Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2026-01-03 @ 6:03 PM
Study NCT ID:
NCT03080961
Status:
COMPLETED
Last Update Posted:
2020-02-13
First Post:
2017-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The VIBLOK SAfety and perFormancE Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006558', 'term': 'Herpes Genitalis'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006561', 'term': 'Herpes Simplex'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tycross@cljiworldwide.com', 'phone': '305-397-8880', 'title': 'Ty Cross, President & CEO', 'organization': 'CLJI WORLDWIDE'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected from the first day of VIBLOK application until 30 days after the last visit to the research clinic.', 'description': 'Definitions are applied conform ISO 14155; 2011.', 'eventGroups': [{'id': 'EG000', 'title': 'During VIBLOK Application', 'description': 'All AEs were recorded in subjects in all subjects applying VIBLOK at least once until 30 days after the last visit to the research clinic.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 39, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Toxic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Possible device related allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itching/tingling/burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 21, 'numAffected': 19}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HSV recurrence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 29, 'numAffected': 19}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Not-device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 16, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Possible not-device related allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other, undefined', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Serious Adverse Device Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'During VIBLOK Application', 'description': "Percentage SADE's in subjects applying VIBLOK for a minimum of 26 days."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7.7'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'SADE percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0.0', 'ciUpperLimit': '7.7', 'groupDescription': 'SADE rate after minimally 26 days of VIBLOK treatment will be assessed by calculating the upper limit of the 2-sided exact 95% Clopper-Pearson confidence interval which needs to be below 10%. With a sample size of 36, an exact two-sided 95.0% confidence interval for a single proportion would show that the SADE incidence is below 10% at an expected incidence of 0.1%.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '26-32 days', 'description': "Percentage SADE's in the as treated population.", 'unitOfMeasure': "Percentage SADE's", 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '46 eligible subjects that applied VIBLOK for an average of 27.2 days.'}, {'type': 'SECONDARY', 'title': 'HSV-2 Detection Rate in AT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Before VIBLOK', 'description': 'Days with HSV detection in the external genital area before application of VIBLOK.'}, {'id': 'OG001', 'title': 'After VIBLOK', 'description': 'Days with HSV detection in the external genital area after application of VIBLOK.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '4.1'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '3.8'}]}]}], 'analyses': [{'pValue': '0.248', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Statistical analysis will evaluate the difference in detection rate between pre and post-VIBLOK swabs. For each person the number of swabs with shedding only pre-VIBLOK will be assessed, and then the number of swabs with shedding only post-VIBLOK will be subtracted. A number above 0 indicates a decreased detection rate after VIBLOK. With an 8% anticipated asymptomatic shedding rate, 80% power, 50 subjects taking samples for 28 days are needed to show a 50% reduction.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '26-32 days', 'description': 'Change in HSV-2 detection rate on days with asymptomatic shedding after applying VIBLOK.', 'unitOfMeasure': 'Mean number of swabs with shedding', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '45 subjects that returned swabs before and after VIBLOK application.'}, {'type': 'SECONDARY', 'title': 'HSV-2 Copy Number in AT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Before VIBLOK', 'description': 'HSV amount in external genital swabs on days with asymptomatic shedding before applying VIBLOK.'}, {'id': 'OG001', 'title': 'After VIBLOK', 'description': 'HSV amount in external genital swabs on days with asymptomatic shedding after applying VIBLOK.'}], 'classes': [{'categories': [{'measurements': [{'value': '100446.2', 'groupId': 'OG000', 'lowerLimit': '24623.8', 'upperLimit': '176268.7'}, {'value': '43691.8', 'groupId': 'OG001', 'lowerLimit': '1954.4', 'upperLimit': '85429.2'}]}]}], 'analyses': [{'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '26-32 days', 'description': 'Change in HSV-2 copy number on days with asymptomatic shedding after applying VIBLOK.', 'unitOfMeasure': 'HSV copy number', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 25 out of 46 subjects in the AT population had days with asymptomatic HSV shedding.'}, {'type': 'SECONDARY', 'title': 'ADE Description', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'During VIBLOK Application', 'description': 'Subjects that applied VIBLOK at least once.'}], 'classes': [{'title': 'Toxic reaction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Possible allergic reaction', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Itching/tingling/burning sensation', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Infection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1-33 days', 'description': 'Nature and frequency of (possible) device related adverse events.', 'unitOfMeasure': 'Count of participants per ADE type', 'reportingStatus': 'POSTED', 'populationDescription': 'AT Population that applied VIBLOK at least once.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Group', 'description': '46 subjects with a confirmed HSV-2 infection, took external genital skin swabs before and after applying minimally 0.8 pack (\\~4 ml) of VIBLOK per swab session.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Upon written informed consent, 82 subjects were enrolled based on their medical history of recurrent genital herpes.', 'preAssignmentDetails': 'Of the 82 subjects enrolled, 46 had a confirmed HSV-2 infection and started applying VIBLOK.