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

Inclusion criteria

• Subjects reviewed and signed a statement of Informed Consent and a HIPAA authorization prior to initiating any study-specific procedures. In addition, subjects were asked to provide a separate release for use of their photographs in publications. Subjects could refuse the photo release without jeopardizing their eligibility to participate in the study.
• Subjects were 18 - 75 years of age, and of any race or sex.
• Female subjects were postmenopausal for at least 1 year, had a hysterectomy, or had a tubal ligation; or, if of childbearing potential, agreed to use an approved method of birth control throughout the study (i.e., oral/systemic contraceptives, intrauterine device [IUD], or spermicide in combination with a barrier method of contraception), were abstinent, or were in a monogamous relationship with a vasectomized partner; and had a negative urine pregnancy test at the screening visit.
• Subjects had bilateral nasolabial folds with a severity score of 2 or 3 on the wrinkle SRS assessed by the blinded evaluator.
• Each subject had an adequate understanding of the language (spoken and written English or Spanish) and was willing to comply with the study requirements.

Exclusion criteria

• A personal history of allergic/anaphylactic reactions including hypersensitivity to local anesthetics (eg, lidocaine, etc), HA preparations, and/or gram-positive bacterial protein.
• A known history of keloids or bleeding disorders.
• 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.
• Women who were pregnant, planning to become pregnant during the study, or who were breast-feeding.
• 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).
• 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).
• Severe physical, neurological or mental disease.
• Excessive facial hair that might interfere with the evaluation of the wrinkle assessments.
• 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).
• Subjects who had used exclusionary medications/treatments.
• Participation in a clinical investigation within the 30 days prior to the first planned device administration or during this trial.