Efficacy and Safety Study of Neuramis in Correction of Nasolabial Fold

Inclusion criteria

• Men and women aged between 30 and 75
• Subjects who wanting to correct his/her nasolabial fold and attaining grade 3 or 4 in the Wrinkle Severity Rating Scale(WSRS) of nasolabial fold
• Subjects whose nasolabial folds are visually symmetric
• Subjects who agreed to restrict any treatment for the wrinkle correction at the lower orbital rim area for the duration of the study
• Subjects who can understand and comply with the instructions and all visit schedule
• Subjects who voluntarily decided the participation of the study and signed the informed consent

Exclusion criteria

• Subjects who had anti-coagulant therapy(excluding low-dose aspirin therapy(100mg, maximum 300mg/day dose)) within 2 weeks from the screening date
• Subjects who had previous treatment at the lower orbital rim for wrinkle correction(e.g., face lift, soft tissue augmentation, medium depth peels, dermal photorejuvenation) within 6 months from screening date
• Subjects who were treated calcium hydroxyapatite at the NLF area within a year from screening date
• Subjects who had dermal augmentation permanent implants(e.g., silicone, Softform®) at the NLF area
• Subjects who have a scar or skin lesion which can be affect to efficacy to the NLF area
• Subjects who had anaphylaxis or severe combined allergy or allergy to lidocain or hyaluronic acid
• Subjects who had a history of keloid formation or hypertrophic scar
• Subjects who have a skin disorder or wound infection in the NLF area
• Subjects who participated in other clinical trial within 30 days from screening date
• The childbearing subjects who disagreed with medically acceptable contraception(e.g., condom, oral contraceptives continuing at least 3 months, contraceptives for injection or insertion, intrauterine contraceptive devices)
• Pregnant or lactating subjects
• Patients who are not eligible for this study at the medical discretion of the investigator