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Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis

Information source: Universita di Verona
Information obtained from ClinicalTrials.gov on February 07, 2013
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

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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; Not yet recruiting
Paolo Gisondi, MD, Phone: 45-812-2547, Ext: 0039, Email: paolo.gisondi@univr.it
Micol Del Giglio, MD, Sub-Investigator
Paolo Gisondi, MD, Sub-Investigator
Giampiero Girolomoni, Prof., Principal Investigator
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
Last updated: June 27, 2008

Page last updated: February 07, 2013

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