CYA Versus MMF for Treatment of Moderate-Severe Psoriasis.

University Hospital Muenster

Status and phase: Unknown; Phase 2

Conditions: Psoriasis

Treatments: Drug: Cyclosporine A versus mycophenolate mofetil for psoriasis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00295425

TALSB002

4016406

Details and patient eligibility

About

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.

Full description

Not needed.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)