Comparison Study of Psoriasis Severity Assessment Tools

NCT ID: NCT02655705

Last Updated: 2016-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cyclosporine A

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

Group Type ACTIVE_COMPARATOR

Cyclosporine A

Intervention Type DRUG

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

Methotrexate

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

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

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

Interventions

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Cyclosporine A

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

Intervention Type DRUG

Methotrexate

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

Intervention Type DRUG

Other Intervention Names

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Cyclosporin Ciclosporin Cyclosporin A Methotrexate tab

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sang Woong Youn

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sang Woong Youn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 25492025 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23518409 (View on PubMed)

Other Identifiers

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oPASI1403

Identifier Type: -

Identifier Source: org_study_id

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