Viewing Study NCT00855595

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Ignite Creation Date: 2025-12-24 @ 1:20 PM
Ignite Modification Date: 2025-12-29 @ 10:16 AM
Study NCT ID: NCT00855595
Status: COMPLETED
Last Update Posted: 2020-03-31
First Post: 2009-03-03
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Efficacy of Topical Azelaic Acid 15% Gel Plus Anti-inflammatory Dose Doxycycline or Metronidazole Gel 1% Plus Anti-inflammatory Dose Doxycycline in Moderate Papulopustular 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'}, {'id': 'D008795', 'term': 'Metronidazole'}, {'id': 'D004318', 'term': 'Doxycycline'}], 'ancestors': [{'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayerhealthcare.com', 'title': 'Therapeutic Area Head', 'organization': 'Intendis GmbH'}, '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 (Finacea, BAY39-6251) Plus Doxycycline (Oracea)', 'description': 'Participants received topical azelaic acid gel 15% twice daily and systemic doxycycline 40 mg once daily for 12 weeks', 'otherNumAtRisk': 106, 'otherNumAffected': 29, 'seriousNumAtRisk': 106, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Metronidazole (Metrogel) Plus Doxycycline (Oracea)', 'description': 'Participants received topical metronidazole 1% gel once daily and systemic doxycycline 40 mg once daily for 12 weeks', 'otherNumAtRisk': 101, 'otherNumAffected': 33, 'seriousNumAtRisk': 101, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Ear congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Gastrointestinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Application site oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Application site urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Application site exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Application site burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Exposure to toxic agent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nerve compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Postnasal drip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nasal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Paranasal sinus hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Seborrhoeic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Elective surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal 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) at Week 2 (LOCF: Last Observation Carried Forward)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)', 'description': 'Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Metronidazole (Metrogel) Plus Doxycycline (Oracea)', 'description': 'Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.5', 'spread': '9.14', 'groupId': 'OG000'}, {'value': '-9.4', 'spread': '9.38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0903', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 2', 'description': 'NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)', 'unitOfMeasure': 'Inflammatory lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS)'}, {'type': 'SECONDARY', 'title': 'Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)', 'description': 'Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Metronidazole (Metrogel) Plus Doxycycline (Oracea)', 'description': 'Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '10.1', 'spread': '8.70', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '9.86', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '7.4', 'spread': '7.29', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '8.09', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '5.9', 'spread': '6.28', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '7.18', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '5.1', 'spread': '6.28', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '7.02', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '4.4', 'spread': '6.51', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '7.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 2, 4, 6, 8 and 12', 'unitOfMeasure': 'Inflammatory lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)', 'description': 'Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Metronidazole (Metrogel) Plus Doxycycline (Oracea)', 'description': 'Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-13.2', 'spread': '9.03', 'groupId': 'OG000'}, {'value': '-12.4', 'spread': '9.23', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-14.8', 'spread': '9.20', 'groupId': 'OG000'}, {'value': '-14.1', 'spread': '9.32', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-15.5', 'spread': '9.69', 'groupId': 'OG000'}, {'value': '-15.6', 'spread': '9.82', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-16.2', 'spread': '9.88', 'groupId': 'OG000'}, {'value': '-16.2', 'spread': '10.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4, 6, 8 and 12', 'description': 'NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)', 'unitOfMeasure': 'Inflammatory lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)', 'description': 'Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Metronidazole (Metrogel) Plus Doxycycline (Oracea)', 'description': 'Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-50.7', 'spread': '29.39', 'groupId': 'OG000'}, {'value': '-43.0', 'spread': '35.68', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-64.9', 'spread': '28.93', 'groupId': 'OG000'}, {'value': '-56.9', 'spread': '31.50', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-72.4', 'spread': '24.67', 'groupId': 'OG000'}, {'value': '-64.5', 'spread': '29.00', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-76.4', 'spread': '23.47', 'groupId': 'OG000'}, {'value': '-71.6', 'spread': '26.94', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-80.2', 'spread': '24.25', 'groupId': 'OG000'}, {'value': '-75.1', 'spread': '27.