Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-04 @ 4:38 PM
Study NCT ID:
NCT03142451
Status:
COMPLETED
Last Update Posted:
2021-01-29
First Post:
2017-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study (Study 1) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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': 'From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])', 'eventGroups': [{'id': 'EG000', 'title': 'FMX103 1.5%', 'description': 'Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.', 'otherNumAtRisk': 494, 'deathsNumAtRisk': 494, 'otherNumAffected': 4, 'seriousNumAtRisk': 494, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Vehicle Foam', 'description': 'Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.', 'otherNumAtRisk': 256, 'deathsNumAtRisk': 256, 'otherNumAffected': 5, 'seriousNumAtRisk': 256, 'deathsNumAffected': 1, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 20.0'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 20.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 20.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 20.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 20.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 20.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 20.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 20.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 20.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 20.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 20.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 256, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 20.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Count at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FMX103 1.5%', 'description': 'Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.'}, {'id': 'OG001', 'title': 'Vehicle Foam', 'description': 'Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.56', 'spread': '0.442', 'groupId': 'OG000'}, {'value': '15.34', 'spread': '0.604', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0031', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.21', 'ciLowerLimit': '0.75', 'ciUpperLimit': '3.68', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.749', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Analysis of covariance (ANCOVA) model includes treatment, baseline inflammatory lesion count, and analysis center.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules.\n\nChange from Baseline was calculated as the value at Baseline minus the post-Baseline value. Thus, a positive change reflects a reduction in lesion count.', 'unitOfMeasure': 'Lesions', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all randomized participants. Analyses using the ITT population were based on the randomized treatment.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Investigator Global Assessments (IGA) Treatment Success at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FMX103 1.5%', 'description': 'Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.'}, {'id': 'OG001', 'title': 'Vehicle Foam', 'description': 'Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.1', 'groupId': 'OG000'}, {'value': '43.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0273', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.210', 'ciLowerLimit': '1.022', 'ciUpperLimit': '1.434', 'pValueComment': 'The p-value is for the null hypothesis that the combined risk ratio equals 1.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel Test Stratified by Analysis Center'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (clear) or 1 (almost clear), and at least a 2-step improvement (decrease) from Day 0/Baseline.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomized participants. Analyses using the ITT population were based on the randomized treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving IGA Treatment Success of at Least 2 Grades at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FMX103 1.5%', 'description': 'Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.'}, {'id': 'OG001', 'title': 'Vehicle Foam', 'description': 'Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.3', 'groupId': 'OG000'}, {'value': '45.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0171', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.210', 'ciLowerLimit': '1.028', 'ciUpperLimit': '1.425', 'pValueComment': 'The p-value is for the null hypothesis that the combined risk ratio equals 1.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel Test Stratified by Analysis Center'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as a 2-grade improvement (decrease) in score at Week 12 compared to Day 0/Baseline.\n\nHere, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomized participants. Analyses using the ITT population were based on the randomized treatment.'}, {'type': 'SECONDARY', 'title': 'The Percent Change From Day 0/Baseline in Inflammatory Lesion Count at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FMX103 1.5%', 'description': 'Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.'}, {'id': 'OG001', 'title': 'Vehicle Foam', 'description': 'Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.13', 'spread': '1.584', 'groupId': 'OG000'}, {'value': '56.52', 'spread': '2.133', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0039', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.62', 'ciLowerLimit': '2.46', 'ciUpperLimit': '12.77', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.626', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model includes treatment, Baseline inflammatory lesion count, and analysis center.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules.