Efficacy and Safety of a 'Graft/Prosthesis, Biomaterial (DKM410)' in the Treatment of Both Nasolabial Folds

The purpose of the study is to assess the efficacy and safety of a 'Graft/prosthesis, biomaterial (DKM410)' in the treatment of both nasolabial folds.

Inclusion Criteria:Age 19 years and olderWrinkle Severity Rating Scale (WSRS) 3 or 4Visually symmetrical bilateral nasolabial foldsAgreed not to use any dermatological treatment and wrinkle-improving functional cosmetics.Voluntarily decided to participate in the study and signed the informed consent formWilling to follow the protocolExclusion Criteria:History of undergoing a permanent or semi-permanent filler treatment on the faceReceived soft tissue augmentation using HA filler or collagen for nasolabial folds within 18 months from screening.Received any surgery or laser treatment, chemical filling, heart attack, or Botox injection within 24 weeks from the screeningHistory of allergic reactions to Hyaluronic Acid or Gram-positive bacteria proteinHypersensitivity to Lidocaine or amide local anestheticPositive for the intradermal response testHistory of severe or plurality of allergiesHaving skin inflammation or infection in nasolabial foldsHistory of keloid formation, hyperpigmentation, or hypertrophic scars on the face.History of streptococcal diseaseUncontrolled epilepsyPorphyriaHaving or being currently suffering from autoimmune diseasesHistory of immunodeficiency or immunosuppressive drugsHistory of herpetic eruptionHaving bleeding disorder or blood clotting disorderHaving anticoagulant drugs or components within 72 hours from the application of medical adviceReceived antiplatelet drugs within 2 weeks from the application of medical adviceHaving high dose vitamin E or nonsteroidal anti-inflammatory drugs (NSAIDs) and high dose vitamin C within one week from the application of medical adviceReceived drugs that inhibit or decrease liver metabolismClinically significant abnormalities on electrocardiogramPregnant or breast-feeding or who planning to conceiveClinically severe cardiovascular, digestive, respiratory, endocrine, central nervous system disorders or mental illnessOther investigational products or procedures within 3 months from screeningNot eligible due to other reasons at the investigator's discretion