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 2, 4, 6, 8 and 12', 'description': 'NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)', 'unitOfMeasure': 'Percent of inflammatory lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)', 'description': 'Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Metronidazole (Metrogel) Plus Doxycycline (Oracea)', 'description': 'Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks'}], 'classes': [{'title': 'Week 2, ≥25% improvement', 'categories': [{'measurements': [{'value': '84.9', 'groupId': 'OG000'}, {'value': '77.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 2, ≥50% improvement', 'categories': [{'measurements': [{'value': '61.3', 'groupId': 'OG000'}, {'value': '47.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 2, ≥75% improvement', 'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000'}, {'value': '17.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 4, ≥25% improvement', 'categories': [{'measurements': [{'value': '90.6', 'groupId': 'OG000'}, {'value': '81.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 4, ≥50% improvement', 'categories': [{'measurements': [{'value': '75.5', 'groupId': 'OG000'}, {'value': '64.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 4, ≥75% improvement', 'categories': [{'measurements': [{'value': '44.3', 'groupId': 'OG000'}, {'value': '40.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 6, ≥25% improvement', 'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000'}, {'value': '91.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 6, ≥50% improvement', 'categories': [{'measurements': [{'value': '84.9', 'groupId': 'OG000'}, {'value': '78.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 6, ≥75% improvement', 'categories': [{'measurements': [{'value': '54.7', 'groupId': 'OG000'}, {'value': '43.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 8, ≥25% improvement', 'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000'}, {'value': '90.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 8, ≥50% improvement', 'categories': [{'measurements': [{'value': '88.7', 'groupId': 'OG000'}, {'value': '87.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 8, ≥75% improvement', 'categories': [{'measurements': [{'value': '67.0', 'groupId': 'OG000'}, {'value': '55.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 12, ≥25% improvement', 'categories': [{'measurements': [{'value': '96.2', 'groupId': 'OG000'}, {'value': '91.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 12, ≥50% improvement', 'categories': [{'measurements': [{'value': '89.6', 'groupId': 'OG000'}, {'value': '85.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 12, ≥75% improvement', 'categories': [{'measurements': [{'value': '68.9', 'groupId': 'OG000'}, {'value': '65.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Weeks 2, 4, 6, 8 and 12', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)', 'description': 'Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Metronidazole (Metrogel) Plus Doxycycline (Oracea)', 'description': 'Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000'}, {'value': '7.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG000'}, {'value': '26.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '45.3', 'groupId': 'OG000'}, {'value': '27.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '50.9', 'groupId': 'OG000'}, {'value': '39.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '62.3', 'groupId': 'OG000'}, {'value': '52.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 2, 4, 6, 8 and 12', 'description': 'IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Therapeutic success is defined as an IGA score of clear or minimal (0 or 1).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)', 'description': 'Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Metronidazole (Metrogel) Plus Doxycycline (Oracea)', 'description': 'Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG000'}, {'value': '27.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '55.7', 'groupId': 'OG000'}, {'value': '44.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '60.4', 'groupId': 'OG000'}, {'value': '53.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '72.6', 'groupId': 'OG000'}, {'value': '59.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '78.3', 'groupId': 'OG000'}, {'value': '72.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 2, 4, 6, 8 and 12', 'description': 'IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Patient response is defined as an IGA score of clear, minimal, or mild (0, 1, or 2)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)', 'description': 'Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Metronidazole (Metrogel) Plus Doxycycline (Oracea)', 'description': 'Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks'}], 'classes': [{'title': '0 - Clear', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}]}]}, {'title': '1 - Minimal', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}, {'value': '6.9', 'groupId': 'OG001'}]}]}, {'title': '2 - Mild', 'categories': [{'measurements': [{'value': '18.9', 'groupId': 'OG000'}, {'value': '19.8', 'groupId': 'OG001'}]}]}, {'title': '3 - Mild to moderate', 'categories': [{'measurements': [{'value': '33.0', 'groupId': 'OG000'}, {'value': '31.7', 'groupId': 'OG001'}]}]}, {'title': '4 - Moderate', 'categories': [{'measurements': [{'value': '25.5', 'groupId': 'OG000'}, {'value': '27.7', 'groupId': 'OG001'}]}]}, {'title': '5 - Moderate to severe', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000'}, {'value': '10.9', 'groupId': 'OG001'}]}]}, {'title': '6 - Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 2', 'description': 'IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)', 'description': 'Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Metronidazole (Metrogel) Plus Doxycycline (Oracea)', 'description': 'Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks'}], 'classes': [{'title': '0 - Clear', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000'}, {'value': '6.9', 