Comparison Study of Psoriasis Severity Assessment Tools

NCT02655705 | Completed Phase 4 DMC

• 1 other identifier: oPASI1403
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Cyclosporine; Methotrexate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of participants with abnormal laboratory values and/or adverse events that are related to treatment

  Screening, 4, and 12 weeks

• Proportion of patients achieving 75% and 90% PASI improvement on every visit

  up to 16 weeks

Study Arms (2)

Cyclosporine A

ACTIVE COMPARATOR

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

Drug: Cyclosporine A

Methotrexate

ACTIVE COMPARATOR

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

Interventions

Cyclosporine A DRUG

Male 200 mg/day, Female 150 mg/day for 16 weeks

Also known as: Cyclosporin, Ciclosporin, Cyclosporin A

Cyclosporine A

Methotrexate DRUG

Initial dose with 10 mg/week, increasing 2.5 mg every 2 weeks up to 15 mg/week maintenance dose

Also known as: Methotrexate tab

Methotrexate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, KS009, South Korea

Location

Related Publications (2)

• 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.

  PMID: 25492025 BACKGROUND

• 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.

  PMID: 23518409 BACKGROUND

MeSH Terms

Conditions

Psoriasis

Interventions

Cyclosporine; Methotrexate

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sang Woong Youn, MD, PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: January 14, 2016
• Study Start: August 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 15, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)