Skip to main content
. 2020 Jul 7;2020(7):CD008946. doi: 10.1002/14651858.CD008946.pub3

Child 2004.

Study characteristics
Methods This was a randomised, open‐label, cross‐over trial, which lasted 12 months.
Participants The study recruited 16 participants (10 were in the PUVA‐first group; 6 were in the ECP‐first group) with plaque‐stage (1B ⁄ T2, Bunn Lamberg 1B) MF and a peripheral blood T‐cell clone (detected by polymerase chain reaction (PCR)‐single‐strand conformational polymorphism (SSCP) methodology), but with no evidence of lymph node involvement.
Demographics of the included participants
  • 12 men and 4 women

  • Mean age (range) = 65.1 years (37 to 80 years)

  • 8 participants were lost to follow‐up (3/10 = 30% in the PUVA‐first group; 5/6 = 83% in the ECP‐first group), resulting in 8 participants evaluated (7 in the PUVA‐first group and 1 in the ECP‐first group)


Exclusion criteria of the trial
  • Haemoglobin < 11 g ⁄dL

  • Cardiac, liver, or renal impairment or positive HTLV‐1 (human T‐lymphotropic virus type 1) serology

  • Pregnancy

  • Progressive disease

Interventions
  • The PUVA‐first group was given PUVA twice a week for 3 months followed by ECP once monthly for 6 months (doses not reported).

  • The ECP‐first group was given ECP once monthly for 6 months followed by PUVA twice a week for 3 months (doses not reported).

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

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

  3. Overall survival (assessed 2 to 21 months after the end of the intervention)

  4. Objective response rate

Notes No information for funding and conflict of interests given. This study was conducted at Skin Tumour Clinic, St John's Institute of Dermatology, United Kingdom.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "envelopes, numbered from 1 to 20, randomly allocating patients to Group 1 or Group 2, were generated by the statistician."
Comment: we judged this to be of low risk.
Allocation concealment (selection bias) Unclear risk It was unclear whether the used envelopes were sealed and opaque.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk This was not possible because of different types of interventions, so we judged this domain as unclear risk.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk There was insufficient information to permit judgement.
Incomplete outcome data (attrition bias)
All outcomes High risk 8/16 participants (50%) were lost to follow‐up: 3/10 participants in the PUVA‐first group and 5/6 participants in the ECP‐first group.
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 High risk It was unclear if concomitant medication was permitted.