Estudo clínico multicêntrico, prospectivo, comparativo, randomizado e duplo cego, entre duas formulações de toxina botulínica tipo A registradas no Brasil para o tratamento das rugas da glabela

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 Introducao: Embora existam diferencas decorrentes de formulacoes diversificadas, a toxina botulinica tipo A e amplamente comercializada no Brasil. Objetivo: Comparar a eficacia e a tolerabilidade de duas formulacoes de toxina botulinica A registradas no Brasil: Toxina botulinica tipo A (denominada Toxina 1) e Onabotulinumtoxin A (Toxina 2), no tratamento de linhas de expressao glabelares, por meio de um estudo multicentrico, prospectivo, comparativo, randomizado e duplo-cego. Metodos: 157 pacientes foram randomizadas em um 1:1 (Toxina 1:Toxina 2) para receber 20U de toxina para tratamento das rugas dinâmicas da glabela. Houve registro fotografico em franzimento maximo, nas cinco visitas do protocolo, por avaliadores independentes. A avaliacao dos resultados incluiu: percentagem de resposta de pacientes com melhora de > 1 ponto em escala facial de rugas de quatro pontos, no maximo de franzimento apos 15 dias de tratamento, melhora de rugas estaticas glabelares, dor e duracao do efeito da toxina. Resultado: Duas semanas apos a injecao, a taxa de resposta ao maximo franzido era 98,4% no grupo tratado com Toxina 1 e 98,2% no grupo tratado com Toxina 2, segundo os avaliadores independentes. Encontramos, para os individuos que receberam Toxina 1, a duracao do efeito de 84,5 ± 38,8 dias e de 89,9 ± 41,1 dias para aqueles que receberam Toxina 2 (p = 0,4303). Conclusoes: A toxina botulinica do tipo A denominada Toxina 1 e igualmente eficaz a denominada Toxina 2 no tratamento das rugas dinâmicas glabelares. Ambas as preparacoes foram bem toleradas