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Dermalfüller Lafullen der Samyang Holdings Biopharmaceuticals Division erweist sich als sicher und wirksam
  • USA - español
  • USA - Français


News provided by

Samyang Holdings Corp.

Jul 04, 2022, 03:00 ET

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- Sicherheit und Wirksamkeit von Lafullen in 24-monatiger klinischer Studie nachgewiesen

- Verbesserung des anfänglichen Volumens und lang anhaltende Wirkung

- Von Fachleuten auf der Grundlage von Forschungsergebnissen entwickeltes wirksames Behandlungsprotokoll

SEOUL, Südkorea, 4. Juli 2022 /PRNewswire/ -- Die Forschungsergebnisse bestätigen die langfristige Sicherheit und Wirksamkeit des neuen Füllstoffs Lafullen der biopharmazeutischen Abteilung der Samyang Holdings. Ein Dermalfüller ist ein nachweislich sicheres medizinisches Produkt, das in die subkutane Fettschicht der Haut injiziert wird, um Volumen hinzuzufügen und Falten im Gesicht aufzufüllen und so ein glatteres, jugendlicheres Aussehen zu erzielen.

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Lafullen, PCL filler of Samyang Holdings Biopharmaceuticals Division
Lafullen, PCL filler of Samyang Holdings Biopharmaceuticals Division

Samyang Holdings Biopharmazeutische Abteilung (CEO: Lee Young-Joon) gab am 30. Juni bekannt, dass eine klinische Studie über die Sicherheit und den Verbesserungseffekt seines Polycaprolacton (PCL)-Füllstoffs Lafullen in der angesehenen internationalen akademischen Fachzeitschrift Dermatologic Therapy veröffentlicht wurde , einer Publikation des Scientific Citation Index (SCI), die die neuesten wissenschaftlichen Erkenntnisse im Bereich der Dermatologie veröffentlicht.

Professor Kim Beom Joon von der Abteilung für Dermatologie des Chung-Ang Universitätskrankenhauses führte diese vergleichende Studie von Lafullen und einem bestehenden PCL-Füllstoff an 59 koreanischen Männern und Frauen durch. Die Studie untersuchte die Wirkung von Lafullen auf die Nasolabialfalten anhand eines weltweit anerkannten Standardindexes und bestätigte eine anfängliche Volumenverbesserung sowie einen sicheren und stabilen Volumenerhalt während der einjährigen Studiendauer.

Die biopharmazeutische Abteilung der Samyang Holdings hat langfristige Sicherheits- und Wirksamkeitsdaten gesichert, indem sie nach Abschluss der Studie weitere 12 Monate lang Beobachtungsstudien durchführte, um die erwartete Dauer der Wirksamkeit von mehr als zwei Jahren zu bewerten. Von Medizinern entwickelte Behandlungsprotokolle lieferten quantitative Daten über die Verbesserung der Nasolabialfalten mithilfe der Wrinkle Severity Rating Scale (WSRS), der Global Aesthetic Improvement Scale (GAIS) nach der Behandlung und der Volumenveränderung mithilfe eines 3D-Scanners.

Die Entwicklung von Lafullen, einem injizierbaren Hautfüller der biopharmazeutischen Abteilung der Samyang Holdings, begann 2015 und erhielt 2021 die Marktzulassung durch das Ministerium für Lebensmittel- und Arzneimittelsicherheit. Lafullen besteht aus PCL (Polycaprolacton), einem biologisch abbaubaren Polymermaterial für medizinische Zwecke, als Hauptbestandteil. Dank der patentierten Technologie der biopharmazeutischen Abteilung der Samyang Holdings ist Lafullen im Vergleich zu bestehenden PCL-Füllstoffen weniger reizend, und es ist ein natürliches Volumen zu erwarten.

Sam Kim, Manager der biopharmazeutischen Abteilung der Samyang Holdings, sagte: „Die wissenschaftliche Forschung hat die Dauer der Wirksamkeit, Sicherheit und Stabilität von Lafullen bestätigt." Er fügte hinzu, dass „die Studienergebnisse zur Verfeinerung des Behandlungsprotokolls verwendet werden, um die höchsten Sicherheits- und Wirksamkeitsstandards für die Anwendung durch nationale und internationale Dermatologen zu gewährleisten."

Foto - https://mma.prnewswire.com/media/1849169/1.jpg 

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