Methods |
Randomised, non‐inferiority trial, split‐face,active‐controlled, facial wrinkles, phase III trial |
Participants |
192 randomised female participants, age ranging from 18 years old to 65 years old 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 in the last three months
Patients are using treatments cosmetics agents anti age (vitamin C pure retinoids flavonoids acid hyaluronic others) or used past 3 months
Patients with known hypersensitivity to any component of the study drug
Pregnant or lactating women
Country: Brazil |
Interventions |
Intervention:3 applications on each side of the face in 15 predetermined sites in three regions of the face (front, glabellar, periocular). Botulift® 90 U Comparator: 3 applications on each side of the face in 15 predetermined sites in three regions of the face (front, glabellar, periocular).OnabotulinumtoxinA |
Outcomes |
Primary Outcomes
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) 30 days of application
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%
Secondary Outcomes
Length of stay of the effect of botulinum toxin A (Test and Comparator) the 24‐week period.The action of both treatments decreases over time and there is no significant difference between the two treatments
Safety of both botulinum toxin A. The occurrence of adverse events was similar in both groups
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Notes |
Sponsor Azidus Brasil We sent an email to this company (http://laboratoriobergamo.com.br/contato/) on June, 23rd, 2018. No answer. |