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

Aksakal 1997.

Study characteristics
Methods Aim of study: to compare the efficacy and skin tolerance of metronidazole 1% cream and AZA 20% cream in the treatment of moderate to severe acne
Design: parallel
Unit of allocation: individuals
Allocation: randomisation; no details of sequence generation methods
Blinding: unclear
Duration of trial (from recruitment to last follow‐up): not described
Dropouts: none
Participants Population description: moderate to severe AV
Setting: not described
Randomised number: 40
Age (years): average 19.2 (range 14 to 27)
Sex (M/F): 2/18 in treatment group; 14/6 in control group
Severity of illness: moderate to severe acne
Interventions Name of treatment group: AZA n = 20
Description: AZA 20%
Treatment period: 12 weeks
Timing: twice‐daily
Name of treatment group: metronidazole n = 20
Description: metronidazole 1%
Treatment period: 12 weeks
Timing: twice‐daily
Outcomes Primary outcomes
  • Participants' global self‐assessment of acne improvement (e.g. measured by a four‐point scale: excellent, good, fair, and poor). Authors did not report this outcome

  • Withdrawal for any reason. No withdrawals


Secondary outcomes
  • Change in lesion counts (inflamed and non‐inflamed). Authors reported P value, 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). Only mentioned but no usable data.

  • Quality of life


Authors did not report this outcome
Notes Funding: not described
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Forty patients with only moderate to severe acne participated in this randomised, comparative study".
Comment: no details of random methods was described
Allocation concealment (selection bias) Unclear risk No details of concealment were described
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Not mentioned
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not mentioned
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "Forty patients...participated in...", "the study was completed with 40 patients".
Comment: no missing outcome data
Selective reporting (reporting bias) Unclear risk Insufficient baseline data reported
Other bias Low risk No other potential bias identified