Recommendations for the Best Possible Use of Botulinum Neurotoxin Type A (Speywood Units) for Aesthetic Applications

January 2013 | Volume 12 | Issue 1 | Original Article | 80 | Copyright © 2013

Berthold Rzany MD ScMa, Alina A.M. Fratila MDb, Tanja C. Fischer MDc, Said Hilton MDd, Tatjana Pavicic MDe, Alexander Rothhaar MDf, Gerhard Sattler MDg, Boris Sommer MDh,and Andy Pickett PhD BSci

aRZANY & HUND, Privatpraxis für Dermatologie und Ästhetische Medizin, Berlin, Germany bJungbrunnen-Klinik Dr. Fratila GmbH, Bonn, Germany cHaut- & Lasercentrum, Potsdam, Germany dMedical Skin Center Dr. Hilton,

Abstract

The botulinum neurotoxin (BoNT) product Azzalure (manufactured by Ipsen Biopharm Limited, Wrexham, UK; distributed by Galderma), measured in Speywood units (s.U) has been available since 2009 for temporary improvement in the appearance of moderate to severe glabellar lines. Although we know much about the use of Azzalure for aesthetic indications, some aspects of product use in the clinic still require an update based on continuing and prevailing misconceptions and new clinical data. Therefore, a group of experts experienced with the use of Azzalure convened to formulate the following recommendations: (1) The key to an optimal effect is adequate dosing per injection point. Ten s.U are indicated for strong muscular activity, 5 s.U for medium activity, and approximately 2 s.U for minor activity. (2) The main factor that influences the area of effectiveness is the dosage per injection point. (3) In contrast to former beliefs, we know now that Azzalure works very fast, with some patients reporting initial drug activity after hours. (4) Various volumes can be used for dilution. However, the first choice is the recommended volume, 0.63 mL per vial of 125 s.U. Nevertheless, for clinicians changing products, keeping the volume they are used to might be an option. (5) Clinicians changing products have to be very careful not to confuse the units between different products. (6) In aesthetic BoNT-A usage, the development of antibodies is very rare and is not the common reason for insufficient results. (7) Probably the most common reason when BoNT-A is not working is the absolute or relative underdosage. The present adjunctive recommendations elaborated in an informal expert meeting should help physicians to optimize their treatment with Speywood unit products.

J Drugs Dermatol. 2013;12(1):80-84.

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INTRODUCTION

The botulinum toxin (BoNT) product Azzalure, manufactured by Ipsen Biopharm Limited, Wrexham, UK, and distributed by Galderma through their aesthetic and corrective division Q-Med, is indicated for temporary improvement in the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows) seen with frowning, in adult patients younger than 65 years, when the severity of these lines has an important psychological impact on the patient. The product is identical to Dysport (Medicis Aesthetics, Inc, Scottsdale, AZ) except the number of product units per vial is reduced to 125 Speywood units (s.U).1 The manufacturing process is the same, and the formulation is identical to that of Dysport, with the exception of the number of units. This means that clinical data generated from one of the product formats are equally applicable to the other. Azzalure has been available as a licensed product since 2009; Dysport was first licensed in 1990.

Although we know much about the use of Azzalure for aesthetic indications, based on good clinical data and several consensus recommendations,2-4 there are still some aspects of product use in the clinic that require an update based on continuing and prevailing misconceptions and new data from recent studies.5,6 So far, these aspects have not been formally considered. Therefore, a group of experts experienced with the use of Azzalure convened to formulate recommendations that will be helpful and adjunctive to the published literature for the treating physicians.


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