Vieyra‐Garcia 2019.

Study characteristics
Methods	A multi‐centre, randomised study on oral 8‐methoxypsoralen plus UVA with or without maintenance therapy in Mycosis Fungoides EORTC/ISCL Stage IA to IIA
Participants	This study recruited 27 participants with cutaneous T‐cell lymphoma stages IA‐IIA, who received treatment with oral 8‐methoxypsoralen followed by UV‐A exposure 2 times per week for 12 to 24 weeks until CR. Then, patients with CR were randomised to PUVA maintenance for 9 months (14 total exposures) or no maintenance. Demographics of the included participants 19/27 (70%) of patients were male (distribution within groups not reported) 9 out of 27 had plaque and patch type lesions while the rest had patch type disease only Stage IA and IB had 13 patients each and one patient had stage IIA disease Exclusion criteria of the trial Photosensitive diseases such as lupus erythematosus or basal cell nevus syndrome Skin cancer syndromes such as xeroderma pigmentosum or basal cell nevus syndrome
Interventions	Arm I PUVA maintenance for 9 months (14 total exposures) after complete response or Arm II No maintenance therapy after complete response
Outcomes	Primary outcomes of the trial Recurrence after complete remission within 12 months post therapy defined as mSWAT (modified severity weighted assessment tool) > 0 Secondary outcomes of the trial Cytokine response in serum Proliferative capacity of blood circulating T‐cells Cytokine expression in the skin Expression of Treg‐related molecules in lesional tissue
Notes	This study was supported by several research grants: Research grant W1241 from the Förderung der wissenschaftlichen Forschung Fund (FWF) Austrian Science Fund Grant 15463 from the Oesterreichische Nationalbank Anniversary Fund and the Austrian Society of Dermatology and Venereology (Dr Wolf) RO1 grant CA203721 from the National Institutes of Health/National Cancer Insitute (Dr Clark) PhD program Molecular Fundamentals of Inflammation (MOLIN) from the Medical University of Graz, Austria, (Dr Vieyra‐Garcia and Mr Patra) The study medication for this trial was provided by G.L. Pharma GmbH, Lannach, Austria
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Patients were randomised by a computer‐generated list.
Allocation concealment (selection bias)	Low risk	Allocation was concealed.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Since blinding of participants was hardly possible, we judged lack of blinding as an unclear risk.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	The study did not provide information about this. The authors stated that blinding was hardly possible due to tanning of the skin.
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis was carried out. There was one dropout due to adverse effects. However, this occurred before randomisation. Seven out of 27 participants were excluded because they did not reach CR, which was a prerequisite for randomisation.
Selective reporting (reporting bias)	High risk	Authors initially planned to report several secondary outcomes such as quality of life or the hospital anxiety depression score. However, these were not reported in the final publication.
Other bias	High risk	The calculated sample size for statistical significance was not met (82 participants and an assumed 10% dropout rate)