Comparison Study of Psoriasis Severity Assessment Tools

April 14, 2016 updated by: Sang Woong Youn, Seoul National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Seongnam, Gyeonggi, Korea, Republic of, KS009
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cyclosporine A
Cyclosporine 200 mg/day (male) and 150 mg/day (female) orally, divided twice daily for 16 weeks
Drug: Cyclosporine A
Male 200 mg/day, Female 150 mg/day for 16 weeks
Other Names:
  • Ciclosporin
  • Cyclosporin
  • Cyclosporin A
Active Comparator: Methotrexate
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
Initial dose with 10 mg/week, increasing 2.5 mg every 2 weeks up to 15 mg/week maintenance dose
Other Names:
  • Methotrexate tab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psoriasis Area and Severity Index (PASI) and Objective PASI (oPASI) change over time
Time Frame: 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.
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
Time Frame: 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.
Screening, 4, and 12 weeks
Proportion of patients achieving 75% and 90% PASI improvement on every visit
Time Frame: up to 16 weeks
Investigators evaluate proportions of patients showing at least 75% and 90% improvement from baseline in PASI.
up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Sang Woong Youn, MD, PhD, Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

January 4, 2016

First Submitted That Met QC Criteria

January 13, 2016

First Posted (Estimate)

January 14, 2016

Study Record Updates

Last Update Posted (Estimate)

April 15, 2016

Last Update Submitted That Met QC Criteria

April 14, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • oPASI1403

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study completion.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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