\n\nHere, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomized participants. Analyses using the ITT population were based on the randomized treatment.'}, {'type': 'SECONDARY', 'title': 'The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Counts at Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FMX103 1.5%', 'description': 'Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.'}, {'id': 'OG001', 'title': 'Vehicle Foam', 'description': 'Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '11.24', 'spread': '0.441', 'groupId': 'OG000'}, {'value': '8.62', 'spread': '0.608', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '15.59', 'spread': '0.445', 'groupId': 'OG000'}, {'value': '12.51', 'spread': '0.610', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.63', 'ciLowerLimit': '1.16', 'ciUpperLimit': '4.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.747', 'groupDescription': 'Statistical analysis for Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model included treatment, Baseline inflammatory lesion count, and analysis center.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.09', 'ciLowerLimit': '1.62', 'ciUpperLimit': '4.56', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.750', 'groupDescription': 'Statistical analysis for Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model included treatment, Baseline inflammatory lesion count, and analysis center.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': 'To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules. The change from Baseline was calculated as the value at Baseline minus the post-Baseline value. Thus, a positive change reflects a reduction in lesion count.', 'unitOfMeasure': 'Lesions', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomized participants. Analyses using the ITT population were based on the randomized treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving IGA Treatment Success at Week 4 and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FMX103 1.5%', 'description': 'Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.'}, {'id': 'OG001', 'title': 'Vehicle Foam', 'description': 'Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000'}, {'value': '9.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '35.2', 'groupId': 'OG000'}, {'value': '29.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0201', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.685', 'ciLowerLimit': '1.085', 'ciUpperLimit': '2.616', 'pValueComment': 'P-value is for the null hypothesis that the risk ratio equals 1.', 'groupDescription': 'Statistical analysis for Week 4', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test stratified by analysis center.'}, {'pValue': '0.1278', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.191', 'ciLowerLimit': '0.951', 'ciUpperLimit': '1.492', 'pValueComment': 'P-value is for the null hypothesis that the risk ratio equals 1.', 'groupDescription': 'Statistical analysis for Week 8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel-Haenszel test stratified by analysis center.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 and Week 8', 'description': 'To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Day 0/Baseline.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomized participants. Analyses using the ITT population were based on the randomized treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '494', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FMX103 1.5%', 'description': 'Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.'}, {'id': 'OG001', 'title': 'Vehicle Foam', 'description': 'Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.'}], 'classes': [{'title': 'All AEs', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': 'TEAEs', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Serious TEAEs (SAEs)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Participants with any severe TEAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-related TEAEs', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'AEs leading to study discontinuation', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'TEAEs resulting in death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])', 'description': 'To evaluate the tolerability and safety of topical minocycline foam applied once daily for 12 weeks. A treatment-emergent adverse events (TEAE) was defined as any AE with an onset date on or after the first application of study drug, and before to the last application of study drug plus 3 days, having been absent pre-treatment or worsening relative to the pre-treatment state.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety (SAF) population included all randomized participants who used at least 1 dose of study drug, including participants who had no post-Baseline assessments unless all dispensed study drug was returned unused.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FMX103 1.5%', 'description': 'Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.'}, {'id': 'FG001', 'title': 'Vehicle Foam', 'description': 'Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '495'}, {'groupId': 'FG001', 'numSubjects': '256'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '437'}, {'groupId': 'FG001', 'numSubjects': '232'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Participant request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'BG000'}, {'value': '256', 'groupId': 'BG001'}, {'value': '751', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'FMX103 1.5%', 'description': 'Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.'