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

Nordberg Medical AB

Status

Enrolling

Conditions

Nasolabial Fold

Treatments

Device: Juläine

Study type

Interventional

Funder types

Industry

Identifiers

NOR-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

59 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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