Berthold-Josef Rzany1, Benjamin Ascher2, Rui L Avelar3, Jesper Bergdahl4, Vince Bertucci5, Isaac Bodokh6, James Alastair Carruthers7, Hugues Cartier8, Henry Delmar9, Ralf Denfeld10, John E Gross11, Marc Heckmann12, Per Hedén13, Said Hilton14, Christopher Inglefield15, Patricia Ogilvie16, Gerhard Sattler17, Michael Sebastian18, Nowell Solish19, Arthur Swift20, Patrick Trévidic21. 1. Dermatologist in private practice in Berlin, Germany. 2. Plastic Surgeon, Lecturer, and Clinical Assistant, Paris Academy, Head of Clinique de Chirurgie Esthétique Iéna, Paris, France. 3. Chief Medical Officer and Head of Research and Development, Evolus, Inc., Newport Beach, CA. 4. Consultant Plastic Surgeon, Department of Plastic Surgery, Örebro University Hospital, and Akademikliniken Örebro, Örebro, Sweden. 5. Instructor, Division of Dermatology, University of Toronto, Toronto, ON, Canada. 6. Dermatologist, Practicien Hospitalier, Service de Dermatologie, Cannes Hospital Simone Veil, Cannes, France. 7. Dermatologist (retired) in private practice, Vancouver, BC, Canada. 8. Dermatologist, Dermatology Clinic, Centre Médical Saint-Jean, Arras, France. 9. Plastic surgeon in private practice in Antibes, France. 10. Private practice physician in Stuttgart, Germany. 11. Vice Dean for Clinical Affairs, School of Medicine, UCI Health, Orange, CA. 12. Associate Professor of Dermatology, Ludwig Maximilian Universität, Munich, Germany. 13. Associate Professor in Plastic Surgery, Akademikliniken Stockholm, Sweden. 14. Dermatologist in private practice in Düsseldorf, Germany. 15. Inglefield is a plastic surgeon in private practice in London, United Kingdom. 16. Dermatologist in private practice in Munich, Germany. 17. Medical Director, Rosenpark Research, Darmstadt, Germany. 18. Dermatologist in private practice in Brandenburg, Germany. 19. Assistant Professor of Dermatology, University of Toronto, Toronto, ON, Canada. 20. Clinical Lecturer, McGill University and University of Montreal, Montreal, PQ, Canada. 21. Scientific Director, Expert2Expert Group, Paris, France.
Abstract
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.
RCT Entities:
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.
Authors: Cristina Pires Camargo; Jun Xia; Caroline S Costa; Rolf Gemperli; Maria Dc Tatini; Max K Bulsara; Rachel Riera Journal: Cochrane Database Syst Rev Date: 2021-07-05
Authors: Sabrina G Fabi; Joel L Cohen; Lawrence J Green; Sunil Dhawan; Theda C Kontis; Leslie Baumann; Todd M Gross; Conor J Gallagher; Jessica Brown; Roman G Rubio Journal: Dermatol Surg Date: 2021-01-01 Impact factor: 2.914