Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-25 @ 1:28 PM
Study NCT ID:
NCT03977792
Status:
UNKNOWN
Last Update Posted:
2020-09-07
First Post:
2019-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open Label Study to Evaluate the Safety and Efficacy of BOR15001L7 for the Treatment of Cold Sores in Patients With Recurrent Herpes Labialis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006560', 'term': 'Herpes Labialis'}, {'id': 'D006561', 'term': 'Herpes Simplex'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}], 'ancestors': [{'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': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 164}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-04', 'studyFirstSubmitDate': '2019-05-29', 'studyFirstSubmitQcDate': '2019-06-05', 'lastUpdatePostDateStruct': {'date': '2020-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The mean change of healing time', 'timeFrame': 'Day 1 to 12'}], 'secondaryOutcomes': [{'measure': 'The change in lesion rates following the prodromal stage', 'timeFrame': 'Day 1 to 12'}, {'measure': 'The mean change in delays (hours) between the prodromal stage and the first visible occurence of lesions', 'timeFrame': 'Day 1 to 12'}, {'measure': 'The percentage change in number of lesions at papule, vesicles and ulcers/soft crust, hard crust stages', 'timeFrame': 'Day 1 to 12'}, {'measure': 'The percentage change in dimensions (mm) of lesions at papule, vesicles and ulcers/soft crust, hard crust stages', 'timeFrame': 'Day 1 to 12'}, {'measure': 'The percentage of patients that demonstrated a change in intensity of drug-related symptoms (pain, tingling, itching, burning sensation) at papule, vesicles and ulcers/soft crust, hard crust stages', 'timeFrame': 'Day 1 to 12'}, {'measure': 'The mean change in duration (hours) of drug-related symptoms (pain, tingling, itching, burning sensation) at papule, vesicles and ulcers/soft crust, hard crust stages', 'timeFrame': 'Day 1 to 12'}, {'measure': 'Safety and tolerability measured by the Incidence of Treatment-Emergent Adverse Events [Side-effects]', 'timeFrame': 'Day 1 to 12'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Herpes Simplex', 'Skin Diseases, Infectious', 'Herpesviridae Infections'], 'conditions': ['Recurrent Herpes Labialis']}, 'referencesModule': {'references': [{'pmid': '28228101', 'type': 'BACKGROUND', 'citation': 'Lavoie S, Cote I, Pichette A, Gauthier C, Ouellet M, Nagau-Lavoie F, Mshvildadze V, Legault J. Chemical composition and anti-herpes simplex virus type 1 (HSV-1) activity of extracts from Cornus canadensis. BMC Complement Altern Med. 2017 Feb 22;17(1):123. doi: 10.1186/s12906-017-1618-2.'}]}, 'descriptionModule': {'briefSummary': 'BOR15001L7 is a natural product. The primary objective of this study is to demonstrate its non-inferiority to docosanol 10% based on the healing time of cold sores in patients with recurrent herpes labialis.', 'detailedDescription': 'Secondary objectives are to:\n\n1. Evaluate the efficacy of BOR1500L7 on:\n\n * The reduction of ulcerative lesions rates following the prodromal stage;\n * The extension of the delay prior to first ulcerative lesions occurence following the prodromal stage;\n * The decrease of cumulative ulcerative lesions dimensions during papule, vesicles, ulcers/soft and hard crust stages;\n * The decrease of symptoms intensity (pain, tingling, itching, burning sensation) during prodromal, erythema, papule, vesicles, ulcers/soft crust, hard crust, re-epithelialize stages;\n * The reduction of symptoms duration (pain, tingling, itching, burning sensation) during the prodromal, erythema, papule, vesicles, ulcers/soft crust, hard crust, re-epithelialize stages in subjects with recurrent herpes labialis;\n2. Evaluate the safety and tolerability of BOR15001L7 in subjects with recurrent herpes labialis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide signed informed consent and willing to comply with study-related procedures;\n* Males and females ≥18 years of age at screening;\n* Diagnosed with recurrent herpes labialis, defined as showing at least 2 episodes of infections per year;\n* Willing to avoid, during the treatment phase, the use of anti-inflammatory, anti-herpetic, antibiotic and antiviral agents as well as steroids or other natural products that would interfere with the immune system response (exception: only the use of valacyclovir will be permitted, if prescribed);\n* Willing to avoid, during the treatment phase, the use of cosmetic products (ex. cream, make-up, etc.) at areas close to the infected region.\n\nExclusion Criteria:\n\n* Patients with skin disease affecting the peribuccal region (eczema, psoriasis, dermatitis, etc.);\n* Patients with herpes labialis occurring within 14 days prior to screening;\n* Patients known for allergies or intolerance to drug and comparator ingredients, or any cream used to treat skin conditions;\n* Treatment with an investigational product or biological agent or device within 30 days or five half˗lives, whichever is longer.\n* Any other condition, which, in the opinion of the investigator or the sponsor would make the patient unsuitable for inclusion, or could interfere with the conduct of the study.'}, 'identificationModule': {'nctId': 'NCT03977792', 'briefTitle': 'An Open Label Study to Evaluate the Safety and Efficacy of BOR15001L7 for the Treatment of Cold Sores in Patients With Recurrent Herpes Labialis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoire Boreaderme Inc.'}, 'officialTitle': 'A Randomized, Open Label, Non-inferiority Study to Compare the Safety and Efficacy of BOR15001L7 to Docosanol 10% in Patients With Recurrent Herpes Labialis', 'orgStudyIdInfo': {'id': 'BOR-15001L7-P2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental treatment', 'description': 'Subjects treated with BOR15001L7.\n\nAll subjects will be randomized 1:1 (BOR15001L7:docosanol 10%) to receive either BOR15001L7 or docosanol 10%.', 'interventionNames': ['Drug: BOR15001L7']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator treatment', 'description': 'Subjects treated with Docosanol 10%.\n\nAll subjects will be randomized 1:1 (BOR15001L7:docosanol 10%) to receive either BOR15001L7 or docosanol 10%.', 'interventionNames': ['Drug: Docosanol Cream 10%']}], 'interventions': [{'name': 'BOR15001L7', 'type': 'DRUG', 'description': 'BOR15001L7 topically applied to infected area, 5 times a day, until complete healing of the infection.', 'armGroupLabels': ['Experimental treatment']}, {'name': 'Docosanol Cream 10%', 'type': 'DRUG', 'description': 'Comparator product topically applied to infected area, 5 times a day, until complete healing of the infection.', 'armGroupLabels': ['Comparator treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Etienne Khoury, PhD, CCRP', 'role': 'CONTACT', 'email': 'etienne.khoury@ecogene21.org', 'phone': '(418) 545-1252', 'phoneExt': '239'}, {'name': 'Diane Brisson, PhD, CCRP', 'role': 'CONTACT', 'email': 'diane.brisson@ecogene21.org', 'phone': '(418) 545-1252', 'phoneExt': '226'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoire Boreaderme Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Ecogene 21', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}