Skip to main content
. 2021 Jul 5;2021(7):CD011301. doi: 10.1002/14651858.CD011301.pub2

Lee 2013.

Study characteristics
Methods Study design‐ double‐blinded, randomised, active‐controlled, parallel‐design, phase III study in glabellar lines (Poster)
Study date‐ no information
Study setting‐ no information
Participants Randomised 314 participants. Age‐ no information. Gender ‐ no information
Inclusion criteria‐ no information
Exclusion criteria‐ no information
Severity of disease‐ moderate to severe glabellar lines at maximal contraction
Ethnicity‐ no information
Interventions Duration of study‐ 16 weeks
Intervention
  • New BontA (20 U) [Medytox®] (N = 157)


Comparator
  • OnabotulinumtoxinA (20 U) (N = 157)


Ratio‐ 1:1 (New BontA[Medytox®]: OnabotulinumtoxinA)
Outcomes Primary outcome
  • Responder rate by the investigator's live assessment at maximum frown at week 4


Secondary outcomes
  • Responder rates by investigator's live assessment with frowning and at rest at weeks 8, 12 and 16, with additional photographic assessment by a panel of blinded raters four weeks after the injections

  • Subjective satisfaction

  • Adverse events

Notes WS Lee worked in the Medical Department of Medytox Inc., Ochang, South Korea
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "patients was randomised at a 1:1 ratio to receive 20U of toxin" page 116
Comment: we considered unclear risk of bias because the authors did not explain how they randomised the participants
Allocation concealment (selection bias) Unclear risk Quote: "patients was randomised at a 1:1 ratio to receive 20U of toxin" page 116
Comment: we considered unclear risk of bias because the authors did not explain the methods used for maintain the allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Quote: "double‐blinded" page 116
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‐blinded" page 116
Comment: we considered this unclear risk of bias because the authors did not explain how they blinded the outcome assessors
Incomplete outcome data (attrition bias)
All outcomes Unclear risk No information about losses
Comment: we considered unclear risk of bias
Selective reporting (reporting bias) High risk Incomplete data. The authors reported only the outcomes assessed at week 4
Comment: we considered this high risk of bias
We e‐mailed authors on June 21, 2018, but the electronic address was wrong and we could not find a valid e‐mail.
Other bias Unclear risk The author worked for Medy‐tox
Comment: we considered this a unclear risk of bias