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| Tracking Information | |||||||||
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| First Received Date ICMJE | June 26, 2008 | ||||||||
| Last Updated Date | June 27, 2008 | ||||||||
| Start Date ICMJE | September 2008 | ||||||||
| Estimated Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
PASI 75 and PASI 50 at week 24 Physician Global Assessment [ Time Frame: week 12 and 24 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00707070 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
SKINDEX 29 at week 24 and AST, ALT, cholesterol, triglycerides at week 12 and week 24 [ Time Frame: week 24 ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis | ||||||||
| Official Title ICMJE | Phase IV Study on Efficacy and Safety of the Combination Treatment Acitretin and Efalizumab in Moderate to Severe Chronic Plaque Psoriasis | ||||||||
| 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. |
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| Detailed Description | |||||||||
| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Chronic Plaque Psoriasis | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | October 2009 | ||||||||
| Estimated Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Italy | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00707070 | ||||||||
| Responsible Party | Giampiero Girolomoni, University of Verona | ||||||||
| Study ID Numbers ICMJE | Gisondi 2, No grants were received | ||||||||
| Study Sponsor ICMJE | Universita di Verona | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Universita di Verona | ||||||||
| Verification Date | June 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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