Comparison Study of Psoriasis Severity Assessment Tools

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02655705
• Other study ID #: oPASI1403
• Status: Completed
• Phase: Phase 4
• First received: January 4, 2016
• Last updated: April 14, 2016
• Start date: August 2014
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Cyclosporine A
Male 200 mg/day, Female 150 mg/day for 16 weeks
• Methotrexate
Initial dose with 10 mg/week, increasing 2.5 mg every 2 weeks up to 15 mg/week maintenance dose

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	No