Evaluating the safety and performance of Juläine for nasolabial fold wrinkles
Official title: 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
Run by Nordberg Medical AB · NCT06471933 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing whether the Juläine device can safely improve nasolabial fold wrinkles in people with certain wrinkle levels over two years.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 59 (estimated) |
| Sponsor | Nordberg Medical AB Industry-sponsored |
| Locations | 2 sites (Barcelona and 1 other locations) |
| Trial ID | NCT06471933 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with nasolabial fold contour deficiencies rated between 2 and 4 on the WSRS scale.
✕Probably not a fit
Patients with a history of facial surgery for wrinkle correction or recent local treatments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This post-market clinical follow-up aims to assess the safety and effectiveness of the CE-marked device Juläine for treating nasolabial fold wrinkles. Participants will receive three treatment sessions and will be monitored for a total of two years to evaluate the device's performance in augmenting shallow to deep wrinkles. The study focuses on immune-competent individuals with specific wrinkle severity scores, ensuring a targeted approach to treatment.
Why it matters
Potential benefit: If successful, this study could provide a safe and effective option for patients seeking to improve the appearance of nasolabial folds.
How similar studies have gone: Other studies evaluating similar devices for wrinkle treatment have shown promising results, indicating a potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Ribé clinic
Barcelona, Spain Recruiting -
The Faculty
Stockholm, Sweden Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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The study tests three concentrations of an injectable hyaluronic acid filler to see if it safely and effectively enhances lips, smooths nasolabial folds, and adds midface volume in adults.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.