Comparison Study of Psoriasis Severity Assessment Tools

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of the Performance of Subjective or Objective Psoriasis Severity Assessment Tools for the Assessment of the Improvement of Psoriasis After Oral Cyclosporine A or Methotrexate Treatment

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Cyclosporine A
* Drug: Methotrexate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cyclosporine A<br>Cyclosporine 200 mg/day (male) and 150 mg/day (female) orally, divided twice daily for 16 weeks | Drug: Cyclosporine A<br>* Male 200 mg/day, Female 150 mg/day for 16 weeks<br>* Other names: Cyclosporin A;|
| Active Comparator: Methotrexate<br>Methotrexate was started with 10 mg/week orally as a single dose, increasing 2.5 mg every 2 weeks up to 15 mg/week maintenance dose | Drug: Methotrexate<br>* Initial dose with 10 mg/week, increasing 2.5 mg every 2 weeks up to 15 mg/week maintenance dose<br>* Other names: Methotrexate tab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Area and Severity Index (PASI) and Objective PASI (oPASI) change over time | 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. | up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with abnormal laboratory values and/or adverse events that are related to treatment | 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. | Screening, 4, and 12 weeks | 
| Proportion of patients achieving 75% and 90% PASI improvement on every visit | Investigators evaluate proportions of patients showing at least 75% and 90% improvement from baseline in PASI. | up to 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cyclosporine, Methotrexate