Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis
Information source: Universita di Verona
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Plaque Psoriasis
Intervention: efalizumab plus placebo (Drug); efalizumab plus acitretin (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Universita di Verona Official(s) and/or principal investigator(s):
Giampiero Girolomoni, Principal Investigator, Affiliation: University of Verona
Giampiero Girolomoni, Principal Investigator, Affiliation: University of Verona
Overall contact:
Giampiero Girolomoni, Prof, Phone: 39-045-812-2547, Ext: 0039, Email: giampiero.girolomoni@univr.it
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.
Clinical Details
Official title: Phase IV Study on Efficacy and Safety of the Combination Treatment Acitretin and Efalizumab in Moderate to Severe Chronic Plaque Psoriasis
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: PASI 75 and PASI 50 at week 24
Physician Global Assessment
Secondary outcome: SKINDEX 29 at week 24 and AST, ALT, cholesterol, triglycerides at week 12 and week 24
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Giampiero Girolomoni, Prof, Phone: 39-045-812-2547, Ext: 0039, Email: giampiero.girolomoni@univr.it
Univeristy Hospital, Verona 37126, Italy
Additional Information
Related publications: Gisondi P, Girolomoni G. Combination of efalizumab and acitretin in chronic plaque psoriasis. J Eur Acad Dermatol Venereol. 2008 Feb;22(2):247-8. No abstract available.
Starting date: September 2008
Ending date: October 2009
Last updated: June 27, 2008
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