Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2026-02-28 @ 11:20 AM
Study NCT ID:
NCT00991367
Status:
COMPLETED
Last Update Posted:
2010-12-08
First Post:
2009-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CICATRIX in the Treatment of Recent Post-surgical Scars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003358', 'term': 'Cosmetics'}], 'ancestors': [{'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D006795', 'term': 'Household Products'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-07', 'studyFirstSubmitDate': '2009-10-07', 'studyFirstSubmitQcDate': '2009-10-07', 'lastUpdatePostDateStruct': {'date': '2010-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of the post-surgical scar(s) measured by a millimetric ruler at week 4 (end of the treatment)', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Occurrence of adverse effects at week 4 (end of the treatment)', 'timeFrame': '4 weeks'}, {'measure': 'Photographs of lesions at week 4 (end of the treatment)', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Post-surgical scars', 'Asian Gotu Kola', 'Asian Pennywort'], 'conditions': ['Post-surgical Scars']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the efficacy of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of recent post-surgical scars. The duration of this double-blind placebo controlled phase 3 clinical trial will be 4 weeks. The estimated number of persons to be recruited and randomized for the study is 90.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recent (less than 48 hours) post-surgical wound\n\nExclusion Criteria:\n\n* Post-surgical wound with sepsis\n* Usage of steroids within 30 days\n* Malignant neoplastic conditions\n* Alcoholism\n* Handicap and/or psychiatric condition preventing treatment accomplishment.'}, 'identificationModule': {'nctId': 'NCT00991367', 'briefTitle': 'CICATRIX in the Treatment of Recent Post-surgical Scars', 'organization': {'class': 'INDUSTRY', 'fullName': 'Catalysis SL'}, 'officialTitle': 'Efficacy of CICATRIX (Asian Gotu Kola or Pennywort) in the Treatment of Recent Post-surgical Scars', 'orgStudyIdInfo': {'id': 'CAT-0909-CU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Cicatrix', 'interventionNames': ['Other: Cicatrix']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Cicatrix', 'type': 'OTHER', 'otherNames': ['Cosmetic'], 'description': 'Dosage commensurate with surface to be treated. After washing and drying the affected area, a thin layer of CICATRIX (Topical use) will be applied on the lesion rubbing in different directions for 2 minutes, three times a day, for 4 weeks.', 'armGroupLabels': ['A']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Dosage commensurate with surface to be treated. After washing and drying the affected area, a thin layer of PLACEBO (Topical use) will be applied on the lesion rubbing in different directions for 2 minutes, three times a day, for 4 weeks.', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Havana', 'state': 'La Habana', 'country': 'Cuba', 'facility': '"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital', 'geoPoint': {'lat': 23.13302, 'lon': -82.38304}}], 'overallOfficials': [{'name': 'Omara Lemus, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catalysis SL', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Alfredo Abreu Daniel PhD', 'oldOrganization': '"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital'}}}}