Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-04-19 @ 12:00 AM
Study NCT ID:
NCT02815267
Status:
COMPLETED
Last Update Posted:
2022-01-18
First Post:
2016-05-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008911', 'term': 'Minocycline'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Iain.Stuart@foamix.com', 'phone': '1 800-775-7936', 'title': 'Iain Stuart, PhD.', 'organization': 'Foamix Pharmaceuticals, Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Double blind: Screening Day until Week 12; Open-label: Week 16 until Week 52', 'eventGroups': [{'id': 'EG000', 'title': 'Double-blind-FMX-101, 4% Minocycline Foam', 'description': 'Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.', 'otherNumAtRisk': 307, 'deathsNumAtRisk': 307, 'otherNumAffected': 13, 'seriousNumAtRisk': 307, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Double-blind-Vehicle Foam', 'description': 'Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.', 'otherNumAtRisk': 159, 'deathsNumAtRisk': 159, 'otherNumAffected': 11, 'seriousNumAtRisk': 159, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Open-label-FMX-101, 4% Minocycline Foam', 'description': 'Selected participants from double-blind period received FMX101 4% minocycline foam for additional 40 weeks as directed in open-label period.', 'otherNumAtRisk': 284, 'deathsNumAtRisk': 284, 'otherNumAffected': 19, 'seriousNumAtRisk': 284, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 284, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 284, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '19.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 284, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '19.0'}], 'seriousEvents': [{'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 284, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '19.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 307, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 284, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '19.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FMX-101, 4% Minocycline Foam', 'description': 'Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.'}, {'id': 'OG001', 'title': 'Vehicle Foam', 'description': 'Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.95', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '11.15', 'spread': '0.90', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0083', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.80', 'ciLowerLimit': '0.72', 'ciUpperLimit': '4.88', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.06', 'groupDescription': 'Change from baseline in inflammatory lesion count was analyzed using an analysis of covariance (ANCOVA) model, which included treatment, Baseline inflammatory lesion count and pooled investigational site as a blocking factor.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Changes from Baseline are calculated as Baseline value minus post-Baseline value, so that decreases appear as positive values. Inflammatory lesion count included: papules, pustules, and nodules.', 'unitOfMeasure': 'Lesion counts', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population: included all randomized participants.'}, {'type': 'PRIMARY', 'title': "Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FMX-101, 4% Minocycline Foam', 'description': 'Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.'}, {'id': 'OG001', 'title': 'Vehicle Foam', 'description': 'Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.09', 'groupId': 'OG000'}, {'value': '4.77', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1805', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.33', 'ciLowerLimit': '-1.54', 'ciUpperLimit': '8.19', 'pValueComment': 'P-value is for the null hypothesis that the combined risk difference equals 0.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.48', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 12', 'description': "The IGA scale for acne vulgaris, was used by the investigators to assess the severity of a participant's acne vulgaris. The scale ranges from 0 (Clear): normal, clear skin with no evidence of acne vulgaris to 5 (Very Severe): highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'An ITT population: included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in the Non-inflammatory Lesion Count at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FMX-101, 4% Minocycline Foam', 'description': 'Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.'}, {'id': 'OG001', 'title': 'Vehicle Foam', 'description': 'Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.34', 'spread': '2.64', 'groupId': 'OG000'}, {'value': '19.60', 'spread': '3.81', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0040', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.73', 'ciLowerLimit': '4.07', 'ciUpperLimit': '21.39', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.42', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Percent change from baseline was analyzed using an ANCOVA model, which included treatment, baseline non-inflammatory lesion counts and pooled investigational site as a blocking factor. For the superiority comparison between FMX101 4% and vehicle.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Percent change from Baseline is calculated as the Baseline value minus the post-Baseline value divided by the baseline value, expressed as a percentage. Non-inflammatory lesions included: open comedones (blackhead) and closed comedones (whitehead).', 'unitOfMeasure': 'Lesion counts', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'An ITT Population: included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in the Inflammatory Lesion Count at Week 6 and Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FMX-101, 4% Minocycline Foam', 'description': 'Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.'}, {'id': 'OG001', 'title': 'Vehicle Foam', 'description': 'Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.'