Benjamin Ascher1, Philippe Kestemont2, Dominique Boineau3, Isaac Bodokh4, Annette Stein5, Marc Heckmann6, Markus Dendorfer6, Tatjana Pavicic7, Magali Volteau8, Anissa Tse9, Philippe Picaut10, Berthold Rzany11. 1. Plastic and Reconstructive Surgeon at the Iena Plastic Surgery Clinic, Paris, France. 2. Plastic Surgeon at the Mediti Centre, Antibes-Juan Les Pins, France. 3. Dermatologist at the Dermatology Clinic, Bordeaux, France. 4. Dermatologist at the Dermatology Department, Cannes Hospital, Cannes, France. 5. Senior Specialist at the Dresden Center of Outpatient Dermatosurgery, University Hospital Dresden, Dresden, Germany. 6. Dermatologists at the Starnberg Skin Centre, Starnberg, Germany. 7. Dermatologist at the Private Practice for Dermatology and Aesthetics Dr Pavicic, Munich, Germany. 8. Statistician at Ipsen Innovation, Les Ulis, Paris, France. 9. Medical Development Director for Ipsen Innovation at the time of this trial. 10. VP for Neurology Development at Ipsen Innovation, Les Ulis, Paris, France. 11. Dermatologist and Clinical Epidemiologist (ScM) at RZANY & HUND, a private practice in Berlin, Germany.
Abstract
BACKGROUND: In most countries, approved botulinum toxin type A formulations require reconstitution before injection. OBJECTIVES: To evaluate the efficacy and safety of a ready-to-use liquid formulation of abobotulinumtoxinA (abobotulinumtoxinA solution for injection, ASI) in subjects with moderate to severe glabellar lines (GL). METHODS: In this Phase II, double-blind, placebo-controlled, randomized study, 176 female subjects (aged 30 to 60 years) were randomized into five treatment groups: ASI 20, 50, or 75 U, reconstituted abobotulinumtoxinA (aboBoNT-A) 50 U, and placebo. GL severity was assessed at maximum frown using a 4-point grading scale. Responders were subjects with severity grade of moderate [2] or severe [3] at baseline improving to none [0] or mild [1], evaluated at each time-point by Investigator's Live Assessment (ILA) or Subject's Self-Assessment (SSA). Safety profiles were also determined. RESULTS: Baseline characteristics were similar across groups. Responder rates on Day 29 by ILA were significantly greater for ASI 20, 50, and 75 U versus placebo (88.9%, 91.4%, and 87.9% vs. 0%, respectively; P < 0.0001). Similar results were observed by SSA. A greater proportion of responders was observed in ASI groups vs placebo from Day 8 to 113 for ILA and SSA (P < 0.001). AboBoNT-A responder rate on Day 29 for ILA was 77.1% (P < 0.1006 vs ASI 50 U); with comparable results by SSA. The ASI safety profile was comparable to that of aboBoNT-A. CONCLUSIONS: Ready-to-use liquid formulation of abobotulinumtoxinA was shown to be efficacious, with comparable results to reconstituted abobotulinumtoxinA, and to have a favorable safety profile in subjects with severe to moderate GL.
BACKGROUND: In most countries, approved botulinum toxin type A formulations require reconstitution before injection. OBJECTIVES: To evaluate the efficacy and safety of a ready-to-use liquid formulation of abobotulinumtoxinA (abobotulinumtoxinA solution for injection, ASI) in subjects with moderate to severe glabellar lines (GL). METHODS: In this Phase II, double-blind, placebo-controlled, randomized study, 176 female subjects (aged 30 to 60 years) were randomized into five treatment groups: ASI 20, 50, or 75 U, reconstituted abobotulinumtoxinA (aboBoNT-A) 50 U, and placebo. GL severity was assessed at maximum frown using a 4-point grading scale. Responders were subjects with severity grade of moderate [2] or severe [3] at baseline improving to none [0] or mild [1], evaluated at each time-point by Investigator's Live Assessment (ILA) or Subject's Self-Assessment (SSA). Safety profiles were also determined. RESULTS: Baseline characteristics were similar across groups. Responder rates on Day 29 by ILA were significantly greater for ASI 20, 50, and 75 U versus placebo (88.9%, 91.4%, and 87.9% vs. 0%, respectively; P < 0.0001). Similar results were observed by SSA. A greater proportion of responders was observed in ASI groups vs placebo from Day 8 to 113 for ILA and SSA (P < 0.001). AboBoNT-A responder rate on Day 29 for ILA was 77.1% (P < 0.1006 vs ASI 50 U); with comparable results by SSA. The ASI safety profile was comparable to that of aboBoNT-A. CONCLUSIONS: Ready-to-use liquid formulation of abobotulinumtoxinA was shown to be efficacious, with comparable results to reconstituted abobotulinumtoxinA, and to have a favorable safety profile in subjects with severe to moderate GL.
Authors: Mark Nestor; Joel L Cohen; Marina Landau; Said Hilton; Andreas Nikolis; Syed Haq; Maurizio Viel; Bill Andriopoulos; Inna Prygova; Keith Foster; Alessio Redaelli; Philippe Picaut Journal: J Clin Aesthet Dermatol Date: 2020-12-01
Authors: Elena Fonfria; Jacquie Maignel; Stephane Lezmi; Vincent Martin; Andrew Splevins; Saif Shubber; Mikhail Kalinichev; Keith Foster; Philippe Picaut; Johannes Krupp Journal: Toxins (Basel) Date: 2018-05-18 Impact factor: 4.546
Authors: Benjamin Ascher; Berthold Rzany; Philippe Kestemont; Said Hilton; Marc Heckmann; Isaac Bodokh; Ernst Magnus Noah; Dominique Boineau; Martina Kerscher; Magali Volteau; Philippe Le Berre; Philippe Picaut Journal: Aesthet Surg J Date: 2020-08-14 Impact factor: 4.283
Authors: Benjamin Ascher; Berthold Rzany; Philippe Kestemont; Said Hilton; Marc Heckmann; Isaac Bodokh; Ernst Magnus Noah; Dominique Boineau; Martina Kerscher; Magali Volteau; Philippe Le Berre; Philippe Picaut Journal: Aesthet Surg J Date: 2020-01-01 Impact factor: 4.283
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