CYA Versus MMF for Treatment of Moderate-Severe Psoriasis.

• Status: Unknown status
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Muenster
• Collaborator: Hoffmann-La Roche
• Treatments: Cyclosporine; Cyclosporins; Mycophenolate mofetil; Mycophenolic Acid

Criteria

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