Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-02-10 @ 2:06 PM
Study NCT ID:
NCT02226068
Status:
COMPLETED
Last Update Posted:
2015-03-27
First Post:
2014-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Photophoresis Versus Ciclosporine in Severe 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D017893', 'term': 'Photopheresis'}], 'ancestors': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011701', 'term': 'PUVA Therapy'}, {'id': 'D014467', 'term': 'Ultraviolet Therapy'}, {'id': 'D010789', 'term': 'Phototherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2004-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-26', 'studyFirstSubmitDate': '2014-08-25', 'studyFirstSubmitQcDate': '2014-08-25', 'lastUpdatePostDateStruct': {'date': '2015-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of SCORAD (SCORing Atopic Dermatitis)', 'timeFrame': '4 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atopic dermatitis', 'Ciclosporine', 'Extracorporal photopheresis'], 'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'Severe atopic dermatitis (AD) is a recurrent and debilitating disease often requiring systemic immunosuppressive treatment. The efficacy of cyclosporine A (CsA) is well proven but potential side effects are concerning. Several reports point at extracorporeal photopheresis (ECP) as an efficient alternative treatment modality with few and mild side effects. However, no direct comparison between CsA and ECP in the treatment of AD has been performed so far. In this trial we test the hypothesis that ECP is non-inferior to standard treatment with CsA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCriteria of inclusion were refractoriness to standard topical treatment (corticosteroid ointments, UVA, UVB, PUVA, tar).\n\nExclusion Criteria:\n\nCriteria of exclusion were pregnancy, uncontrolled hypertension, previous malignancy, infectious disease, liver/kidney disease or active treatment with ECP or immunosuppressants within 4 weeks prior to start of trial.'}, 'identificationModule': {'nctId': 'NCT02226068', 'briefTitle': 'Photophoresis Versus Ciclosporine in Severe Atopic Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Ciclosporine and Extracorporal Photopheresis (ECP) Are Equipotent in Treating Severe Atopic Dermatitis (AD): A Randomized Cross-over Study Comparing Two Efficient Treatment Modalities', 'orgStudyIdInfo': {'id': 'CsAvsECP-AUH'}, 'secondaryIdInfos': [{'id': 'CsA-ECP', 'type': 'OTHER', 'domain': 'DermatologyAUH-UK'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'CsA-ECP', 'description': 'Sequence of therapy: First ciclosporin was given and after relapse extra corporal photopheresis was given', 'interventionNames': ['Drug: Cyclosporine A (CsA)', 'Other: Extracorporeal photopheresis (ECP)']}, {'type': 'OTHER', 'label': 'ECP-CsA', 'description': 'Sequence of therapy: First extra corporal photopheresis was given and after relapse ciclosporin was given', 'interventionNames': ['Drug: Cyclosporine A (CsA)', 'Other: Extracorporeal photopheresis (ECP)']}], 'interventions': [{'name': 'Cyclosporine A (CsA)', 'type': 'DRUG', 'otherNames': ['Sandimmune'], 'description': '3 mg/kg/day for 4 month', 'armGroupLabels': ['CsA-ECP', 'ECP-CsA']}, {'name': 'Extracorporeal photopheresis (ECP)', 'type': 'OTHER', 'description': 'Administered two consecutive days twice a month for 4 month', 'armGroupLabels': ['CsA-ECP', 'ECP-CsA']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Erik Obitz, MD, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}