BOTULINUM TOXIN-A FOR HYPERKINETIC FACIAL LINES - RESULTS OF A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

Previous work on patients with muscular dystonia has shown that small intramuscular doses of botulinum toxin A eliminated hyperkinetic facia l lines for approximately 6 months. The purpose of this study was to d etermine the efficacy of botulinum toxin A injections in eliminating f acial wrinkles in aesthetic surgery patients who do not have muscular dystonia. Eleven healthy subjects were studied in a double-blind fashi on. On both sides of the face, 0.2 cc of either normal saline or botul inum toxin A was injected into the forehead or into the periorbital wr inkles (crow's feet). Documentation of results was made by photographs taken of the patients during repose and during facial animation befor e and after injection. Assessment of facial wrinkles was done from a g rading system in which the patient and the facial plastic surgeon were asked to judge the severity of the wrinkles on a scale from 0 to 3, w ith 0 reflecting no facial wrinkles and 3 reflecting severe facial wri nkling. Nine of 11 subjects injected with botulinum toxin A noted a si gnificant improvement in the severity of their facial wrinkles in comp arison with the side of the face injected with saline, with a rating i mprovement of 2 points. Two of 11 subjects noted a moderate improvemen t, with a rating improvement of 1 point. No patient injected with sali ne reported an improvement in the severity of the facial wrinkles on t he control side. There were no serious complications. Botulinum toxin A is an efficacious method of nonsurgically eliminating facial wrinkle s and may play a role in the cosmetic enhancement of the aging face.