Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-01-01 @ 11:36 AM
Study NCT ID:
NCT01902303
Status:
COMPLETED
Last Update Posted:
2016-04-28
First Post:
2013-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Cold Sore Treatments on Ultra Violet (UV) Induced Cold Sores
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, 'conditionBrowseModule': {'meshes': [{'id': 'D013283', 'term': 'Stomatitis, Herpetic'}, {'id': 'D006560', 'term': 'Herpes Labialis'}, {'id': 'D006561', 'term': 'Herpes Simplex'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D013280', 'term': 'Stomatitis'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D008047', 'term': 'Lip Diseases'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '518-872-1144', 'title': 'Dr. John McMichael', 'organization': 'Beech Tree Labs, Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs were collected from the time of informed consent until end of follow up period which was up to 14 days after start of treatment.', 'description': 'Serious AE were collected for all patients. AEs noted over 5% were only for those patients that took study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Matching Placebo', 'description': 'Placebo Safety Population - All subjects that enrolled and were allocated to placebo test article except for SAEs and that includes all subjects that signed informed consent.', 'otherNumAtRisk': 56, 'otherNumAffected': 7, 'seriousNumAtRisk': 222, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BTL-TML-HSV Active Treatment', 'description': 'BTL-TML Safety Population - All subjects enrolled and allocated to active test article except for SAEs which includes all subjects that signed informed consent.', 'otherNumAtRisk': 62, 'otherNumAffected': 6, 'seriousNumAtRisk': 81, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Blood pressure diastolic increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16)'}, {'term': 'Heart rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by a Trained Evaluator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Placebo Efficacy Population - All subjects enrolled and received placebo test article and met Per protocol definition'}, {'id': 'OG001', 'title': 'BTL-TML-HSV Active Treatment', 'description': 'BTL-TML Efficacy Population - All subjects enrolled and received active test article and met Per Protocol definition'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>.5000', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0- Day 7', 'description': 'The primary efficacy endpoint of this study is to determine if a recurrent oral herpes episode initiated with prodromal symptoms is aborted before progressing to a lesion (vesicle stage) via assessing lesion stages by the trained evaluator. Any episode of oral herpes that did not reach a vesicle stage or higher by Day 7 (based on evaluator and self-assessments of legion stage) was considered "aborted" or "blocked". Any episode of oral herpes that reached a vesicle stage or higher by Day 7 was considered a treatment failure.', 'unitOfMeasure': 'participants who had aborted lesions', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants that did not experience prodrome stage as assessed by the evaluator or met major protocol violations were not included in the PP analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by the Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Placebo efficacy Population - All subjects who received placebo test article and were compliant with protocol'}, {'id': 'OG001', 'title': 'BTL-TML-HSV Active Treatment', 'description': 'BTL-TML Efficacy Population - All subjects who received active test article and were compliant with protocol'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.3835', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '0 -7 days', 'description': 'The secondary efficacy endpoint of this study is to determine if a recurrent oral herpes episode initiated with prodromal symptoms is aborted before progressing to a lesion (vesicle stage) via assessing lesion stages by the participant. Any episode of oral herpes that did not reach a vesicle stage or higher by Day 7 (based on evaluator and self-assessments of legion stage) was considered "aborted" or "blocked". Any episode of oral herpes that reached a vesicle stage or higher by Day 7 was considered a treatment failure.', 'unitOfMeasure': 'participants with aborted lesions', 'reportingStatus': 'POSTED', 'populationDescription': '158 subjects randomized to treatment. 118 subjects used allocated assigned treatment (62 test article and 56 placebo). 7 subjects failed to complete and 111 completed study. For this secondary analysis (self assessments) 53 subjects noted prodrome occurring on Day 0.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Matching Placebo', 'description': 'Matching Placebo\n\nTreatment regimens will be as follows (upon the first signs/symptoms of prodrome (tingling, itching, burning):\n\n* Day 0 - Take 1 drop every 10 minutes for the 1st hour following appearance of prodrome symptoms (0, 10, 20, 30, 40, 50 and 60 minutes), then 1 drop every hour until bedtime.\n* Days 1 \\& 2 - Take 1 drop six times daily -\n* Days 3-7 - Take one drop twice daily'}, {'id': 'FG001', 'title': 'BTL-TML-HSV', 'description': 'Experimental Product\n\nBTL-TML-HSV: Sublingual micro dosing of BTL-TML-HSV for 7 days\n\nTreatment regimens will be as follows (upon the first signs/symptoms of prodrome (tingling, itching, burning):\n\n* Day 0 - Take 1 drop every 10 minutes for the 1st hour following appearance of prodrome symptoms (0, 10, 20, 30, 40, 50 and 60 minutes), then 1 drop every hour until bedtime.