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

NCT ID: NCT06471933

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-24
• Study Completion Date: 2027-06-30

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.

Conditions

Nasolabial Fold

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Juläine

Group Type: EXPERIMENTAL

Juläine

Intervention Type: DEVICE

Dermal filler (PLLA)

Interventions

Juläine

Dermal filler (PLLA)

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nordberg Medical AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ribé clinic

Barcelona, , Spain

The Faculty

Stockholm, , Sweden

Countries

Spain; Sweden

Other Identifiers

NOR-001

Identifier Type: -

Identifier Source: org_study_id