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. 2020 Jul 7;2020(7):CD008946. doi: 10.1002/14651858.CD008946.pub3

Chong 2004.

Study characteristics
Methods This was a randomised, double‐blind, parallel‐group trial, which lasted 4 months.
Participants The study recruited 4 participants (3 in the intervention group and 1 in the control group) with histologically‐proven MF plaque stage 1B MF (T2N0M0).
Demographics of the included participants
  • 4 men and 0 women

  • Mean age (range) = 54 years (39 to 61 years)

  • 0 participants were lost to follow‐up


Exclusion criteria of the trial
These were not reported.
Interventions
  • The intervention group was given imiquimod 5% applied daily; the contact time was 8 hours for 16 weeks.

  • The control group was given placebo cream applied daily; the contact time was 8 hours for 16 weeks.

Outcomes Outcomes of the trial
  1. Common adverse effects of the treatments

  2. Percentage of participants demonstrating complete response (CR) (defined as complete disappearance of all clinical evidence of disease)

  3. Objective response rate (ORR) defined as proportion of patients with CR and partial response (PR). A PR is considered as a regression of measurable disease of at least 50% in one of the categories T, N, M and B without any progression of disease.

  4. Rare adverse effects

Notes The funding body was 3M Health Care Limited supplied Aldara. Conflict of interest not reported.
This study was conducted in the United Kindom (1 centre).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The study did not provide information about this.
Allocation concealment (selection bias) Unclear risk The study did not provide information about this.
Blinding of participants and personnel (performance bias)
All outcomes Low risk The study was described as double‐blind.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk There were insufficient information to permit judgement.
Incomplete outcome data (attrition bias)
All outcomes Low risk No dropouts were reported.
Selective reporting (reporting bias) Unclear risk This was unknown. We contacted the corresponding author for additional outcome data, but we received no reply within 4 weeks.
Other bias Low risk None were found.