Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-03-02 @ 4:08 AM
Study NCT ID:
NCT03346902
Status:
COMPLETED
Last Update Posted:
2019-01-08
First Post:
2017-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of EB-001 in Facial Scar Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wajdie@bonti.com', 'phone': '9493796569', 'title': 'Wajdie Ahmad', 'phoneExt': '9493796569', 'organization': 'Bonti'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '90 Days', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': '0.9% Sodium Chloride Injection: Single Injection of Saline into area of scarring (forehead)', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'EB001', 'description': 'EB-001: Single Injection (0.5mL total) of EB-001 into area of scarring (forehead)', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 1, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Asymmetry in facial features as a result of the temporal nerve being affected during the Mohs Surger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Assessment of Visual Analog Scale (VAS) Change (Values From 0 (Worst) to 10 (Best))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '0.9% Sodium Chloride Injection: Single Injection of Saline into area of scarring (forehead)'}, {'id': 'OG001', 'title': 'EB001', 'description': 'EB-001: Single Injection (0.5mL total) of EB-001 into area of scarring (forehead)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 30', 'description': 'Assessment of change in Visual Analog Scale score (values from 0 (worst) to 10 (best)) from day of surgery to Day 30. Percentage of subjects reporting an improvement in Visual Analog Scale score.', 'unitOfMeasure': 'Percentage reporting improvement', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': '0.9% Sodium Chloride Injection: Single Injection of Saline into area of scarring (forehead)'}, {'id': 'FG001', 'title': 'EB001', 'description': 'EB-001: Single Injection (0.5mL total) of EB-001 into area of scarring (forehead).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': '0.9% Sodium Chloride Injection: Single Injection of Saline into area of scarring (forehead)'}, {'id': 'BG001', 'title': 'EB001', 'description': 'EB-001: Single Injection (0.5mL total) of EB-001 into area of scarring (forehead)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000', 'lowerLimit': '60', 'upperLimit': '75'}, {'value': '59', 'groupId': 'BG001', 'lowerLimit': '34', 'upperLimit': '72'}, {'value': '62', 'groupId': 'BG002', 'lowerLimit': '34', 'upperLimit': '75'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '87.28', 'spread': '25.528', 'groupId': 'BG000'}, {'value': '79.94', 'spread': '19.352', 'groupId': 'BG001'}, {'value': '82.38', 'spread': '21.055', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-02', 'size': 308644, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-10-12T10:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-10-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-14', 'studyFirstSubmitDate': '2017-11-13', 'resultsFirstSubmitDate': '2018-10-17', 'studyFirstSubmitQcDate': '2017-11-16', 'lastUpdatePostDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-16', 'studyFirstPostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of Visual Analog Scale (VAS) Change (Values From 0 (Worst) to 10 (Best))', 'timeFrame': 'Day 30', 'description': 'Assessment of change in Visual Analog Scale score (values from 0 (worst) to 10 (best)) from day of surgery to Day 30. Percentage of subjects reporting an improvement in Visual Analog Scale score.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mohs Surgery']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of EB-001 in improving wound healing and reducing scar formation in patients undergoing Mohs surgery for skin lesions in the forehead area following a single treatment of EB-001 when injected into the muscles underlying the incision area.', 'detailedDescription': 'This study will evaluate the safety and efficacy of EB-001 in improving wound healing and reducing scar formation in patients undergoing Mohs surgery for skin lesions in the forehead area following a single treatment of EB-001 when injected into the muscles underlying the incision area.\n\nThe safety objective is to determine the safety and tolerability of single treatment of EB-001 when injected into facial muscles underlying a surgical wound during Mohs surgery.\n\nThe efficacy objective is to evaluate the efficacy of a single treatment of EB-001 when injected into the facial muscles (frontalis) underlying the surgical wound in improving wound healing, and reducing scar formation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Between 18 and 75 years of age, inclusive\n2. Subject in good health, or with stable treated medical condition, as determined by the investigator.