Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2026-03-04 @ 8:23 PM
Study NCT ID:
NCT01757392
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2012-12-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Candin Safety & Efficacy Study for the Treatment of Warts
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014860', 'term': 'Warts'}], 'ancestors': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david@nielsenbio.com', 'phone': '858-571-2726', 'title': 'David Burney', 'organization': 'Nielsen Biosciences, Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All Post Dose visits over approximately 9 months, including treatment phase (5 months) and follow up period (4 months)', 'eventGroups': [{'id': 'EG000', 'title': 'Candin® 0.3 mL', 'description': 'Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml until lesion resolves or up to 6 injections.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 34, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Injection site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Injection site exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Injection site vesicles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Alanine aminotranferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'seriousEvents': [{'term': 'Cholecystitis', 'notes': 'cholecystitis followed by cholecystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Complete Resolution of Primary Injected Wart', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Candin® 0.3 mL', 'description': 'Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml into single wart until lesions resolve or up to 6 injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Complete Resolution of the Primary Injected Wart by Number of Injection Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Candin® 0.3 mL', 'description': 'Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml into single wart until lesions resolve or up to 6 injections.'}], 'classes': [{'categories': [{'title': 'One Injection visit', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Two Injection visits', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Three Injection visits', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Four Injection visits', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Five Injection visits', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Six Injection visits', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects experiencing complete resolution of the primary injected wart'}, {'type': 'POST_HOC', 'title': 'Number of Participants With Complete Resolution of the First Non-injected Wart by Injection Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Candin® 0.3 mL', 'description': 'Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml into single wart until lesions resolve or up to 6 injections.'}], 'classes': [{'categories': [{'title': 'One injection visit', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Two injection visits', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Three Injection visits', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Four Injection visits', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Five Injection visits', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Six Injection visits', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Number of Participants With Complete Resolution of All Qualified Warts by Injection Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Candin® 0.3 mL', 'description': 'Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml into single wart until lesions resolve or up to 6 injections.'}], 'classes': [{'categories': [{'title': 'One injection visit', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Two injection visits', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Three injection visits', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Four injection visits', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Five injection visits', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Six injection visits', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Recurrence of Resolved Primary Wart at Follow up 2 Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Candin® 0.3 mL', 'description': 'Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml into single wart until lesions resolve or up to 6 injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 months after last injection', 'description': 'Number of participants with recurrence of primary wart seen at the final follow up visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Candin® 0.3 mL', 'description': 'Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml into single wart until lesions resolve or up to 6 injections.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Number of participants who were screened', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'comment': 'Number of participants who received at least one wart injection', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Screen Fail', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Candin® 0.3 mL', 'description': 'Monthly intralesional injections of Candida albicans Skin Test Antigen 0.3 ml into single wart until lesion resolves or up to 6 injections.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.9', 'spread': '11.76', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '87.32', 'spread': '22.508', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '173.52', 'spread': '10.982', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '28.66', 'spread': '5.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'ITT population/ Safety Population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'dispFirstSubmitDate': '2018-07-20', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-13', 'studyFirstSubmitDate': '2012-12-21', 'dispFirstSubmitQcDate': '2019-03-06', 'resultsFirstSubmitDate': '2020-12-15', 'studyFirstSubmitQcDate': '2012-12-27', 'dispFirstPostDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-15', 'studyFirstPostDateStruct': {'date': '2012-12-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Complete Resolution of Primary Injected Wart', 'timeFrame': 'Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Complete Resolution of the Primary Injected Wart by Number of Injection Visits', 'timeFrame': 'Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Treatment', 'common wart lesions', '(verruca vulgaris)'], 'conditions': ['Warts', 'Human Papilloma Virus']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the safety of Candin® (Candida albicans Skin Test Antigen) at a 0.3 ml dose level at up to 6 monthly injections for treating common warts (Verruca vulgaris).', 'detailedDescription': 'The primary objective of this study is to determine the safety of Candin® (Candida albicans Skin Test Antigen) at either 0.3 mL dose levels at up to 6 monthly injections (a maximal, cumulative dose of 1.9 mL, including the delayed-type hypersensitivity (DTH) test) for treating common warts (Verruca vulgaris). A secondary objective is to understand the relative effectiveness of the 0.3 dose level for treating common warts, both those that were injected and those that were not injected as well as other types of warts that were not injected to allow a determination of appropriate dose levels to use in a future dose-ranging efficacy trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have at least 3 and not more than 10 common warts not located on the palms or digits\n* Positive DTH response to Candin® required\n\nExclusion Criteria:\n\n* No previous medical treatment for warts other than OTC\n* No immunocompromising medical conditions or medicines allowed\n* No preexisting inflammatory conditions at treatment site allowed'}, 'identificationModule': {'nctId': 'NCT01757392', 'briefTitle': 'Candin Safety & Efficacy Study for the Treatment of Warts', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nielsen BioSciences, Inc.'}, 'officialTitle': 'Study of the Safety and Effectiveness of Candin for the Treatment of Common Warts', 'orgStudyIdInfo': {'id': 'Nieslen Protocol CFW-2c'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Candin® 0.3 mL', 'description': 'Monthly intralesional injections of Candin® 0.3 ml until lesion resolves or up to 6 injections.', 'interventionNames': ['Biological: Candida albicans Skin Test Antigen']}], 'interventions': [{'name': 'Candida albicans Skin Test Antigen', 'type': 'BIOLOGICAL', 'otherNames': ['Candin®'], 'description': '0.3 ml injected intralesionally monthly. Number of injections: until wart lesion is resolved or up to 6 injections.', 'armGroupLabels': ['Candin® 0.3 mL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72916', 'city': 'Fort Smith', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Johnson Dermatology', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}], 'overallOfficials': [{'name': 'Sandy M Johnson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johnson Dermatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nielsen BioSciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}