Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-28 @ 2:23 AM
Study NCT ID:
NCT00973856
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2009-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D014860', 'term': 'Warts'}, {'id': 'D003218', 'term': 'Condylomata Acuminata'}, {'id': 'D004819', 'term': 'Epidermodysplasia Verruciformis'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'emostow@akronderm.com', 'title': 'Eliot Mostow, MD', 'organization': 'Cleveland Clinic Akron General'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 years', 'description': 'Same definition', 'eventGroups': [{'id': 'EG000', 'title': 'Purell VF481', 'description': 'Active Ingredient: 70% ethanol', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': '15% alcohol formulation that aesthetically resembles VF481', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Difference in % Reduction in Wart Size Between Product A and Product B at Each Timepoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}, {'units': 'wart reduction %', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Purell VF481', 'description': 'Active Ingredient: 70% ethanol'}], 'timeFrame': 'Baseline, 4, 8, and 12 weeks, change at 12 weeks reported', 'description': 'Data is not available due to study closure and data destruction', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'wart reduction %', 'denomUnitsSelected': 'wart reduction %', 'populationDescription': 'Data is not available due to study closure and data destruction'}, {'type': 'SECONDARY', 'title': 'Change in Size of Warts Treated by Each Product at Each Time Point.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PURELL Left Hand/ Placebo Right Hand', 'description': 'One product will be assigned to each hand to minimize treatment confusion for the participants.\n\nPURELL VF481 Left Hand/ Placebo Right Hand\n\nPURELL VF481: One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed\n\nPlacebo Solution: One (1) pump of product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed'}, {'id': 'OG001', 'title': 'Placebo Solution Left Hand/ PURELL Right Hand', 'description': 'One (1) product will be assigned to each hand to minimize treatment confusion for the participants PURELL VF481 Right Hand/ Placebo Left Hand\n\nOne (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed\n\nPURELL VF481: One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed\n\nPlacebo Solution: One (1) pump of product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed'}], 'timeFrame': 'Baseline, 4, 8 and 12 weeks, change at 12 weeks reported', 'description': 'Data is not available due to study closure and data destruction', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is not available due to study closure and data destruction'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PURELL VF481 Left Hand/ Placebo Right Hand', 'description': 'Warts are equally distributed between products so that an equal number of warts treated on each person. One (1) product will be assigned to each hand to minimize treatment confusion for the participants\n\nPURELL VF481: One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed'}, {'id': 'FG001', 'title': 'Placebo Solution Left Hand/ PURELL VF481 Right Hand', 'description': 'Warts are equally distributed between products so that an equal number of warts treated on each person One (1) product will be assigned to each hand to minimize treatment confusion for the participants\n\nOne (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed\n\nPlacebo Comparator: One (1) pump of product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '3'}, {'groupId': 'FG001', 'numUnits': '5', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '3'}, {'groupId': 'FG001', 'numUnits': '5', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'warts,not pts assigned to intervention', 'preAssignmentDetails': 'There were no pre-assignment details. Once consented, pts were enrolled into both study arms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'units': 'warts', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PURELL VF481 Left Hand/ Placebo Right Hand', 'description': 'Warts are equally distributed between products so that an equal number of warts treated on each person. One (1) product will be assigned to each hand to minimize treatment confusion for the participants\n\nPURELL VF481: One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed'}, {'id': 'BG001', 'title': 'Placebo Solution Left Hand/ PURELL VF481 Right Hand', 'description': 'Warts are equally distributed between products so that an equal number of warts treated on each person. One (1) product will be assigned to each hand to minimize treatment confusion for the participants\n\nOne (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed\n\nPlacebo Comparator: One (1) pump of product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'units': 'warts', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'warts', 'denomUnitsSelected': 'warts'}, {'title': 'Sex/Gender, Customized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'units': 'warts', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}], 'classes': [{'title': 'Sex/Gender unspecified', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'warts', 'denomUnitsSelected': 'warts'}, {'title': 'Race and Ethnicity Not Collected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'units': 'warts', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'units': 'warts', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}], 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'denomUnitsSelected': 