Fumaric Acid Versus Fumaric Acid Plus Narrow Band Type B Ultraviolet (UVB) for Psoriasis

Phase 3

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: Fumaric acid esters; Device: Full Body UV Therapy System UV 7002 plus fumaric acid esters

• Registration Number: NCT01321164
• Lead Sponsor: Medical University of Vienna

Brief Summary

The main objective of the study is to evaluate the additional effect of a narrow band Type B Ultraviolet (UVB) therapy on the treatment of severe plaque psoriasis with fumaric acid esters (FAE) in comparison to FAE monotherapy. The secondary objectives are to evaluate the effect of an additional narrow band UVB therapy on the cumulative FAE dose required to reach Psoriasis Area and Severity Index (PASI) 75 in comparison to FAE monotherapy and to evaluate whether a leukopenia and lymphopenia frequently occurring during the FAE treatment is a positive predictive factor for the treatment response.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-03-22
• Study First Submitted QC: 2011-03-22
• Study First Posted: 2011-03-23
• Study Start: 2011-04
• Primary Completion: 2013-12
• Study Completion: 2014-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-08
• Last Update Posted: 2014-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patient with moderately severe to severe Psoriasis (BSA ≥ 10 and PASI ≥ 10)
• Age between 18 and 80 years old

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Exclusion Criteria

• pregnant woman and satisfying women
• cancer, chronic infections, autoimmune diseases
• gastrointestinal illnesses
• liver diseases
• renal malfunctions

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fumaric acid esters	Fumaric acid esters	Fumaric acid esters monotherapy
fumaric acid esters plus narrow band UVB	Full Body UV Therapy System UV 7002 plus fumaric acid esters	Combination therapy of fumaric acid esters plus narrow band type B ultraviolet therapy (UVB)

Primary Outcome Measures

Name	Time	Method
Mean reduction in Psoriasis Area and Severity Index (PASI)	Baseline and 6 weeks

Secondary Outcome Measures

Name	Time	Method
Mean reduction in Psoriasis Log-based Area and Severity Index (PLASI)	Baseline and 6 months
Mean reduction in Dermatology Life Quality INDEX (DLQI)	Baseline and 6 months
Mean white blood cells (Leukocytes and Lymphocytes) count	Baseline and 6 months	Correlation between the mean white blood cells (Leukocytes and Lymphocytes) count and PASI reduction and between the mean white blood cells count and cumulative FAE dose.
Mean cumulative FAE dose required to reach PASI 75	6 months
Mean reduction in Psoriasis Area and Severity Index (PASI)	Baseline and 6 months

Trial Locations

Locations (1)

Medical University of Vienna; Department of Dermatology; 🇦🇹 Vienna, Austria