CYA Versus MMF for Treatment of Moderate-Severe Psoriasis.

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-31

Study Completion Date

2006-10-31

Brief Summary

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Psoriasis is an immuno-mediated skin disorder, which affects about 2-3% of the population worldwide. For moderate-severe forms of psoriasis systemic immunosuppression is the treatment of choice. This clinical trial was initiated to compare the safety and effectiveness of mycophenolate mofetil and cyclosporine A for the treatment of psoriasis. Patients are randomized to receive either 2.5 mg/kg BW cyclosporine A or 1 g bid mycophenolate mofetil. If after six weeks no decrease in the PASI score occures cyclosporine A doses are increased to 5 mg/kg BW for additional six weeks. In the other arm mycophenolate mofetil is increased to 1 g tid for additional six weeks.

Detailed Description

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Not needed.

Conditions

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Psoriasis

Keywords

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psoriasis randomized clinical trial cyclosporine A mycophenolate mofetil immunosuppression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Cyclosporine A versus mycophenolate mofetil for psoriasis

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* moderate-to-severe psoriasis (PASI Score equal and greated 10)
* written informed consent
* for female patients effective birth control

Exclusion Criteria

* psoriasis arthritis
* psoriasis palmo-plantaris
* erythrodermic psoriasis
* drug-induced psoriasis
* pregnancy
* previous treatment with cyclosporine A or mycophenolate mofetil
* pregnancy
* reduced liver function
* high blood pressure
* reduced kidney function
* severe viral or bacterial infection
* 2 weeks before or after vaccinations
* innate or acquired immunodeficiency
* severe neurologic or psychiatric symptoms
* participation in other trials
* other reasons voiced by the treating physician

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Stefan Beissert, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, University Hospital Muenster, Muenster, Germany

Locations

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Nicolas Hunzelmann

Cologne, , Germany

Site Status

Prof. Michael Sticherling

Leipzig, , Germany

Site Status

Countries

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Germany

Other Identifiers

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4016406

Identifier Type: -

Identifier Source: secondary_id

TALSB002