Conditions: Chronic Plaque Psoriasis
Keywords: Cyclosporine, chronic plaque psoriasis, intermittent therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 243

Brief summary:
The study will evaluate the efficacy of cyclosporine at 2, 5 mg/kg/day bid (i.e. bis in a day), when administered twice a week compared to continuous administration, in patients with chronic plaque psoriasis.

Detailed description:

Arms:
arm 1: Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations arm 2: Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations

Interventions: intervention 1: Cyclosporine A microemulsion intervention 2: Placebo
Intervention descriptions: intervention 1: Oral soft gelatin capsules of Cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations intervention 2: Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations

Protocol document: