A multicenter, randomized, double-blind, placebo-controlled study of efficacy and safety of 3 doses of botulinum toxin A in the treatment of glabellar lines.
BACKGROUND
Botulinum toxin A (BTX-A) is used to treat glabellar lines but the rigorous demonstration of its efficacy in a well-designed study had never been reported.


OBJECTIVE
This study was designed to evaluate the efficacy and the safety of 3 doses of BTX-A in the treatment of glabellar lines.


METHODS
A total of 119 patients with moderate to severe glabellar lines at rest were treated with 25, 50, or 75 U of BTX-A (Dysport, Ipsen) or placebo divided into 5 intramuscular glabellar sites. Outcome measures included evaluations of glabellar lines by independent experts from blinded standardized photographs at rest 1 month after treatment, physician evaluations, and patient assessments during a 6-month period.


RESULTS
A significant efficacy was reported for the 3 BTX-A groups for at least 3 months after injection (at least P <.015). Investigator and patient evaluations suggested that 50 U was the optimal dose. BTX-A was well tolerated. No blepharoptosis was reported. An evaluation in blinded conditions by independent experts was necessary because the results were overestimated by the investigators.


CONCLUSIONS
BTX-A is an effective and safe treatment for glabellar lines.
Ascher
Benjamin
B
Hôpital de St-Cloud, France. benjaminascher@wanadoo.fr
Zakine
Benjamin
B
Kestemont
Philippe
P
Baspeyras
Martine
M
Bougara
Ali
A
Santini
José
J
D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005152:Facial Muscles; D005260:Female; D005546:Forehead; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D010781:Photography; D015595:Skin Aging; D016896:Treatment Outcome
D019274:Botulinum Toxins, Type A