Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-04-08 @ 3:46 PM
Study NCT ID:
NCT01689805
Status:
UNKNOWN
Last Update Posted:
2012-09-21
First Post:
2011-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Importance of Filaggrin Gene Mutation for Treatment Outcome in Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum samples are collected to investigate if the patient has a mutation in the filaggrin gene.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'lastUpdateSubmitDate': '2012-09-18', 'studyFirstSubmitDate': '2011-06-23', 'studyFirstSubmitQcDate': '2012-09-18', 'lastUpdatePostDateStruct': {'date': '2012-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Filaggrin mutation'}], 'secondaryOutcomes': [{'measure': 'Response to treatment', 'timeFrame': '12 months'}, {'measure': 'Serum IgE', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atopic dermatitis', 'Filaggrin'], 'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nThe 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).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (patients with atopic dermatitis):\n\n* Age at least 18 years\n* Clinical diagnosis of atopic dermatitis\n* Need for follow-up at the Skin and Allergy Hospital\n* Patient gives signed informed consent to participate in this study\n* Patients parents and grandparents are of Finnish origin\n\nInclusion Criteria (Controls):\n\n* No history of atopy or skin disease\n* Age at least 18 years'}, 'identificationModule': {'nctId': 'NCT01689805', 'briefTitle': 'Clinical Importance of Filaggrin Gene Mutation for Treatment Outcome in Atopic Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Do Mutations in the Filaggrin Gene Have Clinical Importance for the Treatment Outcome in Atopic Dermatitis?', 'orgStudyIdInfo': {'id': 'FLG-255-AR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with atopic dermatitis'}, {'label': 'Non-atopic controls'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PB 160', 'city': 'Helsinki', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Anita Remitz, MD, PhD', 'role': 'CONTACT', 'email': 'anita.remitz@hus.fi'}, {'name': 'Anita Remitz, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sakari Reitamo, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Johanna M Mandelin, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ville Kiiski, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Minna Pöyhönen, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Eveliina Salminen, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sirpa Kivirikko, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Skin and Allergy Hospital, Departments of Dermatology and Clinical Genetics', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'centralContacts': [{'name': 'Anita Remitz, MD, PhD', 'role': 'CONTACT', 'email': 'anita.remitz@hus.fi', 'phone': '+358-9-4711'}], 'overallOfficials': [{'name': 'Anita Remitz, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Skin and Allergy Hospital, Helsinki University Central Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Specialist in Dermatology', 'investigatorFullName': 'Anita Remitz', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}