Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2025-12-26 @ 6:56 PM
Study NCT ID:
NCT00820534
Status:
COMPLETED
Last Update Posted:
2012-04-20
First Post:
2009-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers
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': 'C053539', 'term': 'penciclovir'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+4122363311', 'title': 'Head of Clinical Research', 'organization': 'Novartis Consumer Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Penciclovir', 'description': 'Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours', 'otherNumAtRisk': 64, 'otherNumAffected': 0, 'seriousNumAtRisk': 64, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo cream every 2 hours during waking hours for 96 hours', 'otherNumAtRisk': 62, 'otherNumAffected': 0, 'seriousNumAtRisk': 62, 'seriousNumAffected': 0}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Penciclovir', 'description': 'Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo cream every 2 hours during waking hours for 96 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '72 hours', 'description': 'Number of participants where the classical cold sore lesion was prevented at 72 hours after first treatment application.Lesion defined as having been prevented if clinical assessment is prodrome, macule or healed and skin temperature of the cold sore is negative (temperature difference of less than 0.5°C between initial site of cold sore and opposite side).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2010-11'}, {'type': 'SECONDARY', 'title': 'Size of the Cold Sore', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Penciclovir', 'description': 'Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo cream every 2 hours during waking hours for 96 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '31.7', 'groupId': 'OG000', 'lowerLimit': '20.8', 'upperLimit': '42.6'}, {'value': '32.7', 'groupId': 'OG001', 'lowerLimit': '21.3', 'upperLimit': '44.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': '72 hours', 'description': 'The size of the cold sore was measured as follows : a standardized photograph was taken before treatment and compared to a photograph taken 72 hours after the first treatment application. The difference was calculated for each participant within each treatment arm.', 'unitOfMeasure': 'square mm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2010-11'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Penciclovir', 'description': 'Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo cream every 2 hours during waking hours for 96 hours'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study start : 30 dec 2008 Study end : 16 Nov 2009 Hospital out patient clinic', 'preAssignmentDetails': 'Cold Sore confirmed by local temperature measurement'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Penciclovir', 'description': 'Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo cream every 2 hours during waking hours for 96 hours'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', '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': '63', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.4', 'spread': '11.3', 'groupId': 'BG000'}, {'value': '31.8', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '31.6', 'spread': '10.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-18', 'studyFirstSubmitDate': '2009-01-09', 'resultsFirstSubmitDate': '2010-11-12', 'studyFirstSubmitQcDate': '2009-01-09', 'lastUpdatePostDateStruct': {'date': '2012-04-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-12-16', 'studyFirstPostDateStruct': {'date': '2009-01-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore.', 'timeFrame': '72 hours', 'description': 'Number of participants where the classical cold sore lesion was prevented at 72 hours after first treatment application.Lesion defined as having been prevented if clinical assessment is prodrome, macule or healed and skin temperature of the cold sore is negative (temperature difference of less than 0.5°C between initial site of cold sore and opposite side).'}], 'secondaryOutcomes': [{'measure': 'Size of the Cold Sore', 'timeFrame': '72 hours', 'description': 'The size of the cold sore was measured as follows : a standardized photograph was taken before treatment and compared to a photograph taken 72 hours after the first treatment application. The difference was calculated for each participant within each treatment arm.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cold sore'], 'conditions': ['Cold Sore']}, 'descriptionModule': {'briefSummary': 'Comparison of the efficacy of penciclovir 10 mg/g (1%) cream with that of vehicle at 72 hours in preventing the appearance of classical lesions following prodromal symptoms (tingling or burning sensation) based on thermographic assessment among recurrent cold sore sufferers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be known to be a cold sore sufferer and presenting a prodromal stage with pain\n* Sign the written informed consent form prior to enrolment in the trial;\n* Be aged 18 to 75 years;\n\nExclusion Criteria:\n\n* If female, are pregnant, planning pregnancy or lactating;\n* Have a known hypersensitivity to penciclovir or any ingredients of the vehicle;\n* Have already ongoing classical cold sore lesions at the baseline visit;\n* Have taken any cold sore product, analgesic or NSAID in the 24 hours before the baseline visit;\n* Have applied a cosmetic lip balm on their lips in the 12 hours before the baseline thermographic assessment;\n* Are known to be immunosuppressed (acquired, congenital or therapeutic);\n* Have been involved in any investigational protocol within the 30 days prior to the trial;\n* Have evidence or history of drug or alcohol abuse;'}, 'identificationModule': {'nctId': 'NCT00820534', 'briefTitle': 'A Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomised, Double-blind, Vehicle Controlled, Single Center, Parallel Group, Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers', 'orgStudyIdInfo': {'id': 'FPP4-DE-401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Penciclovir', 'description': 'Penciclovir', 'interventionNames': ['Drug: Penciclovir']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Penciclovir', 'type': 'DRUG', 'description': 'Penciclovir every 2 hours during waking hours for 96 hours', 'armGroupLabels': ['Penciclovir']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo every 2 hous during waking hours for 96 hours', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BT12 6BA', 'city': 'Belfast', 'country': 'United Kingdom', 'facility': 'Belfast Health and Social Care Trust, Royal Victoria Hospital', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}], 'overallOfficials': [{'name': 'Philip Lamey', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Principal Investigator'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}