Ignite Creation Date:
2025-12-24 @ 6:57 PM
Ignite Modification Date:
2026-02-22 @ 1:00 PM
Study NCT ID:
NCT00625157
Status:
COMPLETED
Last Update Posted:
2008-02-29
First Post:
2008-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions (2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008179', 'term': 'Lupus Erythematosus, Discoid'}], 'ancestors': [{'id': 'D008178', 'term': 'Lupus Erythematosus, Cutaneous'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'lastUpdateSubmitDate': '2008-02-28', 'studyFirstSubmitDate': '2008-02-20', 'studyFirstSubmitQcDate': '2008-02-20', 'lastUpdatePostDateStruct': {'date': '2008-02-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-28', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Discoid Lupus Erythematosus']}, 'descriptionModule': {'briefSummary': 'Lupus Erythematosus (LE) is an autoimmune disorder that includes a broad spectrum of clinical forms. One of these forms, Discoid Lupus Erythematosus (DLE) is a chronic disfiguring disease confined to the skin.\n\nThe aim of this pivotal trial is to investigate the efficacy and safety of ASF-1096 cream 0.5% in the treatment of patients with DLE or SLE presenting newly developed discoid lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A clinical diagnosis of either DLE or SLE\n* Histological results from biopsy confirming the diagnosis (biopsy can be taken at screening)\n* Is prepared to grant authorised persons access to the medical records\n* Has signed informed consent\n\nExclusion Criteria:\n\n* Has an active skin disease other than DLE or another progressive or serious disease that interferes with the study outcome\n* Has scarring at the target lesion\n* Systemic treatment of SLE'}, 'identificationModule': {'nctId': 'NCT00625157', 'briefTitle': 'Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions (2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astion Pharma A/S'}, 'officialTitle': 'Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Patients With Newly Developed Discoid Lupus Erythematosus (DLE) Lesions. An International Multi-Centre Clinical Phase 2, Placebo Controlled and Double Blind Proof of Concept Study (2)', 'orgStudyIdInfo': {'id': 'ASF1096-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: ASF 1096 0.5 % cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: ASF 1096 placebo cream']}], 'interventions': [{'name': 'ASF 1096 0.5 % cream', 'type': 'DRUG', 'armGroupLabels': ['1']}, {'name': 'ASF 1096 placebo cream', 'type': 'DRUG', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Roskilde Hospital', 'country': 'Denmark', 'facility': 'Gregor Jemec'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astion Pharma A/S', 'class': 'INDUSTRY'}}}}