Ireland
--:--IST
Active, not recruiting Not applicable

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

NCT06471933 · tracked via the Priya Life Science Spain tracker
Sponsor
Nordberg Medical AB
Phase
Not applicable
Started
2024-07-24
Last updated
2026-10-02

Condition(s) studied

Nasolabial Fold

Investigational drug(s) / intervention(s)

Juläine

Juläine: Dermal filler (PLLA)

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Improvement on Wrinkle Severity Rating Scale (WSRS) of at least 1 grade. — 12 months after final injection
    Average improvement of at least 1 grade on the WSRS of the combined left and right NLF score. Score 1-5, Higher scores are a worse outcome.

Trial sites (2)

FacilityCityRegionStatus
Ribé clinic Barcelona Spain
The Faculty Stockholm Sweden
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06471933 on ClinicalTrials.gov ↗ ← All trials in Spain