This research will be conducted on Dermatology patients diagnosed with "psoriasis" which is a common skin problem adversly affects the quality of life of affected patients. MedDRA version: 12.1 Level: LLT Classification code 10037153 Term: Psoriasis MedDRA version: 12.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris
Conditions
Interventions
Trade Name: Dovobet
Product Name: n/a
Product Code: n/a
Pharmaceutical Form: Ointment
Trade Name: neotigason
Product Name: n/a
Product Code: n/a
Pharmaceutical Form: Capsule, hard
Trade Name: Enbrel
Sponsors
University of Aberdeen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Male and female patients in the age range from 18 to 70 who are diagnosed with moderate to severe psoriasis. •Patients must be treatment free for at least 2 weeks for topical application and 4 weeks for systemic treatment of psoriasis. •Women of child bearing potential must be on reliable contraception. •Patients in whom a decision to treat with one of the following therapies has already been made based on normal clinical care: o Dovobet o Neotigason o Narrow-band UVB o Etanercept o Adalimumab o Infliximab 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: •Children below 18 years and patients over 70 years. •Pregnant and lactating patients. •Patients who are known to have immunosuppressive disease (e.g. HIV) or on any immunosuppressive therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) The objective is to test whether patient's response to conventional currently used psoriasis treatment, used in normal clinical practice is determined by regulatory T cells (cells which control the inflammtory response in psoriasis). 2) This will be acheived for each of 4 routinely used types of psoriasis therapy (topical calcipotriol/betamethasone combination, oral retinoid, NBUVB and anti-TNF a therapy) by taking blood tests and a skin sample before treatment and after 6weeks 3) The analysis of samples for Treg and Teffector cells. ;Secondary Objective: To determine whether changes in CD25hiFoxP3+ natural Treg or the IL-10+ induced Treg we have identified in lesions show the stronger correlations with clinical outcome.;Primary end point(s): Response to therapy measured by PASI score. Absolute and relative changes in Treg cells and Teffector cells in peripheral blood and skin samples. | — |
Countries
United Kingdom
Outcome results
None listed