CYA Versus MMF for Treatment of Moderate-Severe Psoriasis.
Recruitment status was Active, not recruiting
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.
Drug: Cyclosporine A versus mycophenolate mofetil for psoriasis
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open, Multicenter, Randomized Clinical Trial in Patients With Moderate-Severe Psoriasis (PASI > 10) to Compare the Efficacy of Mycophenolate Mofetil Versus Cyclosporine A.|
- Comparison of the two treatment arms with regard to time until psoriasis recurrence.
- 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 rate of partial remission.
- The cumulative cyclosporine A or mycophenolate mofetil doses.
|Study Start Date:||May 2000|
|Estimated Study Completion Date:||October 2006|
|Prof. Michael Sticherling|
|Principal Investigator:||Stefan Beissert, Professor||Department of Dermatology, University Hospital Muenster, Muenster, Germany|