Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-25 @ 10:59 PM
Study NCT ID:
NCT00651820
Status:
COMPLETED
Last Update Posted:
2011-06-09
First Post:
2008-03-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Collagenase on Healing and Scarring
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002921', 'term': 'Cicatrix'}], 'ancestors': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bert.slade@healthpoint.com', 'phone': '817-900-4000', 'title': 'Herbert B. Slade, M.D., FAAAI', 'organization': 'Healthpoint, Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected over the 9 month period of the study', 'description': 'Adverse events were captured, but the Investigator did not always capture which arm exhibited the adverse event, so no in depth analysis could be performed. Of the 2 subjects whose adverse event was probably related to test article (as designated by the Investigator), only 1 had the arm designated and that arm was treated with vehicle.', 'eventGroups': [{'id': 'EG000', 'title': 'Rate of Wound Closure Collagenase Santyl vs. Vehicle', 'description': 'Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.', 'otherNumAtRisk': 28, 'otherNumAffected': 4, 'seriousNumAtRisk': 28, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Erythema', 'notes': 'Wound redness (erythema)- Investigator specified Right Arm for 1 subject, which was treated with Vehicle. Investigator did not specify arm for the second subject with erythema, so causative agent could not be determined.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Rash', 'notes': 'For 1 subject the Investigator did not specify which arm developed the rash, so unable to determine if Collagenase Santyl or its vehicle was causative agent. For the other subject the Investigator specified that both arms developed a rash.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'seriousEvents': [{'term': 'Brain Aneurysm', 'notes': 'The 1 SAE (brain aneurysm) was reported as severe and was unrelated to the test articles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Complete Wound Closure Collagenase Santyl and Vehicle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'units': 'Dermatome-induced wounds on Arms', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Collagenase Santyl Rate of Wound Closure', 'description': 'Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.'}, {'id': 'OG001', 'title': 'Vehicle Rate to Complete Wound Healing', 'description': 'Dermatome-induced skin wounds treated with Vehicle alone. Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '26'}, {'value': '13.0', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '26'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'Each subject served as their own control, each receiving duplicate dermatome-induced wounds with 1 wound treated with active drug and the other treated with vehicle. Mean time to wound closure was calculated for the wounds treated with drug, the wounds treated with vehicle, and an over-all mean time to wound closure', 'statisticalMethod': 'Paired-Prentice Wilcoxon (PPW)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Time to complete wound closure Drug(T1)and Vehicle(T2)Hypothesis, Ho: T1=T2,using paired Prentice-Wilcoxon at significant level of 5%, 2-sided.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '21 days', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Dermatome-induced wounds on Arms', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Analysis was performed on all subjects as intent-to-treat (ITT).'}, {'type': 'SECONDARY', 'title': 'Differences in Scar Viscoelasticity Between Wounds Treated With Collagenase Santyl and Its Vehicle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'units': 'Dermatome-induced wounds on Arms', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Collagenase Santyl Rate of Wound Closure', 'description': 'Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.'}, {'id': 'OG001', 'title': 'Vehicle Rate of Wound Closure', 'description': 'Dermatome-induced skin wounds treated with Vehicle alone. Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.'}], 'classes': [{'title': 'Stiffness', 'categories': [{'measurements': [{'value': '184.25', 'spread': '37.47', 'groupId': 'OG000'}, {'value': '174.05', 'spread': '46.51', 'groupId': 'OG001'}]}]}, {'title': 'Energy Absorption', 'categories': [{'measurements': [{'value': '72.6', 'spread': '18.33', 'groupId': 'OG000'}, {'value': '78.48', 'spread': '24.96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.20', 'groupDescription': 'Stiffness: Paired t-test and Wilcoxon signed rank test were used for testing any significant differences (Sig. diff.) between the two treatments', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.88', 'groupDescription': 'Energy Absorption: Paired t-test and Wilcoxon signed rank test were used for testing any significant differences (Sig. diff.) between the two treatments', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '9 Months', 'description': 'Differences in Scar Viscoelasticity between wounds treated with Collagenase Santyl and its vehicle as measured by Stiffness and Energy Absorption using BTC-2000 measurements.', 'unitOfMeasure': 'mmHg/mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Dermatome-induced wounds on Arms', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Analysis performed on Intent-to-Treat (ITT) population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rate of Wound Closure Collagenase Santyl vs. Vehicle', 'description': 'Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Rate of Wound Closure Collagenase Santyl vs. Vehicle', 'description': 'Dermatome-induced skin wounds treated with drug active (collagenase). Each subject received 2 identical wounds, one on each arm. One arm was treated with Collagenase Santyl, the other with Vehicle. Each subject acted as their own control.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.6', 'spread': '8.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-07', 'studyFirstSubmitDate': '2008-03-20', 'resultsFirstSubmitDate': '2010-06-04', 'studyFirstSubmitQcDate': '2008-04-02', 'lastUpdatePostDateStruct': {'date': '2011-06-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-01-07', 'studyFirstPostDateStruct': {'date': '2008-04-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Complete Wound Closure Collagenase Santyl and Vehicle', 'timeFrame': '21 days'}], 'secondaryOutcomes': [{'measure': 'Differences in Scar Viscoelasticity Between Wounds Treated With Collagenase Santyl and Its Vehicle', 'timeFrame': '9 Months', 'description': 'Differences in Scar Viscoelasticity between wounds treated with Collagenase Santyl and its vehicle as measured by Stiffness and Energy Absorption using BTC-2000 measurements.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['wound healing', 'scarring', 'collagenase', 'Santyl'], 'conditions': ['Scarring', 'Impaired Wound Healing']}, 'descriptionModule': {'briefSummary': 'A study to compare the rate of complete wound closure and quality of resulting scar at 3, 6 and 9 months, between dermatome-induced skin wounds treated with Collagenase Santyl Ointment versus vehicle alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provide written informed consent\n2. Willing to attend all required study visits\n\nExclusion Criteria:\n\n1. Known hypersensitivity to Clostridial collagenase\n2. Anticoagulants (blood thinners, including aspirin) within two weeks\n3. Congenital skin disorder which affects keratinocytes, elastin, or collagen\n4. Any dermatologic disease which may be aggravated or provoked by the wounding procedure\n5. Dark skin pigmentation to a degree which is very likely to obscure the assessment of vascularization post-wounding\n6. At risk of keloid or hypertrophic scar formation\n7. Scars, tattoos or deformities (i.e., contractures) on the inner aspect of the upper arm area where the wound will be placed\n8. Any skin disorder which causes delayed healing\n9. Disrupted lymphatic drainage of the arm to be studied, or previously diagnosed thoracic outlet syndrome\n10. Taking concomitant medications at doses which are known to interfere with healing, such as non-steroidal anti-inflammatory drugs, anti-neoplastic drugs, or immunosuppressive drugs'}, 'identificationModule': {'nctId': 'NCT00651820', 'briefTitle': 'Effect of Collagenase on Healing and Scarring', 'organization': {'class': 'INDUSTRY', 'fullName': 'Healthpoint'}, 'officialTitle': 'A Randomized, Double-blind, Paired-Comparison of the Effect of Collagenase Santyl® Ointment on Healing and Scarring Characteristics of 600μm Dermatome Wounds', 'orgStudyIdInfo': {'id': '017 101 09 001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Collagenase Santyl Rate of Wound Closure', 'description': 'Dermatome-induced skin wounds treated with drug active (collagenase).', 'interventionNames': ['Drug: Collagenase Santyl']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Rate of Wound Closure', 'description': 'Dermatome-induced skin wounds treated with Vehicle alone.', 'interventionNames': ['Drug: Collagenase Santyl Vehicle']}], 'interventions': [{'name': 'Collagenase Santyl', 'type': 'DRUG', 'description': 'Dermatome-induced skin wounds treated with drug active.\n\nEach subject serves as his own control receiving both treatments in parallel.', 'armGroupLabels': ['Collagenase Santyl Rate of Wound Closure']}, {'name': 'Collagenase Santyl Vehicle', 'type': 'DRUG', 'description': 'Dermatome-induced skin wounds treated with Vehicle alone. Each subject serves as his own control receiving both treatments in parallel.', 'armGroupLabels': ['Vehicle Rate of Wound Closure']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Herbert B Slade, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Healthpoint'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Healthpoint', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Shai M. Rozen, MD', 'oldOrganization': 'University of Texas Southwestern Medical Center'}}}}