Gűműşel 2011.

Methods	This was a randomised, single‐blind, actively‐controlled study. Intention‐to‐treat analysis was not performed.
Participants	Inclusion criteria of the trial The study included 37 consecutive psoriatic participants with nail involvement aged between 25 and 68 years of either gender. 34 participants completed the 6‐month study. Diagnosis of psoriatic nail was based on the presence of diagnostic psoriatic nail signs on fingernails. Psoriatic participants with nail involvement had psoriatic lesions on more than 10% of their total body surface area (BSA), a minimum PASI of 10, and a NAPSI score of 10 or greater. Participants had stopped all topical therapy at least 4 weeks before and all systemic therapies for at least 6 months before initiating the study protocol. Exclusion criteria of the trial The study excluded participants with positive findings from native or culture for fungi.
Interventions	Methotrexate was administered at 15 mg single dose weekly (subcutaneously) with folic acid 5 mg daily except on the days of administration of methotrexate. If no side‐effects occurred, it was applied for the first 3 months. In the second 3 months, the dose was planned to be decreased to 10 mg/week. Ciclosporin 5 mg/kg daily (divided into 2 doses) was applied. In case of absence of side‐effects, it was planned to apply this dose for the first 3 months. In the second 3 months, the dose was planned to be decreased to 2.5 to 3.5 mg/kg/day. The treatment period lasted 24 weeks, and follow up was for at least 3 months after the end of treatment.
Outcomes	Outcome measures were evaluated at baseline and at weeks 4, 8, 12, 16, 20, and 24 using the NAPSI. In addition, nail matrix and bed scores in hand and foot were evaluated separately before and after the treatment in the 2 groups. Outcomes of the trial Using the NAPSI score, the participants' responses were classified at the end of the treatments as no improvement (< 5% improvement), mild improvement (> 5% to 50% improvement), moderate improvement (> 50% to 99%), and complete improvement (100% improvement). At each visit, the physician performed a global assessment, which is a general evaluation of a psoriatic nail, using a scale of 0 to 10, with a score of 0 indicating the worst involvement of nail and a score of 10 for the absence of nail involvement. Similar evaluation was performed by the participants as the participant's global score. All participants were monitored for adverse effects at each visit using a standardised questionnaire and followed up for at least 3 months after the end of treatment.
Notes	During the study and the follow‐up period, additional therapy was restricted to the use of emollients that were applied once daily in the evening.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomized assignment of either of the two treatments was performed by asking the patients to throw a dice."
Allocation concealment (selection bias)	Low risk	Randomised assignment of either of the 2 treatments was performed by asking the participants to throw a dice without knowing the underlying allocation criteria (numbers 1 to 3 = ciclosporin; numbers 4 to 6 = methotrexate).
Blinding (performance bias and detection bias) Clinician/ Investigator	Unclear risk	Quote: "...a one‐blind study. Outcome measures were evaluated by an independent observer (MÖ). At each visit, the physician (MÖ) performed a global assessment." Comment: It was unclear if the physician was blinded. It was unclear if the physician was the same person as the independent/blinded observer.
Blinding (performance bias and detection bias) Participants	High risk	Quote: "...a one‐blind study." Comment: The participants were not blinded for the treatment.
Blinding (performance bias and detection bias) Outcome assessor	Unclear risk	Quote: "...a one‐blind study. The scores were determined by a blinded observer. Outcome measures were evaluated by an independent observer (MÖ). At each visit, the physician (MÖ) performed a global assessment." Comment: It was unclear if the independent/blinded observer was the physician, who probably was not blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "Of the 37 participants, 34 completed the study. 1 participant discontinued treatment before the end of the treatment in the methotrexate group because of elevation of liver transaminase. Of the ciclosporin withdrawals, 2 participants developed elevation in serum creatinine and lipids. These 3 participants were excluded from the statistical analysis." Comment: These dropouts were < 20% and present in both study arms.
Selective reporting (reporting bias)	Low risk	Comment: The expected outcomes were reported.
Other bias	Low risk	Baseline demographics and disease features were similar to that of the groups. There was no conflict of interest