Overview

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

Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Medical University of Vienna
Criteria
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