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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
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
Monotherapy, Capsules, schema therapy, 1 to 3 times a day, 6 months
Medical University of Vienna; Department of Dermatology
Vienna, Austria
Mean reduction in Psoriasis Area and Severity Index (PASI)
Time frame: Baseline and 6 weeks
Mean cumulative FAE dose required to reach PASI 75
Time frame: 6 months
Mean reduction in Psoriasis Area and Severity Index (PASI)
Time frame: Baseline and 6 months
Mean reduction in Psoriasis Log-based Area and Severity Index (PLASI)
Time frame: Baseline and 6 months
Mean reduction in Dermatology Life Quality INDEX (DLQI)
Time frame: 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.
Time frame: Baseline and 6 months
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