Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-01-04 @ 4:37 PM
Study NCT ID:
NCT02622568
Status:
COMPLETED
Last Update Posted:
2017-09-08
First Post:
2015-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Investigating Veregen ™ 15% Ointment Treatment For Non-facial Verrucae in Pediatric Patients: A Pilot Study
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017679', 'term': 'Cryotherapy'}, {'id': 'C527126', 'term': 'green tea extract polyphenone E'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Nnenna.Agim@childrens.com', 'phone': '2144561631', 'title': 'Dr. Nnenna Agim', 'organization': 'University of Texas Southwestern'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Attrition rate acceptable for pilot study. Some participants were lost at the first measurement follow-up, others at the second (6 and 12 weeks respectively).'}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Cryotherapy + Veregen', 'description': "Cryotherapy will be performed on the day of first clinic visit according to current standard of care in Children's Medical Center pediatric outpatient dermatology clinic, which consists of two freeze/thaw cycles for maximum of 10 seconds each. Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.\n\nVeregen or Sinecatechins", 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 1, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Veregen Only', 'description': "Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.\n\nVeregen or Sinecatechins", 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 1, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Minor irritation', 'notes': 'transient itching and redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Size of Verrucae (Warts)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cryotherapy + Veregen', 'description': "Cryotherapy will be performed on the day of first clinic visit according to current standard of care in Children's Medical Center pediatric outpatient dermatology clinic, which consists of two freeze/thaw cycles for maximum of 10 seconds each. Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.\n\nVeregen or Sinecatechins following cryotherapy"}, {'id': 'OG001', 'title': 'Veregen Only', 'description': "Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.\n\nVeregen or Sinecatechins"}], 'classes': [{'categories': [{'measurements': [{'value': '2.333', 'spread': '3.3541', 'groupId': 'OG000'}, {'value': '3.889', 'spread': '3.9826', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.383', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.556', 'pValueComment': 'Comparison at week 12', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Veregen alone has efficacy compared to Veregen + cryotherapy'}, {'pValue': '0.81', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.222', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Comparison at week 0'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Diameter of verrucae (warts) at week 12', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants completing study are included in analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cryotherapy + Veregen', 'description': "Cryotherapy will be performed on the day of first clinic visit according to current standard of care in Children's Medical Center pediatric outpatient dermatology clinic, which consists of two freeze/thaw cycles for maximum of 10 seconds each. Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.\n\nVeregen or Sinecatechins"}, {'id': 'FG001', 'title': 'Veregen Only', 'description': "Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.\n\nVeregen or Sinecatechins"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Pediatric Dermatology Medical Clinic'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cryotherapy + Veregen', 'description': "Cryotherapy will be performed on the day of first clinic visit according to current standard of care in Children's Medical Center pediatric outpatient dermatology clinic, which consists of two freeze/thaw cycles for maximum of 10 seconds each. Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.\n\nVeregen or Sinecatechins + cryotherapy"}, {'id': 'BG001', 'title': 'Veregen Only', 'description': "Veregen ™ 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. The first day of treatment will begin on the day of first clinic visit (0 weeks). Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.\n\nVeregen or Sinecatechins"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9.1', 'spread': '3.14', 'groupId': 'BG000'}, {'value': '10.1', 'spread': '2.47', 'groupId': 'BG001'}, {'value': '9.6', 'spread': '2.79', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Analysis limited to participants that completed the study'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diameter of verrucae at presentation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.444', 'spread': '1.9437', 'groupId': 'BG000'}, {'value': '6.222', 'spread': '1.922', 'groupId': 'BG001'}, {'value': '6.3', 'spread': '1.88', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only participants completing study are included in analysis.'