Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:24 PM
Study NCT ID:
NCT01772056
Status:
TERMINATED
Last Update Posted:
2015-01-09
First Post:
2013-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy Study of Topical Twice Weekly Fluticasone Treatment to Reduce Relapse in Atopic Dermatitis in Children
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': 'D000068298', 'term': 'Fluticasone'}], 'ancestors': [{'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'whyStopped': 'Patient recruitment is very slow, economic grant has ended and the number of patients is enough according to sample size (22 children/ arm).', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-08', 'studyFirstSubmitDate': '2013-01-16', 'studyFirstSubmitQcDate': '2013-01-18', 'lastUpdatePostDateStruct': {'date': '2015-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse in Atopic Dermatitis (AD).', 'timeFrame': '16 weeks', 'description': 'The primary study end point will be probability of a relapse of AD occurring (the relapse rate of AD).'}], 'secondaryOutcomes': [{'measure': 'Time to relapse', 'timeFrame': '16 weeks', 'description': 'The number of days from start of the Fluticasone propionate treatment in Double-blind Maintenance Phase (DMP) until AD relapse.'}, {'measure': 'Incidence of relapse', 'timeFrame': '16 weeks', 'description': 'The proportion of children experiencing a relapse of AD during DMP.'}, {'measure': 'severity of the relapse', 'timeFrame': '16 weeks', 'description': 'Severity of AD was scored by means of the modified Scoring of Atopic Dermatitis system (SCORAD).The difference of SCORAD intensity between initial values, Open-label Stabilization Phase (OSP), and end values (end of DMP)'}, {'measure': 'Adverse events and adverse effects', 'timeFrame': '22 weeks', 'description': 'Safety was assessed by monitoring adverse events and adverse effects throughout the study.'}, {'measure': 'Therapeutic compliance', 'timeFrame': '18 weeks', 'description': 'To describe the therapeutic compliance by means of the control of the drug used.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dermatitis, Atopic', 'Randomized Controlled Trial', 'Child', 'Fluticasone', 'Preventive therapy'], 'conditions': ['Dermatitis, Atopic']}, 'descriptionModule': {'briefSummary': 'The relapsing nature of atopic dermatitis (AD) presents a challenge for its long-term treatment. Efficacy and safety of corticosteroids have been proven in the acute treatment of AD, but not its efficacy and security to reduce or prevent relapses.\n\nObjectives To investigate long-term management (16 weeks) of AD with fluticasone propionate (FP) 0,05% cream twice weekly in addition to an emollient (vehicle) after stabilization of an acute flare of AD with FP cream.', 'detailedDescription': 'Patients 2-10 years of age with a history of mild to moderate AD will be eligible for this multicentre, randomized, double-blind, controlled study if they present an acute flare of AD (\\<30% affected body surface area; no head). After successful treatment of the flare in an acute phase, patients will receive either, FP twice weekly plus vehicle or vehicle alone over a 16-week maintenance phase. The primary study end point will be probability of a relapse of AD occurring. We will conduct survivor analysis of results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children, aged 2 to 10 years, with mild or moderate acute flare of AD (SCORAD up to 50) and no treatment for this episode of AD.\n* written informed consent to patients' parents.\n\nExclusion Criteria:\n\n* \\>30% of affected body surface area AD.\n* Head affected.\n* Fluticasone o vehicle allergy.\n* Patients with any medical condition for which topical corticosteroids were contraindicated\n* Patients with other dermatological conditions that may have prevented accurate assessment of AD\n* Patients with receiving any concomitant medications that might have affected the study's outcome.\n* Other medical history that could interfere with the evaluation of study treatment."}, 'identificationModule': {'nctId': 'NCT01772056', 'briefTitle': 'Efficacy Study of Topical Twice Weekly Fluticasone Treatment to Reduce Relapse in Atopic Dermatitis in Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Valencia'}, 'officialTitle': 'Randomised Controlled, Double Blind Trial of Topical Twice Weekly Fluticasone Propionate Maintenance Treatment to Reduce Risk of Relapse in Mild or Moderate Atopic Dermatitis in Children', 'orgStudyIdInfo': {'id': 'FLUTIDANENES08'}, 'secondaryIdInfos': [{'id': 'EC08/00004', 'type': 'OTHER_GRANT', 'domain': 'Instituto de Salud Carlos III (ISCIII). Spain'}, {'id': '2008-005360-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluticasone, cream', 'description': 'fluticasone propionate (FP) cream of 0.05%. The vehicle is:Base PFCO/W, Propyleneglycol and Water conservant.', 'interventionNames': ['Drug: Fluticasone, cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo, cream', 'description': 'Vehicle cream is composed by Base PFCO/W, Propyleneglycol and Water conservant.', 'interventionNames': ['Drug: Placebo,']}], 'interventions': [{'name': 'Fluticasone, cream', 'type': 'DRUG', 'description': 'Experimental Group: on treatment with twice weekly on consecutive days FP cream of 0.05% for 16 weeks or at relapse', 'armGroupLabels': ['Fluticasone, cream']}, {'name': 'Placebo,', 'type': 'DRUG', 'description': 'Control Group: on treatment with twice weekly on consecutive days vehicle cream for 16 weeks or at relapse.', 'armGroupLabels': ['Placebo, cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46600', 'city': 'Alzira', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Departamento de Salud Valencia-La Ribera', 'geoPoint': {'lat': 39.15, 'lon': -0.43333}}, {'zip': '46010', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Departamento Valencia-Clinic-Malvarrosa', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46014', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Departamento de Salud Valencia - Hospital General', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46015', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Departamento de Salud Valencia-Arnau-Lliria', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Elena Rubio Gomis, PhD MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Consorcio Hospital General Universitario de Valencia y Universidad de Valencia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elena Rubio Gomis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto de Salud Carlos III', 'class': 'OTHER_GOV'}, {'name': 'Fundacion Investigación Hospital General Universitario de Valencia', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Pharmacology. Clinical Pharmacology', 'investigatorFullName': 'Elena Rubio Gomis', 'investigatorAffiliation': 'University of Valencia'}}}}