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.

Study Overview

• Status: Active, not recruiting
• Conditions: Nasolabial Fold
• Intervention / Treatment: Device: Juläine

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Ribé clinic
• Sweden
  • Stockholm, Sweden
    • The Faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Juläine	Device: Juläine; Dermal filler (PLLA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects with improvement of at least 1 grade on the WSRS.	Percentage of subjects with an improvement of at least 1 grade on the WSRS of the left and right (mean of the two) NLF at 3, 6 and 24 months after final injection compared to baseline (investigator assessment at all visits, blinded assessment at 12 months).	Up to 24 months after final injection
Mean WSRS of <2 at each follow-up time	Proportion of subjects with a mean WSRS of <2 at each follow-up time point at 3, 6, 12, and 24 months after final injection.	Up to 24 months after final injection
Time to at least one grade improvement in mean WSRS and time to mean WSRS <2.	Time to at least one grade improvement in mean WSRS and time to mean WSRS <2.	Up to 24 months after final injection
Change in WSRS score	Change in WSRS score of the NLF at 3, 6, 12 and 24 months after final injection compared to baseline. Score 1-5, Higher scores are a worse outcome.	Up to 24 months after final injection
Change Face-Q score of Nasolabial Fold	Change in FACE-Q score of the NLF at 6, 12, and 24 months after final injection compared to baseline. Scores 1-4: high scores better outcome	Up to 24 months after final injection
Change in Global Aesthetic in Improvement Scale	Change in Global Aesthetic Improvement Scale (GAIS) scores evaluated by the subject, the investigator and a blinded assessor from 2D facial digital imaging at 6, 12, and 24 months after final injection compared to baseline. Scale 1-5; High scores worse outcome	Up to 24 months after final injection
Subject Satisfaction Scores	Assessment of Subject Satisfaction Scores at 6, 12, and 24 months after final injection. Scale 1-5; High scores better outcome	Up to 24 months after final injection

Collaborators and Investigators

• Sponsor: Nordberg Medical AB

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: June 23, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: NOR-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The IPD will not be shared due to the proprietary nature of the product under investigation, which is already commercialized. Sharing participant-level data could compromise competitive advantage and intellectual property, and therefore is not aligned with the sponsor's strategic interests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No