A Phase II, Randomised, Double-Blind Study to Compare the Safety and Efficacy of One Treatment Cycle of Clostridium Botulinum Type A Toxin (50 Units) When Reconstituted from Either a 125 Unit or a 500 Unit Presentation for the Treatment of Glabellar Lines

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Extrait

The main objective is the assessment of the relative clinical safety of the two different presentations (125 U vial (referred to as Reloxin) and 500 U vial (Dysport®)) by comparison of the incidence and severity of AEs, vital signs and concomitant medications. Because the presentations have different excipient concentrations when reconstituted, this pilot study is necessary to demonstrate that the effect in man of the new presentation (125 units, referred to as Reloxin) is not different to that of the reference product (500 units, Dysport®), which is registered for this indication in Germany. The long term aim is to register and market a presentation that has a more appropriate dose and therefore is more suitable for treatment of facial lines.

Critère d'inclusion

Moderate to severe vertical glabellar lines

Liens

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A Phase II, Randomised, Double-Blind Study to Compare the Safety and Efficacy of One Treatment Cycle of Clostridium Botulinum Type A Toxin (50 Units) When Reconstituted from Either a 125 Unit or a 500...