Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT01705860
Status:
COMPLETED
Last Update Posted:
2013-04-15
First Post:
2012-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Follow Up to Determine the Effects of Collagenase SANTYL Ointment on Scar Formation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-10-31', 'releaseDate': '2016-09-13'}], 'estimatedResultsFirstSubmitDate': '2016-09-13'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002921', 'term': 'Cicatrix'}], 'ancestors': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017364', 'term': 'Collagenases'}], 'ancestors': [{'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-11', 'studyFirstSubmitDate': '2012-10-09', 'studyFirstSubmitQcDate': '2012-10-11', 'lastUpdatePostDateStruct': {'date': '2013-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scar Assessment', 'timeFrame': '1 Day', 'description': 'Vancouver Scar Scale assessment of dermatome wounds previously treated with Santyl Ointment or White Petrolatum'}], 'secondaryOutcomes': [{'measure': 'Scar Quality', 'timeFrame': '1 Day', 'description': 'Quality of scars over time will be assessed with the BTC-2000 instrument assessment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Collagen, collagenase, scar'], 'conditions': ['Follow up to Acute Wound Scar Study']}, 'descriptionModule': {'briefSummary': 'The present study will evaluate the long term effects on scar formation for dermatome-induced skin wounds treated with Collagenase Santyl® Ointment or vehicle (white petrolatum ointment) alone. The previous study, 017-101-09-001, utilized a small, experimental, cutaneous wound to evaluate both time to complete wound closure and quality of the resulting scar when Collagenase Santyl® Ointment was used to treat the wound.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy adult volunteers who were previously treated in study 017-101-09-001 with Collagenase Santyl Ointment and Vehicle (white petrolatum ointment).', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects will be considered qualified for enrollment if they participated in the Collagenase Santyl® Ointment Study 017 101-09-001 and provide written informed consent.\n* The informed consent document must be read, signed, and dated by the suubject before conducting any study procedures or exams. In addition, the informed consent document must be signed and dated by the individual who consents the subject. A photocopy of the signed informed consent document must be provided to the subject and the original signed document placed in the subject's chart.\n* Subject participated in the 017-101-09-001 study and received at least one application of a test article, whether Collagenase Santyl® Ointment or White Petrolatum.\n\nExclusion Criteria:\n\n* N/A"}, 'identificationModule': {'nctId': 'NCT01705860', 'briefTitle': 'Long Term Follow Up to Determine the Effects of Collagenase SANTYL Ointment on Scar Formation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Healthpoint'}, 'officialTitle': 'A Long Term Follow-Up to Study 017-101-09-001: Effect of Collagenase Santyl® Ointment vs. Placebo on Healing and Scarring Characteristics of 600um Dermatome Wounds', 'orgStudyIdInfo': {'id': '017-101-09-032'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Assessment', 'description': 'All subjects will receive same assessments.', 'interventionNames': ['Biological: Santyl']}], 'interventions': [{'name': 'Santyl', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Herbert B Slade, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Healthpoint'}, {'name': 'Shai Rozen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Healthpoint', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-09-13', 'type': 'RELEASE'}, {'date': '2016-10-31', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Healthpoint'}}}}