Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT00820820
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2009-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IDA (Immunothérapie de la Dermatite Atopique) Adult - Immunotherapy 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2012-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-11', 'studyFirstSubmitDate': '2009-01-09', 'studyFirstSubmitQcDate': '2009-01-09', 'lastUpdatePostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of anti-measles vaccination on the T cell responses in patients', 'timeFrame': '7 / 10 days after vaccine / placebo injection'}], 'secondaryOutcomes': [{'measure': 'Clinical evolution of AD, as measured by the SCORAD', 'timeFrame': '3 weeks after injection'}, {'measure': 'blood level of measles specific IgE and antibodies', 'timeFrame': '3 weeks after injection'}, {'measure': 'Biomarkers - E selectin, CD25, soluble CD30, CCL 17 and CCL 18', 'timeFrame': '7 days, 14 days, 3 weeks after injection'}, {'measure': 'phenotypic characteristics of T lymphocytes', 'timeFrame': '7 days, 14 days, 3 weeks, and 6 weeks after injection'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atopic Dermatitis', 'immunosuppression', 'Measles vaccine', 'T lymphocytes', 'Atopic Dermatitis in adults'], 'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'Atopic dermatitis (AD) is a chronic inflammatory disease of the skin. AD is very frequent, and involves T lymphocytes cells. Measles vaccination, as well as measles vaccine, induces a temporary immunosuppression; furthermore, an improvement of AD has been observed during measles infection.\n\nThis trial is aimed at demonstrating that measles vaccine is able to create an immunomodulation and to improve AD symptoms.\n\n30 adult patients of both sexes with moderate to severe AD will be randomly assigned to measles vaccine (ROUVAX ®), or placebo (vehicle) and follow-up for 45 days.\n\nThe primary outcome is the effect of anti-measles vaccination on the T cell responses in patients; Other outcomes include: clinical evolution of AD, as measured by the SCORAD, the evolution of blood level of measles specific IgE and antibodies; evolution of other biomarkers and phenotypic characteristics of T lymphocytes.', 'detailedDescription': 'Atopic dermatitis (AD) is a chronic inflammatory disease of the skin. AD is very frequent, and involves T lymphocytes cells. Measles vaccination, as well as measles vaccine, induces a temporary immunosuppression; furthermore, an improvement of AD has been observed during measles infection.\n\nThis trial is aimed at demonstrating that measles vaccine is able to create an immunomodulation and to improve AD symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults patients of both sexes, with moderate to severe Atopic Dermatitis (SCORAD (Score for Atopic Dermatitis) ≥ 15).\n\nExclusion Criteria:\n\n* hypersensititvity or contra-indication to a Rouvax® component, Tubertest® component, to egg proteins, immunological deficiency, pregnancy, neomycin\n* allergy,\n* systemic immnosuppressive treatment in the previous 3 months,\n* topic immunosuppressive treatment during the week preceeding the inclusion (gluco-corticoid, or immunosuppressive agent),\n* fever or acute disease (the inclusion must be postpone in such cases).'}, 'identificationModule': {'nctId': 'NCT00820820', 'acronym': 'IDA-Adult', 'briefTitle': 'IDA (Immunothérapie de la Dermatite Atopique) Adult - Immunotherapy in Atopic Dermatitis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut National de la Santé Et de la Recherche Médicale, France'}, 'officialTitle': 'Immunotherapy of Atopic Dermatitis in Adult Patients by Anti-measles Vaccination IDA (Immunothérapie de la Dermatite Atopique)Protocol', 'orgStudyIdInfo': {'id': 'C07-38'}, 'secondaryIdInfos': [{'id': '2007-007267-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rouvax', 'interventionNames': ['Biological: ROUVAX']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Sub cutaneous injection of vehicle', 'interventionNames': ['Biological: placebo']}], 'interventions': [{'name': 'ROUVAX', 'type': 'BIOLOGICAL', 'description': 'Measles vaccine (ROUVAX ®), Schwarz strain (\\>1000 DICC 50) in 0.5 ml of water for injection. One single subcutaneous injection.', 'armGroupLabels': ['Rouvax']}, {'name': 'placebo', 'type': 'BIOLOGICAL', 'description': 'Vehicle (water for injection), 0.5 ml, once', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69495', 'city': 'Pierre-Bénite', 'state': 'Lyon', 'country': 'France', 'facility': 'Unité de Recherche Clinique et Immunologique', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}], 'overallOfficials': [{'name': 'Branka Horvat, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut National de la Santé Et de la Recherche Médicale, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}