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Aesthet Surg J. 2019 Apr 5. pii: sjz110. doi: 10.1093/asj/sjz110. [Epub ahead of print]

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 Subjects.

Author information

1
Private practice in Berlin, Germany.
2
Paris Academy, Head of Clinique de Chirurgie Esthétique Iéna, Paris, France.
3
Evolus, Inc., Newport Beach, CA.
4
Department of Plastic Surgery, Örebro University Hospital, and Akademikliniken Örebro, Örebro, Sweden.
5
Division of Dermatology, University of Toronto, Toronto, ON, Canada.
6
Service de Dermatologie, Cannes Hospital Simone Veil, Cannes, France.
7
Private practice, Vancouver, BC, Canada.
8
Dermatology Clinic, Centre Médical Saint-Jean, Arras, France.
9
Private practice in Antibes, France.
10
Private Practice in Stuttgart, Germany.
11
Clinical Affairs, School of Medicine, UCI Health, Orange, CA.
12
Ludwig Maximilian Universität, Munich, Germany.
13
Private Practice in Stockholm, Sweden.
14
Private Practice in Düsseldorf, Germany.
15
Private Practice in London, United Kingdom.
16
Private Practice in Munich, Germany.
17
Rosenpark Research, Darmstadt, Germany.
18
Private Practice in Brandenburg, Germany.
19
University of Toronto, Toronto, ON, Canada.
20
McGill University and University of Montreal; Montreal, PQ, Canada.
21
Expert2Expert Group, Paris, France.

Abstract

BACKGROUND:

PrabotulinumtoxinA is a 900 kDa botulinum toxin type A produced by Clostridium botulinum.

OBJECTIVE:

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 subjects (n=540) with moderate to severe glabellar lines at maximum frown as assessed by the investigator on the validated 4-point Glabellar Line Scale (GLS, 0=no lines, 1=mild, 2=moderate, 3=severe), who also felt that their glabellar lines had an important psychological impact, were enrolled. Subjects 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 (subjects with a GLS 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% CI (-1.9, 10.8). Given that the lower bound of the 95% CI for the difference was > -10.0%, non-inferiority of prabotulinumtoxinA versus onabotulinumtoxinA was concluded. Five subjects (3 prabotulinumtoxinA, 1.2%; 1 onabotulinumtoxinA, 0.4%; 1 placebo, 2.0%) experienced serious adverse events; none were study-drug related.

CONCLUSION:

A single treatment of 20 U prabotulinumtoxinA was safe and effective and non-inferior to 20 U onabotulinumtoxinA for the treatment of moderate to severe glabellar lines.

PMID:
30951166
DOI:
10.1093/asj/sjz110

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