Different formulations of botulinum toxin type A have different migration characteristics: a double-blind, randomized study.
OBJECTIVE
Different formulations of botulinum toxin type A (BoNTA) are not identical and may behave differently in clinical practice. The reportedly lower incidence of adverse effects with one formulation (from Allergan, Ltd.) relative to another (from Ipsen, Ltd.) may be due to differences in the degree of migration of the neurotoxin-protein complex from its injection site. A double-blind, randomized, within-subject pilot study was performed to compare the migration characteristics of each formulation.


METHODS
Twelve healthy volunteers were randomly assigned to receive three 0.1 mL intradermal injections in their forehead: 4 U BoNTA (Allergan) on one side, 12 U BoNTA (Ipsen) on the contralateral side, and saline in the center. At day 14, Minor's iodine starch test was performed, and the subjects walked around a hot room to induce sweating. The appearance of each forehead was documented using Canfield photography and the area of each anhidrotic halo calculated using software.


RESULTS
Overall, the area of anhidrosis was significantly larger with BoNTA (Ipsen) than BoNTA (Allergan) - mean +/- SD of 2.7 +/- 0.78 cm(2) vs. 1.8 +/- 0.65 cm(2) (P = 0.005) - with the area of anhidrosis being greater with BoNTA (Ipsen) than BoNTA (Allergan) in 11 of the 12 subjects. Across all subjects, the area of anhidrosis was greater with BoNTA (Ipsen) than BoNTA (Allergan) by a mean of 77%.


CONCLUSIONS
BoNTA (Ipsen) migrates more than BoNTA (Allergan) under the conditions described. The lower potential of BoNTA (Allergan) to migrate promotes more precise localization of clinical effects, thereby helping to optimize the risk/benefit ratio.
Cliff
Sandeep H
SH
Epsom and St. Helier University NHS Trust, and Surrey and Sussex NHS Trust, UK. sandeep_cliff@hotmail.com
Judodihardjo
Harryono
H
Eltringham
Elizabeth
E
D000328:Adult; D000704:Analysis of Variance; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry / Q000493:pharmacokinetics*; D004311:Double-Blind Method; D005260:Female; D005546:Forehead; D006801:Humans; D007007:Hypohidrosis / Q000139:chemically induced* / Q000175:diagnosis; D007091:Image Processing, Computer-Assisted; D007271:Injections, Intradermal; D007455:Iodine; D008297:Male; D009465:Neuromuscular Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry / Q000493:pharmacokinetics*; D010865:Pilot Projects; D013213:Starch
D009465:Neuromuscular Agents; D013213:Starch; D007455:Iodine; D019274:Botulinum Toxins, Type A