Klinisk oppfølging etter markedet Evaluering av ytelsen og sikkerheten til Juläine(TM) på nasolabialfoldrynker
En prospektiv, enarms, intervensjonell, multisenter, post-markeds klinisk oppfølgingsundersøkelse (PMCF) for å evaluere ytelsen og sikkerheten til injiserbart poly-LLactic Acid dermalt fyllstoff for behandling av nasolabiale folderrynker
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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Juläine
|
Dermal filler (PLLA) |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Improvement on Wrinkle Severity Rating Scale (WSRS) of at least 1 grade.
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of subjects with improvement of at least 1 grade on the WSRS.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- NOR-001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .