Viewing Study NCT00617903

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Ignite Creation Date: 2025-12-24 @ 7:34 PM
Ignite Modification Date: 2026-01-21 @ 1:20 PM
Study NCT ID: NCT00617903
Status: COMPLETED
Last Update Posted: 2020-04-07
First Post: 2008-01-22
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012393', 'term': 'Rosacea'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C010038', 'term': 'azelaic acid'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayer.com', 'title': 'Therapeutic Area Head', 'organization': 'Bayer'}, 'certainAgreement': {'otherDetails': 'A) Investigator shall provide Sponsor with intended publication 60 days upfront publication date, Sponsor has 30 d to comment, recommended changes shall not be unreasonably refused B) Sponsor has the right to ask Investigator to delay publication for a maximum of 90 days C) Investigative data will be pooled and published by Sponsor - no other publication without the consent of all parties prior to publication of the pooled data, or within 12 months after LPLV, whatever comes first', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Azelaic Acid Foam, 15% (BAY39-6251)', 'description': 'Participants received azelaic acid foam, 15% topically twice daily for 12 weeks', 'otherNumAtRisk': 41, 'otherNumAffected': 14, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vehicle Foam', 'description': 'Participants received vehicle foam topically twice daily for 12 weeks', 'otherNumAtRisk': 42, 'otherNumAffected': 10, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Administration site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Application site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Vaginitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Sunburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Rosacea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, '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': 'Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Study (LOCF: Last Observation Carried Forward)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid Foam, 15% (BAY39-6251)', 'description': 'Participants received azelaic acid foam, 15% topically twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Vehicle Foam', 'description': 'Participants received vehicle foam topically twice daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.7', 'spread': '8.53', 'groupId': 'OG000'}, {'value': '-10.8', 'spread': '7.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and End of Study (Week 12)', 'unitOfMeasure': 'Inflammatory lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid Foam, 15% (BAY39-6251)', 'description': 'Participants received azelaic acid foam, 15% topically twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Vehicle Foam', 'description': 'Participants received vehicle foam topically twice daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '46.3', 'groupId': 'OG000'}, {'value': '47.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At End of Study (Week 12)', 'description': 'IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid Foam, 15% (BAY39-6251)', 'description': 'Participants received azelaic acid foam, 15% topically twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Vehicle Foam', 'description': 'Participants received vehicle foam topically twice daily for 12 weeks'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '61.0', 'groupId': 'OG000'}, {'value': '47.6', 'groupId': 'OG001'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '36.6', 'groupId': 'OG000'}, {'value': '45.2', 'groupId': 'OG001'}]}]}, {'title': 'Worse', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and End of Study (Week 12)', 'description': 'Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid Foam, 15% (BAY39-6251)', 'description': 'Participants received azelaic acid foam, 15% topically twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Vehicle Foam', 'description': 'Participants received vehicle foam topically twice daily for 12 weeks'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '9.1', 'spread': '7.93', 'groupId': 'OG000'}, {'value': '11.7', 'spread': '9.23', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '6.8', 'spread': '7.59', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '5.57', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '4.3', 'spread': '5.86', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '5.47', 'groupId': 'OG001'}]}]}, {'title': 'End of Study', 'categories': [{'measurements': [{'value': '6.3', 'spread': '10.64', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '8.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Weeks 4, 8, 12 and End of Study (LOCF)', 'unitOfMeasure': 'Inflammatory lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid Foam, 15% (BAY39-6251)', 'description': 'Participants received azelaic acid foam, 15% topically twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Vehicle Foam', 'description': 'Participants received vehicle foam topically twice daily for 12 weeks'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-7.5', 'spread': '4.68', 'groupId': 'OG000'}, {'value': '-5.8', 'spread': '4.95', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-9.9', 'spread': '5.88', 'groupId': 'OG000'}, {'value': '-10.3', 'spread': '6.62', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-12.4', 'spread': '8.38', 'groupId': 'OG000'}, {'value': '-12.4', 'spread': '7.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 4, 8 and 12', 'unitOfMeasure': 'Inflammatory lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid Foam, 15% (BAY39-6251)', 'description': 'Participants received azelaic acid foam, 15% topically twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Vehicle Foam', 'description': 'Participants received vehicle foam topically twice daily for 12 weeks'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-49.5', 'spread': '23.68', 'groupId': 'OG000'}, {'value': '-37.7', 'spread': '36.70', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-62.7', 'spread': '29.82', 'groupId': 'OG000'}, {'value': '-62.8', 'spread': '27.71', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-75.1', 'spread': '33.80', 'groupId': 'OG000'}, {'value': '-74.8', 'spread': '32.40', 'groupId': 'OG001'}]}]}, {'title': 'End of Study', 'categories': [{'measurements': [{'value': '-71.2', 'spread': '36.42', 'groupId': 'OG000'}, {'value': '-65.3', 'spread': '40.