Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-04 @ 7:07 AM
Study NCT ID:
NCT03450369
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2018-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of the Safety, Engraftment, and Action of NB01 in Adults With Moderate Acne
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'emma.t@nakedbiome.com', 'phone': '626-260-1230', 'title': 'Emma Taylor, MD CEO', 'organization': 'Naked Biome'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From Screening to 28 days after application, typically 2 months', 'eventGroups': [{'id': 'EG000', 'title': 'Low Dose', 'description': '10\\^4 CFU/cm\\^2 NB01', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 1, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'High Dose', 'description': '10\\^5 CFU/cm\\^2 NB01', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 1, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Application site dermatitis', 'notes': 'ADMINISTRATION SITE CONDITIONS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Successful Engraftment of Probiotic Following a Single Application.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose', 'description': '10\\^4 CFU/cm\\^2 NB01'}, {'id': 'OG001', 'title': 'High Dose', 'description': '10\\^5 CFU/cm\\^2 NB01'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 Months', 'description': 'Engraftment is defined as the percentage of bacteria recovered from hair follicles that are health-associated (NB01) as measured with proprietary quantitative polymerase chain assays. Successful follicular engraftment, defined as both deoR/PanBac \\>40% and Cas5/PanBac \\>40% in the Day 2 (24H) ) Biore Strip samples. Cas5/PanBac and deoR/PanBac are the percentages of bacteria in a sample containing the CRISPR associated protein Cas5 and a repressor of porphyrin production deoR, respectively. Pan-Bacterial (PanBac) is a loci found in nearly all bacteria found on the face and thus serves as the denominator to calculate the percentage of bacteria with any loci.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Dose Schedule Determination Based on Time to Peak deoR and Cas5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose', 'description': '10\\^4 CFU/cm\\^2 NB01'}, {'id': 'OG001', 'title': 'High Dose', 'description': '10\\^5 CFU/cm\\^2 NB01'}], 'classes': [{'title': 'Genotype 1 (deoR), 6 hours', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '36.3', 'groupId': 'OG000'}, {'value': '51.2', 'spread': '28.6', 'groupId': 'OG001'}]}]}, {'title': 'Genotype 1 (deoR), 24 hours', 'categories': [{'measurements': [{'value': '-4.2', 'spread': '25.7', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '7.6', 'groupId': 'OG001'}]}]}, {'title': 'Genotype 1 (deoR), 48 hours', 'categories': [{'measurements': [{'value': '13.8', 'spread': '33.5', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '10.9', 'groupId': 'OG001'}]}]}, {'title': 'Genotype 2 (Cas 5), 6 hours', 'categories': [{'measurements': [{'value': '12.8', 'spread': '27.9', 'groupId': 'OG000'}, {'value': '48.4', 'spread': '21.7', 'groupId': 'OG001'}]}]}, {'title': 'Genotype 2 (Cas 5), 24 hours', 'categories': [{'measurements': [{'value': '3.4', 'spread': '15.6', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '8.8', 'groupId': 'OG001'}]}]}, {'title': 'Genotype 2 (Cas 5), 48 hours', 'categories': [{'measurements': [{'value': '3.2', 'spread': '12.2', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '12.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to 48 hours after application', 'description': 'To determine longevity of the live biotherapeutic after a single application, swab samples were collected at Baseline, 6, 24 and 48 hours after application, and genotyped as above. For each participant the absolute change, from Baseline, in the percentage of the two loci present in the live biotherapeutic (deoR and Cas5) were calculated. A significant positive change is indicative of the continued presence of the live biotherapeutic.', 'unitOfMeasure': '% of total bacteria w/ genotype', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Change in Investigator Global Assessment (IGA) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose', 'description': '10\\^4 CFU/cm\\^2 NB01'}, {'id': 'OG001', 'title': 'High Dose', 'description': '10\\^5 CFU/cm\\^2 NB01'}], 'classes': [{'title': 'Participants with changed IGA @ 6 hours', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Participants with changed IGA @ 1 day', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Participants with changed IGA @ 2 days', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Participants with changed IGA @ 6 days', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Participants with changed IGA @ 28 days', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 Days', 'description': 'Number of participants with a changed Investigator Global Assessment (IGA) score after single application of NB01; positive number if grade is reduced (e.g. from 3 to 2) or negative number is IGA grade increased.\n\nThe Investigator Global Assessment 5-Point Score is a standard FDA acne assessment tool with scoring as follows:\n\nGrade 0-Clear (Clear skin with no inflammatory or non-inflammatory lesions. The category of clear should represent true absence of disease) Grade1-Almost Clear (A few scattered comedones and no more than one small papule) Grade 2-Mild (Some comedones, some papules and pustules; no nodules) Grade 3-Moderate (Many comedones, papules and pustules; one nodule may be present) Grade 4-Severe (Covered with comedones, numerous papules and pustules and no more than a few nodular lesions)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Safety Profile and Tolerability of a Singly Applied NB01 Using Acne Lesion Counts.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose', 'description': '10\\^4 CFU/cm\\^2 NB01'}, {'id': 'OG001', 'title': 'High Dose', 'description': '10\\^5 CFU/cm\\^2 NB01'}], 'classes': [{'title': 'Screening', 'categories': [{'measurements': [{'value': '49.4', 'spread': '21.08', 'groupId': 'OG000'}, {'value': '38.8', 'spread': '16.60', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 (0 hours)', 'categories': [{'measurements': [{'value': '22.6', 'spread': '13.26', 'groupId': 'OG000'}, {'value': '42.6', 'spread': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 (6 hours)', 'categories': [{'measurements': [{'value': '21.0', 'spread': '9.22', 'groupId': 'OG000'}, {'value': '39.8', 'spread': '25.41', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '31.6', 'spread': '3.51', 'groupId': 'OG000'}, {'value': '38.2', 'spread': '25.29', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'categories': [{'measurements': [{'value': '32.2', 'spread': '6.18', 'groupId': 'OG000'}, {'value': '35.4', 'spread': '24.17', 'groupId': 'OG001'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '25.6', 'spread': '4.72', 'groupId': 'OG000'}, {'value': '34.2', 'spread': '19.11', 'groupId': 'OG001'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '25.8', 'spread': '14.31', 'groupId': 'OG000'}, {'value': '32.6', 'spread': '59.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Screening to 28 days after application, typically 2 months', 'description': 'Absolute Lesion Count: All Lesions for the Whole Face; with higher numbers of lesion representing worsening or more severe acne', 'unitOfMeasure': 'count of lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Peeling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose', 'description': '10\\^4 CFU/cm\\^2 NB01'}, {'id': 'OG001', 'title': 'High Dose', 'description': '10\\^5 CFU/cm\\^2 NB01'}], 'classes': [{'title': 'Screening, scale = 0 (none)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Screening, scale = 1 (slight)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 (0 hours), scale = 0 (none)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 (0 hours), scale = 1 (slight)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 (6 hours), scale = 0 (none)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 (6 hours), scale = 1 (slight)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 2, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 3, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 28, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Screening to 28 days after application, typically 2 months', 'description': 'Safety profile and tolerability of a singly applied NB01 using the Investigator Assessment of Tolerability Scoring (0 = None; 1 = Slight; 2 = Moderate; 3 = Intense) for Skin Peeling. Reference: ClinicalTrials.gov: Investigator Assessment Tolerability Scoring: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Acne.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Change in Investigator Assessment of Tolerability Score: Irritant/Allergic Contact Dermatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose', 'description': '10\\^4 CFU/cm\\^2 NB01'}, {'id': 'OG001', 'title': 'High Dose', 'description': '10\\^5 CFU/cm\\^2 NB01'}], 'classes': [{'title': 'Screening, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 (0 hours), scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 (6 hours), scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 2, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 3, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 28, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Screening to 28 days after application, typically 2 months', 'description': 'Safety profile and tolerability of a singly applied NB01 using the Investigator Assessment of Tolerability Scoring (0 = None; 1 = Slight; 2 = Moderate; 3 = Intense) for Irritant/Allergic Contact Dermatitis. Reference: ClinicalTrials.gov: Investigator Assessment Tolerability Scoring: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Acne.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Change in Investigator Assessment of Tolerability Score: Hyperpigmentation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose', 'description': '10\\^4 CFU/cm\\^2 NB01'}, {'id': 'OG001', 'title': 'High Dose', 'description': '10\\^5 CFU/cm\\^2 NB01'}], 'classes': [{'title': 'Screening, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 (0 hours), scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 (6 hours), scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 2, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 3, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 28, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Screening to 28 days after application, typically 2 months', 'description': 'Safety profile and tolerability of a singly applied NB01 using the Investigator Assessment of Tolerability Scoring (0 = None; 1 = Slight; 2 = Moderate; 3 = Intense) for Hyperpigmentation. Reference: ClinicalTrials.gov: Investigator Assessment Tolerability Scoring: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Acne.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Change in Investigator Assessment of Tolerability Score: Ocular Irritation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose', 'description': '10\\^4 CFU/cm\\^2 NB01'}, {'id': 'OG001', 'title': 'High Dose', 'description': '10\\^5 CFU/cm\\^2 NB01'}], 'classes': [{'title': 'Screening, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 (0 hours), scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 (6 hours), scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 2, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 3, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 28, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Screening to 28 days after application, typically 2 months', 'description': 'Safety profile and tolerability of a singly applied NB01 using the Investigator Assessment of Tolerability Scoring (0 = None; 1 = Slight; 2 = Moderate; 3 = Intense) for Ocular Irritation. Reference: ClinicalTrials.gov: Investigator Assessment Tolerability Scoring: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Acne.