\n3. Scheduled to undergo Mohs surgery to remove a single skin lesion in the forehead. This could be\n\n 1. Basal Cell Carcinoma\n 2. Squamous Cell Carcinoma (non-metastatic)\n 3. Other suitable lesions according to the investigator opinion\n4. Lesion closure size at least 2 cm in length\n5. Women of non-childbearing potential must be postmenopausal (at least 12 consecutive months of amenorrhea)\n6. Women of childbearing potential must not be pregnant, lactating, or planning to become pregnant during the study\n7. Women of childbearing potential agreeing to use either\n\n 1. a highly effective method of contraception with failures rates less than 1% per year such as implant, intrauterine device (IUD), or sterilization from the day of dosing for 3 months (subjects who underwent sterilization must have initiated the procedure at least 3 months prior to the day of dosing) or\n 2. dual methods of contraception with overall failures rates less than 1% per year such as injectable, pill, patch, ring, and diaphragm from the day of dosing for 3 months (subjects using oral contraception must have initiated treatment at least 2 months prior to the day of dosing)\n8. Willing and able to complete and comply with procedures, protocol requirements and instructions, which includes completion of all required visits\n9. Willing and able to sign and date IRB-approved informed consent\n10. Able to speak, read, and understand the language of the informed consent form (ICF) and study questionnaires\n\nExclusion Criteria:\n\n1. Pregnant or breast feeding, or planning a pregnancy\n2. Body weight less than 50 kg (110 pounds)\n3. Reported use of any botulinum toxin of any serotype within last 6 months before study drug administration\n4. Anticipated use of any botulinum toxin of any serotype during the study\n5. Known hypersensitivity to any botulinum toxin serotype\n6. Known allergy or sensitivity to any of the components of the study treatments, or any materials used in the study procedures\n7. Aminoglycoside intake within 48 hours prior to or during surgery\n8. Pre-existing disorders of the neuromuscular junction (myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral Sclerosis)\n9. Any uncontrolled medical condition that in opinion of investigator, puts subject at undue safety risk\n10. Any clinically significant psychiatric condition that, in opinion of investigator, may interfere with study assessments or protocol compliance\n11. Any cosmetic procedure, laser resurfacing treatment, or retinoid therapy in the forehead area in the past 30 days before study drug administration\n12. Any eyebrow or eyelid ptosis at baseline as determined by the Investigator\n13. History of hypertrophic scars or keloid formation or other wound abnormalities as assessed by the investigator\n14. History of alcohol or drug abuse in the last 3 years, based on investigator judgement\n15. User or former user of nicotine-containing products, as follows:\n\n 1. including but not limited to cigarettes, cigars, and chewing or dipping tobacco) who stopped use or consumption (i.e., smoking, chewing, or pinching) of these nicotine-containing products less than 1 year before study drug administration, or\n 2. topical or oral nicotine preparations for smoking cessation within the past 90 days before study drug administration\n16. Anticipated need for surgery or overnight hospitalization during the study\n17. Current enrollment in an investigational drug or device study or participation in such a study within 30 days or 5 half-lives of the drug, whichever is longer, of entry into this study'}, 'identificationModule': {'nctId': 'NCT03346902', 'briefTitle': 'Study of EB-001 in Facial Scar Reduction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bonti, Inc.'}, 'officialTitle': 'A Phase 2 Study to Evaluate Safety and Efficacy of EB-001 Injections in Facial Scar Reduction After Undergoing Mohs Surgery', 'orgStudyIdInfo': {'id': 'EB001-SR201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Drug: : Placebo: 0.9% Sodium Chloride Injection\n\nInjection of Placebo into area of scarring (forehead)', 'interventionNames': ['Drug: 0.9% Sodium Chloride Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EB001', 'description': 'Drug: EB-001 Injection of EB-001 into area of scarring (forehead)', 'interventionNames': ['Drug: EB-001']}], 'interventions': [{'name': 'EB-001', 'type': 'DRUG', 'description': 'Injection of EB-001 into area of scarring (forehead)', 'armGroupLabels': ['EB001']}, {'name': '0.9% Sodium Chloride Injection', 'type': 'DRUG', 'description': 'Injection of Saline into area of scarring (forehead)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Earvin Liang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bonti, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bonti, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}