Clinical trial NCT06471933: Post Market Clinical Follow up Evaluating the Performance and Safety of Juläine(TM) on Nasolabial Fold Wrinkles
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nasolabial Fold
Lead sponsor: Nordberg Medical AB
Sponsor class: INDUSTRY
First posted: 2024-06-24
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Improvement on Wrinkle Severity Rating Scale (WSRS) of at least 1 grade.
timeFrame: 12 months after final injection
Secondary outcomes:
measure: Percentage of subjects with improvement of at least 1 grade on the WSRS.
timeFrame: Up to 24 months after final injection
measure: Change in WSRS score
timeFrame: Up to 24 months after final injection
measure: Mean WSRS of <2 at each follow-up time
timeFrame: Up to 24 months after final injection
measure: Time to at least one grade improvement in mean WSRS and time to mean WSRS <2.
timeFrame: Up to 24 months after final injection
measure: Change Face-Q score of Nasolabial Fold
timeFrame: Up to 24 months after final injection
measure: Change in Global Aesthetic in Improvement Scale
timeFrame: Up to 24 months after final injection
measure: Subject Satisfaction Scores
timeFrame: Up to 24 months after final injection
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Ribé clinic
city: Stockholm
country: Sweden
facility: The Faculty
Study officials:
References: