Efficacy and safety of 3- and 5-injection patterns (30 and 50 U) of botulinum toxin A (Dysport) for the treatment of wrinkles in the glabella and the central forehead region.
OBJECTIVE
To investigate the efficacy and safety of 2 injection site patterns (3- and 5-injection patterns [30 and 50 U]) of botulinum toxin A (Dysport; Ipsen Pharma, Ettlingen, Germany), in the treatment of glabellar and central forehead wrinkles.


METHODS
Multicenter, double-blind, placebo-controlled, randomized, 16-week trial.


METHODS
Twenty-three German dermatologic centers.


METHODS
Two hundred twenty-one patients with moderate or severe glabellar wrinkles when frowning maximally. Intervention Centers were randomly assigned to the 3-injection site pattern (3 injections of 10 U of botulinum toxin A or placebo) or 5-injection site pattern (5 injections of 10 U of botulinum toxin A or placebo). All centers used 3 sites in the procerus and corrugator muscles; the 2 additional sites were approximately 1-cm cranial from the corrugator sites.


METHODS
Wrinkle severity was graded by 4 independent experts blinded to the treatment received using digital photographs and a standardized clinical scale (range, 0 [no wrinkles] to 3 [severe wrinkles]). A reduction of at least 1 point between weeks 0 and 4 was considered a therapeutic success (responder).


RESULTS
One hundred ten patients (73 receiving botulinum toxin A vs 37 receiving placebo) received 3 injections; 111 patients (73 receiving botulinum toxin A vs 38 receiving placebo) received 5 injections. After 4 weeks, the proportions of responders were 86.1% vs 18.9% and 86.3% vs 7.9%, respectively (P<.001 for both). No major adverse effects were observed.


CONCLUSIONS
The 3 central injection sites are essential for the treatment of glabellar wrinkles. The 2 additional injection sites in the forehead region, targeting the frontalis muscle, did not significantly improve efficacy.
Rzany
Berthold
B
Division of Evidence Based Medicine, Klinik für Dermatologie, Venerologie und Allergologie, Charité Universitätsmedizin, Campus Charité Mitte, Schumannstrasse 20/23, D-10117 Berlin, Germany. berthold.rzany@charite.de
Ascher
Benjamin
B
Fratila
Alina
A
Monheit
Gary D
GD
Talarico
Sergio
S
Sterry
Wolfram
W
D000293:Adolescent; D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage*; D003357:Cosmetic Techniques; D004311:Double-Blind Method; D005152:Facial Muscles; D005260:Female; D005546:Forehead; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000008:administration & dosage*; D017060:Patient Satisfaction; D015595:Skin Aging
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A