NCT01180348

Efficacy and Safety of a New Botulinum Toxin Type A for Treatment of Facial Expression Lines

Randomized Study of Clinical Non-inferiority of Medicine Botulift (Laboratório Químico Farmacêutico Bergamo Ltd.) Compared to Botox ® (Allergan Inc.) in the Improvement of Wrinkles in the Facial Region.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: Azidus Brasil · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The dermatological treatment for reducing facial wrinkles with injectable drug Botulift (botulinum toxin type A - Laboratório Químico Farmacêutico BergamoLtd.) has a not inferior activity when compared with Botox ® (botulinum toxin - Allergan Inc.) in clinical trials.

Detailed description

The study will evaluate non-inferiority in clinical improvement in the intensity of expression lines over 16 weeks of drug Botulift (Laboratório Químico Farmacêutico Bergamo Ltd.) compared with Botox ® (Allergan Inc.). So that the homogeneity of the group opted to use in female patients with glabellar wrinkles grade 2 (moderate) and 3 (severe) Scale Standard Facial Wrinkles, established by Honecker et al. (2003). The first area of the face perceived in mime is the glabellar complex, located in the space between the eyebrows, wrinkles eventually show (Almeida et al., 2010). Patients will be evaluated at each visit, the doctor Principal Investigator and digital photos of the glabellar region at maximum contraction and relaxation will be obtained using the apparatus Visia (Canfield Imaging Systems, version 4.0.2) for further analysis by random team dermatologists.

Conditions

• Wrinkles

Interventions

Type	Name	Description
DRUG	Botulift	Application of 90 U of Botulift divided in 3 applications on each side of the face in fifteen predetermined sites in three regions of the face (front, glabellar, periocular).
DRUG	Botox	Application of 90 U of Botox divided in 3 applications on each side of the face in fifteen predetermined sites in three regions of the face (front, glabellar, periocular).

Timeline

• Start date: 2011-08-01
• Primary completion: 2011-10-01
• Completion: 2012-09-01
• First posted: 2010-08-12
• Last updated: 2016-03-04

Locations

1 site across 1 country: Brazil