}], 'classes': [{'title': 'Week 6', 'categories': [{'measurements': [{'value': '11.65', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '7.79', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'Week 9', 'categories': [{'measurements': [{'value': '13.24', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '8.85', 'spread': '0.87', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.86', 'ciLowerLimit': '1.85', 'ciUpperLimit': '5.87', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.03', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Change from baseline in inflammatory lesion count for Week 6 was analyzed using an ANCOVA model, which included treatment, baseline inflammatory lesion counts and pooled investigational site as a blocking factor.'}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.39', 'ciLowerLimit': '2.38', 'ciUpperLimit': '6.40', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.03', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Change from baseline in inflammatory lesion count for Week 9 was analyzed using an ANCOVA model, which included treatment, baseline inflammatory lesion counts and pooled investigational site as a blocking factor.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, at Week 6 and at Week 9', 'description': 'To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Changes from Baseline are calculated as Baseline value minus post-Baseline value, so that decreases appear as positive values. Inflammatory lesion count included: papules, pustules, and nodules.', 'unitOfMeasure': 'Lesion counts', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'An ITT population: included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving IGA Treatment Success at Week 6 and Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FMX-101, 4% Minocycline Foam', 'description': 'Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.'}, {'id': 'OG001', 'title': 'Vehicle Foam', 'description': 'Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.'}], 'classes': [{'title': 'Week 6', 'categories': [{'measurements': [{'value': '3.47', 'groupId': 'OG000'}, {'value': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'Week 9', 'categories': [{'measurements': [{'value': '4.19', 'groupId': 'OG000'}, {'value': '1.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0395', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.71', 'ciLowerLimit': '0.13', 'ciUpperLimit': '5.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.32', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'P-value is for null hypothesis that the combined risk difference equals 0. Percentage of participants achieving IGA treatment success at Week 6'}, {'pValue': '0.0748', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.76', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '5.80', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.55', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'P-value is for null hypothesis that the combined risk difference equals 0. Percentage of participants achieving IGA treatment success at Week 9.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, at Week 6 and at Week 9', 'description': "The IGA scale for acne vulgaris, was used by the investigators to assess the severity of a participant's acne vulgaris. The scale ranges from 0 (Clear): normal, clear skin with no evidence of acne vulgaris to 5 (Very Severe): highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'An ITT population: included all randomized population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and and Treatment-emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '284', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind-FMX-101, 4% Minocycline Foam', 'description': 'Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.'}, {'id': 'OG001', 'title': 'Double-blind-Vehicle Foam', 'description': 'Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.'}, {'id': 'OG002', 'title': 'Open-label-FMX-101, 4% Minocycline Foam', 'description': 'Selected participants from double-blind period received FMX101 4% minocycline foam for additional 40 weeks as directed in open-label period.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}]}, {'title': 'Any Treatment-related TEAE', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Any Serious TEAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Any TEAE Leading to IP Discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Double blind: Screening Day until Week 12; Open-label: Week 16 until Week 52', 'description': 'To evaluate the safety compared to vehicle of topical FMX101 4% administered daily for 12 weeks and to evaluate the long-term safety of topical FMX101 4% administered daily for up to an additional 40 weeks. TEAEs of the double-blind phase were defined as AEs starting on or after date of first application of investigational product (IP), but before the date of the first application of the open-label phase, and AEs starting on or after the first application of the open-label phase are considered as TEAEs of the open-label phase.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: included all randomized participants who received IP. Participants who had no post-Baseline assessments were included in the Safety population unless all dispensed IP was returned unused.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FMX-101, 4% Minocycline Foam', 'description': 'Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.'}, {'id': 'FG001', 'title': 'Vehicle Foam', 'description': 'Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.'}], 'periods': [{'title': 'Double-Blind Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '307'}, {'groupId': 'FG001', 'numSubjects': '159'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '274'}, {'groupId': 'FG001', 'numSubjects': '128'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Site withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Received a disallowed medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Open-Label Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '193'}, {'groupId': 'FG001', 'numSubjects': '91'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '41'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Administrative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'The study was conducted at 35 sites in the United States and one site in the Dominican Republic from 06 May 2016 to 13 October 2017.', 'preAssignmentDetails': 'The study consisted of a varied screening period. All participants underwent inclusion and exclusion criteria assessment and all eligible participants signed the informed consent before undergoing any study related procedures. All assessments at screening were done as per the schedule of assessment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '466', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Double-blind-FMX-101, 4% Minocycline Foam', 'description': 'Randomized participants applied FMX101 4% topically to the face once daily for 12 weeks as directed.'