Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-02-20 @ 9:11 AM
Study NCT ID:
NCT03617068
Status:
COMPLETED
Last Update Posted:
2019-08-06
First Post:
2018-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Coconut Oil Cream as a Prevention Treatment for Occupational Hand Dermatitis Among Batik Workers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006229', 'term': 'Hand Dermatoses'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'blinding had to be done by Clinical Research Supporting Unit Faculty of Medicine, Universitas Indonesia'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Batik traditional workers with occupational hand dermatitis using emolient for prevention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-05', 'studyFirstSubmitDate': '2018-07-31', 'studyFirstSubmitQcDate': '2018-07-31', 'lastUpdatePostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical improvement of hand dermatitis measured by Hand Eczema Severity Index (HECSI) after using coconut oil', 'timeFrame': '14 days', 'description': 'Batik workers who had hand dermatitis was measured using HECSI score before and after intervention with coconut oil cream. They used the cream twice daily for 14 days'}], 'secondaryOutcomes': [{'measure': 'Transepidermal water loss (TEWL)', 'timeFrame': '14 days', 'description': 'TEWL is the amount of water that passively evaporates through skin to the external environment'}, {'measure': 'Skin capacitance', 'timeFrame': '14 days', 'description': 'Skin capacitance depends on the water content of the stratum corneum'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hand Dermatoses']}, 'descriptionModule': {'briefSummary': 'Empirically, mosturizer is used to prevent and treat many occupational dermatoses that has skin barrier impairment. Evidence based medicine about the effectivity of mosturizer in occupational dermatoses is limited. Coconut oil is one of traditional substance that is used as a skin care. There is study shows that coconut oil is effective for atopic dermatitis treatment in children. Other studies are needed to assess the effectivity coconut oil mosturizer cream to overcome occupational hand dermatitis.', 'detailedDescription': 'The aim of this study is to measure the effectivenes of coconut oil cream for batik workers who suffer from occupational hand dermatitis. The gloves that used as a protective equipment are made from rubber which have its own limitations. Therefore other interventions are needed to improve barrier skin.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signing the informed consent document before the study start\n* adult population include patients between the ages of 18 and 64 years who work in the dyeing and washing process more than 6 months.\n* suffering from occupational hand dermatitis that meet Mathias Criteria.\n* willing to obey the research protocol\n* willing to fill in diary periodically\n\nExclusion Criteria:\n\n* having history of allergy or irritation caused by coconut oil or other mosturizer\n* suffering from symptoms including edema, exudation, crust, fissures, liver problems, and signs of infection\n* on corticosteroid treatment ( medium to high potency) or on systemic immunosuppressive therapy'}, 'identificationModule': {'nctId': 'NCT03617068', 'briefTitle': 'The Effectiveness of Coconut Oil Cream as a Prevention Treatment for Occupational Hand Dermatitis Among Batik Workers', 'organization': {'class': 'OTHER', 'fullName': 'Fakultas Kedokteran Universitas Indonesia'}, 'officialTitle': 'The Effectiveness and Dermato-pharmacokinetic of Coconut Oil Cream as a Prevention Treatment for Occupational Hand Dermatitis Among Batik Workers', 'orgStudyIdInfo': {'id': '05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Coconut Oil Cream', 'description': 'This group consist of batik traditional workers who use coconut oil cream for 2 weeks.', 'interventionNames': ['Drug: Cocos Nucifera Whole']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Cream', 'description': 'This group consist of batik traditional workers who use placebo cream which contained the vehiculum of the cream; using for 2 weeks.', 'interventionNames': ['Drug: Cocos Nucifera Whole']}], 'interventions': [{'name': 'Cocos Nucifera Whole', 'type': 'DRUG', 'otherNames': ['Coconut Oil Cream'], 'description': 'Applying the Cocos Nucifera Whole cream for 2 weeks, on both of arms. We evaluated the score of hand dermatitis using Hand Eczema Score Index ( HECSI), transepidermal water loss (TEWL), and Skin capacitance', 'armGroupLabels': ['Coconut Oil Cream', 'Placebo Cream']}, {'name': 'Cocos Nucifera Whole', 'type': 'DRUG', 'otherNames': ['Coconut Oil Cream'], 'description': 'For dermatopharmacokinetic evaluation using tape/ skin stripping', 'armGroupLabels': ['Coconut Oil Cream', 'Placebo Cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'Jakarta Special Capital Region', 'country': 'Indonesia', 'facility': 'Faculty of Medicine Universitas Indonesia', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'overallOfficials': [{'name': 'Retno W Soebaryo, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fakultas Kedokteran Universitas Indonesia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make individual participant data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fakultas Kedokteran Universitas Indonesia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}