Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT04937920
Status:
COMPLETED
Last Update Posted:
2025-07-03
First Post:
2021-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Trial to Evaluate the Safety and Antimicrobial Efficacy of DBI-002 Probiotic in Adults With Tinea Versicolor
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014010', 'term': 'Tinea Versicolor'}], 'ancestors': [{'id': 'D003881', 'term': 'Dermatomycoses'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C106521', 'term': 'BANG polymer gel'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'emma@dermbiont.com', 'phone': '510-607-8155', 'title': 'Emma Taylor, MD (Chief Medical Officer)', 'organization': 'DermBiont, Inc'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 14 (Visit 6) from the baseline Day 1 (Visit 1)', 'description': "AE is any untoward medical occurrence in a subject administered a pharmaceutical product, that doesn't necessarily have a causal relationship with the treatment.It can be any unfavorable \\& unintended sign(e.g., an abnormal laboratory finding), symptom/ disease temporally associated with use of the study drug, whether or not it's considered to be drug related.This includes any newly occurring event/previous condition that has increased in severity/frequency since the administration of study drug.", 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1 Probiotic Gel', 'description': 'Low dose 10\\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 1 Aqueous Gel', 'description': 'Low dose 10\\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 2 Probiotic Gel', 'description': 'Medium dose 10\\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 2 Aqueous Gel', 'description': 'Medium dose 10\\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Cohort 3 Aqueous Gel', 'description': 'High dose 10\\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Cohort 3 Probiotic Gel', 'description': 'High dose 10\\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Cohort 1EXT Aqueous Gel', 'description': 'Low dose 10\\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Cohort 1EXT Probiotic Gel', 'description': 'Low dose 10\\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Cohort 2EXT Aqueous Gel', 'description': 'Medium dose 10\\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Cohort 2EXT Probiotic Gel', 'description': 'Medium dose 10\\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'Cohort 3EXT Aqueous Gel', 'description': 'High dose 10\\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'Cohort 3EXT Probiotic Gel', 'description': 'High dose 10\\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'Cohort 4 Aqueous', 'description': 'Vehicle gel vs. aqueous (CMC) gel Once-daily application for 5 consecutive days', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG013', 'title': 'Cohort 4 Probiotic', 'description': 'Vehicle gel vs. aqueous (CMC) gel Once-daily application for 5 consecutive days', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Low dose 10\\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Medium dose 10\\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'High dose 10\\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days'}, {'id': 'OG003', 'title': 'Cohort 1EXT', 'description': 'Low dose 10\\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days'}, {'id': 'OG004', 'title': 'Cohort 2EXT', 'description': 'Medium dose 10\\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive day'}, {'id': 'OG005', 'title': 'Cohort 3EXT', 'description': 'High dose 10\\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days'}], 'classes': [{'title': 'Day 5 qPCR DBI-002 Drug Product: # Subjects where Active Improves More than Aqueous Gel (Control)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'Day 14 qPCR DBI-002 Drug Product: # Subjects where Active Improves More than Aqueous Gel (Control)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Day 5 qPCR Malassezia(fungal cause of TV):# Subjects where Active Improves More than Aqueous Gel', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Day 14 qPCR Malassezia(fungal cause of TV):# Subjects where Active Improves More than Aqueous Gel', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.2', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'paramType': 'Mean Paired Change from Baseline', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-29620', 'groupDescription': 'The analysis compared the differences at Day 5 between DBI-002 probiotic gel (active) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '1.0', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'paramType': 'Mean Paired Change from Baseline', 'ciNumSides': 'TWO_SIDED', 'paramValue': '127195', 'groupDescription': 'The analysis compared the differences at Day 14 between DBI-002 probiotic gel (active) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.6', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'paramType': 'Mean Paired Change from Baseline', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-41659', 'groupDescription': 'The analysis compared the differences at Day 5 between aqueous gel (control) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '1.0', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'paramType': 'Mean Paired Change from Baseline', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-483', 'groupDescription': 'The analysis compared the differences at Day 14 between aqueous gel (control) and vehicle gel (active Cohort 4 only) in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days of participation', 'description': 'The primary analysis will summarize the number of subjects with more qPCR DBI-002 drug product and more improvement in qPCR Malassezia (fungal cause of tinea versicolor) between DBI-002 Drug Product (Active) and aqueous gel (Control) at Day 5 or Day 14 versus Baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis will compare the differences at Day 5 between DBI-002 Drug Product (DP), vehicle gel, and/or aqueous gel in abundance of Malassezia based on molecular diagnostic qPCR using a 2-sided Wilcoxon sign rank test, alpha = 0.05, with a null hypothesis of median difference equal to zero.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Decrease in Signs and Symptoms of Tinea Versicolor for the DBI-002 DP-treated Lesion Compared to the Aqueous Gel Treated Lesion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'Low dose 10\\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'Medium dose 10\\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'High dose 10\\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days'}, {'id': 'OG003', 'title': 'Cohort 1EXT', 'description': 'Low dose 10\\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days'}, {'id': 'OG004', 'title': 'Cohort 2EXT', 'description': 'Medium dose 10\\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive day'}, {'id': 'OG005', 'title': 'Cohort 3EXT', 'description': 'High dose 10\\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days'}], 'classes': [{'title': 'Day 5 proportion of subjects with a greater decrease in the scoring of individual signs and symptoms', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Day 14 proportion of subjects with a greater decrease in the scoring of individual signs and symptom', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days of participation', 'description': 'The secondary analysis will summarize the number of subjects with more improvement in individual signs and symptoms of TV between DBI-002 Drug Product (Active) and aqueous gel (Control) at Day 5 or Day 14 versus Baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The proportion of subjects with a greater decrease in the scoring of individual signs and symptoms of TV for the DBI-002 Drug Product-treated lesion than the vehicle-treated or aqueous gel-treated lesion is be summarized descriptively for Days 5 and 14.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1', 'description': 'Low dose 10\\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose (first 2 subjects) OR Once-daily application for 5 consecutive days (last 4 subjects) Safety pauses between single and multi-dose subjects, and prior to enrolling next cohort. No subject is dose escalated. Subjects are enrolled in only one cohort.'}, {'id': 'FG001', 'title': 'Cohort 2', 'description': 'Medium dose 10\\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose (first 2 subjects) OR Once-daily application for 5 consecutive days (last 4 subjects) Safety pauses between single and multi-dose subjects, and prior to enrolling next cohort. No subject is dose escalated. Subjects are enrolled in only one cohort.'}, {'id': 'FG002', 'title': 'Cohort 3', 'description': 'High dose 10\\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose (first 2 subjects) OR Once-daily application for 5 consecutive days (last 4 subjects) Safety pauses between single and multi-dose subjects, and prior to enrolling next cohort. No subject is dose escalated. Subjects are enrolled in only one cohort.'}, {'id': 'FG003', 'title': 'Cohort 1EXT', 'description': 'Low dose 10\\^6 CFUs/ml of DBI- 002 probiotic vs. aqueous gel Once-daily application for 5 consecutive days (4 subjects) Safety pause prior to enrolling next cohort. No subject is dose escalated. Subjects are enrolled in only one cohort.'