Paller 2005a.
Methods | Randomised controlled trial | |
Participants | 125 children, 1 to 12 years of age, with molluscum contagiosum in 9 outpatient clinics in the USA and Canada were randomised. | |
Interventions | Imiquimod cream 5% vs vehicle cream daily for 8 weeks | |
Outcomes | Lesion clearance, lesion counts, time to complete clearance, side effects, 12 weeks after start of treatment | |
Notes | Funding by pharmaceutical company (3M), unpublished | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “Subjects were randomly assigned to a treatment arm in blocks of 4 according to a computer‐generated randomizations.” (p.32) |
Allocation concealment (selection bias) | Low risk | “Subjects/legal parental custodian(s) and investigators were unaware of the study assignment” (p.25) "This was a double‐blind, vehicle‐controlled study. 3M held the master code for the treatment randomizations schedule and supplied the investigators with each subject’s randomizations code as a hidden (tear‐off) disclosure panel on the study cream carton label. The randomizations code for an individual subject was to be broken only in case of an emergency, such as a serious adverse event (SAE)." (p.34) |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | See allocation concealment. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | See allocation concealment. |
Incomplete outcome data (attrition bias) Short‐term outcomes (up to 3 months) | Low risk | Not applicable: primary analysis by intention‐to‐treat |
Incomplete outcome data (attrition bias) Medium‐ and long‐term outcomes (3‐6 months and longer) | Unclear risk | No long‐term outcomes |
Selective reporting (reporting bias) | Low risk | All outcomes seem to have been reported. |
Other bias | Low risk | No baseline imbalance, compliance data available, primary analysis by intention‐to‐treat |