Seguimiento clínico posterior a la comercialización que evalúa el rendimiento y la seguridad de Juläine(TM) en las arrugas del pliegue nasolabial
Una investigación prospectiva, de un solo brazo, intervencionista, multicéntrica y de seguimiento clínico poscomercialización (PMCF) para evaluar el rendimiento y la seguridad del relleno dérmico de ácido poliláctico inyectable para el tratamiento de las arrugas del pliegue nasolabial
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Juläine
|
Dermal filler (PLLA) |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Improvement on Wrinkle Severity Rating Scale (WSRS) of at least 1 grade.
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of subjects with improvement of at least 1 grade on the WSRS.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- NOR-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .