Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-06 @ 6:11 PM
Study NCT ID:
NCT00993005
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 Hypertrophic Scars and Keloids Scars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017439', 'term': 'Cicatrix, Hypertrophic'}, {'id': 'D007627', 'term': 'Keloid'}], 'ancestors': [{'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, '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': '2009-10-08', 'lastUpdatePostDateStruct': {'date': '2010-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of the hypertrophic scar(s) and keloids measured by a millimetric ruler at week 12 (end of the treatment)', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Occurrence of adverse effects at week 12 (end of the treatment)', 'timeFrame': '12 weeks'}, {'measure': 'Photographs of lesions at week 12 (end of the treatment)', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hypertrophic scars', 'Keloids', 'Asian Gotu Kola', 'Asian Pennywort'], 'conditions': ['Hypertrophic Scars', 'Keloids']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the efficacy of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of Hypertrophic scars and keloids. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 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* Hypertrophic wound or keloid with no treatment for more than 1 month.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Usage of steroids within 30 days.\n* Malignant neoplastic conditions.\n* Alcoholism.\n* Handicap and/or psychiatric condition preventing treatment accomplishment.'}, 'identificationModule': {'nctId': 'NCT00993005', 'briefTitle': 'CICATRIX in the Treatment of Hypertrophic Scars and Keloids Scars', 'organization': {'class': 'INDUSTRY', 'fullName': 'Catalysis SL'}, 'officialTitle': 'Efficacy of CICATRIX (Asian Gotu Kola or Pennywort) in the Treatment of Hypertrophic Scars and Keloids Scars.', 'orgStudyIdInfo': {'id': 'CAT-0910-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 scar rubbing in different directions for 2 minutes, three times a day, for 12 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 scar 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', 'oldOrganization': '"Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital'}}}}