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 |
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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 |
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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 |
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Outcomes |
Primary outcomes
Secondary outcomes
Other outcomes that were not analysed in this review
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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 |