Nasolabial Fold
Conditions
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.
Interventions
DEVICEJuläine
Dermal filler (PLLA)
Sponsors
Nordberg Medical AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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. * Female who is pregnant and/or lactating * Any other condition that as judged by the investigator may make follow-up or Investigation procedures inappropriate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| 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 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 |
| 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 |
| 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 |
Countries
Spain, Sweden
Outcome results
None listed