Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT01736969
Status:
UNKNOWN
Last Update Posted:
2012-12-03
First Post:
2012-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Substantial Equivalence Study of RD04723 and Predicate Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-05-11', 'releaseDate': '2018-04-10'}, {'resetDate': '2018-06-14', 'releaseDate': '2018-05-16'}, {'resetDate': '2018-07-12', 'releaseDate': '2018-06-15'}, {'resetDate': '2019-09-23', 'releaseDate': '2019-08-30'}], 'estimatedResultsFirstSubmitDate': '2018-04-10'}}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'lastUpdateSubmitDate': '2012-11-30', 'studyFirstSubmitDate': '2012-10-12', 'studyFirstSubmitQcDate': '2012-11-26', 'lastUpdatePostDateStruct': {'date': '2012-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison between groups in Vancouver Scar Scale total score from Baseline to Day 112 (or early termination)', 'timeFrame': '4 weeks, 8 weeks, 12 weeks', 'description': 'Vascularity, height/thickness, pliability, and pigmentation. Scoring from zero to thirteen.'}], 'secondaryOutcomes': [{'measure': 'Pain and itch', 'timeFrame': '4 weeks, 8 weeks, 12 weeks', 'description': 'Patient assessment of pain and itch. Scoring from 0-3.'}, {'measure': 'Adverse Events', 'timeFrame': 'Baseline, Weeks: 2, 4, 8, 12 and early termination', 'description': 'Number of subjects with related adverse events'}, {'measure': 'Treatment satisfaction', 'timeFrame': '8 weeks, 12 weeks', 'description': 'Patient assessment (satisfaction) with scar treatment. Stated as: "very good, good, moderate or unsatisfactory".'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypertrophic Scar', 'Keloid Scar']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a developmental formulation is substantially equivalent to the predicate device in the treatment of hypertrophic and keloid scars.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to provide informed consent and release health information\n* Ability to follow study instructions and study requirements\n* Have a hypertrophic or keloid scar accessible for treatment and evaluation\n* Negative pregnancy test for women of childbearing potential\n* Agreement to use effective birth control method for study duration\n\nExclusion Criteria:\n\n* History of allergy or sensitivity to components\n* History of diabetes\n* History of collagen vascular disorders\n* Anticipated need for surgery or hospitalization during the study\n* Pregnant, nursing, or planning a pregnancy during the study\n* Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to Baseline (Day 0)'}, 'identificationModule': {'nctId': 'NCT01736969', 'briefTitle': 'A Substantial Equivalence Study of RD04723 and Predicate Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oculus Innovative Sciences, Inc.'}, 'officialTitle': 'Microcyn Scar Management HydroGel, K103163 vs. Kelo-cote® Scar Gel for the Management of Hypertrophic or Keloid Scars', 'orgStudyIdInfo': {'id': 'MSM-RD-023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RD047-023', 'description': 'RD-047-023', 'interventionNames': ['Device: RD047-023']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Predicate Device', 'description': 'legally marketed predicate device', 'interventionNames': ['Device: Predicate Device']}], 'interventions': [{'name': 'RD047-023', 'type': 'DEVICE', 'description': 'Experimental hydrogel', 'armGroupLabels': ['RD047-023']}, {'name': 'Predicate Device', 'type': 'DEVICE', 'otherNames': ['Kelo-Cote'], 'armGroupLabels': ['Predicate Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'DermResearch Inc', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Janet C DuBois, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Derm Research, PLLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oculus Innovative Sciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-04-10', 'type': 'RELEASE'}, {'date': '2018-05-11', 'type': 'RESET'}, {'date': '2018-05-16', 'type': 'RELEASE'}, {'date': '2018-06-14', 'type': 'RESET'}, {'date': '2018-06-15', 'type': 'RELEASE'}, {'date': '2018-07-12', 'type': 'RESET'}, {'date': '2019-08-30', 'type': 'RELEASE'}, {'date': '2019-09-23', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Oculus Innovative Sciences, Inc.'}}}}