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Change in Investigator Assessment of Tolerability Score: Conjunctival Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose', 'description': '10\\^4 CFU/cm\\^2 NB01'}, {'id': 'OG001', 'title': 'High Dose', 'description': '10\\^5 CFU/cm\\^2 NB01'}], 'classes': [{'title': 'Screening, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 (0 hours), scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 (6 hours), scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 2, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 3, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 28, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Screening to 28 days after application, typically 2 months', 'description': 'Safety profile and tolerability of a singly applied NB01 using the Investigator Assessment of Tolerability Scoring (0 = None; 1 = Slight; 2 = Moderate; 3 = Intense) for Conjunctival Injection. Reference: ClinicalTrials.gov: Investigator Assessment Tolerability Scoring: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Acne.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Change in Investigator Assessment of Tolerability Score: Mucosal Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose', 'description': '10\\^4 CFU/cm\\^2 NB01'}, {'id': 'OG001', 'title': 'High Dose', 'description': '10\\^5 CFU/cm\\^2 NB01'}], 'classes': [{'title': 'Screening, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 (0 hours), scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 (6 hours), scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 2, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 3, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 28, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Screening to 28 days after application, typically 2 months', 'description': 'Safety profile and tolerability of a singly applied NB01 using the Investigator Assessment of Tolerability Scoring (0 = None; 1 = Slight; 2 = Moderate; 3 = Intense) for Mucosal Toxicity. Reference: ClinicalTrials.gov: Investigator Assessment Tolerability Scoring: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Acne.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Erythema.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose', 'description': '10\\^4 CFU/cm\\^2 NB01'}, {'id': 'OG001', 'title': 'High Dose', 'description': '10\\^5 CFU/cm\\^2 NB01'}], 'classes': [{'title': 'Screening, scale = 0 (none)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Screening, scale = 1 (slight)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 (0 hours), scale = 0 (none)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 (0 hours), scale = 1 (slight)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 (0 hours), scale = 2 (moderate)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 (6 hours), scale = 0 (none)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 (6 hours), scale = 1 (slight)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 (6 hours), scale = 2 (moderate)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 2, scale = 0 (none)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 2, scale = 1 (slight)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 3, scale = 0 (none)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 3, scale = 1 (slight)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, scale = 0 (none)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, scale = 1 (slight)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 28, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Screening to 28 days after application, typically 2 months', 'description': 'Safety profile and tolerability of a singly applied NB01 using the Investigator Assessment of Tolerability Scoring (0 = None; 1 = Slight; 2 = Moderate; 3 = Intense) for Skin Erythema. Reference: ClinicalTrials.gov: Investigator Assessment Tolerability Scoring: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Acne.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Dryness.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose', 'description': '10\\^4 CFU/cm\\^2 NB01'}, {'id': 'OG001', 'title': 'High Dose', 'description': '10\\^5 CFU/cm\\^2 NB01'}], 'classes': [{'title': 'Screening, scale = 0 (none)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Screening, scale = 1 (slight)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 (0 hours), scale = 0 (none)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 (0 hours), scale = 1 (slight)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 (6 hours), scale = 0 (none)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 (6 hours), scale = 1 (slight)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 2, scale = 0 (none)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 2, scale = 1 (slight)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 3, scale = 0 (none)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 3, scale = 1 (slight)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 7, scale = 0 (none)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 28, scale = 0 (none)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day 28, scale = 1 (slight)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Screening to 28 days after application, typically 2 months', 'description': 'Safety profile and tolerability of a singly applied NB01 using the Investigator Assessment of Tolerability Scoring (0 = None; 1 = Slight; 2 = Moderate; 3 = Intense) for Skin Dryness. Reference: ClinicalTrials.gov: Investigator Assessment Tolerability Scoring: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Acne.