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. 2021 Jul 5;2021(7):CD011301. doi: 10.1002/14651858.CD011301.pub2

NCT01180348.

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

Notes Sponsor Azidus Brasil
We sent an email to this company (http://laboratoriobergamo.com.br/contato/) on June, 23rd, 2018. No answer.