}, {'id': 'FG004', 'title': 'Cohort 2EXT', 'description': 'Medium dose 10\\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel Once-daily application for 5 consecutive days (4 subjects) Safety pause prior to enrolling next cohort. No subject is dose escalated. Subjects are enrolled in only one cohort.'}, {'id': 'FG005', 'title': 'Cohort 3EXT', 'description': 'High dose 10\\^10 CFUs/ml of DBI- 002 probiotic vs. aqueous gel Once-daily application for 5 consecutive days (4 subjects) Safety pause prior to enrolling next cohort. No subject is dose escalated. Subjects are enrolled in only one cohort'}, {'id': 'FG006', 'title': 'Cohort 4', 'description': 'Vehicle gel vs. aqueous (CMC) gel\n\nOnce-daily application for 5 consecutive days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '12', 'numSubjects': '6'}, {'groupId': 'FG001', 'numUnits': '12', 'numSubjects': '6'}, {'groupId': 'FG002', 'numUnits': '12', 'numSubjects': '6'}, {'groupId': 'FG003', 'numUnits': '8', 'numSubjects': '4'}, {'groupId': 'FG004', 'numUnits': '8', 'numSubjects': '4'}, {'groupId': 'FG005', 'numUnits': '8', 'numSubjects': '4'}, {'groupId': 'FG006', 'numUnits': '8', 'numSubjects': '4'}]}, {'type': 'Aqueous Gel (Back or Chest)', 'comment': "Each subject functions as their own control. (Subject's chest or back)", 'achievements': [{'groupId': 'FG000', 'numUnits': '6', 'numSubjects': '6'}, {'groupId': 'FG001', 'numUnits': '6', 'numSubjects': '6'}, {'groupId': 'FG002', 'numUnits': '6', 'numSubjects': '6'}, {'groupId': 'FG003', 'numUnits': '4', 'numSubjects': '4'}, {'groupId': 'FG004', 'numUnits': '4', 'numSubjects': '4'}, {'groupId': 'FG005', 'numUnits': '4', 'numSubjects': '4'}, {'groupId': 'FG006', 'numUnits': '4', 'numSubjects': '4'}]}, {'type': 'DBI-002 Probiotic (Back or Chest)', 'comment': "Each subject functions as their own control. (Subject's chest or back)", 'achievements': [{'groupId': 'FG000', 'numUnits': '6', 'numSubjects': '6'}, {'groupId': 'FG001', 'numUnits': '6', 'numSubjects': '6'}, {'groupId': 'FG002', 'numUnits': '6', 'numSubjects': '6'}, {'groupId': 'FG003', 'numUnits': '4', 'numSubjects': '4'}, {'groupId': 'FG004', 'numUnits': '4', 'numSubjects': '4'}, {'groupId': 'FG005', 'numUnits': '4', 'numSubjects': '4'}, {'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'Vehicle Gel (Back or Chest)', 'comment': "Each subject functions as their own control. (Subject's chest or back)", 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG006', 'numUnits': '4', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '12', 'numSubjects': '6'}, {'groupId': 'FG001', 'numUnits': '12', 'numSubjects': '6'}, {'groupId': 'FG002', 'numUnits': '12', 'numSubjects': '6'}, {'groupId': 'FG003', 'numUnits': '8', 'numSubjects': '4'}, {'groupId': 'FG004', 'numUnits': '8', 'numSubjects': '4'}, {'groupId': 'FG005', 'numUnits': '8', 'numSubjects': '4'}, {'groupId': 'FG006', 'numUnits': '8', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG006', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Treatment sites', 'preAssignmentDetails': 'All subjects are required to have Tinea Versicolor on their chest and back, with no pre-assignment, as each subject functions as their own control. Each subject had test article (aqueous gel and active) applied, randomized, within treatment sites to 100cm2. The dose-escalating DBI-002 cohorts (1, 2, and 3) were enrolled in sequence, with a safety pause between cohorts to assess adverse events and local reactions to topical application. 34 total subjects were enrolled and received treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '34', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1', 'description': 'Low dose 10\\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days'}, {'id': 'BG001', 'title': 'Cohort 2', 'description': 'Medium dose 10\\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days'}, {'id': 'BG002', 'title': 'Cohort 3', 'description': 'High dose 10\\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days'}, {'id': 'BG003', 'title': 'Cohort 1EXT', 'description': 'Low dose 10\\^6 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days'}, {'id': 'BG004', 'title': 'Cohort 2EXT', 'description': 'Medium dose 10\\^8 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days'}, {'id': 'BG005', 'title': 'Cohort 3EXT', 'description': 'High dose 10\\^10 CFUs /ml of DBI-002 probiotic vs. aqueous gel\n\nSingle treatment dose OR Once-daily application for 5 consecutive days'}, {'id': 'BG006', 'title': 'Cohort 4', 'description': 'Vehicle gel vs. aqueous (CMC) gel\n\nOnce-daily application for 5 consecutive days'}, {'id': 'BG007', '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '34', 'groupId': 'BG007'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Age: 18 to 65 years of age, at enrollment', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.0', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '24.5', 'spread': '1.52', 'groupId': 'BG001'}, {'value': '29.0', 'spread': '8.22', 'groupId': 'BG002'}, {'value': '29.0', 'spread': '8.29', 'groupId': 'BG003'}, {'value': '47.3', 'spread': '13.6', 'groupId': 'BG004'}, {'value': '31.3', 'spread': '13.1', 'groupId': 'BG005'}, {'value': '34.8', 'spread': '13.1', 'groupId': 'BG006'}, {'value': '32.0', 'spread': '11.2', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '22', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '34', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'El Salvador', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '34', 'groupId': 'BG007'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Clinical diagnosis of Tinea Versicolor on the chest and back', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '34', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Clinical diagnosis of Tinea Versicolor on the chest and back, by the Investigator and KOH', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-09', 'size': 9651398, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-09-25T14:05', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-16', 'studyFirstSubmitDate': '2021-06-01', 'resultsFirstSubmitDate': '2022-11-04', 'studyFirstSubmitQcDate': '2021-06-16', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-16', 'studyFirstPostDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Molecular Diagnostic qPCR Comparison of DBI-002 Drug Product and Malassezia (Fungal Cause of Tinea Versicolor)', 'timeFrame': '14 days of participation', 'description': 'The primary analysis will summarize the number of subjects with more qPCR DBI-002 drug product and more improvement in qPCR Malassezia (fungal cause of tinea versicolor) between DBI-002 Drug Product (Active) and aqueous gel (Control) at Day 5 or Day 14 versus Baseline.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants With Decrease in Signs and Symptoms of Tinea Versicolor for the DBI-002 DP-treated Lesion Compared to the Aqueous Gel Treated Lesion', 'timeFrame': '14 days of participation', 'description': 'The secondary analysis will summarize the number of subjects with more improvement in individual signs and symptoms of TV between DBI-002 Drug Product (Active) and aqueous gel (Control) at Day 5 or Day 14 versus Baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tinea Versicolor']}, 'descriptionModule': {'briefSummary': 'A Randomized, Double-Blinded, Aqueous Gel-Controlled Dose Escalating Trial to Study the Safety and Antimicrobial Efficacy of DBI-002 Probiotic vs. Aqueous Gel and Vehicle Gel vs. Aqueous Gel in Adults with Tinea Versicolor (DBI-202).', 'detailedDescription': 'All subjects are required to have a clinical diagnosis of Tinea Versicolor on their chest and back. Each subject will serve as their own control, with aqueous gel applied to the chest or back, and the non-aqueous gel (DBI-002 or vehicle) applied to the opposite side. Treatment kits will be assigned sequentially to subjects. The subject and the investigator will be blinded to the pre-defined randomization assignments.\n\nIn this Phase IIA proof-of-mechanism study, cohorts 1, 2, and 3 were designed to be similar to a dose-escalating study. These cohorts will be enrolled sequentially, with a safety pause in between cohorts to evaluate events and/or local tolerability to topical application of the investigational product (DBI-002) or aqueous gel. Within each cohort, the first two subjects enrolled will have a single application of DBI-002 and aqueous gel, with a pause to assess adverse events and local tolerability. In the absence of safety concerns, the remaining subjects in that cohort will be enrolled to receive five consecutive daily applications of DBI-002 and aqueous gel. Cohort 1 will be low dose. Cohort 2 will be medium dose. Cohort 3 will be high dose. In the absence of safety concerns, the Investigator will proceed to enroll the next cohort, or extend (EXT) the enrollment of a cohort upon receiving Ethics Committee approval. Single-dose subjects remain in their original single-dose cohort assignment and do not dose-escalate, nor participate in the multiple-dose portion of that cohort, nor Cohort 4.