}, {'id': 'BG001', 'title': 'Vehicle Foam', 'description': 'Participants applied the assigned vehicle foam topically 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': '48.9', 'spread': '13.71', 'groupId': 'BG000'}, {'value': '49.7', 'spread': '12.85', 'groupId': 'BG001'}, {'value': '49.2', 'spread': '13.42', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '355', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '541', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '253', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '328', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '496', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '474', 'groupId': 'BG000'}, {'value': '241', 'groupId': 'BG001'}, {'value': '715', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-12', 'size': 3154076, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-11-23T01:21', 'hasProtocol': True}, {'date': '2018-07-31', 'size': 1929835, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-11-23T01:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'This is a double-blind study, with limited access to the randomization code. The randomization code will be held in confidence until after the study database is locked and a memo documenting the database lock has been issued. Every effort will be made to retain the integrity of the blind. When issued to the sites, the study drug will be identical in appearance for all participants, regardless of treatment assignment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 751}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'dispFirstSubmitDate': '2019-11-08', 'completionDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-27', 'studyFirstSubmitDate': '2017-04-27', 'dispFirstSubmitQcDate': '2019-11-08', 'resultsFirstSubmitDate': '2020-11-23', 'studyFirstSubmitQcDate': '2017-05-04', 'dispFirstPostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-23', 'studyFirstPostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Count at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules.\n\nChange from Baseline was calculated as the value at Baseline minus the post-Baseline value. Thus, a positive change reflects a reduction in lesion count.'}, {'measure': 'Percentage of Participants Achieving Investigator Global Assessments (IGA) Treatment Success at Week 12', 'timeFrame': 'Week 12', 'description': 'To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (clear) or 1 (almost clear), and at least a 2-step improvement (decrease) from Day 0/Baseline.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving IGA Treatment Success of at Least 2 Grades at Week 12', 'timeFrame': 'Week 12', 'description': 'To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as a 2-grade improvement (decrease) in score at Week 12 compared to Day 0/Baseline.\n\nHere, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.'}, {'measure': 'The Percent Change From Day 0/Baseline in Inflammatory Lesion Count at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules.\n\nHere, overall number of participants analyzed signifies only the participants with available data that were analyzed for the outcome measure.'}, {'measure': 'The Absolute Change From Day 0/Baseline in the Inflammatory Lesion Counts at Week 4 and Week 8', 'timeFrame': 'Baseline, Week 4 and Week 8', 'description': 'To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. Lesion counts included the number of papules, pustules, and nodules. The change from Baseline was calculated as the value at Baseline minus the post-Baseline value. Thus, a positive change reflects a reduction in lesion count.'}, {'measure': 'Percentage of Participants Achieving IGA Treatment Success at Week 4 and Week 8', 'timeFrame': 'Week 4 and Week 8', 'description': 'To determine the efficacy of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea. The Investigator assessed the global severity of rosacea using the IGA scale. The scale ranges from 0 (Clear): No inflammatory papules or pustules to 4 (Severe): Many inflammatory papules or pustules, and up to 2 nodules. Higher scores indicated severe outcome. Treatment success was defined as an IGA score of 0 (clear) or 1 (almost clear), and at least a 2-grade improvement (decrease) from Day 0/Baseline.'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])', 'description': 'To evaluate the tolerability and safety of topical minocycline foam applied once daily for 12 weeks. A treatment-emergent adverse events (TEAE) was defined as any AE with an onset date on or after the first application of study drug, and before to the last application of study drug plus 3 days, having been absent pre-treatment or worsening relative to the pre-treatment state.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Topical Minocycline Foam', '2-Arm study', 'Inflammatory lesion counts', "Investigator's Global Assessment score"], 'conditions': ['Facial Papulopustular Rosacea']}, 'referencesModule': {'availIpds': [{'url': 'http://foamix.co.il/', 'type': 'Study Protocol'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives of this study are to determine the efficacy and safety of FMX103 1.5% minocycline foam applied topically once daily for 12 weeks in the treatment of rosacea.', 'detailedDescription': "This is a randomized, multicenter, double-blind, vehicle-controlled, 2 arm study to evaluate the safety and efficacy of FMX103 topical foam containing 1.5% minocycline compared to vehicle, in the treatment of participants with moderate-to-severe facial papulopustular rosacea. Qualified participants will be randomized in a 2:1 ratio (active:vehicle) to receive 1 of the following 2 treatments:\n\n* FMX103 minocycline foam 1.5%\n* Vehicle foam\n\nParticipants will be assigned to 1 of 2 treatments according to the randomization schedule. Participants will apply (or have applied) the study drug topically once daily for 12 weeks as directed. Participants will be advised to use the study drug at approximately the same time each day. Both the Investigator and participant will be blinded to the study drug identity. Participants will return for visits at Weeks 1, 4, 6, 8, 10, and 12. Efficacy evaluations (inflammatory lesion counts and Investigator's Global Assessment \\[IGA\\] score) will be performed at Weeks 4, 8, and 12 during the study.