Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-04-23 @ 11:05 PM
Study NCT ID:
NCT02665260
Status:
COMPLETED
Last Update Posted:
2017-05-05
First Post:
2015-12-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Topical Cantharidin for the Treatment of Molluscum Contagiosum
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008976', 'term': 'Molluscum Contagiosum'}], 'ancestors': [{'id': 'D011213', 'term': 'Poxviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002193', 'term': 'Cantharidin'}], 'ancestors': [{'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dermpharmeinstein@gmail.com', 'phone': '718-920-8470', 'title': 'Dr. Steven Cohen', 'organization': 'Montefiore Medical center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cantharidin', 'description': 'Subjects treated with topical cantharidin 0.7% without occlusion', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cantharidin With Occlusion', 'description': 'Subjects treated with topical cantharidin 0.7% with occlusion', 'otherNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Subjects treated with placebo without occlusion', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo With Occlusion', 'description': 'Subjects treated with placebo with occlusion', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Who Achieve Complete Clearance at 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cantharidin With Occlusion', 'description': 'Patients treated with cantharidin 0.7% topical with occlusion'}, {'id': 'OG001', 'title': 'Cantharidin Without Occlusion', 'description': 'Patients treated with cantharidin 0.7% topical without occlusion'}, {'id': 'OG002', 'title': 'Placebo With Occlusion', 'description': 'Patients treated with placebo and occlusion'}, {'id': 'OG003', 'title': 'Placebo Without Occlusion', 'description': 'Patients treated with placebo without conclusion'}], 'classes': [{'categories': [{'title': 'Number of subjects achieving lesion clearance', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}, {'title': 'Number of subjects not achieving lesion clearance', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks', 'description': 'Assess number of subjects who achieve a lesion count of zero at 6 weeks (end of open-label phase)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Experienced an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cantharidin', 'description': 'Patients treated with 0.7% topical cantharidin without occlusion'}, {'id': 'OG001', 'title': 'Cantharidin With Occlusion', 'description': 'Patients treated with 0.7% topical cantharidin with occlusion'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Patients treated with placebo without occlusion'}, {'id': 'OG003', 'title': 'Placebo With Occlusion', 'description': 'Patients treated with placebo vehicle with occlusion'}], 'classes': [{'categories': [{'title': 'Number experiencing adverse event', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Number not experiencing adverse event', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '33 weeks', 'description': 'Number of subjects who experienced an adverse event as assessed by patient-reported outcomes questionnaire at each visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cantharidin With Occlusion', 'description': 'Patients treated with cantharidin 0.7% topical with occlusion'}, {'id': 'FG001', 'title': 'Cantharidin Without Occlusion', 'description': 'Patients treated with cantharidin 0.7% topical without occlusion'}, {'id': 'FG002', 'title': 'Placebo With Occlusion', 'description': 'Patients treated with placebo and occlusion'}, {'id': 'FG003', 'title': 'Placebo Without Occlusion', 'description': 'Patients treated with placebo without conclusion'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of 6 subjects met exclusion criteria for having greater than 50 molluscum contagiosum lesions at screening.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '94', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Cantharidin', 'description': 'Patients treated with 0.7% topical cantharidin without occlusion'}, {'id': 'BG001', 'title': 'Cantharidin With Occlusion', 'description': 'Patients treated with 0.7% topical cantharidin with occlusion'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Patients treated with placebo without occlusion'}, {'id': 'BG003', 'title': 'Placebo With Occlusion', 'description': 'Patients treated with placebo vehicle with occlusion'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '94', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}, {'title': 'Jamaican', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-23', 'studyFirstSubmitDate': '2015-12-31', 'resultsFirstSubmitDate': '2016-12-06', 'studyFirstSubmitQcDate': '2016-01-22', 'lastUpdatePostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-23', 'studyFirstPostDateStruct': {'date': '2016-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Who Achieve Complete Clearance at 6 Weeks', 'timeFrame': '6 weeks', 'description': 'Assess number of subjects who achieve a lesion count of zero at 6 weeks (end of open-label phase)'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects Who Experienced an Adverse Event', 'timeFrame': '33 weeks', 'description': 'Number of subjects who experienced an adverse event as assessed by patient-reported outcomes questionnaire at each visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Molluscum Contagiosum']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if cantharidin is a safe and effective treatment for molluscum contagiosum in kids', 'detailedDescription': 'This was a double-blind, placebo-controlled trial. Participants were recruited from the Pediatric Dermatology clinic at Montefiore Medical Center. One hundred eligible participants were randomly assigned to receive cantharidin 0.7% topical, cantharidin 0.7% topical with occlusion, placebo, or placebo with occlusion. Treatments were applied at weeks 0 and 3 (blinded phase). At week 6, all participants were treated with open-label, topical cantharidin 0.7% without occlusion every 3 weeks until all lesions resolved (open-label phase).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 2-17years\n* Healthy\n* \\<50 molluscum contagiosum lesions\n\nExclusion Criteria:\n\n* Immunosuppressed\n* Oral corticosteroids\n* Sexually active/pregnant'}, 'identificationModule': {'nctId': 'NCT02665260', 'briefTitle': 'Safety and Efficacy Study of Topical Cantharidin for the Treatment of Molluscum Contagiosum', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Randomized Pilot Study Investigating the Safety and Efficacy of Topical Cantharidin for the Treatment of Molluscum Contagiosum', 'orgStudyIdInfo': {'id': '12-01-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cantharidin with occlusion', 'description': 'Cantharidin 0.7% topical with occlusion', 'interventionNames': ['Drug: Cantharidin', 'Device: Gauze occlusion bandage']}, {'type': 'EXPERIMENTAL', 'label': 'Cantharidin without occlusion', 'description': 'Cantharidin 0.7% topical without occlusion', 'interventionNames': ['Drug: Cantharidin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo with occlusion', 'description': 'Placebo topical with occlusion', 'interventionNames': ['Drug: Placebo', 'Device: Gauze occlusion bandage']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo without occlusion', 'description': 'Placebo topical without occlusion', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Cantharidin', 'type': 'DRUG', 'otherNames': ['2,6-Dimethyl-4,10-dioxatricyclo-decane-3,5-dione'], 'description': 'cantharidin 0.7% topical liquid', 'armGroupLabels': ['Cantharidin with occlusion', 'Cantharidin without occlusion']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['flexible collodion'], 'description': 'Placebo topical liquid', 'armGroupLabels': ['Placebo with occlusion', 'Placebo without occlusion']}, {'name': 'Gauze occlusion bandage', 'type': 'DEVICE', 'description': 'Gauze occlusion bandage with adhesive tape', 'armGroupLabels': ['Cantharidin with occlusion', 'Placebo with occlusion']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Steven R Cohen', 'investigatorAffiliation': 'Montefiore Medical Center'}}}}