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 4, 8, 12 and End of Study (LOCF)', 'unitOfMeasure': 'Percent change in Inflammatory lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid Foam, 15% (BAY39-6251)', 'description': 'Participants received azelaic acid foam, 15% topically twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Vehicle Foam', 'description': 'Participants received vehicle foam topically twice daily for 12 weeks'}], 'classes': [{'title': 'Week 4-clear', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 4-minimal', 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000'}, {'value': '10.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 4-mild', 'categories': [{'measurements': [{'value': '17.9', 'groupId': 'OG000'}, {'value': '21.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 4-mild to moderate', 'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000'}, {'value': '21.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 4-moderate', 'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000'}, {'value': '26.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 4-moderate to severe', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '13.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 4-severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 8-clear', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}, {'value': '8.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 8-minimal', 'categories': [{'measurements': [{'value': '28.9', 'groupId': 'OG000'}, {'value': '27.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 8-mild', 'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000'}, {'value': '16.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 8-mild to moderate', 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000'}, {'value': '16.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 8-moderate', 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000'}, {'value': '21.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 8-moderate to severe', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}, {'value': '8.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 8-severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 12-clear', 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000'}, {'value': '17.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 12-minimal', 'categories': [{'measurements': [{'value': '36.8', 'groupId': 'OG000'}, {'value': '37.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 12-mild', 'categories': [{'measurements': [{'value': '26.3', 'groupId': 'OG000'}, {'value': '8.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 12-mild to moderate', 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 12-moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 12-moderate to severe', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}, {'value': '8.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 12-severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'End of Study-clear', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}]}]}, {'title': 'End of Study-minimal', 'categories': [{'measurements': [{'value': '36.6', 'groupId': 'OG000'}, {'value': '31.0', 'groupId': 'OG001'}]}]}, {'title': 'End of Study-mild', 'categories': [{'measurements': [{'value': '24.4', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}]}]}, {'title': 'End of Study-mild to moderate', 'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG000'}, {'value': '19.0', 'groupId': 'OG001'}]}]}, {'title': 'End of Study-moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '11.9', 'groupId': 'OG001'}]}]}, {'title': 'End of Study-moderate to severe', 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}]}]}, {'title': 'End of Study-severe', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Weeks 4, 8, 12 and End of Study (LOCF)', 'description': 'IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid Foam, 15% (BAY39-6251)', 'description': 'Participants received azelaic acid foam, 15% topically twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Vehicle Foam', 'description': 'Participants received vehicle foam topically twice daily for 12 weeks'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'End of Study', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 4, 8, 12 and End of Study (LOCF)', 'description': 'IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 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'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000'}, {'value': '10.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 8-mild', 'categories': [{'measurements': [{'value': '36.8', 'groupId': 'OG000'}, {'value': '32.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 8-moderate', 'categories': [{'measurements': [{'value': '42.1', 'groupId': 'OG000'}, {'value': '45.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 8-severe', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}, {'value': '10.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 12-clear or almost clear', 'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000'}, {'value': '25.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 12-mild', 'categories': [{'measurements': [{'value': '42.1', 'groupId': 'OG000'}, {'value': '22.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 12-moderate', 'categories': [{'measurements': [{'value': '34.2', 'groupId': 'OG000'}, {'value': '45.