A randomised, double-blind comparison of 20 units of onabotulinumtoxinA with 30 units of incobotulinumtoxinA for glabellar lines.
BACKGROUND
Biological activity data indicate that the units of incobotulinumtoxinA are not equivalent to those of onabotulinumtoxinA.


OBJECTIVE
This study compared 20 units of onabotulinumtoxinA with 30 units of incobotulinumtoxinA in the treatment of glabellar lines.


METHODS
In this multicenter, randomised, double-blind study, subjects with moderate or severe glabellar lines received a single treatment with 20 units of onabotulinumtoxinA (n = 112), or 30 units of incobotulinumtoxinA (n = 112). The primary endpoint was the percentage of subjects with a reduction of ≥ 1 point on the Facial Wrinkle Scale at maximum contraction as rated by injectors on day 28 post injection. The same variable was evaluated on days 84, 98, and 112.


RESULTS
At the primary endpoint, 20 units of onabotulinumtoxinA was as effective as 30 units of incobotulinumtoxinA (96% vs. 95% responders, respectively; difference in proportion of responders = 0.02, 95% confidence interval [CI] - 0.04, 0.07). At subsequent time points, a trend towards a higher percentage of responders was observed in the group treated with 20 units of onabotulinumtoxinA. Given that the 95% CI surpassed the upper equivalence margin at these time points, equivalence was not established.


CONCLUSIONS
These data support the non-interchangeability of units of onabotulinumtoxinA and incobotulinumtoxinA, and the absence of a fixed dose ratio in clinical practice.
hautok und hautok cosmetics, München, Germany. DrMarion@hautok.de
Marion
M
Moers-Carpi
Thomas
T
Dirschka
Gabrielle
G
Feller-Heppt
Said
S
Hilton
Klaus
K
Hoffmann
Wolfgang G
WG
Philipp-Dormston
Anita
A
Rütter
Kelvin
K
Tan
Mary Ann
MA
Chapman
Antony
A
Fulford-Smith
D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000627:therapeutic use; D016001:Confidence Intervals; D004311:Double-Blind Method; D005260:Female; D005546:Forehead; D006801:Humans; D008297:Male; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D012720:Severity of Illness Index; D015595:Skin Aging / Q000187:drug effects*; D013997:Time Factors; D055815:Young Adult
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A; C545476:incobotulinumtoxinA