NCT00959907

Comparison of Two Commercial Preparations of Botulinum Toxin Type A

A Phase iv Controlled Randomized Blinded Study on the Anhydrotic Action Halos and Muscle Activity of Two Commercial Preparations Type a Botulinum Toxin (Dysport® and Botox® ) Administered to the Upper Third of the Face

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Hexsel Dermatology Clinic · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the action halos 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.

Detailed description

This was a monocentric, prospective, randomized and double-blind study. Fifty nine female patients, presenting with moderate to severe forehead wrinkles, with sweating ability who had never undergone previous BoNT-A injections were enrolled. There were two randomizations, one related to the dose-equivalence (2:1U and 2.5:1U), both reconstituted in the same volume of 0.02 mL per point and another related to the forehead side (left or right) for application of the tested drugs. Baseline, twenty-eight and 112 days later, clinical and photographic assessments, Minor´s test, and electromyographic (EMG) evaluations were performed.

Conditions

• Wrinkles in Frontal Area

Interventions

Type	Name	Description
DRUG	BOTULINUM TOXIN TYPE-A	On Visit 1 (Day 0): Botulinum toxin A (Dysport® and Botox®) will be administered according to an equivalence ratio of 2:1. Both reconstituted in the same volume per point, injected in the forehead determined site. * Dysport®: 4 units will be injected in the left or right forehead side. * Botox® : 2 units will be injected in the left or right forehead side.(opposite side of dysport injection)

Timeline

• Start date: 2005-05-01
• Primary completion: 2007-11-01
• Completion: 2007-12-01
• First posted: 2009-08-17
• Last updated: 2009-12-15
• Results posted: 2009-08-17

Locations

1 site across 1 country: Brazil