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

Sponsor
Helsinki University Central Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01689805
Collaborator
(none)
800
Enrollment
1
Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    800 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Do Mutations in the Filaggrin Gene Have Clinical Importance for the Treatment Outcome in Atopic Dermatitis?
    Study Start Date :
    Jun 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with atopic dermatitis
    Non-atopic controls

    Outcome Measures

    Primary Outcome Measures

    1. Filaggrin mutation []

    Secondary Outcome Measures

    1. Response to treatment [12 months]

    2. Serum IgE [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Skin and Allergy Hospital, Departments of Dermatology and Clinical Genetics Helsinki Finland PB 160

    Sponsors and Collaborators

    • Helsinki University Central Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anita Remitz, MD, PhD, Specialist in Dermatology, Helsinki University Central Hospital
    ClinicalTrials.gov Identifier:
    NCT01689805
    Other Study ID Numbers:
    • FLG-255-AR
    First Posted:
    Sep 21, 2012
    Last Update Posted:
    Sep 21, 2012
    Last Verified:
    Sep 1, 2012
    Keywords provided by Anita Remitz, MD, PhD, Specialist in Dermatology, Helsinki University Central Hospital
    Atopic dermatitis
    Filaggrin
    Additional relevant MeSH terms:
    Dermatitis, Atopic
    Dermatitis
    Eczema

    Study Results

    No Results Posted as of Sep 21, 2012