| Methods |
Randomised controlled trial |
| Participants |
23 children, 1 to 9 years of age, M/F 12/11, USA, Alabama, Illinois, New York |
| Interventions |
Imiquimod cream 5% or vehicle 3 times a week for 12 weeks |
| Outcomes |
Complete or partial clearance (> 30% decrease from baseline lesion count), adverse events after 4, 8, and 12 weeks |
| Notes |
Presented as a pilot study. Funding: not mentioned, but 1 of the authors was reported to be a consultant for 3M Pharmaceuticals, and was also the principal investigator of 2 other unpublished studies funded by this company (Paller 2005a; Paller 2005b). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "Eligible patients were randomised to either imiquimod or vehicle". Insufficient information |
| Allocation concealment (selection bias) |
Unclear risk |
Quote: "Eligible patients were randomised to either imiquimod or vehicle". Insufficient information |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "In a Double Blind, Randomized Pilot Trial"; "imiquimod vs vehicle". Only participants and physicians involved, so probably at low risk of bias. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "In a Double Blind, Randomized Pilot Trial"; "imiquimod vs vehicle". Only participants and physicians involved, so probably at low risk of bias. |
| Incomplete outcome data (attrition bias)
Short‐term outcomes (up to 3 months) |
Low risk |
2 weeks: 2/23 did not complete the study (discontinued treatment) |
| Incomplete outcome data (attrition bias)
Medium‐ and long‐term outcomes (3‐6 months and longer) |
Unclear risk |
No medium‐ or long‐term follow‐up |
| Selective reporting (reporting bias) |
Unclear risk |
Unclear |
| Other bias |
Unclear risk |
Baseline imbalance for mean lesion count, imiquimod: 27.0 versus vehicle: 19.4 (not statistically significant). No compliance data |
