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
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.
||Observational Model: Case Control
Time Perspective: Prospective
||Do Mutations in the Filaggrin Gene Have Clinical Importance for the Treatment Outcome in Atopic Dermatitis?
Primary Outcome Measures:
- Filaggrin mutation [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
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 ]
Serum samples are collected to investigate if the patient has a mutation in the filaggrin gene.
| Estimated Enrollment:
| Study Start Date:
Patients with atopic dermatitis
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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
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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 ClinicalTrials.gov identifier: NCT01689805
|Skin and Allergy Hospital, Departments of Dermatology and Clinical Genetics
|Helsinki, Finland, PB 160 |
|Contact: Anita Remitz, MD, PhD firstname.lastname@example.org |
|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 |
Helsinki University Central Hospital
||Anita Remitz, MD, PhD
||Skin and Allergy Hospital, Helsinki University Central Hospital
No publications provided
||Anita Remitz, MD, PhD, Specialist in Dermatology, Helsinki University Central Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 23, 2011
||September 18, 2012
||Finland: Ministry of Social Affairs and Health
Keywords provided by Helsinki University Central Hospital:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 21, 2014
Genetic Diseases, Inborn
Immune System Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic