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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00707070
Other study ID # Gisondi 2
Secondary ID No grants were r
Status Not yet recruiting
Phase Phase 4
First received June 26, 2008
Last updated June 27, 2008
Start date September 2008
Est. completion date October 2009

Study information

Verified date June 2008
Source Universita di Verona
Contact Giampiero Girolomoni, Prof
Phone 39-045-812-2547
Email giampiero.girolomoni@univr.it
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

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


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
Italy Univeristy Hospital Verona

Sponsors (1)

Lead Sponsor Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary PASI 75 and PASI 50 at week 24 Physician Global Assessment week 12 and 24 No
Secondary SKINDEX 29 at week 24 and AST, ALT, cholesterol, triglycerides at week 12 and week 24 week 24 Yes
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