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

Atopic Dermatitis Clinical Trial

Official title:

Do Mutations in the Filaggrin Gene Have Clinical Importance for the Treatment Outcome in Atopic Dermatitis?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01689805
• Other study ID #: FLG-255-AR
• Status: Recruiting
• Phase: N/A
• First received: June 23, 2011
• Last updated: September 18, 2012
• Start date: June 2011

Study information

• Verified date: September 2012
• Source: Helsinki University Central Hospital
• Contact: Anita Remitz, MD, PhD
• Phone: +358-9-4711
• Email: anita.remitz[@]hus.fi
• Is FDA regulated: No
• Health authority: Finland: Ministry of Social Affairs and Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Locations

Country	Name	City	State
Finland	Skin and Allergy Hospital, Departments of Dermatology and Clinical Genetics	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Filaggrin mutation			No
Secondary	Response to treatment		12 months	No
Secondary	Serum IgE		12 months	No