A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Phase III, Non-Inferiority Study Comparing PrabotulinumtoxinA and OnabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients.

Autor:	Rzany BJ; Dermatologist in private practice in Berlin, Germany., Ascher B; Plastic Surgeon, Lecturer, and Clinical Assistant, Paris Academy, Head of Clinique de Chirurgie Esthétique Iéna, Paris, France., Avelar RL; Chief Medical Officer and Head of Research and Development, Evolus, Inc., Newport Beach, CA., Bergdahl J; Consultant Plastic Surgeon, Department of Plastic Surgery, Örebro University Hospital, and Akademikliniken Örebro, Örebro, Sweden., Bertucci V; Instructor, Division of Dermatology, University of Toronto, Toronto, ON, Canada., Bodokh I; Dermatologist, Practicien Hospitalier, Service de Dermatologie, Cannes Hospital Simone Veil, Cannes, France., Carruthers JA; Dermatologist (retired) in private practice, Vancouver, BC, Canada., Cartier H; Dermatologist, Dermatology Clinic, Centre Médical Saint-Jean, Arras, France., Delmar H; Plastic surgeon in private practice in Antibes, France., Denfeld R; Private practice physician in Stuttgart, Germany., Gross JE; Vice Dean for Clinical Affairs, School of Medicine, UCI Health, Orange, CA., Heckmann M; Associate Professor of Dermatology, Ludwig Maximilian Universität, Munich, Germany., Hedén P; Associate Professor in Plastic Surgery, Akademikliniken Stockholm, Sweden., Hilton S; Dermatologist in private practice in Düsseldorf, Germany., Inglefield C; Inglefield is a plastic surgeon in private practice in London, United Kingdom., Ogilvie P; Dermatologist in private practice in Munich, Germany., Sattler G; Medical Director, Rosenpark Research, Darmstadt, Germany., Sebastian M; Dermatologist in private practice in Brandenburg, Germany., Solish N; Assistant Professor of Dermatology, University of Toronto, Toronto, ON, Canada., Swift A; Clinical Lecturer, McGill University and University of Montreal, Montreal, PQ, Canada., Trévidic P; Scientific Director, Expert2Expert Group, Paris, France.
Jazyk:	angličtina
Zdroj:	Aesthetic surgery journal [Aesthet Surg J] 2020 Mar 23; Vol. 40 (4), pp. 413-429.
DOI:	10.1093/asj/sjz110
Abstrakt:	Background: PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum. Objectives: The authors sought to investigate the efficacy and safety of prabotulinumtoxinA compared to onabotulinumtoxinA and placebo for the treatment of glabellar lines. Methods: This was a 150-day, multicenter, double-blind, controlled, single-dose Phase III study. Adult patients (n = 540) with moderate to severe glabellar lines at maximum frown as assessed by the investigator on the validated 4-point Glabellar Line Scale (0 = no lines, 1 = mild, 2 = moderate, 3 = severe), who also felt that their glabellar lines had an important psychological impact, were enrolled. Patients were randomized 5:5:1 to receive a single treatment (0.1 mL injected into each of 5 glabellar sites) of 20 U prabotulinumtoxinA (n = 245), 20 U onabotulinumtoxinA (n = 246), or placebo (n = 49). The primary efficacy endpoint was the proportion of responders (patients with a Glabellar Line Scale score of 0 or 1 at maximum frown by investigator assessment) on day 30. Results: Responder rates for the primary efficacy endpoint were 87.2%, 82.8%, and 4.2% in the prabotulinumtoxinA, onabotulinumtoxinA, and placebo groups, respectively. The absolute difference between prabotulinumtoxinA and onabotulinumtoxinA groups was 4.4% (95% confidence interval [-1.9, 10.8]). Given that the lower bound of the 95% confidence interval for the difference was less than -10.0%, noninferiority of prabotulinumtoxinA vs onabotulinumtoxinA was concluded. Five patients (3 prabotulinumtoxinA, 1.2%; 1 onabotulinumtoxinA, 0.4%; 1 placebo, 2.0%) experienced serious adverse events, none of which were study drug related. Conclusions: A single treatment of 20 U prabotulinumtoxinA was safe and effective and noninferior to 20 U onabotulinumtoxinA for the treatment of moderate to severe glabellar lines. (© 2019 The Aesthetic Society.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu