Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-04 @ 7:17 PM
Study NCT ID:
NCT00310492
Status:
COMPLETED
Last Update Posted:
2015-12-29
First Post:
2006-04-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Trial of ALK-depot SQ Mites in Subjects With 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-28', 'studyFirstSubmitDate': '2006-04-02', 'studyFirstSubmitQcDate': '2006-04-02', 'lastUpdatePostDateStruct': {'date': '2015-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'SCORAD extent criteria, index, subjective symptoms, IGA score, oral rescue medication, exacerbation of atopic dermatitis, DLQI, treatment expectation questionnaire', 'timeFrame': '1 year', 'description': 'Investigator´s Global Assessment (IGA), Dermatology Life Quality Index (DLQI)'}], 'primaryOutcomes': [{'measure': 'Changes from baseline in SCORAD and topical medication consumption', 'timeFrame': '1 year', 'description': 'Sccore of atopic dermatitis (SCORAD)'}], 'secondaryOutcomes': [{'measure': 'Changes from baseline in SCORAD intensity score, EASI score and change in topical medication consumption', 'timeFrame': '1 year', 'description': 'Eczema Area Severity Index (EASI)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'This trial is performed to assess the efficacy and safety of ALK-depot SQ mites for treatment of atopic dermatitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Positive specific IgE to house dust mites\n* Atopic dermatitis according to Hanifin/Rajka\n* Chronic course of Atopic dermatitis\n* SCORAD larger than 25 points\n\nExclusion Criteria:\n\n* Erythrodermia\n* Syst.treatment with gcs or immunosuppressive agents in the prev.4 weeks\n* History of specific immunotherapy with mites\n* UV radiation\n* Group 4 topical corticosteroids (European classification)'}, 'identificationModule': {'nctId': 'NCT00310492', 'briefTitle': 'Efficacy and Safety Trial of ALK-depot SQ Mites in Subjects With Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'ALK-Abelló A/S'}, 'officialTitle': 'Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Study to Demonstrate the Efficacy of a 12-month Subcutaneous Specific Immunotherapy With ALK-depot SQ Milbenmischung in Patients With Atopic Dermatitis and Proven IgE-mediated Sensitization to House Dust Mites', 'orgStudyIdInfo': {'id': 'SHX0556'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Subcutaneous immunotherapy', 'description': 'Subcutaneous injections with ALK-depot SQ mites to 100,000 SQ-U', 'interventionNames': ['Biological: subcutaneous immunotherapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Subcutaneous injections', 'description': 'placebo injections', 'interventionNames': ['Biological: subcutaneous immunotherapy']}], 'interventions': [{'name': 'subcutaneous immunotherapy', 'type': 'BIOLOGICAL', 'otherNames': ['ALK-depot SQ mites'], 'description': 'Updosing by 16 injections to 100,000 SQ-U', 'armGroupLabels': ['Subcutaneous immunotherapy', 'Subcutaneous injections']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-30449 Hannover', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover, Klinik für Dermatologie und Venerologie', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}], 'overallOfficials': [{'name': 'Hendrik Wolf, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ALK-SCHERAX Arzneimittel GmbH'}, {'name': 'Alexander Kapp, MD, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hannover Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ALK-Abelló A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}