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Treatment of glabellar lines with botulinum toxin type A (Speywood Unit): a clinical overview
Author(s) -
Rzany B,
Ascher B,
Monheit GD
Publication year - 2010
Publication title -
journal of the european academy of dermatology and venereology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.655
H-Index - 107
eISSN - 1468-3083
pISSN - 0926-9959
DOI - 10.1111/j.1468-3083.2009.03475.x
Subject(s) - medicine , adverse effect , botulinum toxin , placebo , ptosis , surgery , dermatology , pharmacology , pathology , alternative medicine
Azzalure (Galderma) is a newly approved European botulinum neurotoxin type A (BoNT‐A) specifically designed for aesthetic usages. It is sourced from Dysport (Ipsen Ltd.), which has a 20‐year product consistency and has been used widely for various therapeutic and aesthetic applications. Azzalure and Dysport are collectively referred to as BoNT‐A (Speywood Unit; s.U) (or abobotulinumtoxinA in the U.S.) after their biological activity unit, which is unique and not interchangeable with units of other commercial BoNT‐A preparations. Azzalure is approved for the treatment of moderate‐to‐severe glabellar lines, with a total dose of 50 s.U distributed evenly among 5 injection points. To ensure optimal treatment outcomes with BoNT‐A (s.U), it is crucial for injectors to adopt proper methods of reconstitution and injection, which can be acquired through training. We review here the method of reconstitution for BoNT‐A (s.U), as well as the injection dose, points and techniques for glabellar line treatment. We also review the efficacy and safety results of BoNT‐A (s.U) demonstrated in 11 clinical studies, most of which were randomized, double‐blind and placebo‐controlled. The studies included assessments after single injections as well as after up to 6 repeated treatment sessions. We summarize the clinical efficacy results, which include the responder rate 1 month post‐injection, onset of response and duration of action, as well as safety results, which include incidence of treatment‐emergent adverse events and specifically eyelid ptosis. The efficacy and safety profiles reported here are unique to BoNT‐A (s.U) and cannot be generalized to other BoNT‐A products.