Aldara 3M 2000b.
Study characteristics | ||
Methods | This was a phase II research trial. The setting was unclear, but it was multicentre. This study was blinded. Intention‐to‐treat analysis was carried out. This study was conducted in the USA. |
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Participants | 200 participants were recruited. Inclusion criteria of the trial
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Interventions |
Four dosing regimens were included ‐ 3 times weekly with tape occlusion, daily with tape occulusion, 3 times weekly with no tape occulusion, daily with no tape occlusion ‐ versus placebo groups with and without tape occlusion. Warts were pared at interval visits (1‐ to 2‐week intervals). There was 12 weeks of treatment. |
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Outcomes |
Outcomes of the trial
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Notes | This was unpublished trial data on 'Aldara' cream. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | This study was randomised. |
Allocation concealment (selection bias) | Unclear risk | This was unclear. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | 'Modified blind' was stated. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | 'Modified blind' was stated. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | This was unclear: Intention‐to‐treat analysis and PP analyses were discussed, but the number of dropouts was not stated. |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes were reported. |