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low Dose', 'description': '10\\^4 CFU/cm\\^2 NB01 colony forming unit (CFU)'}, {'id': 'FG001', 'title': 'High Dose', 'description': '10\\^5 CFU/cm\\^2 NB01 colony forming unit (CFU)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Dose', 'description': '10\\^4 CFU/cm\\^2 NB01'}, {'id': 'BG001', 'title': 'High Dose', 'description': '10\\^5 CFU/cm\\^2 NB01'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22.6', 'spread': '4.77', 'groupId': 'BG000'}, {'value': '26.6', 'spread': '3.78', 'groupId': 'BG001'}, {'value': '24.6', 'spread': '4.58', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', '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': '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': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', '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': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Reproductive Status', 'classes': [{'categories': [{'title': 'Able to bear children', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Total abstinence (male)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Method of Contraception (Female)', 'classes': [{'title': 'Total abstinence', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Barrier method with spermicide', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Oral, injected or implanted combined hormonal meth', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'male subject: not recorded', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Note only females in Low Dose, one male in High Dose.', 'unitOfMeasure': 'Participants'}, {'title': "Investigator's Global Assessment (IGA) Score - Face", 'classes': [{'categories': [{'measurements': [{'value': '3', 'spread': '0', 'groupId': 'BG000'}, {'value': '3', 'spread': '0', 'groupId': 'BG001'}, {'value': '3', 'spread': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The investigator assessed the participant's inflammatory lesions on the face using the IGA 5-point scale at screening visit.\n\nThe scale ranges from 0 (best): clear, to 4 (worst).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-15', 'size': 1095104, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-30T19:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open label.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-10', 'studyFirstSubmitDate': '2018-02-13', 'resultsFirstSubmitDate': '2020-06-04', 'studyFirstSubmitQcDate': '2018-02-27', 'lastUpdatePostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-10', 'studyFirstPostDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Successful Engraftment of Probiotic Following a Single Application.', 'timeFrame': '2 Months', 'description': 'Engraftment is defined as the percentage of bacteria recovered from hair follicles that are health-associated (NB01) as measured with proprietary quantitative polymerase chain assays. Successful follicular engraftment, defined as both deoR/PanBac \\>40% and Cas5/PanBac \\>40% in the Day 2 (24H) ) Biore Strip samples. Cas5/PanBac and deoR/PanBac are the percentages of bacteria in a sample containing the CRISPR associated protein Cas5 and a repressor of porphyrin production deoR, respectively. Pan-Bacterial (PanBac) is a loci found in nearly all bacteria found on the face and thus serves as the denominator to calculate the percentage of bacteria with any loci.'}, {'measure': 'Dose Schedule Determination Based on Time to Peak deoR and Cas5', 'timeFrame': 'From Baseline to 48 hours after application', 'description': 'To determine longevity of the live biotherapeutic after a single application, swab samples were collected at Baseline, 6, 24 and 48 hours after application, and genotyped as above. For each participant the absolute change, from Baseline, in the percentage of the two loci present in the live biotherapeutic (deoR and Cas5) were calculated. A significant positive change is indicative of the continued presence of the live biotherapeutic.'}, {'measure': 'Number of Participants With Change in Investigator Global Assessment (IGA) Score', 'timeFrame': '28 Days', 'description': 'Number of participants with a changed Investigator Global Assessment (IGA) score after single application of NB01; positive number if grade is reduced (e.g. from 3 to 2) or negative number is IGA grade increased.\n\nThe Investigator Global Assessment 5-Point Score is a standard FDA acne assessment tool with scoring as follows:\n\nGrade 0-Clear (Clear skin with no inflammatory or non-inflammatory lesions. The category of clear should represent true absence of disease) Grade1-Almost Clear (A few scattered comedones and no more than one small papule) Grade 2-Mild (Some comedones, some papules and pustules; no nodules) Grade 3-Moderate (Many comedones, papules and pustules; one nodule may be present) Grade 4-Severe (Covered with comedones, numerous papules and pustules and no more than a few nodular lesions)'}, {'measure': 'Safety Profile and Tolerability of a Singly Applied NB01 Using Acne Lesion Counts.', 'timeFrame': 'From Screening to 28 days after application, typically 2 months', 'description': 'Absolute Lesion Count: All Lesions for the Whole Face; with higher numbers of lesion representing worsening or more severe acne'}, {'measure': 'Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Peeling', 'timeFrame': 'From Screening to 28 days after application, typically 2 months', 'description': 'Safety profile and tolerability of a singly applied NB01 using the Investigator Assessment of Tolerability Scoring (0 = None; 1 = Slight; 2 = Moderate; 3 = Intense) for Skin Peeling. Reference: ClinicalTrials.gov: Investigator Assessment Tolerability Scoring: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Acne.'