Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2026-02-02 @ 6:19 PM
Study NCT ID:
NCT02230761
Status:
COMPLETED
Last Update Posted:
2016-02-08
First Post:
2014-08-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 2 Study of XAF5 (XOPH5) Ointment for Reduction of Excess Eyelid Fat (Steatoblepharon)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001763', 'term': 'Blepharoptosis'}, {'id': 'D003483', 'term': 'Cutis Laxa'}], 'ancestors': [{'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CSO@topokine.com', 'phone': '617 203 2034', 'title': 'Chief Scientific Officer', 'organization': 'Topokine Therapeutics, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'XOPH5 Ointment', 'description': 'XOPH5 Ointment is the investigational drug to be studied.\n\nXOPH5 Ointment', 'otherNumAtRisk': 60, 'otherNumAffected': 11, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Ointment', 'description': 'Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.\n\nPlacebo', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Hyperemia eyelid (mild, transient)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increase in vellus hair (mild)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Guillan-Barre syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Lower Eyelid Steatoblepharon Severity (LESS) Score--Clinician-Reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'XOPH5 Ointment', 'description': 'XOPH5 Ointment is the investigational drug to be studied.\n\nXOPH5 Ointment'}, {'id': 'OG001', 'title': 'Placebo Ointment', 'description': 'Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.020', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '11 weeks', 'description': 'Photonumeric scale, range 0-4, 0 is absence of steatoblepharon, 4 is very severe steatoblepharon.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention-to-treat'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient Satisfaction Scale 1 (PSS1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'XOPH5 Ointment', 'description': 'XOPH5 Ointment is the investigational drug to be studied.\n\nXOPH5 Ointment'}, {'id': 'OG001', 'title': 'Placebo Ointment', 'description': 'Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '17.9', 'spread': '14.4', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '13.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0-11 weeks', 'description': 'Change from Baseline to Week 11 in PSS1 score. PSS1 scale items use an ordinal scale with range 0-10, where 0 is the least favorable and 10 is the most favorable. The composite score is the sum of 6 items and has a possible response range of 0 to 60.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intention-to-treat'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient Satisfaction Scale 2 (PSS2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'XOPH5 Ointment', 'description': 'XOPH5 Ointment is the investigational drug to be studied.\n\nXOPH5 Ointment'}, {'id': 'OG001', 'title': 'Placebo Ointment', 'description': 'Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '16.3', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '14.0', 'spread': '3.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '11 weeks', 'description': 'Composite score on PSS2 scale. PSS2 is an ordinal scale with range 1-7, where 1 is least favorable and 7 is most favorable. The composite score is the sum of 3 items and has a possible response range of 3 to 21.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intention-to-treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'XOPH5 Ointment', 'description': 'XOPH5 Ointment is the investigational drug to be studied.\n\nXOPH5 Ointment'}, {'id': 'FG001', 'title': 'Placebo Ointment', 'description': 'Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.\n\nPlacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'XOPH5 Ointment', 'description': 'XOPH5 Ointment is the investigational drug to be studied.\n\nXOPH5 Ointment'}, {'id': 'BG001', 'title': 'Placebo Ointment', 'description': 'Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.\n\nPlacebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.2', 'spread': '7.4', 'groupId': 'BG000'}, {'value': '55.1', 'spread': '7.5', 'groupId': 'BG001'}, {'value': '54.5', 'spread': '7.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-09', 'studyFirstSubmitDate': '2014-08-28', 'resultsFirstSubmitDate': '2015-11-19', 'studyFirstSubmitQcDate': '2014-09-02', 'lastUpdatePostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-01-09', 'studyFirstPostDateStruct': {'date': '2014-09-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient Satisfaction Scale 1 (PSS1)', 'timeFrame': '0-11 weeks', 'description': 'Change from Baseline to Week 11 in PSS1 score. PSS1 scale items use an ordinal scale with range 0-10, where 0 is the least favorable and 10 is the most favorable. The composite score is the sum of 6 items and has a possible response range of 0 to 60.'}, {'measure': 'Patient Satisfaction Scale 2 (PSS2)', 'timeFrame': '11 weeks', 'description': 'Composite score on PSS2 scale. PSS2 is an ordinal scale with range 1-7, where 1 is least favorable and 7 is most favorable. The composite score is the sum of 3 items and has a possible response range of 3 to 21.'}], 'primaryOutcomes': [{'measure': 'Lower Eyelid Steatoblepharon Severity (LESS) Score--Clinician-Reported', 'timeFrame': '11 weeks', 'description': 'Photonumeric scale, range 0-4, 0 is absence of steatoblepharon, 4 is very severe steatoblepharon.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['steatoblepharon', 'blepharoptosis', 'dermatochalasis', 'blepharoplasty', 'periorbital', 'orbital', 'eyelid', 'eyebags', 'eye bags'], 'conditions': ['Lower Eyelid Steatoblepharon (Excess Eyelid Fat)']}, 'descriptionModule': {'briefSummary': 'This study will test whether XAF5 (XOPH5) ointment, applied once daily to the lower eyelids for 10 weeks, reduces the prominence of lower eyelid fat in adults with moderate to severe steatoblepharon (excess eyelid fat).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (abbreviated):\n\n* Moderate to severe lower eyelid steatoblepharon (LESS score of 2-4 bilaterally)\n* Men and women 40-70 years old\n* Healthy facial skin\n* Must understand and provide informed consent\n\nExclusion Criteria (abbreviated):\n\n* Best corrected visual acuity worse than 20/40 in either eye\n* Regular use of ophthalmic medication in either eye\n* Planned use of contact lenses during the study\n* Any history of lower eyelid surgery'}, 'identificationModule': {'nctId': 'NCT02230761', 'briefTitle': 'Phase 2 Study of XAF5 (XOPH5) Ointment for Reduction of Excess Eyelid Fat (Steatoblepharon)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Topokine Therapeutics, Inc.'}, 'officialTitle': 'A Phase 2, Randomized, Double-masked, Placebo-controlled Study of XOPH5 Ointment for Reduction of Lower Lid Steatoblepharon', 'orgStudyIdInfo': {'id': 'XOPH5-OINT-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'XOPH5 Ointment', 'description': 'XOPH5 Ointment is the investigational drug to be studied.', 'interventionNames': ['Drug: XOPH5 Ointment']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Ointment', 'description': 'Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'XOPH5 Ointment', 'type': 'DRUG', 'armGroupLabels': ['XOPH5 Ointment']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo Ointment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Topokine Therapeutics Clinical Study Centers', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Michael S. Singer, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Topokine Therapeutics, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Topokine Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}