}, {'id': 'BG001', 'title': 'Double-blind-Vehicle Foam', 'description': 'Randomized participants applied matching vehicle foam topically to the face once daily for 12 weeks as directed.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.5', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '20.0', 'spread': '8.1', 'groupId': 'BG001'}, {'value': '20.3', 'spread': '7.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '231', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '354', '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': '19', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '29', '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': '86', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '292', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', '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'}], 'populationDescription': 'Double-blind participants (Intent-to-Treat population) were moved to open-label (safety population)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-14', 'size': 1166253, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-09-01T03:50', 'hasProtocol': True}, {'date': '2017-12-07', 'size': 2320481, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-09-01T04:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 466}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'dispFirstSubmitDate': '2018-11-01', 'completionDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-13', 'studyFirstSubmitDate': '2016-05-24', 'dispFirstSubmitQcDate': '2018-11-01', 'resultsFirstSubmitDate': '2020-09-01', 'studyFirstSubmitQcDate': '2016-06-23', 'dispFirstPostDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-01', 'studyFirstPostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Changes from Baseline are calculated as Baseline value minus post-Baseline value, so that decreases appear as positive values. Inflammatory lesion count included: papules, pustules, and nodules.'}, {'measure': "Percentage of Participants Achieving Investigator's Global Assessments (IGA) Treatment Success at Week 12", 'timeFrame': 'Baseline and Week 12', 'description': "The IGA scale for acne vulgaris, was used by the investigators to assess the severity of a participant's acne vulgaris. The scale ranges from 0 (Clear): normal, clear skin with no evidence of acne vulgaris to 5 (Very Severe): highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline."}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in the Non-inflammatory Lesion Count at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Percent change from Baseline is calculated as the Baseline value minus the post-Baseline value divided by the baseline value, expressed as a percentage. Non-inflammatory lesions included: open comedones (blackhead) and closed comedones (whitehead).'}, {'measure': 'Absolute Change From Baseline in the Inflammatory Lesion Count at Week 6 and Week 9', 'timeFrame': 'Baseline, at Week 6 and at Week 9', 'description': 'To evaluate the efficacy in the treatment of acne compared to vehicle of topical FMX101 4% administered daily for 12 weeks. Changes from Baseline are calculated as Baseline value minus post-Baseline value, so that decreases appear as positive values. Inflammatory lesion count included: papules, pustules, and nodules.'}, {'measure': 'Percentage of Participants Achieving IGA Treatment Success at Week 6 and Week 9', 'timeFrame': 'Baseline, at Week 6 and at Week 9', 'description': "The IGA scale for acne vulgaris, was used by the investigators to assess the severity of a participant's acne vulgaris. The scale ranges from 0 (Clear): normal, clear skin with no evidence of acne vulgaris to 5 (Very Severe): highly inflammatory lesions predominate, variable number of comedones, many papules/pustules and many nodulocystic lesions. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (score of clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Baseline."}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and and Treatment-emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'Double blind: Screening Day until Week 12; Open-label: Week 16 until Week 52', 'description': 'To evaluate the safety compared to vehicle of topical FMX101 4% administered daily for 12 weeks and to evaluate the long-term safety of topical FMX101 4% administered daily for up to an additional 40 weeks. TEAEs of the double-blind phase were defined as AEs starting on or after date of first application of investigational product (IP), but before the date of the first application of the open-label phase, and AEs starting on or after the first application of the open-label phase are considered as TEAEs of the open-label phase.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acne'], 'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has facial acne vulgaris with:\n\n * 20 to 50 inflammatory lesions (papules, pustules, and nodules);\n * 25 to 100 noninflammatory lesions (open and closed comedones);\n * no more than 2 nodules on the face; and\n * IGA score of moderate (3) to severe (4)\n* Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin Cleanser) and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study\n\nExclusion Criteria:\n\n* Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne) or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations\n* Sunburn on the face\n* Severe systemic disease, which might interfere with the conduct of the study or the interpretation of the results.\n* Abnormal baseline laboratory values that are considered clinically significant\n* Allergy to tetracycline-class antibiotics or to any ingredient in the study drug\n* 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