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Cyclosporine A microemulsion · 1 trial · 1 indication
PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of severest degree. Relapse is considered a worsening of psoriasis associated to a PASI score \>75% of PASI score recorded before starting induction therapy with CsA (before study start). Each patient was considered as failure (relapse occurrence) if rate was \>= 75%. In all the other cases the patient was considered as success (no relapse).
| Arm | Type | Description |
|---|---|---|
| Cyclosporine A | ACTIVE_COMPARATOR | 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 |
| Placebo | PLACEBO_COMPARATOR | Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations |
| Name | Type | Description |
|---|---|---|
| Cyclosporine A microemulsion | DRUG | 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 |
| Placebo | DRUG | Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations |
Inclusion criteria: * Outpatients 18 years of age and older (max 65 years) * Patients with chronic plaque psoriasis on disease remission (i.e. PASI ≤75% of PASI before cyclosporine continuous treatment course) entering a maintenance period * Disease remission obtained with only cyclosporine as syst...