Chronic Plaque Psoriasis
Conditions
Keywords
psoriasis, acitretin, efalizumab
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.
Interventions
DRUGefalizumab plus placebo
1 mg/kg/week subcutaneous for 24 weeks
DRUGefalizumab plus acitretin
1 mg/Kg/week for 24 weeks plus oral acitretin 0.4 mg/kg/day
Sponsors
Universita di Verona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PASI 75 and PASI 50 at week 24 Physician Global Assessment | week 12 and 24 |
Secondary
| Measure | Time frame |
|---|---|
| SKINDEX 29 at week 24 and AST, ALT, cholesterol, triglycerides at week 12 and week 24 | week 24 |
Countries
Italy
Contacts
Primary ContactGiampiero Girolomoni, Prof
Outcome results
None listed