Wozniak 2008.

Study characteristics
Methods	This was a randomised, open‐label, parallel‐group trial, which lasted 24 weeks.
Participants	The study recruited 29 participants (12 in the intervention group and 17 in the control group) with mycosis fungoides stage IA to IIA. Demographics of the included participants 12 men and 17 women Median age = 52 years Stages of disease: IA: 14, IB: 6, IIA: 9 0 participants were lost to follow‐up Exclusion criteria of the trial Pregnant or lactating women Fertile women not accepting contraception Medical history of melanoma or non‐melanoma skin cancer Concomitant infections Immunodeficiency states Previous heart disease Respiratory insufficiency Chronic renal insufficiency Chronic hepatopathy Epilepsy Depression Leucocytes < 3000, or neutrophils < 1000, or thrombocytes < 100000, or haemoglobin < 12 g/dL, or ANA < 1/80 Treatment with systemic steroids Altered thyroid hormones Previous resistance to PUVA, IFN‐α, or both Hypersensitivity to IFN‐α Participants under treatment with theophylline, dicumarol, or both Previous total skin electron beam Wash‐up period less than 3 month for IFN‐α, PUVA, or both Wash‐up period less than 1 month for topical treatments
Interventions	The intervention group was given PUVA in weeks 1 to 24, 0.6 mg/kg methoxsalen (8‐MOP) 3 times a week, with 2 hours pre UVA irradiation (1 to 2 Jul/cm² according to phototype, increasing to 10 Jul/cm², if tolerated) and IFN‐α week 1: 3, 6, and 9 MU (Monday, Wednesday, Friday), weeks 2 to 24: 9 MU 3 times a week). The control group was given PUVA as described above.
Outcomes	Outcomes of the trial Percentage of participants demonstrating clearance (defined by clearance of at least 90% of all lesion surfaces, lesions, or tumour size) Relapse defined as the time period after remission when the eruption reappears after short‐term clearance
Notes	The funding body was Ministerio de Ciencia y Tecnologia (BIO2000‐0275‐C02 ⁄01‐⁄02, SAF2001‐0060, SAF2005‐00221), Comunidad Autonoma de Madrid (CAM 08.1 ⁄0011 ⁄2001.1), and the Ministerio de Sanidad y Consumo (FISP05 ⁄1710, FIS 01‐0035, G03 ⁄179, PI051623) RETICS, Spain. The author, MBW, was supported by FISP05 ⁄1710, and LT was supported by grants from the CNIO and the Higher Education Authority of Ireland, St James Hospital, Dublin. Participants were categorised to responders and non‐responders instead of treatment groups. Some information was taken from the clinicaltrials.gov website (NCT00630903). The main primary aim of the study was to examine the gene expression profiles of primary skin biopsies from these participants. This study was conducted in 9 tertiary care hospitals in Madrid, Spain.
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	High risk	This was taken from the previous version of the NCT00630903 protocol: "The study was described as open‐label."
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	The study did not provide information about this. We sought information, but received no response.
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis was carried out. There were no dropouts.
Selective reporting (reporting bias)	High risk	Participants were characterised and divided into responders and non‐responders instead of treatment groups. We contacted the corresponding author for additional outcome data, but we received no reply within 4 weeks.
Other bias	High risk	Some information was taken from protocol NCT00630903 (www.clinicaltrials.gov). The study was described as terminated due to insufficient accrual.

AEs: adverse effects; CR: complete response; CTCL: cutaneous T‐cell lymphomas; ITT: intention‐to‐treat; LCT: large cell trnsformation; MF: Mycosis fungoides; MFCG: Mycosis Fungoides Cooperative Group; mSWAT: modified severity weighted assessment tool; PR: partial response; PUVA: psoralen plus ultraviolet A; QoL: quality of life;SS: Sézary syndrome.