rosacea, herpes, acne, blotches or other pathology in the face, at the investigator appreciation. * predisposed to keloidosis or hypertrophic scarring. * known history of hyper- or hypo-pigmentation in the face. * known history of multiple allergies, allergic/anaphylactic reactions including allergy/ hypersensitivity to lidocaine, anaesthetics of the amide type, the used antiseptic components, the used antibiotic cream components. * known bleeding disorder or is receiving medication that will likely increase the risk of bleeding during treatment. * extensive skin laxity, thin skin and/or severe malar fat sagging. * foreign body sensitivity or known or suspected allergies to implant or instrument materials in particular plastic/biomaterial. * any medication which may interfere, at the interpretation of the investigator, with the study objectives in term of efficacy and safety/tolerance. * dental care in the past 2 weeks or who planned to receive dental care in the 2 months after the treatment. * anticoagulant (such as aspirin, warfarin, blood circulation enhancer and clotbuster) during the week before the injection session . * chemotherapy agents, immunosuppressive medications or systemic corticosteroids in the past 3 months and during the study. * lifting of the face in the past 12 months or other surgery of the face in the past 6 months. * resorbable fillers within the past 12 months, other resorbable threads within the past 12 months, neurotoxin in the past 5 months or plans to receive such treatments during the study. * permanent filler on the face. * subcutaneous permanent retaining structure on the face (meshing, permanent threads, gold strand etc.). * intensive exposure to sunlight or uv-rays within the previous month and/or foreseen during the study.

Keywords: lifting threads eyebrow lift jaw laxity