Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis
Phase 4
- Conditions
- Chronic Plaque Psoriasis
- Interventions
- Registration Number
- NCT00707070
- Lead Sponsor
- Universita di Verona
- Brief Summary
It is a phase IV multicentric, placebo-controlled, clinical trial investigating the efficacy and safety of acitretin combined to efalizumab in the therapy of chronic plaque psoriasis. PASI 75 at week 24 will be the primary end point. PASI 75 at week 12, and PASI 50 at week 24 will be the secondary end points. Safety measures will be the monitoring of serum parameters including AST; ALT; gammaGT; creatinine; cholesterol and triglycerides.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Men aged 18-70
- Women in postmenopausal
- Moderate to severe chronic plaque psoriasis in patients with contraindication, intolerance or non responsive to cyclosporine, methotrexate or PUVA
- PASI > 10 e/o BSA (Body Surface Area) > 10
Exclusion Criteria
- Drug induced psoriasis
- Pustular or erythrodermic psoriasis
- Fertile women
- Pregnancy or lactation
- cholesterol > 230mg/dL e triglyceride > 200 mg/dL
- Known intolerance to efalizumab and acitretin
- Serious infection at enrollement
- History of previous neoplasia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 efalizumab plus acitretin efalizumab 1 mg/kg/week subcutaneous plus acitretin 0.4 mg/kg/day oral 2 efalizumab plus placebo efalizumab 1 mg/Kg/week subcutaneous plus oral placebo
- Primary Outcome Measures
Name Time Method PASI 75 and PASI 50 at week 24 Physician Global Assessment week 12 and 24
- Secondary Outcome Measures
Name Time Method SKINDEX 29 at week 24 and AST, ALT, cholesterol, triglycerides at week 12 and week 24 week 24
Trial Locations
- Locations (1)
Univeristy Hospital
🇮🇹Verona, Italy