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

Not Applicable

Recruiting

• Conditions: Nasolabial Fold
• Interventions: Device: Juläine

• Registration Number: NCT06471933
• Lead Sponsor: Nordberg Medical AB

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.

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 Timeline

• Study First Submitted: 2024-06-18
• Study First Submitted QC: 2024-06-23
• Study First Posted: 2024-06-24
• Study Start: 2024-07-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02
• Primary Completion: 2026-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Juläine	Juläine	-

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Change in WSRS score	Up to 24 months after final injection	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.
Time to at least one grade improvement in mean WSRS and time to mean WSRS <2.	Up to 24 months after final injection	Time to at least one grade improvement in mean WSRS and time to mean WSRS \<2.
Change in Global Aesthetic in Improvement Scale	Up to 24 months after final injection	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
Percentage of subjects with improvement of at least 1 grade on the WSRS.	Up to 24 months after final injection	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).
Change Face-Q score of Nasolabial Fold	Up to 24 months after final injection	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
Subject Satisfaction Scores	Up to 24 months after final injection	Assessment of Subject Satisfaction Scores at 6, 12, and 24 months after final injection.; Scale 1-5; High scores better outcome
Mean WSRS of <2 at each follow-up time	Up to 24 months after final injection	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.

Trial Locations

Locations (2)

Ribé clinic; 🇪🇸 Barcelona, Spain

The Faculty; 🇸🇪 Stockholm, Sweden