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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Wrinkles

Intervention / Treatment
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* Drug: Botulift
* Drug: Botox


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulift<br>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: Botulift<br>* 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).<br>* Other names: Botulinum Toxin Type A;|
| Active Comparator: Botox<br>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). | Drug: Botox<br>* 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).<br>* Other names: Botulinum Toxin Type A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | The non-inferiority of T group compared to the group Co was demonstrated in evaluations in a state of relaxation and maximal contraction in the PP analysis population, because as defined for the study, the lower limits of 95% of the mean of these assessments (-2 , 7% and -5.4%) are contained within the non-inferiority limit set at -10%. | after 30 days of application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay of the effect of botulinum toxin A (Test and Comparator) | The action of both treatments decreases over time and there is no significant difference between the two treatments. | during the 24-week period | 
| Safety of both botulinum toxin A | The occurrence of adverse events was similar in both groups. | during the whole period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wrinkles, glabellar, facial.