NCT02655705

Trial name or title	Comparison study of psoriasis severity assessment tools
Methods	RCT, placebo‐controlled, open‐label study Date of study: September 2015 ‐ Location: Korea Phase 4
Participants	Randomised: 34 participants Inclusion criteria Present with chronic plaque psoriasis based on a clinical diagnosis Have > 5% BSA involvement at screening Are a candidate for systemic therapy Are male or female patients ≥18 years Have given written informed consent approved by the Institutional Review Board Exclusion criteria Have predominant pattern of pustular, erythrodermic, or guttate forms of psoriasis Have had any of the systemic non‐biologic psoriasis therapy (including neotigason, ciclosporin, and methotrexate) within 4 weeks prior to baseline Have had etanercept within 4 weeks prior to baseline Have had adalimumab and infliximab within 8 weeks prior to baseline Have had ustekinumab within 16 weeks prior to baseline Presence of significant hepatic or renal disorders Have uncontrolled arterial hypertension Are women who are lactating, breastfeeding or planning pregnancy Have any other condition that precludes from following and completing the protocol
Interventions	Intervention Ciclosporin A (men 200 mg/day, women 150 mg/day for 16 weeks) Control intervention Methotrexate (initial dose 10 mg/week, increasing 2.5 mg every 2 weeks up to 15 mg/week)
Outcomes	At week 16 Primary outcome Change in PASI Secondary outcome PASI 75, PASI 90 AEs
Starting date	Study start date: August 2014 Study completion date: March 2016
Contact information	Sang Woong Youn, Associate Professor, Seoul National University Hospital
Notes	Ongoing study