Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-26 @ 5:38 PM
Study NCT ID:
NCT01426035
Status:
WITHDRAWN
Last Update Posted:
2021-02-24
First Post:
2011-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety And Efficacy Study Of Topic Mucopolysaccharide Polysulfate Cream In The Superficial Varicose Veins Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014648', 'term': 'Varicose Veins'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Sponsor decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-23', 'studyFirstSubmitDate': '2011-05-09', 'studyFirstSubmitQcDate': '2011-08-29', 'lastUpdatePostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy - Symptoms reduction', 'timeFrame': 'Evaluation time: 15 days treatment', 'description': 'The primary outcome measure will be evaluated for: Lesion area reduction, reduction of symptoms time and edema'}], 'secondaryOutcomes': [{'measure': 'Efficacy - patient evaluation', 'timeFrame': 'Evaluation time: 15 days treatment', 'description': 'The secondary outcome measure will be measured by subjective opinion (daily register).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['SUPERFICIAL VARICOSE VEINS'], 'conditions': ['VARICOSE VEINS']}, 'descriptionModule': {'briefSummary': 'Evaluate the safety, tolerability and effectiveness of mucopolysaccharide polysulfate cream in the treatment of superficial varicose veins'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be able to understand the study procedures, agree to participate, and give written consent.\n* Patients must be able to follow the study medication regimen.\n* Patients with inflammatory process in superficial veins for more than 72 hours.\n* Presence of symmetric lesions to compare one side to the other.\n\nExclusion Criteria:\n\n* Pregnancy or risk of pregnancy.\n* Lactation.\n* Use of topical or systemic anti-inflammatory, antihistamine or immunosuppressive drugs within the last 48 hours prior to the study\n* Any alteration at other deep veins.\n* History of atopy or allergic diseases.\n* History of allergy to any component of the formulations.\n* Other conditions considered by the investigator as reasonable for non-eligibility'}, 'identificationModule': {'nctId': 'NCT01426035', 'briefTitle': 'Safety And Efficacy Study Of Topic Mucopolysaccharide Polysulfate Cream In The Superficial Varicose Veins Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMS'}, 'officialTitle': 'Phase III of Safety and Efficacy Study of Topic Mucopolysaccharide Polysulfate Cream 5mg/g in the Superficial Varicose Veins Treatment', 'orgStudyIdInfo': {'id': 'MPSEMS0110_cream'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GROUP 1', 'interventionNames': ['Drug: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE CREAM 5MG/G']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GROUP 2', 'interventionNames': ['Drug: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE CREAM 5MG/G']}], 'interventions': [{'name': 'TOPIC MUCOPOLYSACCHARIDE POLYSULFATE CREAM 5MG/G', 'type': 'DRUG', 'description': 'APLIED 4 TIMES/DAY AT LESION', 'armGroupLabels': ['GROUP 1', 'GROUP 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Osasco', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Medcin Instituto Da Pele', 'geoPoint': {'lat': -23.5325, 'lon': -46.79167}}], 'overallOfficials': [{'name': 'FLAVIA ADDOR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medcin Instituto da Pele'}, {'name': 'Felipe Pinho, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'EMS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}