NCT00989768

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

Field Effects of Two Commercial Preparations of Botulinum Toxin Type a Administered to the Frontalis Muscles

• 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 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.

Detailed description

This was a monocentric, prospective, randomized and double-blind study. Twenty nine female patients, presenting with moderate to severe forehead wrinkles, with sweating ability who had never undergone previous BoNT-A injections were enrolled. Subjects have received botulinum toxin type-A injections in two forehead sites, Botox 2U and Dysport 5U, both reconstituted in the same volume of 0.02 mL per point. 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 (Dysport®)	Botulinum toxin A (Dysport®)will be administered according to an equivalence ratio of 2,5:1. Both reconstituted in the same volume per point, injected in the forehead determined site. -Dysport®: 5 units will be injected in the left or right forehead side.
DRUG	Botulinum Toxin Type A/Botox®	2 units will be injected in the left or right forehead side.(opposite side of dysport injection)
DRUG	Botulinum Toxin Type A/Dysport®	Botulinum toxin A (Dysport®)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, 2:1 ratio Dysport/Botox.

Timeline

• Start date: 2005-05-01
• Primary completion: 2007-11-01
• Completion: 2007-12-01
• First posted: 2009-10-06
• Last updated: 2010-06-02
• Results posted: 2010-04-27

Locations

1 site across 1 country: Brazil