}, {'measure': 'Number of Participants With Change in Investigator Assessment of Tolerability Score: Irritant/Allergic Contact Dermatitis', 'timeFrame': 'From Screening to 28 days after application, typically 2 months', 'description': 'Safety profile and tolerability of a singly applied NB01 using the Investigator Assessment of Tolerability Scoring (0 = None; 1 = Slight; 2 = Moderate; 3 = Intense) for Irritant/Allergic Contact Dermatitis. Reference: ClinicalTrials.gov: Investigator Assessment Tolerability Scoring: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Acne.'}, {'measure': 'Number of Participants With Change in Investigator Assessment of Tolerability Score: Hyperpigmentation', 'timeFrame': 'From Screening to 28 days after application, typically 2 months', 'description': 'Safety profile and tolerability of a singly applied NB01 using the Investigator Assessment of Tolerability Scoring (0 = None; 1 = Slight; 2 = Moderate; 3 = Intense) for Hyperpigmentation. Reference: ClinicalTrials.gov: Investigator Assessment Tolerability Scoring: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Acne.'}, {'measure': 'Number of Participants With Change in Investigator Assessment of Tolerability Score: Ocular Irritation', 'timeFrame': 'From Screening to 28 days after application, typically 2 months', 'description': 'Safety profile and tolerability of a singly applied NB01 using the Investigator Assessment of Tolerability Scoring (0 = None; 1 = Slight; 2 = Moderate; 3 = Intense) for Ocular Irritation. Reference: ClinicalTrials.gov: Investigator Assessment Tolerability Scoring: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Acne.'}, {'measure': 'Number of Participants With Change in Investigator Assessment of Tolerability Score: Conjunctival Injection', 'timeFrame': 'From Screening to 28 days after application, typically 2 months', 'description': 'Safety profile and tolerability of a singly applied NB01 using the Investigator Assessment of Tolerability Scoring (0 = None; 1 = Slight; 2 = Moderate; 3 = Intense) for Conjunctival Injection. Reference: ClinicalTrials.gov: Investigator Assessment Tolerability Scoring: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Acne.'}, {'measure': 'Number of Participants With Change in Investigator Assessment of Tolerability Score: Mucosal Toxicity', 'timeFrame': 'From Screening to 28 days after application, typically 2 months', 'description': 'Safety profile and tolerability of a singly applied NB01 using the Investigator Assessment of Tolerability Scoring (0 = None; 1 = Slight; 2 = Moderate; 3 = Intense) for Mucosal Toxicity. Reference: ClinicalTrials.gov: Investigator Assessment Tolerability Scoring: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Acne.'}, {'measure': 'Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Erythema.', 'timeFrame': 'From Screening to 28 days after application, typically 2 months', 'description': 'Safety profile and tolerability of a singly applied NB01 using the Investigator Assessment of Tolerability Scoring (0 = None; 1 = Slight; 2 = Moderate; 3 = Intense) for Skin Erythema. Reference: ClinicalTrials.gov: Investigator Assessment Tolerability Scoring: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Acne.'}, {'measure': 'Number of Participants With Change in Investigator Assessment of Tolerability Score: Skin Dryness.', 'timeFrame': 'From Screening to 28 days after application, typically 2 months', 'description': 'Safety profile and tolerability of a singly applied NB01 using the Investigator Assessment of Tolerability Scoring (0 = None; 1 = Slight; 2 = Moderate; 3 = Intense) for Skin Dryness. Reference: ClinicalTrials.gov: Investigator Assessment Tolerability Scoring: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Acne.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris']}, 'referencesModule': {'references': [{'pmid': '24982315', 'type': 'BACKGROUND', 'citation': 'Achermann Y, Goldstein EJ, Coenye T, Shirtliff ME. Propionibacterium acnes: from commensal to opportunistic biofilm-associated implant pathogen. Clin Microbiol Rev. 2014 Jul;27(3):419-40. doi: 10.1128/CMR.00092-13.'}, {'pmid': '26705192', 'type': 'BACKGROUND', 'citation': 'Akaza N, Akamatsu H, Numata S, Yamada S, Yagami A, Nakata S, Matsunaga K. Microorganisms inhabiting follicular contents of facial acne are not only Propionibacterium but also Malassezia spp. J Dermatol. 2016 Aug;43(8):906-11. doi: 10.1111/1346-8138.13245. Epub 2015 Dec 24.'}, {'pmid': '24906613', 'type': 'BACKGROUND', 'citation': 'Baquerizo Nole KL, Yim E, Keri JE. Probiotics and prebiotics in dermatology. J Am Acad Dermatol. 2014 Oct;71(4):814-21. doi: 10.1016/j.jaad.2014.04.050. Epub 2014 Jun 4.'}, {'pmid': '19892944', 'type': 'BACKGROUND', 'citation': 'Costello EK, Lauber CL, Hamady M, Fierer N, Gordon JI, Knight R. Bacterial community variation in human body habitats across space and time. Science. 2009 Dec 18;326(5960):1694-7. doi: 10.1126/science.1177486. Epub 2009 Nov 5.'}, {'pmid': '25646457', 'type': 'BACKGROUND', 'citation': 'Dailey HA, Gerdes S, Dailey TA, Burch JS, Phillips JD. Noncanonical coproporphyrin-dependent bacterial heme biosynthesis pathway that does not use protoporphyrin. Proc Natl Acad Sci U S A. 2015 Feb 17;112(7):2210-5. doi: 10.1073/pnas.1416285112. Epub 2015 Feb 2.'}, {'pmid': '23337890', 'type': 'BACKGROUND', 'citation': 'Fitz-Gibbon S, Tomida S, Chiu BH, Nguyen L, Du C, Liu M, Elashoff D, Erfe MC, Loncaric A, Kim J, Modlin RL, Miller JF, Sodergren E, Craft N, Weinstock GM, Li H. Propionibacterium acnes strain populations in the human skin microbiome associated with acne. J Invest Dermatol. 2013 Sep;133(9):2152-60. doi: 10.1038/jid.2013.21. Epub 2013 Jan 21.'}, {'pmid': '8409917', 'type': 'BACKGROUND', 'citation': 'Gribbon EM, Cunliffe WJ, Holland KT. Interaction of Propionibacterium acnes with skin lipids in vitro. J Gen Microbiol. 