Multicenter Study of the Safety and Effectiveness of Dermal Filler, Belotero®.

Exclusion Criteria

• •1. A personal history of allergic/anaphylactic reactions including hypersensitivity to local anesthetics (eg, lidocaine, etc), HA preparations, and/or gram-positive bacterial protein.
• •2. A known history of keloids or bleeding disorders.
• •3. An active inflammatory process in the nasolabial fold area (skin eruptions such as cysts, pimples, rashes, cancerous/pre-cancerous lesions, psoriasis, neurodermatitis, or any other active skin disease) or severe scarring that might interfere with study assessments.
• •4. Women who were pregnant, planning to become pregnant during the study, or who were breast-feeding.
• •5. Subjects who planned to undergo major facial surgery during the course of the study (eg, rhinoplasty \[with or without implant\], facelift, congenital defect repair, etc).
• •6. Subjects with clinically important disease, as judged by the investigator, within 3 months of the study (eg, significant laboratory test abnormalities, myocardial infarct, stroke, cancer, connective tissue diseases \[scleroderma, systemic lupus erythematous\], systemic infection, uncontrolled diabetes, etc.), including those with medical conditions that might require the use of immunosuppressive medications during the trial (eg, severe, uncontrolled asthma, rheumatoid arthritis, autoimmune diseases, etc).
• •7. Severe physical, neurological or mental disease.
• •8. Excessive facial hair that might interfere with the evaluation of the wrinkle assessments.
• •9. Any systemic or dermatologic disorder, which, in the opinion of the investigator,would interfere with the study results or increase the risk of adverse events (AEs).
• •10. Subjects who had used exclusionary medications/treatments.
• •11. Participation in a clinical investigation within the 30 days prior to the first planned device administration or during this trial.