\n\nNote: Originally the two studies FX2016-11 and FX2016-12 were combinedly presented in the protocol registration form under one NCT number (NCT03142451), and later separated since results were analyzed separately."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Moderate-to-severe rosacea (as per the IGA score) on the proposed facial treatment area consisting of:\n\n 1. At least 15 and not more than 75 facial papules and pustules, excluding lesions involving the eyes and scalp;\n 2. No more than 2 nodules on the face.\n2. Presence of or history of erythema and/or flushing on the face.\n\nExclusion Criteria:\n\n1. Presence of any skin condition and/or Excessive facial hair, on the face that would interfere with the diagnosis or assessment of rosacea.\n2. Moderate or severe rhinophyma, dense telangiectasia (score 3, severe), or plaque-like facial edema.\n3. History of hypersensitivity or allergy to minocycline, any other tetracycline, or of any other component of the formulation.\n4. Active ocular rosacea (eg, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.'}, 'identificationModule': {'nctId': 'NCT03142451', 'briefTitle': 'A Study (Study 1) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vyne Therapeutics Inc.'}, 'officialTitle': 'A Randomized, Multicenter, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam Compared to Vehicle in the Treatment of Facial Papulopustular Rosacea (FX2016-11)', 'orgStudyIdInfo': {'id': 'FX2016-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FMX103 1.5%', 'description': 'Participants will apply the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed.', 'interventionNames': ['Drug: FMX103 minocycline foam 1.5%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle foam', 'description': 'Participants will apply the assigned vehicle foam topically once daily for 12 weeks as directed.', 'interventionNames': ['Drug: Vehicle foam']}], 'interventions': [{'name': 'FMX103 minocycline foam 1.5%', 'type': 'DRUG', 'description': 'Dosage form description: Foam containing minocycline HCl 1.5%. Once daily application of a sufficient amount of foam to cover the entire face. Estimated maximum is 0.5 g of drug product containing 7.5 mg (1.5% active) of minocycline. Participants will apply a small amount of the drug as a thin layer over all areas of the face. Participants should apply the drug at approximately the same time each day, about 1 hour before bedtime.', 'armGroupLabels': ['FMX103 1.5%']}, {'name': 'Vehicle foam', 'type': 'DRUG', 'description': 'Dosage form description: Foam containing minocycline vehicle foam. Once daily application of a sufficient amount of foam to cover the entire face. Estimated maximum is 0.5 g of drug product containing 0.0 mg (vehicle) of minocycline. Participants will apply a small amount of the drug as a thin layer over all areas of the face. Participants should apply the drug at approximately the same time each day, about 1 hour before bedtime.', 'armGroupLabels': ['Vehicle foam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Foamix Investigational Site #152', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Foamix Investigational Site # 127', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Foamix Investigational Site #155', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91324', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Foamix Investigational Site #143', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Foamix Investigational Site # 131', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Foamix Investigational Site #156', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Foamix Investigational Site #153', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Foamix Investigational Site # 114', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '93405', 'city': 'San Luis Obispo', 'state': 'California', 'country': 'United States', 'facility': 'Foamix Investigational Site # 116', 'geoPoint': {'lat': 35.28275, 'lon': -120.65962}}, {'zip': '92705', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Foamix Investigational Site # 135', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '90403', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Foamix Investigational Site # 123', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '33757', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Foamix Investigational Site # 109', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33016', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Foamix Investigational Site # 112', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '33467', 'city': 'Lake Worth', 'state': 'Florida', 'country': 'United States', 'facility': 'Foamix Investigational Site #150', 'geoPoint': {'lat': 26.61708, 'lon': -80.07231}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Foamix Investigational Site #149', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Foamix Investigational Site #151', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33016', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Foamix Investigational Site #144', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Foamix Investigational Site # 104', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'zip': '32771', 'city': 'Sanford', 'state': 'Florida', 