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

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

Autor Rzany, B. Google Scholar
Ascher, B. Google Scholar
Fratila, A. Google Scholar
Monheit, G. D. Google Scholar
Talarico, S. Google Scholar
Sterry, W. Google Scholar
GLADYS Study Grp Google Scholar
Instituição Charite Univ Med Berlin
Jungbrunnen Klin Dr Fratila GmbH
Clin Lena
Dermatol Associates
Universidade Federal de São Paulo (UNIFESP)
Resumo 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.Design: Multicenter, double-blind, placebo-con trolled, randomized, 16-week trial.Setting: Twenty-three German dermatologic centersPatients: 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 botiulinum 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.Main Outcome Measure: 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 I point between weeks 0 and 4 was considered a therapeutic success (responder).Result: 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.
Idioma Inglês
Data de publicação 2006-03-01
Publicado em Archives of Dermatology. Chicago: Amer Medical Assoc, v. 142, n. 3, p. 320-326, 2006.
ISSN 0003-987X (Sherpa/Romeo, fator de impacto)
Publicador Amer Medical Assoc
Extensão 320-326
Fonte http://dx.doi.org/10.1001/archderm.142.3.320
Direito de acesso Acesso restrito
Tipo Artigo
Web of Science WOS:000236124900007
Endereço permanente http://repositorio.unifesp.br/handle/11600/28763

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