\n* Days 1 \\& 2 - Take 1 drop six times daily -\n* Days 3-7 - Take one drop twice daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Allocated to placebo', 'groupId': 'FG000', 'numSubjects': '77'}, {'comment': 'Allocated to active treatment', 'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'Number of Participants', 'achievements': [{'comment': 'Number of randomized participants who developed a cold sore and used the assigned treatment.', 'groupId': 'FG000', 'numSubjects': '56'}, {'comment': 'Number of randomized participants who developed a cold sore and used the assigned treatment.', 'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '21 not treated - did not use placebo medication as they did not develop cold sore', 'groupId': 'FG000', 'numSubjects': '54'}, {'comment': '19 not treated /did not use medication as they did not develop a cold sore', 'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'subject lost investigational product', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Did not develop a cold sore', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '19'}]}]}], 'recruitmentDetails': 'Recruitment occurred from 29Jul2013 through 09Sep2014. Subjects were recruited through three research clinics located in the US who had been trained in UVr application used to trigger recurrent oral Herpes Simplex Labialis.', 'preAssignmentDetails': 'Subjects who did not meet inclusion/exclusion or withdrew consent prior to enrollment were not enrolled in the study. Eligible subjects underwent minimum erythema dose (MED) UVr determination and if MED criteria was met were randomized. Those enrolled who did not develop prodrome following the UVr induced process were not treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Matching Placebo', 'description': 'Placebo Safety Population - All subjects enrolled and received placebo test article'}, {'id': 'BG001', 'title': 'BTL-TML-HSV Active Treatment', 'description': 'BTL-TML Safety Population - All subjects enrolled and received active test article'}, {'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': '72', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Demographics based on number of subjects who were randomization and subsequently assigned investigational product'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 303}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-27', 'studyFirstSubmitDate': '2013-07-15', 'resultsFirstSubmitDate': '2016-02-14', 'studyFirstSubmitQcDate': '2013-07-15', 'lastUpdatePostDateStruct': {'date': '2016-04-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-02-14', 'studyFirstPostDateStruct': {'date': '2013-07-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by a Trained Evaluator', 'timeFrame': 'Day 0- Day 7', 'description': 'The primary efficacy endpoint of this study is to determine if a recurrent oral herpes episode initiated with prodromal symptoms is aborted before progressing to a lesion (vesicle stage) via assessing lesion stages by the trained evaluator. Any episode of oral herpes that did not reach a vesicle stage or higher by Day 7 (based on evaluator and self-assessments of legion stage) was considered "aborted" or "blocked". Any episode of oral herpes that reached a vesicle stage or higher by Day 7 was considered a treatment failure.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by the Participant', 'timeFrame': '0 -7 days', 'description': 'The secondary efficacy endpoint of this study is to determine if a recurrent oral herpes episode initiated with prodromal symptoms is aborted before progressing to a lesion (vesicle stage) via assessing lesion stages by the participant. Any episode of oral herpes that did not reach a vesicle stage or higher by Day 7 (based on evaluator and self-assessments of legion stage) was considered "aborted" or "blocked". Any episode of oral herpes that reached a vesicle stage or higher by Day 7 was considered a treatment failure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Herpes Labialis', 'Herpes Simplex', 'Herpes', 'Ultra Violet (UV) Induced'], 'conditions': ['Oral Herpes Simplex']}, 'referencesModule': {'references': [{'pmid': '35142535', 'type': 'DERIVED', 'citation': 'Mamber SW, Hatch T, Miller CS, Murray JV, Strout C, McMichael J. Low-dose Oral Thimerosal for the Treatment of Oral Herpes: Clinical Trial Results and Improved Outcome After Post-hoc Analysis. J Evid Based Integr Med. 2022 Jan-Dec;27:2515690X221078004. doi: 10.1177/2515690X221078004.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if a new drug treatment is effective to block the development of a cold sore lesion following Ultra Violet (UV) exposure.', 'detailedDescription': 'This was a multi-center, randomized, evaluator and subject-blind, placebo controlled study design\n\nThe objective of this study was to evaluate the ability of the test articles to block the development of a cold sore lesion from progressing beyond the prodromal stage following a UV-induced process.\n\nThe primary efficacy endpoint of this study was to determine if a recurrent oral herpes episode initiated with prodromal symptoms was aborted before progressing to a lesion (vesicle) via assessing lesion stages by a trained evaluator.\n\nThe secondary efficacy endpoints included: a) subject self-assessments and b) test article weights and diaries to track treatment compliance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical history of recurrent cold sores averaging 2 or more episodes per year\n* UV exposure is known to cause a cold sore outbreak\n\nExclusion Criteria:\n\n* History of abnormal reactions to sunlight\n* Used antiviral therapy directly prior to entering study\n* Any other condition which in the opinion of the Investigator may affect the results or place the subject at undue risk.'}, 'identificationModule': {'nctId': 'NCT01902303', 'briefTitle': 'Evaluation of Cold Sore Treatments on Ultra Violet (UV) Induced Cold Sores', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beech Tree Labs, Inc.'}, 'officialTitle': 'Evaluation of Cold Sore Treatments on UV Induced Cold Sores', 'orgStudyIdInfo': {'id': 'BTL - 2013-06-0161'}, 'secondaryIdInfos': [{'id': 'HTR - 13-131178', 'type': 'OTHER', 'domain': 'Hill Top Research'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Matching Placebo', 'description': 'Matching Placebo', 'interventionNames': ['Drug: Matching Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BTL-TML-HSV', 'description': 'Experimental Product', 'interventionNames': ['Drug: BTL-TML-HSV']}], 'interventions': [{'name': 'Matching Placebo', 'type': 'DRUG', 'description': 'Sublingual micro dosing of placebo for 7 days', 'armGroupLabels': ['Matching Placebo']}, {'name': 'BTL-TML-HSV', 'type': 'DRUG', 'description': 'Sublingual micro dosing of BTL-TML-HSV for 7 days', 'armGroupLabels': ['BTL-TML-HSV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33714', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Hill Top Research', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Hill Top Research', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Coastal Carolina Research Center', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}], 'overallOfficials': [{'name': 'John McMichael, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'President, Beech Tree Labs, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beech Tree Labs, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Norwich Clinical Research Associates Ltd.', 'class': 'OTHER'}, {'name': 'Hill Top Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}