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

Park 2014.

Study characteristics
Methods Study design‐ randomised, double‐blind, split‐face design in crow's feet lines and masseter
Study date‐ no information
Study setting‐ no information
Participants Randomised 56 participants, with mean age of 43.4 years, range 23‐69 years. Gender: 94.6% female, 5.4% male
Inclusion criteria
  • Patients complaining of periocular wrinkles


Exclusion criteria
  • Patients who had been treated with filler, BT injection, or other photo rejuvenation procedure within 6 months before enrolment

  • Patients were not permitted to use topical tretinoin or other retinol‐containing cosmetics during and after treatment until the end of the study.

  • Pregnancy, active nursing

  • Pre‐existing neuromuscular conditions

  • History of drug allergy or any other serious medical disorder, and medications which can be affected by BontA injection (e.g. aminoglycosides, penicillamine, quinine, calcium channel blocker, and anticoagulant drugs, etc)


Severity of disease‐ crow's feet lines, masseter
Ethnicity‐ no information
Interventions Duration of study‐ 16 weeks
Intervention
  • IncobotulinumtoxinA (7.5 U), 3 points (N = 56)


Comparator
  • OnabotulinumtoxinA (7.5 U), 3 points (N = 56)


Ratio‐ 1:1 (IncobotulinumtoxinA:OnabotulinumtoxinA)
Outcomes Primary outcome
  • Investigator assessment of maximal contraction at week 1 and 16. Difference of FWS by investigator week 1 and 16


Secondary outcomes
  • Onset time

  • Patient FWS maximum contraction in weeks 1 and 16

  • Visual analogic scale by patient weeks 1, 4 and 16

  • Adverse events

Notes Quote: "Authors do not have any kind of conflict of interest regarding this study"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "a randomised,double‐blind" page 326
Comment: we considered this unclear risk of bias because the authors did not explain how they randomised the participants
Allocation concealment (selection bias) Unclear risk No information
Comment: we considered this unclear risk of bias due to the authors did not explain the methods used to maintain the allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Quote: "double‐blind, split‐face" page 326
Comment: we considered this unclear risk of bias because the authors did not explain how they blinded the participants
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Quote: "double‐blind,split‐face" page 326
Comment: we considered this unclear risk of bias because the authors did not explain how they blinded the participants
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Quote: "in the periocular rhytides group 56 subjects completed the study" page 328
Comment: we considered this unclear risk of bias because the authors did not explain the reason of drop outs
Selective reporting (reporting bias) Low risk All prespecified outcomes were reported
Comment: we considered this low risk of bias
Other bias Low risk We considered this study at low risk of other bias