Severe Plaque Psoriasis MedDRA version: 12.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris
Conditions
Interventions
Product Name: Fumarsäurekapseln forte
Product Code: 100344
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Fumarsäure Dimethylester
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
Medizinische Universität Wien, Univ.Klinik f.Dermatologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient with moderately severe to severe Psoriasis (BSA = 10 and PASI = 10) Age between 18 and 80 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: pregnant woman and satisfying women cancer, chronic infections, autoimmune diseases gastrointestinal illnesses liver disease renal malfunctions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the additional effect of a narrow band UVB therapy on the treatment of severe plaque psoriasis with fumaric acid esters (FAE) in comparison to FAE monotrherapy;Secondary Objective: To evaluate the effect of an additional narrow band UVB therapy on the cumulative FAE dose required to reach PASI 75 in comparison to FAE monotherapy To evaluate wheter a leukopenia and lymphopenia frequently occuring during the FAE treatment is a positive predictive factor for the treatment response;Primary end point(s): Mean reduction in PASI after 6 weeks of treatment | — |
Countries
Austria
Outcome results
None listed