Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis
NCT ID: NCT00707070
Last Updated: 2008-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2008-09-30
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
efalizumab 1 mg/kg/week subcutaneous plus acitretin 0.4 mg/kg/day oral
efalizumab plus acitretin
1 mg/Kg/week for 24 weeks plus oral acitretin 0.4 mg/kg/day
2
efalizumab 1 mg/Kg/week subcutaneous plus oral placebo
efalizumab plus placebo
1 mg/kg/week subcutaneous for 24 weeks
Interventions
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efalizumab plus placebo
1 mg/kg/week subcutaneous for 24 weeks
efalizumab plus acitretin
1 mg/Kg/week for 24 weeks plus oral acitretin 0.4 mg/kg/day
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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Universita di Verona
OTHER
Responsible Party
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University of Verona
Principal Investigators
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Giampiero Girolomoni
Role: PRINCIPAL_INVESTIGATOR
Universita di Verona
Locations
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Univeristy Hospital
Verona, , Italy
Countries
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Central Contacts
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Facility Contacts
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Paolo Gisondi, MD
Role: primary
References
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Gisondi P, Girolomoni G. Combination of efalizumab and acitretin in chronic plaque psoriasis. J Eur Acad Dermatol Venereol. 2008 Feb;22(2):247-8. doi: 10.1111/j.1468-3083.2007.02303.x. No abstract available.
Other Identifiers
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No grants were received
Identifier Type: -
Identifier Source: secondary_id
Gisondi 2
Identifier Type: -
Identifier Source: org_study_id