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

ACTIVE_NOT_RECRUITINGNA

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

NCT06471933•Nordberg Medical AB

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.
+2 more criteria

Locations (2)

Ribé clinic

Barcelona, Spain

The Faculty

Stockholm, Sweden

Key Dates

Start Date

July 24, 2024

Primary Completion Date

June 1, 2026

Completion Date

June 1, 2027

Last Updated

August 26, 2025

Enrollment

ESTIMATED participants

Conditions

Nasolabial Fold

Interventions

Juläine

DEVICE

Evaluation of Facial HA Dermal Fillers in Real-Life Conditions

NCT07255261

Lips EnhancementPerioral Wrinkles+3 more

View study

ENROLLING_BY_INVITATIONNA

Prospective, Multicentre, Randomized, Blind, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Recombinant Collagen Gel for Correcting Moderate to Severe Nasolabial Wrinkles

NCT06854796

Nasolabial Fold Wrinkles

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Evaluation of Facial HA Dermal Fillers in Real-Life Conditions

Prospective, Multicentre, Randomized, Blind, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Recombinant Collagen Gel for Correcting Moderate to Severe Nasolabial Wrinkles

Randomized Masked Trial of Injectable Cross-Linked Hyaluronic Acid for Moderate-to-Severe Nasolabial Folds

Safety Study of TPX-121 on Nasolabial Folds

BC-101 in Treatment of Nasolabial Fold Wrinkles

Safety and Efficacy Evaluation of the Monopolar Radiofrequency Device for the Improvement of Facial Wrinkles