Wolff 1985.
Study characteristics | ||
Methods | This was a randomised, double‐blind, parallel‐group trial, which lasted 8 weeks. | |
Participants | The study recruited 12 participants (9 from the intervention group and 3 from the control group) with early plaque or patch stage MF (stage IA or IB), with no evidence of physical examination on lymphadenopathy or organomegaly. Demographics of the included participants
Exclusion criteria of the trial
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Interventions |
a) IFN‐α 2MU in superficial dermis 3 times weekly; b) betamethasone dipropionate ointment 0.05% twice daily; or c) no treatment.
a) placebo (buffered glycine serum human albumin) in superficial dermis 3 times weekly; b) betamethasone dipropionate ointment 0.05% twice daily; or c) no treatment. |
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Outcomes |
Outcomes of the trial
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Notes | Objective response was reported as mean difference in size of lesions without the possibility to identify participants' objective response rate according to our defined secondary outcome. Lesions in the IFN‐α group generally improved better than in the placebo group, possibly due to a systemic effect of IFN‐α as discussed by the authors. The IFN‐α was supplied by Schering Corp. This study was conducted in a tertiary care centre in Pittsburgh, USA. Conflicts of interest were not declared. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The study did not provide information about this. We sought information, but received no response. |
Allocation concealment (selection bias) | Unclear risk | The study did not provide information about this. We sought information, but received no response. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | This trial had a double‐blind setting. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Histopathological features of biopsies were assessed without knowledge of the treatment or group. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT analysis was carried out. There were no dropouts. |
Selective reporting (reporting bias) | High risk | Only the mean difference in the decrease of the lesions were reported; no incidence of partial remission (i.e. > 50% reduction of disease) was reported. The corresponding author was contacted for additional outcome data but did not respond within 4 weeks. |
Other bias | High risk | The groups were unequal: There was a higher proportion of stage 1B, more men, longer duration of skin disease, and longer time since diagnosis in intervention group. |