Clinical Study to Evaluate Safety and Effectiveness of Noble Lift® Lifting Threads

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.