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. 2020 May 1;2020(5):CD011368. doi: 10.1002/14651858.CD011368.pub2

Hayashi 2012.

Study characteristics
Methods Aim of study: to evaluate AZA 20% cream efficacy in Japanese participants with AV
Design: randomised placebo‐controlled investigator‐blinded split‐face study
Unit of allocation: face
Allocation: randomisation; no details
Blinding: blinding for investigators
Duration of trial (from recruitment to last follow‐up): not described
Dropouts: not described
Participants Population description: Japanese participants with AV
Setting: multicentres in Japan, all participants were Japanese
Randomised number: 66
Age: ≥ 16 years old
Sex: unclear
Severity of illness: AV with more than 30 total lesion counts
Interventions Name of treatment group: 20% AZA cream n = unclear (see notes)
Description: 20% AZA cream
Treatment period: 12 weeks
Timing: twice daily
Name of treatment group: placebo n = unclear (see notes)
Description: placebo group
Treatment period: 12 weeks
Timing: twice daily
Outcomes Primary outcomes
  • Participants' global self‐assessment of acne improvement (e.g. measured by a 4‐point scale: excellent, good, fair, and poor). Authors did not report this outcome

  • Withdrawal for any reason. Authors did not report this outcome


Secondary outcomes
  • Change in lesion counts (total or inflamed and non‐inflamed separately). Week 12

  • Physicians' global evaluation of acne improvement. Authors did not report this outcome

  • Minor adverse events (assessed as total number of participants who experienced at least one minor adverse event). Authors reported subjective symptoms, but with no numerical data

  • Quality of life. Authors did not report this outcome

Notes The study authors did not report the number of participants allocated to each group.
Funding: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Although 'randomised' was mentioned, no details were reported for random sequence generation.
Allocation concealment (selection bias) Unclear risk No details of allocation concealment were described.
Blinding of participants and personnel (performance bias)
All outcomes Low risk This study was an 'investigator‐blinded', 'placebo‐controlled' study. Blinding probably sufficient
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk This study was an 'investigator‐blinded', 'placebo‐controlled' study.
Insufficient information about how blinding of outcome assessor was ensured.
Incomplete outcome data (attrition bias)
All outcomes Unclear risk This was not stated.
Selective reporting (reporting bias) Unclear risk Study published as poster only
Other bias Low risk No other potential bias identified