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

NCT06471933 | Active Not Recruiting

• 1 other identifier: NOR-001
• Study Type: interventional
• Target: 59
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Nasolabial Fold

Outcome Measures

Primary Outcomes (1)

• Improvement on Wrinkle Severity Rating Scale (WSRS) of at least 1 grade.

  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.

  12 months after final injection

Secondary Outcomes (7)

• Percentage of subjects with improvement of at least 1 grade on the WSRS.

  Up to 24 months after final injection

• Change in WSRS score

  Up to 24 months after final injection

• Mean WSRS of <2 at each follow-up time

  Up to 24 months after final injection

• Time to at least one grade improvement in mean WSRS and time to mean WSRS <2.

  Up to 24 months after final injection

• Change Face-Q score of Nasolabial Fold

  Up to 24 months after final injection

Study Arms (1)

Juläine

EXPERIMENTAL

Device: Juläine

Interventions

Juläine DEVICE

Dermal filler (PLLA)

Juläine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nordberg Medical AB: lead

Study Sites (2)

Ribé clinic

Barcelona, Spain

Location

The Faculty

Stockholm, Sweden

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 24, 2024
• Study Start: July 24, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); ES (1)