Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:04 PM
Study NCT ID:
NCT01779258
Status:
COMPLETED
Last Update Posted:
2014-02-19
First Post:
2013-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Emollients in the Management of Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D004485', 'term': 'Eczema'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'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': 'D005990', 'term': 'Glycerol'}, {'id': 'D010232', 'term': 'Paraffin'}, {'id': 'D005440', 'term': 'Fluid Therapy'}, {'id': 'D003898', 'term': 'Desonide'}], 'ancestors': [{'id': 'D000073999', 'term': 'Triose Sugar Alcohols'}, {'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 347}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-18', 'studyFirstSubmitDate': '2013-01-28', 'studyFirstSubmitQcDate': '2013-01-29', 'lastUpdatePostDateStruct': {'date': '2014-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with at least one flare over the treatment period', 'timeFrame': '12 weeks of treatment.', 'description': 'A flare is defined as following: measurable increased extend or intensity of lesions in less than 2 weeks under continued treatment corresponding to a significant increase in medical score (\\> 25%) or to the introduction of a new line of therapy(topical corticosteroid).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['xerosis', 'dry skin', 'dermatitis', 'eczema', 'emollient', 'corticosteroid', 'flare'], 'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to confirm that emollients play a major role in the maintenance therapy after clearing of inflammatory lesions and can reduce occurrence of flares in children with atopic dermatitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 2 and 6 years included,\n* Presenting with atopic dermatitis, with at least one duly documented flare treated by corticosteroids within the previous 6 months, and presenting a current flare (objective Scoring for Atopic Dermatitis (SCORAD score) is \\[15-40\\] at inclusion),\n* After treatment of the current flare, patients should have for randomization an Objective SCORAD score \\< 15, with Xerosis intensity≥ 1 and no subjective signs\n\nExclusion Criteria:\n\n* Severe form of atopic dermatitis requiring either systemic corticosteroid treatment and/or antibiotic or antiviral treatment and/or hospitalisation,\n* Primary bacterial, viral, fungal or parasitic skin infection,\n* Ulcerated lesions, acne or rosacea,\n* Dermatological disease other than atopic dermatitis which could interfere with the assessment,\n* Immunosuppression,'}, 'identificationModule': {'nctId': 'NCT01779258', 'briefTitle': 'Emollients in the Management of Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pierre Fabre Medicament'}, 'officialTitle': 'Emollients in the Management of Atopic Dermatitis in Children: Prevention of Flares.', 'orgStudyIdInfo': {'id': 'V00034 CR 3 13 1B'}, 'secondaryIdInfos': [{'id': '2012-004621-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group 2', 'description': 'Active control arm, Locatop@, Locapred@', 'interventionNames': ['Device: Atopiclair®', 'Drug: Locatop@', 'Drug: Locapred@']}, {'type': 'OTHER', 'label': 'Group 3', 'description': 'Absence of emollient treatment, Locatop@, Locapred@', 'interventionNames': ['Drug: Locatop@', 'Drug: Locapred@']}, {'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'glycerol, paraffin (liquid and white soft), Locatop@\n\n, Locapred@', 'interventionNames': ['Drug: glycerol, paraffin (liquid and white soft)', 'Drug: Locatop@', 'Drug: Locapred@']}], 'interventions': [{'name': 'glycerol, paraffin (liquid and white soft)', 'type': 'DRUG', 'otherNames': ['Dexeryl®'], 'description': '1 application in the morning and in the evening', 'armGroupLabels': ['Group 1']}, {'name': 'Atopiclair®', 'type': 'DEVICE', 'description': '1 application in the morning, in the afternoon and in the evening', 'armGroupLabels': ['Group 2']}, {'name': 'Locatop@', 'type': 'DRUG', 'description': 'During the Run-In period:\n\n1 application in the morning and in the evening during a maximum of 21 days', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}, {'name': 'Locapred@', 'type': 'DRUG', 'description': 'During the 3 months study treatment:\n\n1 application in the evening in case of flare "', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tallinn', 'country': 'Estonia', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'city': 'Tartu', 'country': 'Estonia', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'city': 'Bordeaux', 'country': 'France', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Poitiers', 'country': 'France', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Vilnius', 'country': 'Lithuania', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'city': 'Lodz', 'country': 'Poland', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Pruszków', 'country': 'Poland', 'geoPoint': {'lat': 52.17072, 'lon': 20.81214}}, {'city': 'Płock', 'country': 'Poland', 'geoPoint': {'lat': 52.54682, 'lon': 19.70638}}, {'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Brasov', 'country': 'Romania', 'geoPoint': {'lat': 45.64861, 'lon': 25.60613}}, {'city': 'Bucharest', 'country': 'Romania', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Craiova', 'country': 'Romania', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'city': 'Iași', 'country': 'Romania', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'city': 'Sibiu', 'country': 'Romania', 'geoPoint': {'lat': 45.8, 'lon': 24.15}}, {'city': 'Targu Mureş', 'country': 'Romania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pierre Fabre Medicament', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}