Enumeration and Functional Evaluation of Regulatory T-cells in Psoriasis Patients Before and After Treatment with: Calcipotriol/Betamethasone, Acitretin, Narrow-Band UVB and Anti-TNF a Therapy (Etanercept, Adalimumab and Infliximab) - Regulatory T-cells in Psoriasis Patients as Targets for Therapy

• Conditions: 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: 12.1Level: LLTClassification code 10037153Term: Psoriasis; MedDRA version: 12.1Level: LLTClassification code 10050576Term: Psoriasis vulgaris

• Registration Number: EUCTR2010-019129-32-GB
• Lead Sponsor: niversity of Aberdeen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-18
• Last Update Posted: 7 April 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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:
oDovobet
oNeotigason
oNarrow-band UVB
oEtanercept
oAdalimumab
oInfliximab

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

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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). <br>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<br>3) The analysis of samples for Treg and Teffector cells.<br>;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.<br>Absolute and relative changes in Treg cells and Teffector cells in peripheral blood and skin samples.