A Phase 3 interventional study of Full Body UV Therapy System UV 7002 plus fumaric acid esters and Fumaric acid esters in Plaque Psoriasis, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-05-12.
Sponsored by Medical University of Vienna · Phase 3, Interventional, and Treatment
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 30 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
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Exclusion Criteria:
Fumaric acid esters monotherapy
Drug: Fumaric acid esters
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
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
Also known as: TL-01;, Irradiation therapy with narrow band UVB
Monotherapy, Capsules, schema therapy, 1 to 3 times a day, 6 months
Also known as: Fumaric acid
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
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Medical University of Vienna