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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fumaric acid esters | Active Comparator | Fumaric acid esters monotherapy |
|
| fumaric acid esters plus narrow band UVB | Experimental | Combination therapy of fumaric acid esters plus narrow band type B ultraviolet therapy (UVB) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full Body UV Therapy System UV 7002 plus fumaric acid esters | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean reduction in Psoriasis Area and Severity Index (PASI) | Baseline and 6 weeks |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Tanew, Prof. Dr. | Medical University of Vienna, Department of Dermatology, Division of General Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna; Department of Dermatology | Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| D005650 | Fumarates |
| C032005 | fumaric acid |
| ID | Term |
|---|---|
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
|
| Fumaric acid esters | Drug | Monotherapy, Capsules, schema therapy, 1 to 3 times a day, 6 months |
|
|
| 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 |