Clinical trial NCT01233583: Regulatory T-cells in Psoriasis Patients as Targets for Therapy
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Regulatory T-cells, psoriasis, IL-10.
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: NHS Grampian
First posted: 2010-11-03
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients and control in this study will be identified and recruited from the department of Dermatology by clinical members of the study team.

Brief 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.

Eligibility 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:

    * Dovobet
    * Neotigason
    * Narrow-band UVB
    * Etanercept
    * Adalimumab
    * Infliximab
  * 10 normal controls

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.

Primary outcomes:
measure: Clincal-immunological correlation of treatment outcome in psoriasis patients
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Burnside House
Study officials:
affiliation: University of Aberdeen & NHS Grampian
name: Anthony D Ormerod, Consultant
role: PRINCIPAL_INVESTIGATOR
References: