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

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azidus Brasil
• Collaborator: Laboratório Químico Farmacêutico Bergamo Ltda.
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Patients who agree with all study procedures and sign for their own free will the TCLE;

• Adult patients were female between 18 and 65 years, regardless of social condition;

• between skin phototype I and IV;

• With good mental and physical health;

• Patients who have not been treated with botulinum toxin type A;

• Patients who agree to abstain from physical activity for a period of 24 hours, previous and subsequent to the initiation of the study;

• Patients presenting at screening visit, wrinkles in the glabellar region between classes 2 and 3 of Table Wrinkles Pattern Classification, which is diagnosed clinically by the dermatologist.

Exclusion Criteria:

• Patients who are in classes 0 and 1 of the Table Pattern Classification Wrinkle;

• Patients who have disorders or diseases that might interfere with neuromuscular function (myasthenia gravis or Lambert-Eaton syndrome);

• Patients being treated with antibiotics (aminoglycosides) and muscle relaxants;

• Patients with pre-existing conditions such as ptosis or scars in the area to be assessed, as they may endanger the health of the patient and the results of the study;

• Patients who have made treatments fill in the glabellar region (retinoic acid, collagen);

• Patients who have been treated in the dermatological peeling úlitmos three months;

• Patients are using treatments dermacosmetics agents anti age (vitamin C pure retinoids flavanoids acid hyaluronic others) or used past 3 months

• Patients with known hypersensitivity to any component of the study drug;

• Pregnant or lactating women;