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'As Treated Population', 'description': 'Participants that applied VIBLOK at least once'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'spread': '10.68', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HSV-1 co-infection', 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of recurrences past year', 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '2.60', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'episodes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Years since diagnosis genital herpes', 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '6.26', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Adults with recurrent genital herpes due to an HSV-2 infection and that applied VIBLOK at least once.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-01', 'size': 1129058, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-01-25T06:03', 'hasProtocol': True}, {'date': '2017-11-03', 'size': 8405529, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-01-25T06:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Vials with the sample will be coded. The assessor does not know the coding.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Trial participants take extra-genital swabs before and after application of the barrier cream.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-12', 'studyFirstSubmitDate': '2017-03-09', 'resultsFirstSubmitDate': '2019-02-12', 'studyFirstSubmitQcDate': '2017-03-14', 'lastUpdatePostDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-12', 'studyFirstPostDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serious Adverse Device Effects', 'timeFrame': '26-32 days', 'description': "Percentage SADE's in the as treated population."}], 'secondaryOutcomes': [{'measure': 'HSV-2 Detection Rate in AT Population', 'timeFrame': '26-32 days', 'description': 'Change in HSV-2 detection rate on days with asymptomatic shedding after applying VIBLOK.'}, {'measure': 'HSV-2 Copy Number in AT Population', 'timeFrame': '26-32 days', 'description': 'Change in HSV-2 copy number on days with asymptomatic shedding after applying VIBLOK.'}, {'measure': 'ADE Description', 'timeFrame': '1-33 days', 'description': 'Nature and frequency of (possible) device related adverse events.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Barrier cream'], 'conditions': ['HSV-2 Infection', 'Genital Herpes']}, 'descriptionModule': {'briefSummary': 'Genital herpes has a high prevalence in industrialized as well as developing countries.\n\nGenital herpes causes genital ulcers, increases risk for acquiring HIV infection, and may be transmitted mother to child during birth with possible serious consequences.\n\nMedical treatments and condoms only partially reduce the risk for transmission from/ to sexual partners. Genital herpes transmission despite use of condoms is thought to be due to transfer via skin-to-skin contact in unprotected areas, and HSV-2 transmission may be enhanced by current shaving habits in the genital area leading to micro lesions (lacerations) of the skin.\n\nVIBLOK™ is a cream designed to impede the passage of viruses, such as HSV-2, across the skin. Bench and animal experiments indicate that it can block virus transmission such as HSV-2 over 80%.\n\nThe objective of the SAFE trial is to assess the safety and performance of VIBLOK in adults with HSV-2 infection by comparing virus detection in the extra-genital area before and after application of the barrier cream.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participant is male or female and at least 18 years of age\n2. HSV-2 seropositive by the UW Western blot or Alegria assay\n3. History of recurrent genital herpes with at least 3 recurrences in the last year or, if currently on suppressive/ prophylactic therapy, prior to starting the therapy (antiviral therapy has to be stopped at least 7 days prior to initiation of the trial product).\n4. General good health at the discretion of the investigator.\n5. Willing to not use any topical genital therapy aside from the study device for the duration of the trial.\n6. Willing to not use any systemic anti HSV therapy during the entire study starting 7 days prior to baseline.\n7. Willing to obtain 2 swabs from external-genital areas once daily for the duration of the trial.\n8. Willing to keep a daily trial diary during the treatment period.\n9. Negative pregnancy test for women at screening.\n10. Willing to use contraceptives for the duration of the study.\n11. Subject must be willing and able (in the opinion of the investigator) to understand the patient information and informed consent form and to comply with the clinical trial protocol and procedures.\n12. Subject must be willing to give written informed consent.\n\nExclusion Criteria:\n\n1. Serious medical conditions, such as diabetes, significant autoimmune disease, cancer or immunosuppression, etc. that at the discretion of the investigator will likely affect study outcomes\n2. Treatment with systemic steroids or other immune-modulating agents\n3. Participation in any investigational drug or device trial within 30 days prior to screening.\n4. Pregnancy or breastfeeding, in case of women.\n5. Any other conditions that in the judgment of the investigator would preclude successful completion of the clinical trial.'}, 'identificationModule': {'nctId': 'NCT03080961', 'acronym': 'SAFE', 'briefTitle': 'The VIBLOK SAfety and perFormancE Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'CLJI Worldwide'}, 'officialTitle': 'The VIBLOK SAfety and perFormancE Trial', 'orgStudyIdInfo': {'id': '2015-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Before and after VIBLOK', 'description': 'The degree to which HSV-2 is blocked by the VIBLOK cream is determined by comparing the amount of HSV in the external genital area before and after application of the cream. So participants are their own control.', 'interventionNames': ['Device: VIBLOK barrier cream']}], 'interventions': [{'name': 'VIBLOK barrier cream', 'type': 'DEVICE', 'description': 'VIBLOK safety and performance has not been proven yet in humans with an HSV-2 infection.', 'armGroupLabels': ['Before and after VIBLOK']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1311 RL', 'city': 'Almere Stad', 'state': 'Flevoland', 'country': 'Netherlands', 'facility': 'EB FlevoResearch', 'geoPoint': {'lat': 52.37025, 'lon': 5.21413}}, {'zip': '6191 JW', 'city': 'Beek', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'PT&R', 'geoPoint': {'lat': 50.94083, 'lon': 5.79722}}, {'zip': '3511 NH', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'EB UtrechtResearch', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Vivienne vd Walle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PreCare Trial & Recruitment B.V.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CLJI Worldwide', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Applied Clinical Services BV', 'class': 'UNKNOWN'}, {'name': 'UMC Utrecht', 'class': 'OTHER'}, {'name': 'University of Rotterdam, The Netherlands', 'class': 'OTHER'}, {'name': 'University of Washington', 'class': 'OTHER'}, {'name': 'EB FlevoResearch BV', 'class': 'UNKNOWN'}, {'name': 'PreCare Trial & Recruitment B.V.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}