NCT01233583

Regulatory T-cells in Psoriasis Patients as Targets for Therapy

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 Alpha Therapy (Etanercept, Adalimumab and Infliximab)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 38 (actual)
• Sponsor: University of Aberdeen · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to understand which therapies will suppress effector cells and promote regulatory T cells and To test whether patients with a better response to therapy and longer psoriasis-free periods develop a higher numerical ratio of regulatory to effectors T-cells and/or regulatory cells more able to suppress the effectors.

Detailed description

This is an observational study for the effect of different treatment options of psorisis on regulatory T-cells. Patients in whom a decision to treat with one of the following therapies (Dovobet, neotigason, narrow-band UVB and anti TNF alpha therapy) and agreed to take part in the study will be selected. Allocation of different treatments to patients is not part of the study. We will enroll 40 patients with moderate to severe psoriasis in the age range from 18 to 70. patients must be treatment-free for at least 2 weeks for topical application and 4 weeks for systemic treatment of psoriasis. females of child bearing potential must be on reliable contraception. Children below 18 years, patients above 70 years, pregnant and lactating patients and immunosuppressed patients are excluded from this study. Blood and tissue samples will be taken before and after treatment. We will also invite 10 patients who are receiving ellipse excisions of naevi, and who known not to have psoriasis, to provide control samples of distal skin beyond the margins required to demonstrate complete removal and control donation of blood.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Dovobet, neotigason, etanercept, adalimumab. infliximab	Dovobet ointment 15g/day for 6 weeks Neotigason capsule 50mg per day (oral) for 6 weeks Enbrel 50mg twice weekly subcutaneous injection for 6 weeks Humira 80mg week 0, 40 mg week 1 then every other week therafter subcutaneous injection for 6 weeks Remicade 3 separate doses of 5mg/kg intavenous injection for 6 weeks

Timeline

• Start date: 2010-06-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2010-11-03
• Last updated: 2014-12-03

Locations

1 site across 1 country: United Kingdom