Post Market Clinical Follow up Evaluating the Performance and Safety of Juläine(TM) on Nasolabial Fold Wrinkles

A Prospective, Single-Arm, Interventional, Multicenter, Post-Market Clinical Follow-up (PMCF) Investigation to Evaluate the Performance and Safety of Injectable Poly-LLactic Acid Dermal Filler for the Treatment of Nasolabial Fold Wrinkles

The goal of this post marketing study is to verify clincal performance and safety of CE-marked device Juläine.

The main objective is to evaluate device performance when used as intended for augmentation of shallow to deep nasolabial folds.

Participants will:

Receive 3 rounds of treatment and will be followed up for a total of 2 years.

The goal of this post marketing study is to verify clincal performance and safety of CE-marked device Juläine.

The main objective is to evaluate device performance when used as intended for augmentation of shallow to deep nasolabial folds.

Participants will:

Receive 3 rounds of treatment and will be followed up for a total of 2 years.

Inclusion Criteria:

• Signed Informed Consent Form
• Male or female, ≥18 years old.
• Immune-competent individuals.
• Presenting NLF contour deficiencies with a WSRS score between 2 (shallow wrinkle) and 4 (deep wrinkle) on both the left and right side of the face.

Exclusion Criteria:

• Having received a prior facial surgery for NLF correction, and/or received any local therapeutic treatment (e.g., dermal fillers).
• Having received in the past 2 weeks any local therapeutic treatment of the face below zygomatic arch.
• Pigmentation in NLF or having a history of hypo melanosis.
• Susceptibility to keloid formation or hypertrophic scarring.
• History of a known allergic reaction (e.g., any subject allergic to lidocaine or amide anesthetics, has a history of allergy to Gram-positive bacterial protein, or known to be allergic to any of the constituents of the product: PLLA, sodium carboxymethyl cellulose, mannitol, or sodium hyaluronate).
• History of herpes eruption, or a history of malignant skin disorder, or a history of any other serious disease.
• Hemorrhagic disease or receiving anti-coagulant therapy.
• Presenting with acute inflammation, infection, or having a history of chronic or recurrent infection potentially affecting the safety or performance of the device or increasing risk for adverse events.
• Having received in the past 2 months immunosuppressant or systemic steroid therapy.
• Having any disease that may affect wound healing, such as connective tissue disorder or serious malnutrition.
• Female who is pregnant and/or lactating
• Any other condition that as judged by the investigator may make follow-up or Investigation procedures inappropriate