Field of Effects of Two Commercial Preparations of Botulinum Toxin Type A

Summary

The objective of this study is to compare the field of effects of the botulinum toxins (Dysport® and Botox®) using two equivalence-ratios and to gather supportive information, such as more detailed data on the effectiveness in reduction of wrinkles and duration of action on the upper part of the face of both products, trough scales and photographs evaluations.

Timeline

Start

2005-05

Primary completion

2007-11

Completion

2007-12

Outcome

Met primary endpoint

registry analysis (superiority or other test); Dysport® 5U vs Botox® 2U; p <0.0001; Mean Difference (Net) 0.16; t-test, 2 sided NCT00989768 ↗

registry analysis (superiority or other test); Dysport® 5U vs Botox® 2U; p = 0.003; t-test, 2 sided NCT00989768 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Botulinum toxin type A	Protein / enzyme biologic	2 unknown	—
Subject	Botulinum toxin type A	Protein / enzyme biologic	4 unknown	—
Subject	Botulinum toxin type A	Protein / enzyme biologic	5 unknown	—

Indications

No indication recorded.