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

Vonderheid 1987.

Study characteristics
Methods This was a randomised, double‐blind, within‐participant trial, which lasted 4 weeks.
Participants The study recruited 6 participants (2 lesions per treatment) with plaque phase MF, MFCG stage nomenclature of 1979 stage IA (T1, Nx, T0, M0), stage IB (T2, Nx, T0, M0), or stage IIA (T2, N1, T0, M0)
Demographics of the included participants
  • 3 men and 3 women

  • Mean age (range) = 59.5 years (33 to 68 years)

  • Stages of disease: IA: 1, IB: 1, IIA: 4

  • 0 participants were lost to follow‐up


Exclusion criteria of the trial
  • Any topical therapy within 4 weeks prior to the study

  • Any previous systemic cytotoxic therapy

  • Any previous exposure to exogenous interferon or interferon‐inducer

  • History of cardiac disease, pulmonary embolism, or thrombophlebitis

  • History of exposure to radiation in areas of observation

Interventions
  • The intervention group was given IFN‐α 2b injections 106 units 3 times weekly at 2 representative sites.

  • The control group was given placebo injections with isotonic sterile water 3 times weekly at 2 representative sites.

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

  2. Percentage of participants demonstrating clearance (defined by clearance of at least 90% of all lesion surfaces, lesions, or tumour size) (assessed 4 weeks after the end of the intervention)

Notes The funding body and conflicts of interest were not declared.
This study was conducted in a tertiary care centre in the USA.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Lesions were allocated by a random code; no further information was given; information was sought, but we received no response.
Allocation concealment (selection bias) Unclear risk Information was sought, but we received no response.
Blinding of participants and personnel (performance bias)
All outcomes Low risk The trial was described as double‐blind for the first part, which we data extracted.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No separate outcome assessor was described.
Incomplete outcome data (attrition bias)
All outcomes Low risk ITT analysis was carried out. There were no dropouts.
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 Unclear risk There were insufficient information to permit judgement.