Multicenter, prospective, comparative, randomized, double-blind clinical study comparing two botulinum toxin type A formulations registered in Brazil for the treatment of glabellar wrinkles

Introduction: Although there are differences arising from diverse formulations, botulinum toxin type A is widely marketed in Brazil.
Objective: To compare the efficacy and tolerability of two botulinum toxin type A formulations registered in Brazil: Botulinum toxin type A (Toxin 1) and Onabotulinumtoxin A (Toxin 2), in the treatment of glabellar expression lines through a multicenter prospective, comparative, randomized, double-blind study.
Methods: One hundred fifty-seven patients were randomized at a 1:1 (Toxin 1: Toxin 2) ratio for receiving 20U toxin for the treatment of the glabella's dynamic wrinkles. Photographic records were taken at maximum frowning in five protocol visits by independent evaluators. The assessment of results included: i) percentage of patients with improvement > 1 point in the four-point facial wrinkles scale, at maximum frowning, fifteen days after the treatment; ii) improvement in the static glabellar wrinkles; iii) pain and iv) duration of effect of the toxin.
Results: According to the independent evaluators, two weeks after injection, the rate of response at maximum frowning was 98.4% in the group treated with Toxin 1 and 98.2% in the group treated with Toxin 2. For individuals who received Toxin 1, the authors found an effect's duration of 84.5 ± 38.8 days, while for those who received Toxin 2, the effect's duration was 89.9 ± 41.1 days (p = 0.4303).
Conclusions: Botulinum toxin type A (Toxin 1) and Toxin 2 have similar effectivenesses in the treatment of dynamic glabellar wrinkles. Both preparations were well tolerated.

Keywords: BOTULINUM TOXIN TYPE A; WRINKLES; PROSIGNE; BOTOX