Clinical trial NCT02655705: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Keywords: Cyclosporine
Methotrexate
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-01-14
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Psoriasis Area and Severity Index (PASI) and Objective PASI (oPASI) change over time
timeFrame: up to 16 weeks
Secondary outcomes:
measure: Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
timeFrame: Screening, 4, and 12 weeks
measure: Proportion of patients achieving 75% and 90% PASI improvement on every visit
timeFrame: up to 16 weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Sang Woong Youn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.