1993 Aug;139(8):1745-51. doi: 10.1099/00221287-139-8-1745.'}, {'pmid': '27303708', 'type': 'BACKGROUND', 'citation': 'Johnson T, Kang D, Barnard E, Li H. Strain-Level Differences in Porphyrin Production and Regulation in Propionibacterium acnes Elucidate Disease Associations. mSphere. 2016 Feb 10;1(1):e00023-15. doi: 10.1128/mSphere.00023-15. eCollection 2016 Jan-Feb.'}, {'pmid': '26109103', 'type': 'BACKGROUND', 'citation': 'Kang D, Shi B, Erfe MC, Craft N, Li H. Vitamin B12 modulates the transcriptome of the skin microbiota in acne pathogenesis. Sci Transl Med. 2015 Jun 24;7(293):293ra103. doi: 10.1126/scitranslmed.aab2009.'}, {'pmid': '23762865', 'type': 'BACKGROUND', 'citation': 'Kasimatis G, Fitz-Gibbon S, Tomida S, Wong M, Li H. Analysis of complete genomes of Propionibacterium acnes reveals a novel plasmid and increased pseudogenes in an acne associated strain. Biomed Res Int. 2013;2013:918320. doi: 10.1155/2013/918320. Epub 2013 May 13.'}, {'pmid': '7470244', 'type': 'BACKGROUND', 'citation': 'Kishishita M, Ushijima T, Ozaki Y, Ito Y. New medium for isolating propionibacteria and its application to assay of normal flora of human facial skin. Appl Environ Microbiol. 1980 Dec;40(6):1100-5. doi: 10.1128/aem.40.6.1100-1105.1980.'}, {'pmid': '6517611', 'type': 'BACKGROUND', 'citation': 'Kjeldstad B, Johnsson A, Sandberg S. Influence of pH on porphyrin production in Propionibacterium acnes. Arch Dermatol Res. 1984;276(6):396-400. doi: 10.1007/BF00413361.'}, {'pmid': '27421121', 'type': 'BACKGROUND', 'citation': 'Kwon HH, Suh DH. Recent progress in the research about Propionibacterium acnes strain diversity and acne: pathogen or bystander? Int J Dermatol. 2016 Nov;55(11):1196-1204. doi: 10.1111/ijd.13282.'}, {'pmid': '20808860', 'type': 'BACKGROUND', 'citation': 'Lomholt HB, Kilian M. Population genetic analysis of Propionibacterium acnes identifies a subpopulation and epidemic clones associated with acne. PLoS One. 2010 Aug 19;5(8):e12277. doi: 10.1371/journal.pone.0012277.'}, {'pmid': '22859988', 'type': 'BACKGROUND', 'citation': "McDowell A, Barnard E, Nagy I, Gao A, Tomida S, Li H, Eady A, Cove J, Nord CE, Patrick S. An expanded multilocus sequence typing scheme for propionibacterium acnes: investigation of 'pathogenic', 'commensal' and antibiotic resistant strains. PLoS One. 2012;7(7):e41480. doi: 10.1371/journal.pone.0041480. Epub 2012 Jul 30."}, {'pmid': '24058439', 'type': 'BACKGROUND', 'citation': 'McDowell A, Nagy I, Magyari M, Barnard E, Patrick S. The opportunistic pathogen Propionibacterium acnes: insights into typing, human disease, clonal diversification and CAMP factor evolution. PLoS One. 2013 Sep 13;8(9):e70897. doi: 10.1371/journal.pone.0070897. eCollection 2013.'}, {'pmid': '18201989', 'type': 'BACKGROUND', 'citation': 'McDowell A, Perry AL, Lambert PA, Patrick S. A new phylogenetic group of Propionibacterium acnes. J Med Microbiol. 2008 Feb;57(Pt 2):218-224. doi: 10.1099/jmm.0.47489-0.'}, {'pmid': '7276142', 'type': 'BACKGROUND', 'citation': 'McGinley KJ, Webster GF, Ruggieri MR, Leyden JJ. Regional variations in density of cutaneous propionibacteria: correlation of Propionibacterium acnes populations with sebaceous secretion. J Clin Microbiol. 1980 Nov;12(5):672-5. doi: 10.1128/jcm.12.5.672-675.1980.'}, {'pmid': '26091385', 'type': 'BACKGROUND', 'citation': 'Meyer K, Pappas A, Dunn K, Cula GO, Seo I, Ruvolo E, Batchvarova N. Evaluation of Seasonal Changes in Facial Skin With and Without Acne. J Drugs Dermatol. 2015 Jun;14(6):593-601.'}, {'pmid': '17687685', 'type': 'BACKGROUND', 'citation': 'Mirshahpanah P, Maibach HI. Models in acnegenesis. Cutan Ocul Toxicol. 2007;26(3):195-202. doi: 10.1080/15569520701502815.'}, {'pmid': '28228596', 'type': 'BACKGROUND', 'citation': 'Nakatsuji T, Chen TH, Narala S, Chun KA, Two AM, Yun T, Shafiq F, Kotol PF, Bouslimani A, Melnik AV, Latif H, Kim JN, Lockhart A, Artis K, David G, Taylor P, Streib J, Dorrestein PC, Grier A, Gill SR, Zengler K, Hata TR, Leung DY, Gallo RL. Antimicrobials from human skin commensal bacteria protect against Staphylococcus aureus and are deficient in atopic dermatitis. Sci Transl Med. 2017 Feb 22;9(378):eaah4680. doi: 10.1126/scitranslmed.aah4680.'}, {'pmid': '2490661', 'type': 'BACKGROUND', 'citation': 'Sanchez A, Castro M, Castilla L, Guerrero P, Martin E. [Spontaneous peritonitis caused by Aeromonas hydrophila]. Enferm Infecc Microbiol Clin. 1989 Feb;7(2):112-3. No abstract available. Spanish.'}, {'pmid': '26804729', 'type': 'BACKGROUND', 'citation': 'Richter C, Trojahn C, Dobos G, Blume-Peytavi U, Kottner J. Follicular fluorescence quantity to characterize acne severity: a validation study. Skin Res Technol. 2016 Nov;22(4):451-459. doi: 10.1111/srt.12286. Epub 2016 Jan 25.'}, {'pmid': '23231351', 'type': 'BACKGROUND', 'citation': 'Shu M, Kuo S, Wang Y, Jiang Y, Liu YT, Gallo RL, Huang CM. Porphyrin metabolisms in human skin commensal Propionibacterium acnes bacteria: potential application to monitor human radiation risk. Curr Med Chem. 2013;20(4):562-8. doi: 10.2174/0929867311320040007.'}, {'pmid': '19376456', 'type': 'BACKGROUND', 'citation': 'Thiboutot D, Gollnick H, Bettoli V, Dreno B, Kang S, Leyden JJ, Shalita AR, Lozada VT, Berson D, Finlay A, Goh CL, Herane MI, Kaminsky A, Kubba R, Layton A, Miyachi Y, Perez M, Martin JP, Ramos-E-Silva M, See JA, Shear N, Wolf J Jr; Global Alliance to Improve Outcomes in Acne. New insights into the management of acne: an update from the Global Alliance to Improve Outcomes in Acne group. J Am Acad Dermatol. 2009 May;60(5 Suppl):S1-50. doi: 10.1016/j.jaad.2009.01.019.'}, {'pmid': '23631911', 'type': 'BACKGROUND', 'citation': 'Tomida S, Nguyen L, Chiu BH, Liu J, Sodergren E, Weinstock GM, Li H. Pan-genome and comparative genome analyses of propionibacterium acnes reveal its genomic diversity in the healthy and diseased human skin microbiome. mBio. 2013 Apr 30;4(3):e00003-13. doi: 10.1128/mBio.00003-13.'