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

This study is currently recruiting participants.
Verified September 2012 by Helsinki University Central Hospital
Sponsor:
Information provided by (Responsible Party):
Anita Remitz, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01689805
First received: June 23, 2011
Last updated: September 18, 2012
Last verified: September 2012
  Purpose

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
Atopic Dermatitis

Study Type: Observational
Study Design: 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?

Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Filaggrin mutation [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response to treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Serum IgE [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum samples are collected to investigate if the patient has a mutation in the filaggrin gene.


Estimated Enrollment: 800
Study Start Date: June 2011
Groups/Cohorts
Patients with atopic dermatitis
Non-atopic controls

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01689805

Contacts
Contact: Anita Remitz, MD, PhD +358-9-4711 anita.remitz@hus.fi

Locations
Finland
Skin and Allergy Hospital, Departments of Dermatology and Clinical Genetics Recruiting
Helsinki, Finland, PB 160
Contact: Anita Remitz, MD, PhD       anita.remitz@hus.fi   
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         
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Principal Investigator: Anita Remitz, MD, PhD Skin and Allergy Hospital, Helsinki University Central Hospital
  More Information

No publications provided

Responsible Party: Anita Remitz, MD, PhD, Specialist in Dermatology, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01689805     History of Changes
Other Study ID Numbers: FLG-255-AR
Study First Received: June 23, 2011
Last Updated: September 18, 2012
Health Authority: Finland: Ministry of Social Affairs and Health

Keywords provided by Helsinki University Central Hospital:
Atopic dermatitis
Filaggrin

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014