Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT00176956
Status:
TERMINATED
Last Update Posted:
2013-02-05
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Atopic Dermatitis-Like Skin Disease in Pediatric Heart Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003872', 'term': 'Dermatitis'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'whyStopped': 'IRB approval has lapsed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-01', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2013-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Post Pediatric Heart Transplant'], 'conditions': ['Dermatitis']}, 'descriptionModule': {'briefSummary': 'The skin disease found in pediatric heart transplant patients represents an atopic dermatitis-like rash that is refractory to systemic immunomodulation.', 'detailedDescription': 'We want to determine whether pediatric heart transplant patients with an atopic dermatitis-like rash report a personal and/or family history of atopy (asthma, allergies and atopic dermatitis). In addition comparisons will be made between the presence of atopy between patients with and without the skin rash. Comparisons will be made of systemic immunosuppressive therapies between patients with and without the atopic dermatitis-like rash. Determination will be made as to whether histologic characterization of a skin biopsy specimen is consistent with AD. Thorough evaluations will be made of patients in the clinic with this rash and the presence of bacterial superinfection will be ruled out.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have had a heart transplant.\n* Patients must be less than 16 years of age.\n\nExclusion Criteria:\n\n* Patients who have not had a heart transplant.\n* Patients who are greater than 16 years of age.'}, 'identificationModule': {'nctId': 'NCT00176956', 'briefTitle': 'Atopic Dermatitis-Like Skin Disease in Pediatric Heart Transplant Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Atopic Dermatitis-Like Skin Disease in Pediatric Heart Transplant Patients', 'orgStudyIdInfo': {'id': '0110M09983'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Skin Biopsy', 'type': 'PROCEDURE', 'otherNames': ['Skin biopsy.'], 'description': 'Skin biopsy.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Maria Hordinsky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hordinsky, Maria K., MD', 'class': 'INDIV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}