Ignite Creation Date:
2025-12-24 @ 10:39 PM
Ignite Modification Date:
2025-12-25 @ 8:10 PM
Study NCT ID:
NCT05796635
Status:
COMPLETED
Last Update Posted:
2023-04-03
First Post:
2023-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Investigation Into the Efficacy of Herpecin L at Reducing the Frequency and Severity of Cold Sores
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D000481', 'term': 'Allantoin'}], 'ancestors': [{'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006827', 'term': 'Hydantoins'}, {'id': 'D048289', 'term': 'Imidazolidines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-01', 'studyFirstSubmitDate': '2023-03-09', 'studyFirstSubmitQcDate': '2023-04-01', 'lastUpdatePostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary aim of this research is to understand the changes in cold sore severity.', 'timeFrame': '12 weeks', 'description': 'Cold sore severity will be measured via survey and cold sore severity grading. Symptom severity is rated on a scale of 0 (Not a problem) to 6 (Severe)'}], 'secondaryOutcomes': [{'measure': 'The secondary objective of this trial is to examine differences in cold sore frequency between the two groups.', 'timeFrame': '12 weeks', 'description': 'Cold sore frequency will be measured via a self-reported survey measuring the frequency of cold sore occurrence during the study period compared to baseline.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cold Sores']}, 'descriptionModule': {'briefSummary': 'Focus Consumer Healthcare has developed Herpecin L. Herpecin L combines many different ingredients hypothesized to promote quick healing and symptom reduction from cold sores.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male Female between 18-60 years of age.\n* Must be in good health with no significant chronic conditions and a BMI under 35.\n* Must experience regular cold sores or fever blisters\n* Must agree to avoid daily lip balm or another product designed to alleviate their cold sore (e.g., Abreva or other over-the-counter cold sore products).\n\nExclusion Criteria:\n\n* Suffers from pre-existing conditions that would prevent them from adhering to the protocol including chronic conditions such as oncological or psychiatric disorders.\n* Anyone with known severe allergic reactions.\n* Unwilling to follow the study protocol.\n* Currently pregnant, breastfeeding, or wanting to become pregnant for the duration of the study.'}, 'identificationModule': {'nctId': 'NCT05796635', 'briefTitle': 'An Investigation Into the Efficacy of Herpecin L at Reducing the Frequency and Severity of Cold Sores', 'organization': {'class': 'INDUSTRY', 'fullName': 'Focus Consumer Healthcare'}, 'officialTitle': 'An Investigation Into the Efficacy of Herpecin L at Reducing the Frequency and Severity of Cold Sores', 'orgStudyIdInfo': {'id': '20274'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Herpecin L', 'description': 'Participants will use Herpecin L Everyday Protection lip balm.', 'interventionNames': ['Other: Herpecin L']}, {'type': 'NO_INTERVENTION', 'label': 'Controlled Arm', 'description': 'Participants will not use any cold sore products or lip balms.'}], 'interventions': [{'name': 'Herpecin L', 'type': 'OTHER', 'description': 'Participants in the Herpecin L arm will use the test product daily as a preventive product by applying the product twice daily. Also, participants will be told they can reapply the product if going outside into the cold, wind, or sun. If participants in the Herpecin L arm do experience a cold sore or fever blister, they will be instructed to use the product at the first sign of the cold sore and then at least four more times during the day until the cold sore is gone (they can use the product more often if they plan to go outside into the cold, sun, or wind).', 'armGroupLabels': ['Herpecin L']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Citruslabs', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Focus Consumer Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Citruslabs', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}