Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-31 @ 12:56 PM
Study NCT ID:
NCT02655705
Status:
COMPLETED
Last Update Posted:
2016-04-15
First Post:
2016-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Study of Psoriasis Severity Assessment Tools
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: