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
Secondary outcomes
|
|
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 |