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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Helsinki University Central Hospital.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Anita Remitz, Helsinki University Central Hospital Identifier:
First received: June 23, 2011
Last updated: September 18, 2012
Last verified: September 2012
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.

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?

Resource links provided by NLM:

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
Patients with atopic dermatitis
Non-atopic controls


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).


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01689805

Contact: Anita Remitz, MD, PhD +358-9-4711

Skin and Allergy Hospital, Departments of Dermatology and Clinical Genetics Recruiting
Helsinki, Finland, PB 160
Contact: Anita Remitz, MD, PhD   
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
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 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

Additional relevant MeSH terms:
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic processed this record on May 25, 2016