Psoriasis
Conditions
Keywords
Cyclosporine, Methotrexate
Brief summary
This study evaluates the performance of objective psoriasis severity assessment tool compared with a subjective assessment tool for the assessment of the improvement of psoriasis after oral cyclosporine A or methotrexate treatment.
Detailed description
Patients with moderate-to-severe psoriasis were randomly assigned to treatment for 16 weeks with either cyclosporine A (20 patients; male 200 mg/day, female 150 mg/day) or methotrexate (20 patients; initial dose with 10 mg/week, increased up to 15 mg/week). The primary outcome was to compare the difference between the conventional subjective Psoriasis Area and Severity Index (PASI) and the objective PASI by using Colorimeter at 2, 4, 8, 12, and 16 weeks of treatment. The secondary outcome was differences between cyclosporine and methotrexate for treatment of psoriasis, evaluating clinical efficacy and side effects.
Interventions
DRUGCyclosporine A
Male 200 mg/day, Female 150 mg/day for 16 weeks
DRUGMethotrexate
Initial dose with 10 mg/week, increasing 2.5 mg every 2 weeks up to 15 mg/week maintenance dose
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Present with chronic plaque psoriasis based on a clinical diagnosis * Have \> 5% body surface area involvement at screening * Are a candidate for systemic therapy * Are male or female patients 18 years or older * 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, cyclosporine, 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis Area and Severity Index (PASI) and Objective PASI (oPASI) change over time | up to 16 weeks | PASI scores and oPASI scores are carried out on every visit. One dermatologist rates a PASI score. A oPASI score is obtained from oPASI formula using Colorimeter parameters L\*, a\* and b\* values. oPASI = 0.1×oPSI (head)×Area (head) + 0.3×oPSI (trunk)×Area (trunk) +0.2×oPSI (arm)×Area (arm) + 0.4×oPSI (leg)×Area (leg) oPSI = 0.05 x L\* - 2.5 x tan-1 (b\*/a\*) + 5 PASI range is 0 to 72 score. oPSI range is 1.073 to 10 score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with abnormal laboratory values and/or adverse events that are related to treatment | Screening, 4, and 12 weeks | Laboratory tests are performed at screening, 4, and 12 weeks. Patients are checked hemoglobin, hematocrit, white blood cell, platelet, aspartate aminotransferase, alanine aminotransferase, blood urea nitrogen, creatinine, c-reactive protein, and erythrocyte sedimentation. All patients are asked treatment-related adverse events on every visit. |
| Proportion of patients achieving 75% and 90% PASI improvement on every visit | up to 16 weeks | Investigators evaluate proportions of patients showing at least 75% and 90% improvement from baseline in PASI. |
Countries
South Korea
Outcome results
None listed