Psoriasis vulgaris (Plaque-Typ) MedDRA version: 9.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris
Conditions
Interventions
Trade Name: Enbrel 25 mg®
Pharmaceutical Form: Solution for injection
Sponsors
Klinik für Dermatologie und Allergologie der RUB, St. Josef Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients eligible for etanercept treatment according to SPC and local guidelines and regulations - Patients ages 18 or older - Psoriasis vulgaris (Plaque-Typ) - given indication of therapy with Etanercept 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: - Pregnancy or nursing mothers - Patients with severe cardio-respiratory insufficiency - known photodermatosis (for example: urticaria solaris) - known genodermatosis with increased UV-sensitivity - intake of photosensitizing drugs - allergy to local anesthetics - anamnesis of wound healing disorders or keloids - skin cancer in the presence or in the past - systemic immunsuppressive therapy - significant UV-exposure 3 months before the beginning of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: There is no data on the interplay of etanercept and UVB treatment with regard to photo-cocarcinogenicity and efficacy in psoriasis.3 In this two part study, we aim I) to investigate the acute impact of etanercept on UVB-induced inflammation, DNA damage and apoptosis (Part 1), and II) to evaluate the benefits from combined treatment in psoriasis using etanercept and narrowband UVB (NB-UVB, Part 2).;Secondary Objective: ;Primary end point(s): Part 1 Primary outcome - scores of immunohistochemistry for thymine dimers, p53, p21 (DNA damage and cell cycle regulation), CD1a (Langerhans cells), CD3 and CD4 (T lymphocytes), CD95/FAS ligand, Bcl-2 and TUNNEL (apoptosis), interleukine 8 and 10 (inflammatory cytokines).Secondary outcome – objective quantification of UVB-induced erythema (inflammation) using colorimetry (Minolta, Osaka, Japan). Quantitative data of real-time RT-PCR of cytokines etc. Part 2 Primary outcome – modified psoriasis area and severity index of two comparable marker lesions (one irradiated, one non-irradiated); Secondary outcome – 20-MHz ultrasound of marker lesions; scores of immunohistochemistry for CD1a (Langerhans cells), CD3 and CD4 (T lymphocytes), CD95/FAS ligand, Bcl-2 and TUNNEL (apoptosis), interleukine 8 and 10 (inflammatory cytokines). Quantitative data of real-time RT-PCR of cytokines etc. | — |
Countries
Germany
Outcome results
None listed