Status:
COMPLETED
Efficacy and Safety of a New Botulinum Toxin Type A for Treatment of Facial Expression Lines
Lead Sponsor:
Azidus Brasil
Collaborating Sponsors:
Laboratório Químico Farmacêutico Bergamo Ltda.
Conditions:
Wrinkles
Eligibility:
FEMALE
18-65 years
Phase:
PHASE3
Brief 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 compare...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT01180348
Start Date
August 1 2011
End Date
September 1 2012
Last Update
March 4 2016
Active Locations (1)
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1
LAL Clinica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo, Brazil, 13276254