Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT02664805
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2016-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proof of Concept, Twice Daily Applications of LEO 124249 Ointment in the Treatment of Chronic Hand Eczema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2016-01-22', 'studyFirstSubmitQcDate': '2016-01-22', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Subjects with treatment success according to Physician's Global Assessment (PGA) at visit 6 (End of Treatment)", 'timeFrame': '56 days', 'description': 'Treatment success according to the PGA is defined as: Subjects having mild disease at baseline must achieve clear. Subjects having moderate or severe disease at baseline must achieve clear or almost clear'}], 'secondaryOutcomes': [{'measure': 'Hand Eczema Severity Index (HECSI) at visit 6', 'timeFrame': '56 days'}, {'measure': "Subjects with treatment success according to the Patient's Global Assessment of disease severity (PaGA) at visit 6 (End of Treatment)", 'timeFrame': '56 days', 'description': 'Treatment success according to the PaGA is defined as: Subjects having very mild or mild disease at baseline must achieve clear. Subjects having moderate or severe disease at baseline must achieve clear or very mild'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hand Eczema']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.leopharmatrials.com/en', 'label': 'LEO Pharma Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'To compare the efficacy of twice daily applications of LEO 124249 ointment with LEO 124249 ointment vehicle for up to 8 weeks in the treatment of subjects with chronic hand eczema.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of chronic hand eczema with or without atopic etiology/background with a history of not adequately controlled disease activity with cutaneously applied steroid\n* Physician's Global Assessment of disease severity graded as at least mild at Visit 1\n* In overall good health including well controlled diseases\n\nExclusion Criteria:\n\n* Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), retinoids (e.g. alitretinoin) or corticosteroids within 6 weeks prior to randomization (inhaled or intra-nasal steroids corresponding to up to 1 mg prednisone for asthma or rhinitis may be used).\n* PUVA (Psoralen Ultraviolet A) or UVB (Ultraviolet B) therapy on the hands within 4 weeks prior to randomization\n* Cutaneously applied treatment with immunomodulators (pimecrolimus, tacrolimus) or corticosteroids on the hands within 2 weeks prior to randomization.\n* Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 2 weeks prior to randomization\n* Concurrent skin diseases on the hands\n* Current diagnosis of exfoliative dermatitis\n* Significant clinical infection (impetiginized hand eczema) on the hands which requires antibiotic treatment\n* A marked abnormal ECG at baseline\n* Known hepatic dysfunction or hepatic dysfunction tested at Screening\n* Current participation in any other interventional clinical trial"}, 'identificationModule': {'nctId': 'NCT02664805', 'briefTitle': 'Proof of Concept, Twice Daily Applications of LEO 124249 Ointment in the Treatment of Chronic Hand Eczema', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'officialTitle': 'A Phase 2a, Proof of Concept Trial, Testing Twice Daily Applications of LEO 124249 Ointment in the Treatment of Chronic Hand Eczema', 'orgStudyIdInfo': {'id': 'LP0133-1180'}, 'secondaryIdInfos': [{'id': '2015-002079-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LEO 124249 ointment', 'description': 'Twice daily cutaneous application for 8 weeks', 'interventionNames': ['Drug: LEO 124249 ointment']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'LEO 124249 ointment vehicle', 'description': 'Twice daily cutaneous application for 8 weeks', 'interventionNames': ['Drug: LEO 124249 ointment vehicle']}], 'interventions': [{'name': 'LEO 124249 ointment', 'type': 'DRUG', 'description': 'Ointment', 'armGroupLabels': ['LEO 124249 ointment']}, {'name': 'LEO 124249 ointment vehicle', 'type': 'DRUG', 'description': 'Ointment vehicle', 'armGroupLabels': ['LEO 124249 ointment vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Allergie-Centrum-Charité Klinik für Dermatologie, Venerologie und Allergologie', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Margitta Worm, Prof Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Allergie-Centrum-Charité Klinik für Dermatologie, Venerologie und Allergologie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LEO Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}