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

Solish 2018.

Study characteristics
Methods Study design‐ multicentre, randomised, dose‐ranging placebo‐controlled, parallel‐design in glabellar lines (BELMONT STUDY). Phase II
Study date‐ no information
Study setting‐ outpatients
Participants Randomised 268 participants aged 30‐65 years of age. Gender: 80% of participants were female
Incluion criteria: no information
Exclusion criteria : no information
Ethinicity‐ 85% were "white"
Severity of the disease: moderate‐to‐severe glabellar lines
Interventions Duration: from 24 weeks to 36 weeks
Intervention
DaxibotulinumtoxinA 20U, 40 U, 60 U in the glabellar lines
Comparator
OnabotulinumtoxinA 20 U in the glabellar lines
Placebo in the glabellar lines
Ratio: (1:1:1)
Outcomes Primary outcome
  • Proportion of participants with 1 grade change in GL severity at week 24.


Secondary outcomes
  • Responders at weeks 4 and 24 for the primary endpoint

  • Proportion of participants with none/mild GL at these time point

  • Adverse events

Notes Poster
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "The BELMONT study was a randomized, "....page S106
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 Quote: "The BELMONT study was a randomized, "....page S106
Comment: we considered this unclear risk of bias because the authors did not explain how they randomised the participants
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Quote: "The BELMONT study was a randomized, "....page S10
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: "The BELMONT study was a randomized, "....page S10
we considered this unclear risk of bias because the authors did not explain how theey keep the participants blinded
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Quote: no information
Comment: we consider an unclear risk of bias
Selective reporting (reporting bias) Unclear risk The authors did not show all the endpoints
Comment: we consider an unclear risk of bias
Other bias Unclear risk This study is a poster