Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
Study NCT ID:
NCT02079168
Status:
COMPLETED
Last Update Posted:
2016-06-14
First Post:
2014-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effectiveness and Safety of RXI-109 on the Outcome of Keloid Excision Surgery in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007627', 'term': 'Keloid'}, {'id': 'D002921', 'term': 'Cicatrix'}], 'ancestors': [{'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-13', 'studyFirstSubmitDate': '2014-03-03', 'studyFirstSubmitQcDate': '2014-03-04', 'lastUpdatePostDateStruct': {'date': '2016-06-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in the recurrence of a keloid after keloid excision', 'timeFrame': '6 months', 'description': 'To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision'}], 'secondaryOutcomes': [{'measure': 'Safety of RXI-109', 'timeFrame': '6 months', 'description': 'To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after elective excision of a keloid'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Keloid', 'Cicatrix', 'Keloid prevention', 'Keloid revision/excision', 'Keloidectomy'], 'conditions': ['Keloid']}, 'descriptionModule': {'briefSummary': 'To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults, 21-55 years of age.\n* Two keloids of approximately similar size and anatomical location on the earlobe, neck, or torso.\n* Keloids to be excised must have been present for \\> 1 year.\n\nExclusion Criteria:\n\n* Use of tobacco or nicotine-containing products\n* Pregnant or lactating\n* Post-menopausal or full hysterectomy'}, 'identificationModule': {'nctId': 'NCT02079168', 'briefTitle': 'A Study to Evaluate the Effectiveness and Safety of RXI-109 on the Outcome of Keloid Excision Surgery in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'RXi Pharmaceuticals, Corp.'}, 'officialTitle': 'A Multi-Center, Prospective, Randomized, Single-Blind, Within-Subject Controlled, Phase 2a Study to Evaluate the Effectiveness and Safety of RXI-109 on the Outcome of Keloid Excision Surgery in Healthy Adults', 'orgStudyIdInfo': {'id': 'RXI-109-1401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Treatment with RXI-109 at the site of one excised keloid and a placebo at the site of a second excised keloid. Dosing to begin at the time of surgery.', 'interventionNames': ['Drug: RXI-109', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Treatment with RXI-109 at the site of one excised keloid and a placebo at the site of a second excised keloid. Dosing to begin two weeks after surgery.', 'interventionNames': ['Drug: RXI-109', 'Drug: Placebo']}], 'interventions': [{'name': 'RXI-109', 'type': 'DRUG', 'armGroupLabels': ['Cohort 1', 'Cohort 2']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Cohort 1', 'Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33137', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'San Cristóbal', 'country': 'Dominican Republic', 'geoPoint': {'lat': 18.41713, 'lon': -70.10682}}], 'overallOfficials': [{'name': 'Pamela Pavco, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'RXi Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RXi Pharmaceuticals, Corp.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}