A multicenter, double-blind, randomized, placebo-controlled study of the efficacy and safety of botulinum toxin type A in the treatment of glabellar lines.
BACKGROUND
Botulinum toxin type A (BTX-A) is widely used for facial esthetics but is incompletely studied.


OBJECTIVE
This study was conducted to evaluate the efficacy and safety of BTX-A treatment of glabellar lines.


METHODS
Patients with moderate to severe glabellar lines at maximum frown received intramuscular injections of 20 U BTX-A (BOTOX, Allergan, Inc, Irvine, Calif) or placebo into 5 glabellar sites. Patients were followed up for 120 days after injection. Outcome measures were physician rating of glabellar line severity at maximum frown and rest, patient assessment of improvement, and vital sign and adverse event monitoring.


RESULTS
Two hundred sixty-four patients were enrolled (BTX-A: 203, placebo: 61). There was a significantly greater reduction in glabellar line severity with BTX-A than with placebo (all measures, every follow-up visit; P <.022). The effect was maintained for many patients through day 120. There was a low occurrence (5.4%) of mostly mild blepharoptosis in the BTX-A group.


CONCLUSIONS
BTX-A injections are safe and effective in reducing the severity of glabellar lines.
Carruthers
J Alastair
JA
Vancouver Hospital, Vancouver, British Columbia, Canada.
Lowe
Nicholas J
NJ
Menter
M Alan
MA
Gibson
John
J
Nordquist
Marian
M
Mordaunt
Julie
J
Walker
Patricia
P
Eadie
Nina
N
D000293:Adolescent; D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005148:Facial Dermatoses / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005546:Forehead; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D012720:Severity of Illness Index; D015595:Skin Aging / Q000473:pathology*; D016896:Treatment Outcome; D014481:United States
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A