\n\nThe fourth cohort, Cohort 4, was designed to compare vehicle with aqueous gel. All subjects in this cohort will be required to receive five consecutive daily applications of vehicle and aqueous gel. The Investigator may enroll cohort 4 in parallel with the above cohorts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Ability to understand, agree to and sign the study Informed Consent Form (ICF). If the subject is unable to provide consent him/herself, the subject's legally acceptable representative may provide written consent.\n2. Male or Female Subjects of any race 18 - 65 years of age.\n3. Subjects with a clinical diagnosis of Tinea versicolor (TV is a common benign superficial cutaneous fungal infection usually characterized by hypopigmented or hyperpigmented macules and patches on the chest and back).\n4. A positive potassium hydroxide (KOH) examination consistent with Malassezia prior to the treatment period done at the clinical site.\n5. Agree to not use soap and water on the chest and back for at least 12 hours before the study visits for Baseline/Day 1, Day 5, and Day 14, and follow all study instructions for use of soap and water on the chest and back during participation in the study.\n\nExclusion Criteria:\n\n1. Females who are pregnant, planning a pregnancy, or breastfeeding.\n2. Any dermatological conditions that could interfere with clinical evaluations or any disease state or physical condition which might expose the patient to an unacceptable risk by study participation.\n3. Any underlying disease(s) or other dermatological conditions that require the use of exclusionary topical or systemic therapy (see below).\n4. Known sensitivity to any of the components of the study medication.\n5. Use of a prescription or non-prescription topical treatment on the targeted TV anatomical locations within the previous 4 weeks, for example: anti-fungal, antibacterial or anti-microbial products, selenium and anti-inflammatories (e.g., corticosteroids).\n6. Use of a systemic anti-fungal or antibiotic treatment for TV within the previous 4 weeks, Use of medicated shampoos and/or soaps within the previous 4 weeks.\n7. Treatment of any type of cancer within the last 6 months.\n8. History of any significant internal disease which contraindicates use of live microbiome (e.g. leukemia, liver failure, cardiovascular disease).\n9. Subjects who are known to be allergic to any of the test product(s) or any components in the investigational product(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure (IB).\n10. AIDS or AIDS related complex by medical history.\n11. Known or suspected use of immunosuppressive medications and/or has a known or suspected autoimmune disease.\n12. Any subject not able to meet the study attendance requirements.\n13. Subjects who have participated in any other trial of an investigational drug or device within 30 days prior to enrollment or participation in a research study concurrent with this study."}, 'identificationModule': {'nctId': 'NCT04937920', 'briefTitle': 'A Trial to Evaluate the Safety and Antimicrobial Efficacy of DBI-002 Probiotic in Adults With Tinea Versicolor', 'organization': {'class': 'INDUSTRY', 'fullName': 'DermBiont, Inc.'}, 'officialTitle': 'A Randomized, Double-Blinded, Aqueous Gel-Controlled Dose Escalating Trial to Study the Safety and Antimicrobial Efficacy of DBI-002 Probiotic vs. Aqueous Gel and Vehicle Gel vs. Aqueous Gel in Adults With Tinea Versicolor', 'orgStudyIdInfo': {'id': 'DBI-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DBI-002 probiotic gel', 'description': 'Topical application of DBI-002 probiotic gel on skin affected with tinea versicolor', 'interventionNames': ['Biological: DBI-002 probiotic gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Aqueous gel', 'description': 'Topical application of aqueous gel on skin affected with tinea versicolor', 'interventionNames': ['Biological: Aqueous gel']}], 'interventions': [{'name': 'DBI-002 probiotic gel', 'type': 'BIOLOGICAL', 'description': 'Topical application on skin affected with tinea versicolor', 'armGroupLabels': ['DBI-002 probiotic gel']}, {'name': 'Aqueous gel', 'type': 'BIOLOGICAL', 'description': 'Topical application on skin affected with tinea versicolor', 'armGroupLabels': ['Aqueous gel']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santa Tecla', 'state': 'La Libertad Department', 'country': 'El Salvador', 'facility': 'Zepeda Dermatologia', 'geoPoint': {'lat': 13.67741, 'lon': -89.28335}}], 'overallOfficials': [{'name': 'David Zepeda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zepeda Dermatologia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DermBiont, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}