}, {'pmid': '26852728', 'type': 'BACKGROUND', 'citation': 'Walsh TR, Efthimiou J, Dreno B. Systematic review of antibiotic resistance in acne: an increasing topical and oral threat. Lancet Infect Dis. 2016 Mar;16(3):e23-33. doi: 10.1016/S1473-3099(15)00527-7. Epub 2016 Feb 5.'}, {'pmid': '26936300', 'type': 'BACKGROUND', 'citation': 'Wei EX, Kirsner RS, Eaglstein WH. End points in dermatologic clinical trials: A review for clinicians. J Am Acad Dermatol. 2016 Jul;75(1):203-9. doi: 10.1016/j.jaad.2016.01.052. Epub 2016 Feb 28.'}], 'seeAlsoLinks': [{'url': 'http://clinicaltrials.gov/ct2/show/NCT00964223', 'label': '\\[ClinicalTrials.gov\\] Investigator Assessment Tolerability Scoring: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne. Received: August 2009; Updated: October 2016.'}, {'url': 'http://www.dermnetnz.org/topics/acne-vulgaris', 'label': 'DermNet New Zealand. Acne vulgaris: Acne Grading'}, {'url': 'http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071292', 'label': '\\[FDA\\] Guidance for Industry: Acne Vulgaris: Developing Drugs for Treatment. Draft: September 2005'}, {'url': 'http://clinicaltrials.gov/ct2/show/study/NCT00964223', 'label': 'Investigator Assessment Tolerability Scoring. A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne, 2009; updated 2016'}, {'url': 'http://www.surgicalcosmetic.org.br/detalhe-artigo/404', 'label': 'Propionibacterium acnes e a resistência bacteriana \\[Propionibacterium acnes and bacterial resistance\\]'}, {'url': 'http://www.springer.com/us/book/9780387950433', 'label': "Propionibacteriales ord. Nov. In: Whitman W, et al. eds. Bergey's Manual of Systematic Bacteriology"}]}, 'descriptionModule': {'briefSummary': 'Acne vulgaris is a multifactorial disease caused by overgrowth of Propionibacterium acnes (P. acnes), impaction of hair follicles, excessive sebum production and hormonal dysregulation. Recent literature from the Human Microbiome Project has shown there are unique microbial signatures specific to healthy and acne disease states.\n\nFrom this data, the investigators hypothesize that by eliminating resident disease-associated bacterial strains and replacing them with health-associated strains, recurrences/fares of acne may be improved, mitigated, and prevented. Instead of current approaches which focus on eliminating all bacteria from the skin, the investigators aim to deliver healthy bacteria to restore the skin to a healthy state via this replacement therapy.\n\nThe investigators aim to test this in a Phase Ib single application study evaluating the safety, tolerability, and clinical impact that a single application of NB01, a live strain of P. acnes, has on adult subjects with moderate acne.', 'detailedDescription': 'A Phase 1B Dose Escalating Study of the Safety, Short-Term Engraftment and Action of a Singly Applied NB01 in Adults with Moderate Acne\n\nAcne vulgaris is a multifactorial disease caused by overgrowth of Propionibacterium acnes (P. acnes), impaction of hair follicles, excessive sebum production and hormonal dysregulation. Recent literature from the Human Microbiome Project has shown there are unique microbial signatures specific to healthy and acne disease states.\n\nFrom this data, the investigators hypothesize that by eliminating resident disease-associated bacterial strains and replacing them with health-associated strains, recurrences/fares of acne may be improved, mitigated, and prevented. Instead of current approaches which focus on eliminating all bacteria from the skin, the investigators aim to deliver healthy bacteria to restore the skin to a healthy state via this replacement therapy.\n\nThe investigators aim to test this in a Phase Ib single application study evaluating the safety, tolerability, and clinical impact that a single application of NB01 has on adult subjects with moderate acne. Investigators will be profiling the change in microbiome over the course of therapy to determine if exogenously delivered bacteria can populate the skin (engraftment) and cause a shift in the microbiome safely and subsequently impact acne biomarkers that may correlate with clinical disease.\n\nThe investigators intend for this therapy to eventually be used in acne subjects with ages ranging from 13-40, and all disease severities as either monotherapy for mild to mild/moderate acne and as an adjuvant therapy for moderate to severe acne at all body sites, with special attention to facial involvement.\n\nThis approach is standard to acne therapy whereby mild disease will be treated with a monotherapy (i.e., topical Benzoyl peroxide \\[BPO\\]) and moderate/severe disease will be treated with various combinatory regimens (topical antibiotics, BPO, topical retinoids, oral antibiotics).\n\nPrimary Objectives:\n\n1. To determine the safety profile and tolerability of a singly applied NB01\n2. To define engraftment of a singly applied topical NB01.\n3. Dose schedule determination based on engraftment\n\nSecondary Objective: To evaluate clinical efficacy using FDA standards of acne clinical assessments, namely the Investigator Global Assessment (IGA) and acne lesion counts of a singly applied NB01.\n\nApproximately 10 total male and female adult subjects combined with moderate, non-cyclical acne will be enrolled into the trial. Approximately five (5) subjects will be assigned to each dose schedule\n\nThis is a single topical application study of live bacteria for the study of acne in adult subjects.\n\nSubject participation in the trial will range from 5 weeks to 2 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Ability to provide written informed e-consent.\n2. Males and Females ages 18-40.\n3. Acne severity: Moderate (Grade 3 on 5-point IGA scale and Moderate on an acne lesion count scale (Appendix B \\[Section 12.2\\], IGA and Lesion Count Acne Grading).