Active, not recruiting
Not applicable
Post Market Clinical Follow up Evaluating the Performance and Safety of Juläine(TM) on Nasolabial Fold Wrinkles
Condition(s) studied
Nasolabial Fold
Investigational drug(s) / intervention(s)
Juläine
Juläine: Dermal filler (PLLA)
Study 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.
Eligibility
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 outcome measure(s)
- 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.
Trial sites (2)
| Facility | City | Region | Status |
| Ribé clinic |
Barcelona |
Spain |
|
| The Faculty |
Stockholm |
Sweden |
|