Zusammenfassung
Hintergrund
Ziel der vorliegenden 2-armigen, randomisierten Pilotstudie war die Prüfung der Wirksamkeit und Verträglichkeit von 2 verschiedenen Verdünnungen eines Botulinum-Neurotoxin Typ A ohne Komplexproteine (BoNT/A) bei der Behandlung der Glabellafalte.
Patienten und Methodik
Es wurden 40 Patienten mit Glabellafalten der Faltenstärke 2–3 nach Facial Wrinkle Scale mit 25 Units BoNT/A (Xeomin®) behandelt. Hierfür wurden 100 Units BoNT/A in 2,5 ml (Gruppe I) oder 4,0 ml NaCl-Lösung (Gruppe II) aufgelöst. Responder zeigten eine Verbesserung im Faltenscore (unabhängiger Untersucher) um mindestens 1 Punkt.
Ergebnisse
Die Responderzahlen betrugen nach 2 Wochen 100/89,5%, nach 3 Monaten 84,2/64,7% und nach 4 Monaten 53,3/61,5% (jeweils Gruppe I/II). Es zeigte sich kein signifikanter Unterschied zwischen den Verdünnungen.
Schlussfolgerungen
Botulinum-Neurotoxin Typ A ohne Komplexproteine reduziert in beiden getesteten Verdünnungen die Ausprägung der Glabellafalte. Es ist kein statistischer Unterschied in der Effizienz der Behandlung mit unterschiedlichen Verdünnungen nachweisbar.
Abstract
Background
In this 2-armed, randomized study we investigated the efficacy and tolerability of complex-protein-free botulinum neurotoxin type A (BoNT/A), applied in two different dilution volumes for treatment of glabellar lines.
Patients and methods
40 patients with grade 2–3 glabellar lines (Facial Wrinkle Scale) received treatment with 25U BoNT/A (Xeomin®). 100U of botulinum neurotoxin were diluted in 2.5ml (group I) or 4ml sodium chloride solution (group II). Responders showed an improvement in the wrinkle score (independent rater) of at least one point.
Results
Response rates two weeks after treatment were 100% / 89.5%, at 3 months 84.2% / 64.7% and at 4 months 53.3% / 61.5% (groups I / II respectively). There was no significant difference between the two dilutions.
Conclusion
Complex-protein-free botulinum neurotoxin type A in both dilutions effectively reduced severity of glabellar lines. There was no statistically significant difference in efficacy between the two dilutions.
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Prager, W., Zschocke, I., Reich, C. et al. Beeinflusst die Verdünnung das kosmetische Ergebnis von BoNT/A?. Hautarzt 60, 815–820 (2009). https://doi.org/10.1007/s00105-009-1840-z
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DOI: https://doi.org/10.1007/s00105-009-1840-z