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 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'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'End of Study', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 4, 8, 12 and End of Study (LOCF)', 'description': 'Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid Foam, 15% (BAY39-6251)', 'description': 'Participants received azelaic acid foam, 15% topically twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Vehicle Foam', 'description': 'Participants received vehicle foam topically twice daily for 12 weeks'}], 'classes': [{'title': 'Week 4-Improved', 'categories': [{'measurements': [{'value': '35.9', 'groupId': 'OG000'}, {'value': '42.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 4-No change', 'categories': [{'measurements': [{'value': '59.0', 'groupId': 'OG000'}, {'value': '52.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 4-Worse', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '5.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 8-Improved', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '48.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 8-No change', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '40.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 8-Worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '10.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 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[{'measurements': [{'value': '42.1', 'groupId': 'OG000'}, {'value': '56.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 8-moderate', 'categories': [{'measurements': [{'value': '57.9', 'groupId': 'OG000'}, {'value': '37.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 8-severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 12-none', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 12-mild', 'categories': [{'measurements': [{'value': '42.1', 'groupId': 'OG000'}, {'value': '62.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 12-moderate', 'categories': [{'measurements': [{'value': '55.3', 'groupId': 'OG000'}, {'value': '34.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 12-severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'End of Study-none', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'End of Study-mild', 'categories': [{'measurements': [{'value': '41.5', 'groupId': 'OG000'}, {'value': '59.5', 'groupId': 'OG001'}]}]}, {'title': 'End of Study-moderate', 'categories': [{'measurements': [{'value': '56.1', 'groupId': 'OG000'}, {'value': '38.1', 'groupId': 'OG001'}]}]}, {'title': 'End of Study-severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Weeks 4, 8, 12 and End of Study (LOCF)', 'description': 'Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid Foam, 15% (BAY39-6251)', 'description': 'Participants received azelaic acid foam, 15% topically twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Vehicle Foam', 'description': 'Participants received vehicle foam topically twice daily for 12 weeks'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'End of Study', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 4, 8, 12 and End of Study (LOCF)', 'description': 'Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid Foam, 15% (BAY39-6251)', 'description': 'Participants received azelaic acid foam, 15% topically twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Vehicle Foam', 'description': 'Participants received vehicle foam topically twice daily for 12 weeks'}], 'classes': [{'title': 'Week 4-Improved', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '10.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 4-No change', 'categories': [{'measurements': [{'value': '92.3', 'groupId': 'OG000'}, {'value': '86.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 4-Worse', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 8-Improved', 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000'}, {'value': '27.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 8-No change', 'categories': [{'measurements': [{'value': '89.5', 'groupId': 'OG000'}, {'value': '73.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 8-Worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 12-Improved', 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 12-No change', 'categories': [{'measurements': [{'value': '84.2', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 12-Worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'End of Study-Improved', 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000'}, {'value': '23.8', 'groupId': 'OG001'}]}]}, {'title': 'End of Study-No change', 'categories': [{'measurements': [{'value': '85.4', 'groupId': 'OG000'}, {'value': '76.2', 'groupId': 'OG001'}]}]}, {'title': 'End of Study-Worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Weeks 4, 8, 12 and End of Study (LOCF)', 'description': 'Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Investigator's Rating of Overall Improvement at End of 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{'value': '12.5', 'groupId': 'OG001'}]}]}, {'title': 'Deterioration', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At End of Study (Week 12)', 'description': "Investigator's rating of overall improvement: 1 - excellent improvement; 2 - marked improvement; 3 - moderate improvement; 4 - no change; 5 - deterioration", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects of the FAS population for which this measurement was evaluated (one-time evaluation at the last study visit; FAS observed cases)'}, {'type': 'SECONDARY', 'title': "Patients' Rating of Overall Improvement at End of Study", 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid Foam, 15% (BAY39-6251)', 'description': 'Participants received azelaic acid foam, 15% topically twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Vehicle Foam', 'description': 'Participants received vehicle foam topically twice daily for 12 weeks'}], 'classes': [{'title': 'Excellent Improvement', 'categories': [{'measurements': [{'value': '36.8', 'groupId': 'OG000'}, {'value': '27.5', 'groupId': 'OG001'}]}]}, {'title': 'Good Improvement', 'categories': [{'measurements': [{'value': '28.9', 'groupId': 'OG000'}, {'value': '22.5', 'groupId': 'OG001'}]}]}, {'title': 'Fair Improvement', 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000'}, {'value': '22.5', 'groupId': 'OG001'}]}]}, {'title': 'No Improvement', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}]}]}, {'title': 'Worse', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}, {'value': '7.