Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-30 @ 9:03 AM
Study NCT ID:
NCT01018212
Status:
COMPLETED
Last Update Posted:
2010-12-08
First Post:
2009-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cicatrix Cream in Cutaneous Groves
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-07', 'studyFirstSubmitDate': '2009-11-20', 'studyFirstSubmitQcDate': '2009-11-20', 'lastUpdatePostDateStruct': {'date': '2010-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'They are the cutaneous grooves, being Observed the reduction of the number of the lesions monthly.', 'timeFrame': '4 month'}], 'secondaryOutcomes': [{'measure': 'Extension of the groves and the reduction of these expressed in centimetres', 'timeFrame': '4 months'}, {'measure': 'Adverse effects', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cutaneous Groves'], 'conditions': ['Cutaneous Groves']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the effect of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of cutaneous grooves. The duration of this phase 2 clinical trial will be 4 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patient that refer manifestations of high sensibility to the medication or to some of the components of the product.\n* Patient that don't want to participate in the study.\n* Patient not very cooperative.\n* Responsible family not very cooperative."}, 'identificationModule': {'nctId': 'NCT01018212', 'briefTitle': 'Cicatrix Cream in Cutaneous Groves', 'organization': {'class': 'INDUSTRY', 'fullName': 'Catalysis SL'}, 'officialTitle': 'Effect the Cicatrix Cream in Cutaneous Groves Treatment', 'orgStudyIdInfo': {'id': 'CAT-0902-CU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Cicatrix cream', 'interventionNames': ['Other: Cicatrix cream']}], 'interventions': [{'name': 'Cicatrix cream', 'type': 'OTHER', 'description': 'We will be carried out the topical application of the product (Cicatrix cream) in the lesions auto administration three times a day during four months, being controlled by the specialist in months consultations.\n\nThe dose of 0,1 ml of cream for each cm. of surface, To the patient will be explained the technique of the application.', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Havana', 'state': 'La Habana', 'country': 'Cuba', 'facility': 'Pediatric Hospital Juan Manuel Marquez', 'geoPoint': {'lat': 23.13302, 'lon': -82.38304}}], 'overallOfficials': [{'name': 'Fernanda Pastrana, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pediatric Hospital Juan Manuel Marquez'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catalysis SL', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Fernanda Pastrana', 'oldOrganization': 'Pediatric Hospital Juan Manuel Márquez'}}}}