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Comparison Study of Psoriasis Severity Assessment Tools

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cyclosporine A
Methotrexate
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Cyclosporine, Methotrexate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cyclosporine A

Methotrexate

Arm Description

Cyclosporine 200 mg/day (male) and 150 mg/day (female) orally, divided twice daily for 16 weeks

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 4, 2016
Last Updated
April 14, 2016
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02655705
Brief Title
Comparison Study of Psoriasis Severity Assessment Tools
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Cyclosporine, Methotrexate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cyclosporine A
Arm Type
Active Comparator
Arm Description
Cyclosporine 200 mg/day (male) and 150 mg/day (female) orally, divided twice daily for 16 weeks
Arm Title
Methotrexate
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Cyclosporine A
Other Intervention Name(s)
Cyclosporin, Ciclosporin, Cyclosporin A
Intervention Description
Male 200 mg/day, Female 150 mg/day for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
Methotrexate tab
Intervention Description
Initial dose with 10 mg/week, increasing 2.5 mg every 2 weeks up to 15 mg/week maintenance dose
Primary Outcome Measure Information:
Title
Psoriasis Area and Severity Index (PASI) and Objective PASI (oPASI) change over time
Description
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.
Time Frame
up to 16 weeks
Secondary Outcome Measure Information:
Title
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
Description
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.
Time Frame
Screening, 4, and 12 weeks
Title
Proportion of patients achieving 75% and 90% PASI improvement on every visit
Description
Investigators evaluate proportions of patients showing at least 75% and 90% improvement from baseline in PASI.
Time Frame
up to 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Woong Youn, MD, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
KS009
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study completion.
Citations:
PubMed Identifier
25492025
Citation
Choi JW, Kim BR, Choi CW, Youn SW. One device, one equation: the simplest way to objectively evaluate psoriasis severity. J Dermatol. 2015 Feb;42(2):154-8. doi: 10.1111/1346-8138.12727. Epub 2014 Dec 10.
Results Reference
background
PubMed Identifier
23518409
Citation
Choi JW, Kwon SH, Youn JI, Youn SW. Objective measurements of erythema, elasticity and scale could overcome the inter- and intra-observer variations of subjective evaluations for psoriasis severity. Eur J Dermatol. 2013 Apr 1;23(2):224-9. doi: 10.1684/ejd.2013.1931.
Results Reference
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Comparison Study of Psoriasis Severity Assessment Tools

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