Klinisk uppföljning efter marknaden som utvärderar prestanda och säkerhet hos Juläine(TM) på rynkor i nasolabialveck
En prospektiv, enarmad, interventionell, multicenter, post-market Clinical Follow-up (PMCF) undersökning för att utvärdera prestandan och säkerheten hos injicerbara poly-LLactic Acid Dermal Filler för behandling av nasolabialveckrynkor
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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Juläine
|
Dermal filler (PLLA) |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Improvement on Wrinkle Severity Rating Scale (WSRS) of at least 1 grade.
Tidsram: 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. |
12 months after final injection
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of subjects with improvement of at least 1 grade on the WSRS.
Tidsram: 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). |
Up to 24 months after final injection
|
|
Change in WSRS score
Tidsram: 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. |
Up to 24 months after final injection
|
|
Mean WSRS of <2 at each follow-up time
Tidsram: 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. |
Up to 24 months after final injection
|
|
Time to at least one grade improvement in mean WSRS and time to mean WSRS <2.
Tidsram: Up to 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
|
|
Change Face-Q score of Nasolabial Fold
Tidsram: 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 |
Up to 24 months after final injection
|
|
Change in Global Aesthetic in Improvement Scale
Tidsram: 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 |
Up to 24 months after final injection
|
|
Subject Satisfaction Scores
Tidsram: 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 |
Up to 24 months after final injection
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- NOR-001
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
The IPD will not be shared due to the proprietary nature of the product under investigation, which is already commercialized. Sharing participant-level data could compromise competitive advantage and intellectual property, and therefore is not aligned with the sponsor's strategic interests.
Läkemedels- och apparatinformation, studiedokument
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