Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2025-12-29 @ 9:56 PM
Study NCT ID:
NCT01257061
Status:
COMPLETED
Last Update Posted:
2020-07-07
First Post:
2010-11-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Clemastine Fumarate + Dexamethasone Compared to Dexchlorpheniramine Maleate in Eczema Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004485', 'term': 'Eczema'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 310}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2013-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-01', 'studyFirstSubmitDate': '2010-11-29', 'studyFirstSubmitQcDate': '2010-12-08', 'lastUpdatePostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction / improvement of signs and symptoms', 'timeFrame': 'DAY 22', 'description': 'The reduction of signs an symptoms will be evaluated by OSAAD index.'}], 'secondaryOutcomes': [{'measure': 'Adverse Events Evaluation', 'timeFrame': 'DAY 22', 'description': 'Adverse events will be collected and followed in order to evaluate safety and tolerability.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dermatitis', 'Dermatitis, Atopic'], 'conditions': ['Eczema']}, 'descriptionModule': {'briefSummary': 'Atopic dermatitis is a recurrent pruritic skin disorder which has a significant morbidity and impaired quality of life due specially pruritus and physical visible skin lesions. The propose of this trial is evaluate the effectiveness of clemastine fumarate 1, 0 mg/g + dexamethasone 0, 5 mg/g compared to dexchlorpheniramine maleate 10 mg/g in eczema treatment.', 'detailedDescription': 'Study design:\n\n• Double blinded, superiority, prospective parallel-group, intend to treat trial.\n\nStudy design:\n\n* Experiment duration: 22 days\n* 2 visits (days 1,7,15 and 22)\n* Reducing Eczema Area and severity index evaluation\n* Adverse events evaluation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients must be able to understand the study procedures agree to participate and give written consent.\n2. Patients with acute or sub-acute eczema.\n3. Presence of symmetric lesions to compare on side to the other.\n\nExclusion Criteria:\n\n1. Pregnancy or risk of pregnancy.\n2. Lactation\n3. Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study).\n4. Sunlight over exposure in the last 15 days.\n5. Any pathology or past medical condition that can interfere with this protocol.'}, 'identificationModule': {'nctId': 'NCT01257061', 'briefTitle': 'Effectiveness of Clemastine Fumarate + Dexamethasone Compared to Dexchlorpheniramine Maleate in Eczema Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMS'}, 'officialTitle': 'Unicentric Comparing Effectiveness Superiority of to Clemastine Fumarate 1, 0 mg/g + Dexamethasone 0, 5 mg/g to Dexchlorpheniramine Maleate 10 mg/g in Eczema Treatment.', 'orgStudyIdInfo': {'id': 'DECEMS1010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Clemastine fumarate 1,0 mg/g + dexamethasone 0,5/g', 'interventionNames': ['Drug: Group 1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Dexchlorpheniramine maleate 10 mg/g', 'interventionNames': ['Drug: Group 2']}], 'interventions': [{'name': 'Group 1', 'type': 'DRUG', 'description': 'Clemastine fumarate 1,0 mg/g + dexamethasone 0,5/g applied 2 times / day at lesion', 'armGroupLabels': ['Group 1']}, {'name': 'Group 2', 'type': 'DRUG', 'description': 'Dexchlorpheniramine maleate 10 mg/g applied 2 times / day at lesion', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '060323-000', 'city': 'Osasco', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Medcin instituto da Pele', 'geoPoint': {'lat': -23.5325, 'lon': -46.79167}}], 'overallOfficials': [{'name': 'Flavia Addor, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medcin Instituto da Pele'}, {'name': 'Felipe Pinho, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'EMS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}