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-07', 'studyFirstSubmitDate': '2015-12-02', 'resultsFirstSubmitDate': '2017-05-16', 'studyFirstSubmitQcDate': '2015-12-03', 'lastUpdatePostDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-07', 'studyFirstPostDateStruct': {'date': '2015-12-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Size of Verrucae (Warts)', 'timeFrame': '12 weeks', 'description': 'Diameter of verrucae (warts) at week 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Verruca, Warts']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate topical treatment with Veregen™ 15% ointment as a single therapeutic agent and compare it to combination therapy with Veregen ™ 15% ointment and a single destructive treatment by cryotherapy for non-facial verruca vulgaris in the pediatric population. This novel treatment modality may be useful in the pediatric dermatology community offering a less invasive, painless option for treatment of non-facial verruca vulgaris.', 'detailedDescription': 'The purpose of this study is to investigate topical treatment with Veregen™ 15% ointment as a single therapeutic agent and compare it to combination therapy with Veregen ™ 15% ointment and a single destructive treatment by cryotherapy for non-facial verruca vulgaris in the pediatric population. The investigators will compare the single and combination treatment modalities over identical time points in patients with non-facial verruca vulgaris. One of the current options for care for non-facial verruca includes cryotherapy, which is a painful and destructive method performed in the pediatric dermatology clinic. This study aims to establish the safety, non-invasivenature, efficiency, and efficacy of Veregen ™ 15% ointment as monotherapyfor non-facial verruca vulgaris in the pediatric population. The investigators hypothesize that Veregen ™ 15% ointment monotherapy will non-invasively treat non-facial verruca vulgaris with similar efficacy as combination therapy with a single cryotherapy treatment followed by topical application of Veregen ™ ointment. This novel treatment modality will be useful in the pediatric dermatology community offering a less invasive, painless option for treatment of non-facial verruca vulgaris.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female of any ethnic background\n* Age between 6 years old and 16 years old\n* A clinical diagnosis of non-facial verruca vulgaris\n* Able to adhere to study visit schedule, Veregen ™ treatment requirements, and baseline cryotherapy treatment in half of patients\n* Verruca size greater than 5 mm\n\nExclusion Criteria:\n\n* Medically unstable patients\n* Patients with immunosuppression\n* Families who decline participation\n* Verruca may not have been treated in preceding 4 weeks prior to enrollment\n* Verruca may not be located on the face or genitalia\n* Verruca size less than 5 mm'}, 'identificationModule': {'nctId': 'NCT02622568', 'briefTitle': 'Investigating Veregen ™ 15% Ointment Treatment For Non-facial Verrucae in Pediatric Patients: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Investigating Veregen ™ 15% Ointment Treatment For Non-facial Verrucae in Pediatric Patients: A Pilot Study', 'orgStudyIdInfo': {'id': '092014-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cryotherapy and Veregen', 'description': "Cryotherapy will be performed on the day of first clinic visit according to current standard of care in Children's Medical Center pediatric outpatient dermatology clinic, which consists of two freeze/thaw cycles for maximum of 10 seconds each. Sinecathecins 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Sinecathecins 15% ointment will be applied to verrucous lesions twice daily. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.", 'interventionNames': ['Procedure: Cryotherapy and Veregen']}, {'type': 'EXPERIMENTAL', 'label': 'Veregen only', 'description': "Veregen ™or sinecathecins 15% ointment will be prescribed and initiated immediately following the day of first clinic visit. Veregen ™ or sinecathecins 15% ointment will be applied to verrucous lesions twice daily per current Children's Medical Center protocol. Follow-up clinical visits will be required at 0 weeks, 6 weeks, and 12 weeks. Clinical photos will be taken at each visit. Verrucae will be measured at each visit using a standard ruler. Outcome measures will be numerical reduction in diameter of verruca.", 'interventionNames': ['Drug: Veregen only']}], 'interventions': [{'name': 'Veregen only', 'type': 'DRUG', 'description': 'Topical application of Veregen 15% ointment on affected areas twice daily', 'armGroupLabels': ['Veregen only']}, {'name': 'Cryotherapy and Veregen', 'type': 'PROCEDURE', 'description': 'Cryotherapy followed by topical application of Veregen 15% ointment on affected areas twice daily', 'armGroupLabels': ['Cryotherapy and Veregen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390-9069', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UTSW Department of Dermatology', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigating Veregen ™ 15% Ointment Treatment For Non-facial Verrucae in Pediatric Patients: A Pilot Study', 'investigatorFullName': 'Nnenna Agim', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}