Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-29 @ 2:23 AM
Study NCT ID:
NCT01574612
Status:
COMPLETED
Last Update Posted:
2014-05-22
First Post:
2012-04-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006560', 'term': 'Herpes Labialis'}], 'ancestors': [{'id': 'D006561', 'term': 'Herpes Simplex'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D008047', 'term': 'Lip Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000212', 'term': 'Acyclovir'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ginsberg.david@gmail.com', 'phone': '732 564 2200', 'title': 'David Ginsberg, DO', 'organization': 'Meda Pharmaceutical'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Topical Cream', 'description': 'commercial product being used\n\nacyclovir/hydrocortisone cream: cream applied topically to lesion five times daily for five days', 'otherNumAtRisk': 54, 'otherNumAffected': 9, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'general disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'URI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lip injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'paresthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1.9'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Reporting of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Cream', 'description': 'commercial cream used'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'day 1 to day 21', 'description': 'treatment period is for 5 days and follow up visits at 7days and 21 days after first dose', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Topical Cream', 'description': 'commercial product being used\n\nacyclovir/hydrocortisone cream: cream applied topically to lesion five times daily for five days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'patients who were identified as having the appropriate medical history of herpes labialis', 'groupId': 'FG000', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'non compliant with drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Topical Cream', 'description': 'xerese topical cream is the only active used in this trial'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'spread': '1.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'age of subjects with prior history of herpes labialis outbreak', 'classes': [{'title': 'less than or equal to 3 years', 'categories': [{'measurements': [{'value': '27', 'spread': '33', 'groupId': 'BG000'}]}]}, {'title': 'age 4 to 6 years', 'categories': [{'measurements': [{'value': '17', 'spread': '21.5', 'groupId': 'BG000'}]}]}, {'title': 'age 7 to 9 years', 'categories': [{'measurements': [{'value': '10', 'spread': '13.9', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-28', 'studyFirstSubmitDate': '2012-04-05', 'resultsFirstSubmitDate': '2014-02-25', 'studyFirstSubmitQcDate': '2012-04-05', 'lastUpdatePostDateStruct': {'date': '2014-05-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-28', 'studyFirstPostDateStruct': {'date': '2012-04-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reporting of Adverse Events', 'timeFrame': 'day 1 to day 21', 'description': 'treatment period is for 5 days and follow up visits at 7days and 21 days after first dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Xerese', 'acyclovir hydrocortisone cream', 'herpes labialis', 'pediatric'], 'conditions': ['Herpes Labialis']}, 'descriptionModule': {'briefSummary': 'To test the safety of Xerese (acyclovir and hydrocortisone)Cream 5%/1% for the treatment of recurrent cold sores in children ages 6-11yrs after 5 days of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, age 6-11 years at time of enrollment\n* General good health, as judged by the Investigator\n* History of recurrent herpes labialis with at least two (2) recurrences during the last twelve (12) months, as based on interview with the subject or subject's caregiver\n* Agreement to refrain from using other topical medical, over-the counter (OTC), or cosmetic products in or around the oral area during the herpes recurrence\n* Agreement to refrain from mechanical disruption of the area affected by herpes labialis during the study recurrence\n* Subjects and their legally acceptable representative(s) must voluntarily sign and date the informed assent (subject) and consent (legally authorized representative).\n* Willingness to comply with all requirements of the study.\n\nExclusion Criteria:\n\n* Any evidence of an immunosuppressed state of the subject due to underlying disease (e.g. HIV infection) or concomitant treatment (e.g. cancer chemotherapy)\n* Significant skin conditions that occur in the area typically affected by herpes recurrences, and that would interfere with assessment of lesions such as atopic dermatitis, acne, eczema, psoriasis or chronic vesiculobullous disorders\n* Administration of an investigational drug or within 30 days prior to inclusion, or concurrent participation in another research study\n* Administration of an immunomodulatory agent within the past 30 days\n* History of immediate hypersensitivity or serum sickness reaction to any nucleoside analog antiviral agent, or to any topical steroid, or to the vehicle\n* Clinically relevant abnormal physical findings at screening which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures Nursing or pregnant (Pubescent females require pregnancy testing)"}, 'identificationModule': {'nctId': 'NCT01574612', 'briefTitle': 'Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old', 'organization': {'class': 'INDUSTRY', 'fullName': 'Meda Pharmaceuticals'}, 'officialTitle': 'An Open Label Multi Center Phase III Subject/Caregiver Initiated Safety Study of Xerese(Acyclovir and Hydrocortisone)Cream 5%/1% in the Treatment of Recurrent Herpes Labialis in Children', 'orgStudyIdInfo': {'id': 'MP 800'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'topical cream acyclovir/hydrocortisone', 'description': 'topical cream acyclovir/hydrocortisone used', 'interventionNames': ['Drug: acyclovir/hydrocortisone cream']}], 'interventions': [{'name': 'acyclovir/hydrocortisone cream', 'type': 'DRUG', 'otherNames': ['Xerese(r)'], 'description': 'cream applied topically to lesion five times daily for five days', 'armGroupLabels': ['topical cream acyclovir/hydrocortisone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'MCS Clinical Trials', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33054', 'city': 'Opa-locka', 'state': 'Florida', 'country': 'United States', 'facility': 'Sunshine Research Center', 'geoPoint': {'lat': 25.90232, 'lon': -80.25033}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Altus Rsearch,INC', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '60101', 'city': 'Addison', 'state': 'Illinois', 'country': 'United States', 'facility': 'Provident Clincal Research', 'geoPoint': {'lat': 41.9317, 'lon': -87.98896}}, {'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Central Kentucky Research', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester Clinical Research', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PGM Research of Winston-Salem, LLC', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '02919', 'city': 'Johnston', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Clinical Partners LLC', 'geoPoint': {'lat': 41.82186, 'lon': -71.50675}}, {'zip': '75110', 'city': 'Corsicana', 'state': 'Texas', 'country': 'United States', 'facility': 'Corsicana Medical Research,PNC', 'geoPoint': {'lat': 32.09543, 'lon': -96.46887}}, {'zip': '23294', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'National Clinical Research-Richmond,Inc.', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'David Ginsburg, D.O.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Meda Pharma US'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meda Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'TKL Research, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}