Clinical trial NCT01180348: Efficacy and Safety of a New Botulinum Toxin Type A for Treatment of Facial Expression Lines
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Wrinkles
Keywords: Wrinkles, glabellar, facial.
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
Collaborators: name: Laboratório Químico Farmacêutico Bergamo Ltda.
First posted: 2010-08-12
Enrollment: 192
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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;

Primary outcomes:
measure: overall improved assessment of hyperkinetic facial lines in a state of relaxation and maximal contraction through the Honeck's scale and photographic images obtained by equipment Visia Digital Compexton Analysis (Canfield Imaging Systems, version 4.0.2)
timeFrame: after 30 days of application
Secondary outcomes:
measure: Length of stay of the effect of botulinum toxin A (Test and Comparator)
timeFrame: during the 24-week period
measure: Safety of both botulinum toxin A
timeFrame: during the whole period
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: LAL Clinica Pesquisa e Desenvolvimento Ltda
state: Sao Paulo
Study officials:
affiliation: LAL Clinical Reseach e Development Ltda
name: Regina M. Doi, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: LAL Clinical Reseach e Development Ltda
name: Alexandre Frederico, Doctor
role: PRINCIPAL_INVESTIGATOR
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