Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT01063218
Status:
COMPLETED
Last Update Posted:
2012-03-12
First Post:
2010-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Cetaphil Advanced Usage to Control Light to Moderate Atopic Dermatitis, in Attempt to Reduce the Necessity of Topic Corticoids Application
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-09', 'studyFirstSubmitDate': '2010-02-04', 'studyFirstSubmitQcDate': '2010-02-04', 'lastUpdatePostDateStruct': {'date': '2012-03-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical evaluation', 'timeFrame': 'Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dermatitis, Atopic', 'Corticoids, topic', 'Corticosteroids'], 'conditions': ['Dermatitis, Atopic']}, 'descriptionModule': {'briefSummary': 'The main goal of this present study is evaluate the decreasing of necessity of topic corticoids usage to control outbreaks of light to moderate atopic dermatitis by using the correct emollients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female patients\n* 2 to 10 years old.\n* with light to moderate with no signs of acute/ sub-acute eczema or in activity.\n* Subjects can not present inflammatory lesions, erythema, edema, eschar, excoriation and lichens.\n* Subjects can present light to moderate dryness.\n\nExclusion Criteria:\n\n* Subjects presenting any serious systemic disease\n* Subjects with medical history regarding serious asthma\n* Subjects with known or suspected allergy to one of the investigational products\n* Subjects with acute atopic eczema or in activity, needing systemic antibiotics\n* Subjects with signs of active infections on skin\n* Subjects whose parents or legal guardian seem to have difficulty in understand the informed consent form (ICF)\n* Female subjects who are not in pre-menarche period.\n* Subjects who need topic corticoids or any other medication that can interfere on Atopic Dermatitis during the study.\n* Patient with a wash-out period for treatment less than:\n* injectable corticoids: 60 days\n* systemic corticoids: 15 days\n* topic corticoids: 8 days\n* topic immunomodulator: 8 days\n* antihistaminic : 48 hours'}, 'identificationModule': {'nctId': 'NCT01063218', 'briefTitle': 'Evaluation of Cetaphil Advanced Usage to Control Light to Moderate Atopic Dermatitis, in Attempt to Reduce the Necessity of Topic Corticoids Application', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma Brasil Ltda.'}, 'officialTitle': 'Phase IV - Evaluation of Cetaphil Advanced Usage to Control Light to Moderate Atopic Dermatitis, in Attempt to Reduce the Necessity of Topic Corticoids Application', 'orgStudyIdInfo': {'id': 'BR.09.001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Emollient', 'description': 'Only one arm: Emollient (Cetaphil Advanced) to be applied twice a day', 'interventionNames': ['Other: Emollient - Cetaphil Advanced']}], 'interventions': [{'name': 'Emollient - Cetaphil Advanced', 'type': 'OTHER', 'description': 'Emollient - Cetaphil Advanced - to be applied twice a day for 20 weeks.', 'armGroupLabels': ['Emollient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70910-900', 'city': 'Brasília', 'state': 'Federal District', 'country': 'Brazil', 'facility': 'Hospital Universitário de Brasília', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}, {'zip': '07051-000', 'city': 'Guarulhos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Complexo Hospitalar Padre Bento de Guarulhos', 'geoPoint': {'lat': -23.46278, 'lon': -46.53333}}], 'overallOfficials': [{'name': 'Mario C Pires, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Complexo Hospitalar Padre Bento de Guarulhos'}, {'name': 'Izelda Costa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitário de Brasília'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma Brasil Ltda.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Mario Cézar Pires', 'oldOrganization': 'Complexo Hospitalar Padre Bento de Guarulhos'}}}}