Formulations of Botulinum Toxin for Cosmetic Use

Two serotypes of botulinum toxin have been formulated for clinical use, including botulinum toxin type A and botulinum toxin type B.

In order to prevent confusion between products, in 2009, the United States Food and Drug Administration (FDA) recommended the use of specific names, rather than serotypes, to refer to the available formulations of botulinum toxin.

  • The formulations of botulinum toxin type A that are available or in development, onabotulinumtoxinA (Botox®, Botox® Cosmetic, Vistabel®, Vistabex®; Allergan, Inc., Irvine, CA) has been studied most extensively. 
  • OnabotulinumtoxinA is supplied as a preservative-free, vacuum-dried powder that contains the C. botulinum type A neurotoxin complex (50 or 100 units per vial) plus human albumin and sodium chloride. 
  • OnabotulinumtoxinA was approved by the US FDA in 2002 for the treatment of glabellar rhytides, but also is widely used for the treatment of other skin lines and for facial contouring.

  • Initially marketed in Europe, abobotulinumtoxinA (Dysport®; Ipsen Ltd., United Kingdom/Medicis, Scottsdale, AZ and Azzalure®; Galderma, France) is another formulation of botulinum toxin type A utilized for cosmetic therapy. Dysport® is supplied in vials that contain 300 or 500 units of lyophilized abobotulinumtoxinA plus serum albumin and lactose. Dysport® became commercially available in North America in 2009, and has US FDA approval for the treatment of glabellar lines.

  • IncobotulinumtoxinA (Xeomin®; Merz Pharmaceuticals, Greensboro, NC or Bocouture®), a newer formulation of botulinum toxin type A, is approved for medical use and for injection of glabellar lines in multiple countries, including the United States. 
  • Xeomin is supplied as a lyophilized powder that contains botulinum toxin A (50 or 100 units), human albumin, and sucrose. IncobotulinumtoxinA is free of complexing proteins, which some authors believe may result in a reduced risk of sensitization and antibody formation against the toxin.

  • RimabotulinumtoxinB is commercially available as Myobloc® or NeuroBloc® (Solstice Neurosciences Inc./Eisai Co., Ltd.). Myobloc®, which is distributed in the United States, Canada, and Korea, is supplied in liquid form in vials that contain 5000 units of botulinum toxin type B per milliliter plus human serum albumin, sodium succinate, and sodium chloride. 
  • It is the primary agent used for the treatment of cervical dystonia, and compared to botulinum toxin type A, has been less studied for cosmetic indications. 
  • However, rimabotulinumtoxinB has been used successfully for the treatment of facial rhytides.

Topical botulinum toxin A 
  • Topical formulations of botulinum toxin type A may have promise for the treatment of dynamic rhytides 
  • In Brandt (2010), a randomized trial of 36 adults with moderate to severe lateral canthal lines, two 30–minute applications of a gel containing botulinum toxin type A separated by four weeks were superior to placebo for treatment [29]. 
  • Additional studies are necessary to determine the role of topical botulinum toxin for cosmetic indications.

Medical Lecture Note Copyright © 2011