miRNAs and mRNAs in Psoriasis

August 22, 2014 updated by: University of Aarhus

miRNAs and mRNAs in Psoriasis During Treatment With Biological Drugs.

PURPOSE - The purpose of this study is to identify and determine miRNA expression and their targets before and during biological treatment of psoriatic patients.

HYPOTHESIS - Changes in the expression of specific miRNAs play an important role for the cytokine expression profile seen in lesional psoriatic skin. miRNAs may therefore serve as a potential target for future anti-psoriatic treatment as well as possible predictors of biological treatment response.

PERSPECTIVES - The results from this novel research project will increase the investigators understanding of the underlying mechanisms leading to psoriasis. Furthermore it is possible that predictors of treatment response can be identified. Identification of biomarkers predicting treatment outcome will individualize patient care, reduce number of treatment failures and thereby have a tremendous socio-economic impact and increase the patients quality of life.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND: Psoriasis is a chronic inflammatory skin disease affecting 2-3% of the population worldwide and having tremendously impact on the patients' quality of life. Progress has been made in the understanding of the cellular immunology and biology of psoriasis, but the ultimate cause for psoriasis is still unknown.

miRNA are ~22 nt noncoding RNAs that modulate gene expression at the post-transcriptional level. miRNAs have regulatory roles in development, differentiation, growth control and apoptosis.

AIM OF PROJECT: To identify psoriasis specific miRNA. To investigate the differences in miRNA expression and their targets between lesional and non-lesional psoriatic skin. To investigate changes in the miRNA expression during biological treatment.

METHODS: Patients included are adults (> 18 years) with psoriasis vulgaris who are going to be treated with biological drugs independent of this project (according to national guidelines). A signed informed consent will be obtained before patients are included in the project.

Patients are not allowed to have received local treatment 2 weeks before inclusion or having had any systemic treatment including UVB 6 weeks before inclusion. 4 mm punch-biopsies from lesional and non-lesional psoriatic skin will be obtained using a local anaesthetic containing 1% Lidocaine at day 0 and up to four times after treatment at the following days 4, 14, 28 or 84. Before and during treatment patients will be monitored with a clinical score including PASI, BSA and PGA. Clinical evaluation will be conducted by a trained dermatologist at day 0 and day 84. That allows us to compare clinical changes to findings obtained during this study.

miRNA and mRNA expression will be analysis with quantitativePCR, protein level with ELISA and cell proliferation will be measure by a standard cell proliferation assay. miRNA microarray are commercially available and will be used to identify miRNA of interest.

NOVELTY: Changes in the expression of miRNA in psoriasis and miRNA regulation during treatment of psoriasis have only been sparsely studied. The results from this research project will therefore increase our understanding of the underlying mechanisms leading to psoriasis and may generate important new tools for individualised treatment of psoriasis.

Study Type

Observational

Enrollment (Anticipated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Region Midt
      • Aarhus, Region Midt, Denmark, 8000
        • Recruiting
        • Aarhus University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lars Iversen, Prof MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients included are adults (> 18 years) with psoriasis vulgaris who are going to be treated with biological drugs independent of this project.

Description

Inclusion Criteria:

  • Males and females aged 18 or above
  • Patients with psoriasis vulgaris who are going to be treated with biological drugs independent of this project.
  • A signed informed consent form prior of any study-mandated procedure.

Exclusion Criteria:

  • No local treatment 2 weeks before inclusion
  • No systemic treatment including UVB 6 weeks before inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Psoriasis vulgaris
Patients with psoriasis vulgaris who are going to be treated with biological drugs independent of this project(according to national guidelines).
4 mm punch-biopsies from lesional and non-lesional psoriatic skin at day 0 and up to four times after treatment at the following days: 4, 14, 28 or 84.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
miRNA and mRNA regulation in psoriatic skin
Time Frame: jan 2015
jan 2015

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

March 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

May 22, 2012

First Submitted That Met QC Criteria

May 23, 2012

First Posted (Estimate)

May 24, 2012

Study Record Updates

Last Update Posted (Estimate)

August 25, 2014

Last Update Submitted That Met QC Criteria

August 22, 2014

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-218/2-86

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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