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At End of Study (Week 12)', 'description': 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'35.0', 'groupId': 'OG001'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '36.8', 'groupId': 'OG000'}, {'value': '37.5', 'groupId': 'OG001'}]}]}, {'title': 'Satisfactory', 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}]}]}, {'title': 'No Opinion', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At End of Study (Week 12)', 'description': "Patient's opinion on cosmetic acceptability: 1 - very good; 2 - good; 3 - satisfactory; 4 - poor; 5 - no opinion", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects of the FAS population for which this measurement was evaluated (one-time evaluation at the last study visit; FAS 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'NUMBER', 'timeFrame': 'At Weeks 4, 8 and 12', 'description': 'IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success was defined as an IGA score of clear or minimal (0 to 1).").', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid Foam, 15% (BAY39-6251)', 'description': 'Participants received azelaic acid foam, 15% topically twice daily for 12 weeks'}, {'id': 'OG001', 'title': 'Vehicle Foam', 'description': 'Participants received vehicle foam topically twice daily for 12 weeks'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000'}, {'value': '34.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '55.3', 'groupId': 'OG000'}, {'value': '51.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '73.7', 'groupId': 'OG000'}, {'value': '62.9', 'groupId': 'OG001'}]}]}, {'title': 'End of Study', 'categories': [{'measurements': [{'value': '70.7', 'groupId': 'OG000'}, {'value': '54.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Weeks 4, 8, 12 and End of Study (LOCF)', 'description': 'IGA based Patient response was defined as an IGA score of clear, minimal or mild (0, 1, 2).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Azelaic Acid Foam, 15% (BAY39-6251)', 'description': 'Participants received azelaic acid foam, 15% topically twice daily for 12 weeks'}, {'id': 'FG001', 'title': 'Vehicle Foam', 'description': 'Participants received vehicle foam topically twice daily for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Azelaic Acid Foam, 15% (BAY39-6251)', 'description': 'Participants received azelaic acid foam, 15% topically twice daily for 12 weeks'}, {'id': 'BG001', 'title': 'Vehicle Foam', 'description': 'Participants received vehicle foam topically twice daily for 12 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.4', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '51.5', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '50.5', 'spread': '12.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous duration of rosacea', 'classes': [{'categories': [{'measurements': [{'value': '88.5', 'spread': '63.8', 'groupId': 'BG000'}, {'value': '91.9', 'spread': '77.0', 'groupId': 'BG001'}, {'value': '90.2', 'spread': '70.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Investigator's Global Assessment (IGA) score at Baseline", 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '3.9', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '3.9', 'spread': '0.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of inflammatory lesions per participant at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '18.0', 'spread': '10.61', 'groupId': 'BG000'}, {'value': '17.6', 'spread': '8.36', 'groupId': 'BG001'}, {'value': '17.8', 'spread': '9.48', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Inflammatory lesions', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Erythema intensity score at baseline', 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '3.0', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '3.0', 'spread': '0.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-30', 'studyFirstSubmitDate': '2008-01-22', 'resultsFirstSubmitDate': '2013-05-02', 'studyFirstSubmitQcDate': '2008-02-15', 'lastUpdatePostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-05-02', 'studyFirstPostDateStruct': {'date': '2008-02-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Study (LOCF: Last Observation Carried Forward)', 'timeFrame': 'Baseline and End of Study (Week 12)'}, {'measure': "Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF)", 'timeFrame': 'At End of Study (Week 12)', 'description': 'IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).'}, {'measure': 'Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF)', 'timeFrame': 'Baseline and End of Study (Week 12)', 'description': 'Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe'}], 'secondaryOutcomes': [{'measure': 'Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)', 'timeFrame': 'At Weeks 4, 8, 12 and End of Study (LOCF)'}, {'measure': 'Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12', 'timeFrame': 'Baseline and Weeks 4, 8 and 12'}, {'measure': 'Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)', 'timeFrame': 'Baseline and Weeks 4, 8, 12 and End of Study (LOCF)'}, {'measure': 'Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)', 'timeFrame': 'At Weeks 4, 8, 12 and End of Study (LOCF)', 'description': 'IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).'}, {'measure': 'Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)', 'timeFrame': 'Baseline and Weeks 4, 8, 12 and End of Study (LOCF)', 'description': 'IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1).'