Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 11:13 PM
Study NCT ID:
NCT00823693
Status:
COMPLETED
Last Update Posted:
2009-08-21
First Post:
2009-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Bimosiamose Cream to Treat Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, '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': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'lastUpdateSubmitDate': '2009-08-20', 'studyFirstSubmitDate': '2009-01-14', 'studyFirstSubmitQcDate': '2009-01-15', 'lastUpdatePostDateStruct': {'date': '2009-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-16', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Bimosiamose Cream is safe and effective in the treatment of plaque type psoriasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of plaque type psoriasis PASI score of 5-15\n* At least 18 years of age\n* Written informed consent\n\nExclusion Criteria:\n\n* Active skin infection\n* More than 20% Body Surface Area (BSA) affected by psoriasis\n* Use of certain anti-psoriasis medication or treatments'}, 'identificationModule': {'nctId': 'NCT00823693', 'briefTitle': 'Safety and Efficacy Study of Bimosiamose Cream to Treat Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Revotar Biopharmaceuticals AG'}, 'officialTitle': 'Multi-center, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Safety and Efficacy of Bimosiamose 5% Cream for the Treatment of Patients With Chronic Plaque Type Psoriasis', 'orgStudyIdInfo': {'id': 'R013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bimosiamose Cream', 'interventionNames': ['Drug: Bimosiamose Cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Cream', 'interventionNames': ['Drug: Placebo Cream']}], 'interventions': [{'name': 'Bimosiamose Cream', 'type': 'DRUG', 'armGroupLabels': ['Bimosiamose Cream']}, {'name': 'Placebo Cream', 'type': 'DRUG', 'armGroupLabels': ['Placebo Cream']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Campus Mitte, Klinik für Dermatologie, Venerologie und Allergologie', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Revotar Biopharmaceuticals AG', 'class': 'INDUSTRY'}}}}