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

Akarsu 2012.

Study characteristics
Methods Aim of study: to evaluate the efficacy and safety of the addition of 3% SA in 70% alcohol treatment to 1% CDP lotion and 5% BPO gel and compare it with the addition of only 70% alcohol to 1% CDP lotion and 5% BPO gel in the treatment of mild to moderate facial AV
Design: parallel
Unit of allocation: individuals
Allocation: randomisation; no details of sequence generation methods
Blinding: only single‐blind (assessors as following) was used
Duration of trial (from recruitment to last follow‐up): not described
Dropouts: one withdrawal because of change of city
Participants Population description: mild to moderate facial AV
Setting: not described
Randomised number: 50
Age (years): 18 to 28 in treatment group; 18 to 29 in control group
Sex (M/F): 7/17 in treatment group; 6/19 in control group
Severity of illness: mild to moderate
Total lesion counts: 80.50 (72.83 to 94.84) in treatment group; and 77.00 (76.06 to 95.14) in control group;
Inflammatory lesion counts: 25.50 (21.01 to 29.24) in treatment group; and 28.00 (21.64 to 29.40) in control group;
Non‐inflammatory lesion counts: 60.00 (49.39 to 68.02) in treatment group; and 59.00 (50.43 to 67.33) in control group
Interventions Name of treatment group: SA and CDP + BPO group n = 25
Description: the addition of 3% SA in 70% alcohol treatment to 1% CDP lotion and 5% BPO gel
Treatment period: 12 weeks
Timing: twice‐daily (morning and evening)
Name of treatment group: CDP + BPO group n = 25
Description: combination of CDP and BPO
Treatment period: 12 weeks
Timing: twice‐daily (morning and evening)
Outcomes Primary outcomes
  • Participants' global self‐assessment of acne improvement (e.g. measured by a four‐point scale: excellent, good, fair, and poor) (week 12; 5‐point scale: 0 = worsening or unchanged, 1 = mild improvement, 2 = moderate improvement, 3 = good improvement, 4 = excellent improvement)

  • Withdrawal for any reason (1 withdrawal, week 2)


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

  • Percentage reduction in lesion counts, from baseline to week 12

  • Physicians' global evaluation of acne improvement (week 12; 5‐point scale: 0 = worsening or unchanged, 1 = mild improvement, 2 = moderate improvement, 3 = good improvement, 4 = excellent improvement)

  • Minor adverse events (assessed as total number of participants who experienced at least one minor adverse event) (symptoms assessed using a 4‐point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe); number of participants who experienced minor adverse event, week 12)

  • Quality of life (AQOL questionnaire)


Other outcomes that were not analysed in this review
  • Time to 50% reduction in total lesion counts

  • Skin barrier functions

Notes Funding: not described
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Patients were randomised to receive topical treatments for AV with one of the two treatment protocols...".
Comment: no details of random methods were described
Allocation concealment (selection bias) Unclear risk No details of concealment were described
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "This 12‐week study was designed as a single‐blind, randomised, 1:1 parallel group comparative investigation...".
Comment: only single‐blind (assessors as following) was used
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Quote: "Evaluations were performed by a blinded investigator to avoid subjective bias at baseline and after 2, 4, 8 and 12 weeks of treatment."
Comment: insufficient information about method to ensure blinding of outcome assessor
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "One patient voluntarily withdrew from the study after the first visit because of change of city."
Comment: 4% of dropouts happened in the intervention group. Although no ITT analysis was used and imbalance rates of dropouts presented in the study, this withdrawal was unlikely to influence the effect.
Selective reporting (reporting bias) Low risk Results reported for all prespecified outcomes in the methods section
Other bias Low risk No other potential bias identified