Plaque Psoriasis
Conditions
Brief 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.
Interventions
DEVICEFull 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
Monotherapy, Capsules, schema therapy, 1 to 3 times a day, 6 months
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean reduction in Psoriasis Area and Severity Index (PASI) | Baseline and 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline and 6 months | 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. |
Countries
Austria
Outcome results
None listed