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

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ClinicalTrials.gov Identifier: NCT01689805
Recruitment Status : Unknown
Verified September 2012 by Anita Remitz, Helsinki University Central Hospital.
Recruitment status was:  Recruiting
First Posted : September 21, 2012
Last Update Posted : September 21, 2012
Sponsor:
Information provided by (Responsible Party):

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
Atopic Dermatitis

Study Design

Study Type : Observational
Estimated 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 : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Patients with atopic dermatitis
Non-atopic controls


Outcome Measures

Primary Outcome Measures :
  1. Filaggrin mutation

Secondary Outcome Measures :
  1. Response to treatment [ Time Frame: 12 months ]
  2. Serum IgE [ Time Frame: 12 months ]

Biospecimen Retention:   Samples With DNA
Serum samples are collected to investigate if the patient has a mutation in the filaggrin gene.

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: September 21, 2012
Last Verified: September 2012

Keywords provided by Anita Remitz, Helsinki University Central Hospital:
Atopic dermatitis
Filaggrin

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