A multicenter, double-blind, randomized, placebo-controlled study of the efficacy and safety of botulinum toxin type A in the treatment of glabellar lines

• Published in: Journal of the American Academy of Dermatology Vol. 46; no. 6; pp. 840 - 849
• Main Authors: Carruthers, J.Alastair, Lowe, Nicholas J., Menter, M.Alan, Gibson, John, Nordquist, Marian, Mordaunt, Julie, Walker, Patricia, Eadie, Nina
• Format: Journal Article
• Language: English
• Published: New York, NY Mosby, Inc 01.06.2002; Elsevier
• Subjects: Adolescent; Adult; Aged; Biological and medical sciences; Botulinum Toxins, Type A - administration & dosage; Botulinum Toxins, Type A - therapeutic use; Diseases of the skin. Cosmetics; Double-Blind Method; Facial Dermatoses - drug therapy; Facial Dermatoses - pathology; Female; Forehead; Humans; Injections, Intramuscular; Male; Medical sciences; Middle Aged; Neuromuscular Agents - administration & dosage; Neuromuscular Agents - therapeutic use; Prospective Studies; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Severity of Illness Index; Skin Aging - pathology; Treatment Outcome; United States; United States; Cosmetic; Human; Skin disease; Enzyme; Wrinkle; Multicenter study; Metalloendopeptidases; Injection; Intramuscular administration; Prospective; Peptidases; Bontoxilysin; Chemotherapy; Forehead; Randomization; Treatment; Efficiency; Hydrolases; Clinical trial; Safety; Face
• ISSN: 0190-9622; 1097-6787
• DOI: 10.1067/mjd.2002.121356

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. Conclusion: BTX-A injections are safe and effective in reducing the severity of glabellar lines. (J Am Acad Dermatol 2002;46:840-9.)