CYA Versus MMF for Treatment of Moderate-Severe Psoriasis.

Phase 2

• Conditions: Psoriasis

• Registration Number: NCT00295425
• Lead Sponsor: University Hospital Muenster

Brief Summary

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

Not needed.

Study Timeline

• Study Start: 2000-05
• Study First Submitted: 2006-02-22
• Study First Submitted QC: 2006-02-22
• Study First Posted: 2006-02-23
• Status Verified: 2006-10
• Study Completion: 2006-10
• Last Update Submitted: 2006-10-04
• Last Update Posted: 2006-10-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of the two treatment arms with regard to time until psoriasis recurrence.

Secondary Outcome Measures

Name	Time	Method
The rate of partial remission.
The treatment that leads to a 75% decrease of the initial PASI score.
The time until complete remission.
The time until partial remission has occured.
The rate of complete remission.
The cumulative cyclosporine A or mycophenolate mofetil doses.

Trial Locations

Locations (2)

Nicolas Hunzelmann; 🇩🇪 Cologne, Germany

Prof. Michael Sticherling; 🇩🇪 Leipzig, Germany