}, {'measure': 'Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)', 'timeFrame': 'At Weeks 4, 8, 12 and End of Study (LOCF)', 'description': 'Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe'}, {'measure': 'Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)', 'timeFrame': 'Baseline and Weeks 4, 8, 12 and End of Study (LOCF)', 'description': 'Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe'}, {'measure': 'Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12', 'timeFrame': 'Baseline and Weeks 4, 8 and 12', 'description': 'Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe'}, {'measure': 'Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)', 'timeFrame': 'At Weeks 4, 8, 12 and End of Study (LOCF)', 'description': 'Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe'}, {'measure': 'Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)', 'timeFrame': 'Baseline and Weeks 4, 8, 12 and End of Study (LOCF)', 'description': 'Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe'}, {'measure': 'Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)', 'timeFrame': 'Baseline and Weeks 4, 8, 12 and End of Study (LOCF)', 'description': 'Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe'}, {'measure': "Investigator's Rating of Overall Improvement at End of Study", 'timeFrame': 'At End of Study (Week 12)', 'description': "Investigator's rating of overall improvement: 1 - excellent improvement; 2 - marked improvement; 3 - moderate improvement; 4 - no change; 5 - deterioration"}, {'measure': "Patients' Rating of Overall Improvement at End of Study", 'timeFrame': 'At End of Study (Week 12)', 'description': "Patient's rating of overall improvement: 1 - excellent; 2 - good; 3 - fair; 4 - no improvement; 5 - worse"}, {'measure': "Patients' Opinion on Cosmetic Acceptability at End of Study", 'timeFrame': 'At End of Study (Week 12)', 'description': "Patient's opinion on cosmetic acceptability: 1 - very good; 2 - good; 3 - satisfactory; 4 - poor; 5 - no opinion"}, {'measure': 'Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12', 'timeFrame': 'At Weeks 4, 8 and 12', 'description': 'IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success was defined as an IGA score of clear or minimal (0 to 1).").'}, {'measure': 'Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF)', 'timeFrame': 'At Weeks 4, 8, 12 and End of Study (LOCF)', 'description': 'IGA based Patient response was defined as an IGA score of clear, minimal or mild (0, 1, 2).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['rosacea', 'papulopustular', 'azelaic acid', 'foam'], 'conditions': ['Papulopustular Rosacea']}, 'descriptionModule': {'briefSummary': 'This exploratory study is being performed to determine whether a new form formulation of azelaic acid 15% is effective in the treatment of papulopustular rosecea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male and female patient at least 18 years of age\n* signed informed consent\n* Papulopustular rosacea with a minimum of 10 and a maximum of 50 papules and/or pustules, persistent erythema, and telangiectasia\n* Ability and willingness to accept and comply with treatment and required medical examinations\n\nExclusion Criteria:\n\n* Known non-responders to azelaic acid\n* Erythematotelangiectatic, rhinophymatous, ocular, or steroid rosacea\n* Presence of dermatoses that could interfere with the rosacea diagnosis\n* Treatment with isotretinoin in the six months prior to randomization\n* Treatment of the face with topical retinoids during the two weeks prior to randomization\n* Treatment with oral antibiotics during the four weeks prior to randomization\n* Treatment with topical antibiotics\n* Treatment with systemic corticosteroids during 4 weeks prior to randomization\n* Treatment of the face with topical corticosteroids during 2 weeks prior to randomization\n* Treatment of the face with topical imidazole antimycotics during 2 weeks prior to randomization\n* Treatment of the face with topical azelaic acid formulations during 2 weeks prior to randomization\n* Use of a sauna during 2 weeks prior to randomization and during the study\n* Facial laser surgery for telangiectasia during 6 weeks prior to randomization\n* Planned concurrent use of any treatment other than study medication that affects rosacea\n* History of hypersensitivity to propylene glycol or any other ingredient of the study drugs\n* Participation in another clinical trial during the last 4 weeks'}, 'identificationModule': {'nctId': 'NCT00617903', 'briefTitle': 'Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'officialTitle': 'A 12-week Exploratory, Multicenter, Double-blind, Vehicle-controlled Study to Investigate the Efficacy and Safety of Topical Azelaic Acid 15% Foam Twice Daily in Patients With Papulopustular Rosacea', 'orgStudyIdInfo': {'id': '1402140'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Azelaic acid foam, 15% (BAY39-6251)', 'description': 'Participants received azelaic acid foam, 15% topically twice daily for 12 weeks', 'interventionNames': ['Drug: Azelaic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle foam', 'description': 'Participants received vehicle foam topically twice daily for 12 weeks', 'interventionNames': ['Drug: Vehicle foam']}], 'interventions': [{'name': 'Azelaic acid', 'type': 'DRUG', 'description': '15% foam to be applied topically twice daily', 'armGroupLabels': ['Azelaic acid foam, 15% (BAY39-6251)']}, {'name': 'Vehicle foam', 'type': 'DRUG', 'description': 'Active-ingredient-free vehicle to be applied topically twice daily', 'armGroupLabels': ['Vehicle foam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80209', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '66062', 'city': 'Olathe', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 38.8814, 'lon': -94.81913}}, {'zip': '89052', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '45040', 'city': 'Mason', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.36006, 'lon': -84.30994}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LEO Pharma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}