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

Babayeva 2011.

Study characteristics
Methods Aim of study: to evaluate the efficacy and safety of combination therapy with all‐TRA 0.05% cream plus CDP 1% lotion (all‐TRA + CDP group) in comparison with the combination of 3% alcohol‐based SA plus CDP 1% lotion (SA + CDP group) in the treatment of mild to moderate facial AV
Design: parallel
Unit of allocation: patients
Allocation: randomised; no details of random methods were provided
Blinding: single‐blinding; open label for assessors
Duration of trial (from recruitment to last follow‐up): not described
Dropouts: none
Participants Population description: mild to moderate facial AV
Setting: not described
Randomised number: 46
Age: 18 to 31 in treatment group; 18 to 26 in control group
Sex (M/F): 5/18 in treatment group; 5/18 in control group
Severity of illness: mild to moderate
Total lesion counts: 66.52 ± 8.04 in treatment group; and 66.52 ± 8.04 in control group;
Inflammatory lesion counts: 21.95 ± 7.18 in treatment group; and 20.65 ± 7.73 in control group;
Non‐inflammatory lesion counts: 44.78 ± 6.12 in treatment group; and 45.43 ± 6.38 in control group
Interventions Name of treatment group: SA + CDP group n = 23
Description: combination of 3% alcohol‐based SA plus CDP 1% lotion
Treatment period: 12 weeks
Timing: twice‐daily
Name of treatment group: all‐TRA + CDP group n = 23
Description: all‐TRA 0.05% cream plus CDP 1% lotion
Treatment period: 12 week
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; week 12; 5‐point scale, 0: worsening or unchanged, 1: mild improvement, 2: moderate improvement, 3: good improvement and 4: excellent improvement)

  • Withdrawal for any reason (no withdrawals)


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

  • Percentage reduction in lesion counts, baseline and week 2, 4, 8, and 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 and 4: excellent improvement)

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

  • Quality of life. AQOL questionnaire, week 12


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

  • Skin surface barrier

Notes Funding: not described
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "This 12‐week study was designed as a single‐blind, randomised, 1:1 parallel group and comparative investigation...";
Quote: "Patients were randomised to receive topical treatments for AV with one of two topical agent combinations..."
Comment: no details of random methods were provided
Allocation concealment (selection bias) Unclear risk No detail of concealment approach was provided
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Quote: "This 12‐week study was designed as a single‐blind, randomised, 1:1 parallel group and comparative investigation...",
Comment: unclear which side was blinded
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote: "Evaluations were performed by an investigator aware of the treatment allocation at baseline and after 2, 4, 8 and 12 weeks of treatment."
Comment: outcome assessment was not blinded
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "The 12‐week treatment periods were completed by all subjects."
Comment: no missing outcome data
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