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Clinical Importance of Filaggrin Gene Mutation for Treatment Outcome in Atopic Dermatitis
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Anita Remitz, Helsinki University Central Hospital.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Helsinki University Central Hospital
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
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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? |
Resource links provided by NLM:
Further study details as provided by Anita Remitz, Helsinki University Central Hospital:
Primary Outcome Measures:
- Filaggrin mutation
Secondary Outcome Measures:
- Response to treatment [ Time Frame: 12 months ]
- 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.
| 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 (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
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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
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
| 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 |
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 |
ClinicalTrials.gov processed this record on June 26, 2017