RESUMEN
BACKGROUND: It is recommended that attention be given to the shelf life of botulinum toxin type A (BT-A) after its reconstitution. OBJECTIVE: To assess the efficacy and safety of 500 U of BT-A after reconstitution up to 15 days after injection. MATERIAL AND METHODS: BT-A vials were diluted 15 days, 8 days, and 8 hours before injection. One hundred five volunteers were randomized to one of three treatment groups, according to dilution dates. They were evaluated at baseline and 28, 56, 84, and 112 days after treatment. At each visit, the investigator and the volunteer evaluated the motility of the treated area using a 4-point qualitative scale. Five independent specialists, who scored the motility of the treated area on the same scale, blind analyzed photographs taken at each visit. The reconstituted vials of BT-A were stored and analyzed before and after the study. RESULTS: No significant difference was shown between the groups. No evidence of contamination was found in the BT-A vials. CONCLUSION: The results confirm the possibility of injecting 500 U of BT-A up to 15 days after its reconstitution safely and without loss of efficacy.
Asunto(s)
Toxinas Botulínicas Tipo A/administración & dosificación , Almacenaje de Medicamentos/métodos , Fármacos Neuromusculares/administración & dosificación , Envejecimiento de la Piel/efectos de los fármacos , Adolescente , Adulto , Método Doble Ciego , Composición de Medicamentos/métodos , Estabilidad de Medicamentos , Femenino , Estudios de Seguimiento , Frente , Humanos , Inyecciones , Masculino , Persona de Mediana Edad , Factores de Tiempo , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: The determination of the action halos of botulinum toxin type A aids in targeting specific muscles and/or sweat glands, thereby preventing the occurrence of side effects. OBJECTIVES: The objective of this study was to compare the action halos of two commercial preparations of botulinum toxin type A, Dysport (Ipsen, Slough, UK) and BOTOX (Allergan, Irvine, CA). MATERIAL AND METHODS: Eighteen volunteers received applications of both products into randomized sides of the frontalis muscle. Equivalent doses of 5 U of Dysport and 2 U of BOTOX were injected using the same technique, in the same volume (0.02 mL), and at a controlled depth. Twenty-eight days later, clinical and photographic assessments were performed. RESULTS: All the areas around the injected points were regular, round, or slightly oval and showed similar effects in the muscles and sweat glands. No statistically significant differences were observed between the mean sizes of the diameters of the halos produced by the two products. CONCLUSION: Injections of Dysport and BOTOX at an equivalence ratio of 2.5:1 U, respectively, applied at the same volume and depth, using the same technique resulted in similar action halos with regard to muscular and sweat gland activity. Both products seem to be safe and very predictable.