'warts'}], 'typeUnitsAnalyzed': 'warts'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-03', 'studyFirstSubmitDate': '2009-09-08', 'resultsFirstSubmitDate': '2017-07-05', 'studyFirstSubmitQcDate': '2009-09-08', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-01', 'studyFirstPostDateStruct': {'date': '2009-09-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in % Reduction in Wart Size Between Product A and Product B at Each Timepoint', 'timeFrame': 'Baseline, 4, 8, and 12 weeks, change at 12 weeks reported', 'description': 'Data is not available due to study closure and data destruction'}], 'secondaryOutcomes': [{'measure': 'Change in Size of Warts Treated by Each Product at Each Time Point.', 'timeFrame': 'Baseline, 4, 8 and 12 weeks, change at 12 weeks reported', 'description': 'Data is not available due to study closure and data destruction'}]}, 'conditionsModule': {'conditions': ['Papillomavirus Infections', 'Warts', 'Condylomata Acuminata', 'Epidermodysplasia Verruciformis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.akrongeneral.org', 'label': 'Akron General Medical Center'}]}, 'descriptionModule': {'briefSummary': 'The objective is to conduct a pilot study to determine the effectiveness of PURELL VF481 to treat warts located on the hands.', 'detailedDescription': '* At least 5, but not more than 20 participants will be enrolled in the study.\n* Each wart is randomly assigned a test product prior to the start of the study\n* Warts are equally distributed between products so that an equal number of warts treated on each person. One (1) product will be assigned to each hand to minimize treatment confusion for the participants\n* The test product will be applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage.\n* Subjects will log date and time of application and anything notable (such as changes in wart appearance or missed dose) in a log book.\n* Measurement of wart (longest diameter) and photos taken at each visit by trained office medical assistants, LPNs, PA-C or MD.\n* Time points for office visitation: Baseline (0 weeks), 4 weeks, 8 weeks, 12 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with 2+ warts being seen at a Dermatologist's office\n* 2 or more warts on the hands that are located at least 1 cm apart or on separate fingers\n* Warts must have been present for at least 2 months\n* Wart size must be between 2 mm-15 mm in diameter\n* Participants must be in good general health\n* Participants must be able to speak and read in English.\n* Participant must be able to read and sign participant instruction sheet, and informed consent and authorization.\n* Subjects must be able to understand and execute the instructions presented in pictorial form.\n\nExclusion Criteria:\n\n* Pregnancy (Patients will be asked to verify using criteria of contraception, menstrual cycle, and pregnancy test, if necessary).\n* Treatment of warts with other methods such as salicylic acid, etc., in the past 14 days.\n* Known allergies to common topical antimicrobials or the individual ingredients in either test product.\n* Participation in a clinical study in the past 7 days or participation in another clinical study\n* Unwillingness to perform requirements of the study\n* Any medical condition that should preclude participation in the study, at the discretion of the physician\n* Missed ≥ 6 of the treatments in a 4 week study period"}, 'identificationModule': {'nctId': 'NCT00973856', 'briefTitle': 'Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands', 'organization': {'class': 'OTHER', 'fullName': 'Cleveland Clinic Akron General'}, 'officialTitle': 'Evaluation of the Effectiveness of an Alcohol Based Hand Gel for the Reduction of Warts on the Hands', 'orgStudyIdInfo': {'id': '09025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PURELL Left Hand/ Placebo Right Hand', 'description': 'One product will be assigned to each hand to minimize treatment confusion for the participants.\n\nPURELL VF481 Left Hand/ Placebo Right Hand', 'interventionNames': ['Other: PURELL VF481', 'Other: Placebo Solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Solution Left Hand/ PURELL Right hand', 'description': 'One (1) product will be assigned to each hand to minimize treatment confusion for the participants PURELL VF481 Right Hand/ Placebo Left Hand\n\nOne (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed', 'interventionNames': ['Other: PURELL VF481', 'Other: Placebo Solution']}], 'interventions': [{'name': 'PURELL VF481', 'type': 'OTHER', 'otherNames': ['PURELL VF481 alcohol based hand gel'], 'description': 'One (1) pump of test product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed', 'armGroupLabels': ['PURELL Left Hand/ Placebo Right Hand', 'Placebo Solution Left Hand/ PURELL Right hand']}, {'name': 'Placebo Solution', 'type': 'OTHER', 'description': 'One (1) pump of product (approximately 1.5ml) is applied to a wooden applicator and gently rubbed into the wart, then covered with a latex free adhesive bandage (it is not necessary to wait until dry) each night before bed', 'armGroupLabels': ['PURELL Left Hand/ Placebo Right Hand', 'Placebo Solution Left Hand/ PURELL Right hand']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44307', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Akron Dermatology', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}], 'overallOfficials': [{'name': 'Eliot Mostow, M.D>', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cleveland Clinic Akron General'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cleveland Clinic Akron General', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}