Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-02-24 @ 8:19 AM
Study NCT ID:
NCT00576550
Status:
COMPLETED
Last Update Posted:
2008-10-13
First Post:
2007-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomised Trial of a Moisturising Cream in Preventing Recurrence of Hand Eczema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014508', 'term': 'Urea'}, {'id': 'D001624', 'term': 'Betamethasone Valerate'}], 'ancestors': [{'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001623', 'term': 'Betamethasone'}, {'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'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-10-10', 'studyFirstSubmitDate': '2007-12-18', 'studyFirstSubmitQcDate': '2007-12-18', 'lastUpdatePostDateStruct': {'date': '2008-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to relapse of hand eczema', 'timeFrame': 'Up to 6 months'}], 'secondaryOutcomes': [{'measure': 'The number of patients showing clearance of hand eczema after betamethasone treatment once versus twice daily', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hand eczema', 'Prevention'], 'conditions': ['Hand Eczema']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether a moisturizing cream can prevent hand eczema.Patients with previous hand eczema will be studied. In the second part of the study, it will be explored if a treatment regimen of a topical corticosteroid once daily is not inferior to treatment twice daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically proven history of hand eczema\n* At inclusion controlled state of hand eczema (≤3 on Hand Eczema Extent Score, HEES)\n* Daily use of moisturising treatment\n* Either gender\n* Age 18 or above\n* Written Informed Consent\n\nExclusion Criteria:\n\n* Possible allergy to ingredients in the study medications\n* At study start active psoriatic lesions or active atopic eczema lesions on the hands. Active bacterial, fungal or viral infection of the hands\n* Patients who are pregnant or breast-feeding, or who plan to become pregnant during the course of the study\n* Use of any concomitant medication that may interfere with the study related activities or assessment of efficacy\n* Any patient related factor suggesting potential poor compliance with study procedures (e.g. psychiatric disorders, history of alcohol or substance abuse)\n* Any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results\n* Inclusion in a study of an investigational drug within 60 days prior to start of treatment'}, 'identificationModule': {'nctId': 'NCT00576550', 'briefTitle': 'A Randomised Trial of a Moisturising Cream in Preventing Recurrence of Hand Eczema', 'organization': {'class': 'INDUSTRY', 'fullName': 'ACO Hud Nordic AB'}, 'officialTitle': 'A Randomised Trial of a Moisturising Cream in Preventing Recurrence of Hand Eczema', 'orgStudyIdInfo': {'id': 'SMR-1588'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1:1', 'description': 'Part 1 of the study (maintenance part)', 'interventionNames': ['Drug: Urea']}, {'type': 'NO_INTERVENTION', 'label': '1:2', 'description': 'Part 1 of the study (maintenance part)'}, {'type': 'EXPERIMENTAL', 'label': '2:1', 'description': 'Part 2 of the study (eczema part)', 'interventionNames': ['Drug: betamethasone valerate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2:2', 'description': 'Part 2 of the study (eczema part)', 'interventionNames': ['Drug: betamethasone valerate']}], 'interventions': [{'name': 'Urea', 'type': 'DRUG', 'otherNames': ['Canoderm 5% kräm'], 'description': 'Urea cream applied twice daily up to six months', 'armGroupLabels': ['1:1']}, {'name': 'betamethasone valerate', 'type': 'DRUG', 'otherNames': ['Betnoderm 0,1 % kräm'], 'description': 'Application once daily for two weeks', 'armGroupLabels': ['2:1']}, {'name': 'betamethasone valerate', 'type': 'DRUG', 'otherNames': ['Betnoderm 0,1 % kräm'], 'description': 'Application twice daily for two weeks', 'armGroupLabels': ['2:2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hamar', 'country': 'Norway', 'facility': 'Medi 3 Innlandet', 'geoPoint': {'lat': 60.7945, 'lon': 11.06798}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Colosseumklinikken', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Dr Funks hudklinikk', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Gro Moerk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rikshospitalet, Oslo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ACO Hud Nordic AB', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Smerud Medical Research International AS', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Karin Wirén', 'oldOrganization': 'ACO HUD NORDIC'}}}}