'country': 'United States', 'facility': 'Foamix Investigational Site # 121', 'geoPoint': {'lat': 28.80055, 'lon': -81.27312}}, {'zip': '33172', 'city': 'Sweetwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Foamix Investigational Site #154', 'geoPoint': {'lat': 25.76343, 'lon': -80.37311}}, {'zip': '33609', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Foamix Investigational Site # 125', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33406', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Foamix Investigational Site # 142', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Foamix Investigational Site # 124', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30022', 'city': 'Alpharetta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Foamix Investigational Site # 118', 'geoPoint': {'lat': 34.07538, 'lon': -84.29409}}, {'zip': '30078', 'city': 'Snellville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Foamix Investigational Site # 139', 'geoPoint': {'lat': 33.85733, 'lon': -84.01991}}, {'zip': '47150', 'city': 'New Albany', 'state': 'Indiana', 'country': 'United States', 'facility': 'Foamix Investigational Site # 138', 'geoPoint': {'lat': 38.28562, 'lon': -85.82413}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Foamix Investigational Site # 102', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '70115', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Foamix Investigational Site # 115', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '01915', 'city': 'Beverly', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Foamix Investigational Site # 110', 'geoPoint': {'lat': 42.55843, 'lon': -70.88005}}, {'zip': '02135', 'city': 'Brighton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Foamix Investigational Site # 107', 'geoPoint': {'lat': 42.3501, 'lon': -71.15644}}, {'zip': '48103', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Foamix Investigational Site # 137', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48059', 'city': 'Fort Gratiot', 'state': 'Michigan', 'country': 'United States', 'facility': 'Foamix Investigational Site # 103'}, {'zip': '48084', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Foamix Investigational Site # 120', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '48088', 'city': 'Warren', 'state': 'Michigan', 'country': 'United States', 'facility': 'Foamix Investigational Site # 140', 'geoPoint': {'lat': 42.49044, 'lon': -83.01304}}, {'zip': '64506', 'city': 'Saint Joseph', 'state': 'Missouri', 'country': 'United States', 'facility': 'Foamix Investigational Site # 130', 'geoPoint': {'lat': 39.76861, 'lon': -94.84663}}, {'zip': '68144', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Foamix Investigational Site # 133', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89148', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Foamix Investigational Site #146', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Foamix Investigational Site # 136', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10155', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Foamix Investigational Site #145', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11790', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Foamix Investigational Site # 111', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '28277', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Foamix Investigational Site # 119', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '43209', 'city': 'Bexley', 'state': 'Ohio', 'country': 'United States', 'facility': 'Foamix Investigational Site # 101', 'geoPoint': {'lat': 39.96895, 'lon': -82.93768}}, {'zip': '43016', 'city': 'Dublin', 'state': 'Ohio', 'country': 'United States', 'facility': 'Foamix Investigational Site # 128', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}, {'zip': '19008', 'city': 'Broomall', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Foamix Investigational Site #147', 'geoPoint': {'lat': 39.9815, 'lon': -75.35658}}, {'zip': '19046', 'city': 'Jenkintown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Foamix Investigational Site # 141', 'geoPoint': {'lat': 40.09594, 'lon': -75.12517}}, {'zip': '15241', 'city': 'Saint Clair', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Foamix Investigational Site #157', 'geoPoint': {'lat': 40.72065, 'lon': -76.19105}}, {'zip': '19067', 'city': 'Yardley', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Foamix Investigational Site # 129', 'geoPoint': {'lat': 40.24566, 'lon': -74.846}}, {'zip': '02919', 'city': 'Johnston', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Foamix Investigational Site # 105', 'geoPoint': {'lat': 41.82186, 'lon': -71.50675}}, {'zip': '29607', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Foamix Investigational Site # 106', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '37130', 'city': 'Murfreesboro', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Foamix Investigational Site # 122', 'geoPoint': {'lat': 35.84562, 'lon': -86.39027}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Foamix Investigational Site # 117', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77074', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Foamix Investigational Site #159', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78213', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Foamix Investigational Site # 108', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84117', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Foamix Investigational Site # 126', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vyne Therapeutics Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Premier Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}