\n4. Acne treatment-free period (including topical or oral antibiotics, retinoids, laser therapy, topical dapsone, topical azelaic acid, facial peels, dermabrasion, sulfacetamide sulfur, and salicylic acid), of at least 3 weeks prior to e-consent (with the exception of BPO pre-treatment under this protocol).\n5. Lesion count: A minimum of at least a total of 15 inflammatory lesions (papules plus pustules), with a minimum of 10 inflammatory lesions within the designated application area (cheek/nose).\n6. Females with non-cyclical acne.\n7. Females of childbearing potential willing to use adequate contraception (e.g., total abstinence, intrauterine device (IUD), barrier method with spermicide, surgical sterilization or surgically sterilized partner, Depo-Provera®, Norplant®, or NuvaRing® for the duration of the Screening Period and during study participation. All oral contraceptive and hormonal implants will need to have been initiated and on a stable dose for at least 3 months prior to the screening period. Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal; postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.\n8. Male participants willing to use an acceptable method of contraception (e.g., total abstinence, barrier methods with spermicide, surgical sterilization or surgically sterilized partner) during study participation.\n\nExclusion Criteria:\n\n1. Active bacterial, viral, or fungal skin infections.\n2. Any noticeable breaks or cracks in the skin on the face, including severely excoriated skin or skin with open or weeping wounds suggestive of an active infection or increased susceptibility to infection.\n3. Comorbid skin conditions in the area of application.\n4. Active periodontal disease or ongoing procedures (e.g., gum grafting).\n5. History/current ocular infections/surgeries within 6 months of enrollment, with the exception of any history of cataracts.\n6. History of sarcoidosis.\n7. History septic joints/endocarditis.\n8. Participants with Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier.\n9. Sensitivity to or difficulty tolerating glycerin, polyethylene glycol.\n10. History of isotretinoin use, with the exception of sub-therapeutic treatment within 8 weeks of enrollment.\n11. Less than 80% compliance with BPO, or less than 5 days' worth of BPO pre-treatment (whichever is greater) during the Screening period.\n12. Current major systemic comorbid conditions.\n13. Currently participating in (or within 8 weeks of enrollment) another acne trial or other investigational drug.\n14. Participants with prosthetic heart valves, pacemakers, intravascular catheters, or other foreign or prosthetic devices/implantable devices/hardware.\n15. Participants with close contact (e.g., spouses, children, or members in the same household) with prosthetic heart valves, pacemakers, intravascular catheters, or other foreign or prosthetic devices/implantable devices/hardware.\n16. Known chronic human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) infections.\n17. History of malignancy (with the exception of non-melanoma skin cancer).\n18. Immunosuppression (such as resulting from transplantation, immunosuppressive therapy, active HIV infection/acquired immune deficiency syndrome \\[AIDS\\], neutropenia).\n19. Major surgical procedure, open biopsy, or significant traumatic injury within 14 days of initiating study drug (unless the wound has healed), or anticipation of the need for major surgery during the study.\n20. The presence of a medical or psychiatric condition, history of drug or alcohol abuse that, in the opinion of the PI, makes the subject inappropriate for study inclusion.\n21. Participants with close contacts (e.g., spouses, children, or members in the same household) that have severe barrier defects or are immunocompromised.\n22. Inability or unwillingness of participant to comply with study protocol procedures.\n23. Pregnant or lactating females, or females who desire to become pregnant and/or breast feed within the duration of study participation.\n24. Imprisonment or under legal guardianship."}, 'identificationModule': {'nctId': 'NCT03450369', 'briefTitle': 'A Study of the Safety, Engraftment, and Action of NB01 in Adults With Moderate Acne', 'organization': {'class': 'INDUSTRY', 'fullName': 'Naked Biome, Inc.'}, 'officialTitle': 'A Phase 1B Dose Escalating Study of the Safety, Short-Term Engraftment and Action of a Singly-Applied NB01 in Adults With Moderate Acne', 'orgStudyIdInfo': {'id': 'NB01-P1BSA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NB01', 'description': 'NB01 is a live probiotic containing a single strain of P. acnes, frozen, on a pad, in a single use pouch, for topical application.\n\nOpen label and dose escalation of a single application of NB01 to subjects with moderate acne, with approximately 5 subjects assigned to lower bound dose before escalation to upper bound dose.', 'interventionNames': ['Biological: NB01']}], 'interventions': [{'name': 'NB01', 'type': 'BIOLOGICAL', 'description': 'Use an existing therapy designed to kill existing facial bacterial followed by populating facial skin with a single application of NB01', 'armGroupLabels': ['NB01']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology Research Associates', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Emma Taylor, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CEO'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Initially there is no plan to share individual participant data (IPD). This may change later as the clinical plan develops.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Naked Biome, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Dermatology Research Institute', 'class': 'OTHER'}, {'name': 'QST Consultations, Ltd.', 'class': 'INDUSTRY'}, {'name': 'Science 37', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}