Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT01640912
Status:
COMPLETED
Last Update Posted:
2014-09-17
First Post:
2012-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Safety, Pharmacokinetics, and Preliminary Effect on Scar Formation by RXI-109
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-16', 'studyFirstSubmitDate': '2012-07-12', 'studyFirstSubmitQcDate': '2012-07-12', 'lastUpdatePostDateStruct': {'date': '2014-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the safety and tolerability of intradermal administration of RXI-109', 'timeFrame': '12 weeks', 'description': 'Evaluate safety and tolerability of RXI-109 at site of intradermal injection. Examination and assessment of any and all local and systemic toxicities'}], 'secondaryOutcomes': [{'measure': 'To assess the effect of RXI-109 on scar formation following small surgical incisions', 'timeFrame': '12 weeks', 'description': 'Visual outcome and histology of scars will be assessed. Digital images of the RXI-109 and placebo-treated incisions/scars will be captured and assessed by a masked, independent, expert panel.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Scar', 'Scar prevention', 'Fibrosis'], 'conditions': ['Cicatrix', 'Scar Prevention']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the safety and tolerability of a single intradermal administration of RXI-109 at small surgical incisions in the abdominal skin that will later be removed during an elective abdominoplasty. The effect of RXI-109 versus placebo on scarring at these incision sites will be evaluated visually and histologically.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must be a female in general good health with normal screening values\n* Subject must be a good surgical candidate for an elective abdominoplasty\n* Subjects must not be pregnant or lactating and utilize an effective method of contraception (if child-bearing potential exists)\n\nExclusion Criteria:\n\n* Currently pregnant or lactating\n* BMI greater than 35 at screening\n* Use of tobacco or nicotine-containing products within the month prior to enrollment and while on study\n* Any medical condition or current therapy which would make the subject unsuitable for this study in the opinion of the PI'}, 'identificationModule': {'nctId': 'NCT01640912', 'briefTitle': 'Evaluation of the Safety, Pharmacokinetics, and Preliminary Effect on Scar Formation by RXI-109', 'organization': {'class': 'INDUSTRY', 'fullName': 'RXi Pharmaceuticals, Corp.'}, 'officialTitle': 'A Phase 1 Single Center, Randomized, Double-Blind, Ascending Dose, Within-Subject Controlled Study of RXI-109 for the Treatment of Incision Scars Made in the Pannus of Healthy Women Who Will Later Undergo Elective Abdominoplasty', 'orgStudyIdInfo': {'id': 'RXI-109-1201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RXI-109', 'interventionNames': ['Drug: RXI-109']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'RXI-109', 'type': 'DRUG', 'description': 'Single intradermal injection of RXI-109 at incision sites', 'armGroupLabels': ['RXI-109']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Single intradermal injection of placebo at incision sites', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RXi Pharmaceuticals, Corp.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}