Clinical Importance of Filaggrin Gene Mutation for Treatment Outcome in Atopic Dermatitis

September 18, 2012 updated by: Anita Remitz, Helsinki University Central Hospital

Do Mutations in the Filaggrin Gene Have Clinical Importance for the Treatment Outcome in Atopic Dermatitis?

Atopic dermatitis is a common disease which affects about one million people in Finland at some stage of their life. In atopic dermatitis we see a superficial inflammation of the skin and a defect in skin barrier function. The filaggrin protein plays a central role in the skin barrier function and studies indicate that about 30% of patients with atopic dermatitis have a mutation in the filaggrin gene. The aim of the study is to investigate whether a mutation in the filaggrin gene affects the clinical treatment outcome in patients with atopic dermatitis. If a mutation predisposes to a worse response to treatment, this could be examined and those patients with the mutation could be given extra treatment support for their atopic dermatitis. The prevalence of filaggrin mutation in the Finnish non-atopic population is studied in the control group.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

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

Study Locations

  • Finland
      • Helsinki, Finland, PB 160
        • Recruiting
        • Skin and Allergy Hospital, Departments of Dermatology and Clinical Genetics
        • Contact:
        • Principal Investigator:
          • Anita Remitz, MD, PhD
        • Sub-Investigator:
          • Sakari Reitamo, MD, PhD
        • Sub-Investigator:
          • Johanna M Mandelin, MD, PhD
        • Sub-Investigator:
          • Ville Kiiski, MD
        • Sub-Investigator:
          • Minna Pöyhönen, MD, PhD
        • Sub-Investigator:
          • Eveliina Salminen, MD, PhD
        • Sub-Investigator:
          • Sirpa Kivirikko, 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with atopic dermatitis who are followed-up at the Skin and Allergy Hospital in Helsinki for at least one year can be included in the study.

The control population consists of non-atopic persons without any other skin disease (samples for the control population are applied for from a sample collection of the National institute for health and welfare).

Description

Inclusion Criteria (patients with atopic dermatitis):

  • Age at least 18 years
  • Clinical diagnosis of atopic dermatitis
  • Need for follow-up at the Skin and Allergy Hospital
  • Patient gives signed informed consent to participate in this study
  • Patients parents and grandparents are of Finnish origin

Inclusion Criteria (Controls):

  • No history of atopy or skin disease
  • Age at least 18 years

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-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patients with atopic dermatitis
Non-atopic controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Filaggrin mutation

Secondary Outcome Measures

Outcome Measure
Time Frame
Response to treatment
Time Frame: 12 months
12 months
Serum IgE
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Helsinki University Central Hospital

Investigators

  • Principal Investigator: Anita Remitz, MD, PhD, Skin and Allergy Hospital, Helsinki University Central Hospital

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

June 1, 2011

Study Registration Dates

First Submitted

June 23, 2011

First Submitted That Met QC Criteria

September 18, 2012

First Posted (Estimate)

September 21, 2012

Study Record Updates

Last Update Posted (Estimate)

September 21, 2012

Last Update Submitted That Met QC Criteria

September 18, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLG-255-AR

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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