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

Study Overview
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Brief Summary
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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.

Official Title
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Fumaric Acid Esters Versus Fumaric Acid Esters Plus Narrow Band Type B Ultraviolet (UVB) in Patients With Severe Plaque Psoriasis

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Device: Full Body UV Therapy System UV 7002 plus fumaric acid esters
* Drug: Fumaric acid esters


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with moderately severe to severe Psoriasis (BSA ≥ 10 and PASI ≥ 10) Age between 18 and 80 years old Exclusion Criteria: pregnant woman and satisfying women cancer, chronic infections, autoimmune diseases gastrointestinal illnesses liver diseases renal malfunctions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fumaric acid esters<br>Fumaric acid esters monotherapy | Drug: Fumaric acid esters<br>* Monotherapy, Capsules, schema therapy, 1 to 3 times a day, 6 months<br>* Other names: Fumaric acid;|
| Experimental: fumaric acid esters plus narrow band UVB<br>Combination therapy of fumaric acid esters plus narrow band type B ultraviolet therapy (UVB) | Device: Full Body UV Therapy System UV 7002 plus fumaric acid esters<br>* Combination therapy of narrow band type B ultraviolet (UVB) therapy plus fumaric acid esters therapy. Narrow band UVB therapy: 3 times a week for 6 weeks; Fumaric acid esters therapy: Capsules, schema therapy, 1 to 3 times a day for 6 months<br>* Other names: Irradiation therapy with narrow band UVB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean reduction in Psoriasis Area and Severity Index (PASI) |  | Baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean cumulative FAE dose required to reach PASI 75 |  | 6 months | 
| Mean reduction in Psoriasis Area and Severity Index (PASI) |  | Baseline and 6 months | 
| 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 | 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. | Baseline and 6 months |