'groupId': 'OG001'}]}]}, {'title': '1 - Minimal', 'categories': [{'measurements': [{'value': '24.5', 'groupId': 'OG000'}, {'value': '19.8', 'groupId': 'OG001'}]}]}, {'title': '2 - Mild', 'categories': [{'measurements': [{'value': '23.6', 'groupId': 'OG000'}, {'value': '17.8', 'groupId': 'OG001'}]}]}, {'title': '3 - Mild to moderate', 'categories': [{'measurements': [{'value': '24.5', 'groupId': 'OG000'}, {'value': '23.8', 'groupId': 'OG001'}]}]}, {'title': '4 - Moderate', 'categories': [{'measurements': [{'value': '15.1', 'groupId': 'OG000'}, {'value': '20.8', 'groupId': 'OG001'}]}]}, {'title': '5 - Moderate to severe', 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000'}, {'value': '9.9', 'groupId': 'OG001'}]}]}, {'title': '6 - Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 4', 'description': 'IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)', 'description': 'Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Metronidazole (Metrogel) Plus Doxycycline (Oracea)', 'description': 'Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks'}], 'classes': [{'title': '0 - Clear', 'categories': [{'measurements': [{'value': '18.9', 'groupId': 'OG000'}, {'value': '9.9', 'groupId': 'OG001'}]}]}, {'title': '1 - Minimal', 'categories': [{'measurements': [{'value': '26.4', 'groupId': 'OG000'}, {'value': '17.8', 'groupId': 'OG001'}]}]}, {'title': '2 - Mild', 'categories': [{'measurements': [{'value': '15.1', 'groupId': 'OG000'}, {'value': '25.7', 'groupId': 'OG001'}]}]}, {'title': '3 - Mild to moderate', 'categories': [{'measurements': [{'value': '24.5', 'groupId': 'OG000'}, {'value': '19.8', 'groupId': 'OG001'}]}]}, {'title': '4 - Moderate', 'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000'}, {'value': '19.8', 'groupId': 'OG001'}]}]}, {'title': '5 - Moderate to severe', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '6.9', 'groupId': 'OG001'}]}]}, {'title': '6 - Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 6', 'description': 'IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)', 'description': 'Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Metronidazole (Metrogel) Plus Doxycycline (Oracea)', 'description': 'Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks'}], 'classes': [{'title': '0 - Clear', 'categories': [{'measurements': [{'value': '18.9', 'groupId': 'OG000'}, {'value': '13.9', 'groupId': 'OG001'}]}]}, {'title': '1 - Minimal', 'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG000'}, {'value': '25.7', 'groupId': 'OG001'}]}]}, {'title': '2 - Mild', 'categories': [{'measurements': [{'value': '21.7', 'groupId': 'OG000'}, {'value': '19.8', 'groupId': 'OG001'}]}]}, {'title': '3 - Mild to moderate', 'categories': [{'measurements': [{'value': '14.2', 'groupId': 'OG000'}, {'value': '23.8', 'groupId': 'OG001'}]}]}, {'title': '4 - Moderate', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000'}, {'value': '12.9', 'groupId': 'OG001'}]}]}, {'title': '5 - Moderate to severe', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '4.0', 'groupId': 'OG001'}]}]}, {'title': '6 - Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 8', 'description': 'IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)', 'description': 'Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Metronidazole (Metrogel) Plus Doxycycline (Oracea)', 'description': 'Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks'}], 'classes': [{'title': '0 - Clear', 'categories': [{'measurements': [{'value': '30.2', 'groupId': 'OG000'}, {'value': '22.8', 'groupId': 'OG001'}]}]}, {'title': '1 - Minimal', 'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG000'}, {'value': '29.7', 'groupId': 'OG001'}]}]}, {'title': '2 - Mild', 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000'}, {'value': '19.8', 'groupId': 'OG001'}]}]}, {'title': '3 - Mild to moderate', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}, {'value': '13.9', 'groupId': 'OG001'}]}]}, {'title': '4 - Moderate', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '10.9', 'groupId': 'OG001'}]}]}, {'title': '5 - Moderate to severe', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '3.0', 'groupId': 'OG001'}]}]}, {'title': '6 - Severe', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 12', 'description': 'IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Investigator Rating of Overall Improvement at End of Study (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)', 'description': 'Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Metronidazole (Metrogel) Plus Doxycycline (Oracea)', 'description': 'Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks'}], 'classes': [{'title': 'Excellent Improvement', 'categories': [{'measurements': [{'value': '46.6', 'groupId': 'OG000'}, {'value': '42.3', 'groupId': 'OG001'}]}]}, {'title': 'Marked Improvement', 'categories': [{'measurements': [{'value': '35.9', 'groupId': 'OG000'}, {'value': '34.0', 'groupId': 'OG001'}]}]}, {'title': 'Moderate Improvement', 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000'}, {'value': '17.5', 'groupId': 'OG001'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}, {'value': '6.2', 'groupId': 'OG001'}]}]}, {'title': 'Deterioration', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the FAS who took part in this evaluation.'}, {'type': 'SECONDARY', 'title': 'Patient Rating of Overall Improvement at End of Study (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)', 'description': 'Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Metronidazole (Metrogel) Plus Doxycycline (Oracea)', 'description': 'Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks'}], 'classes': [{'title': 'Excellent Improvement', 'categories': [{'measurements': [{'value': '51.0', 'groupId': 'OG000'}, {'value': '49.0', 'groupId': 'OG001'}]}]}, {'title': 'Good Improvement', 'categories': [{'measurements': [{'value': '39.2', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Fair Improvement', 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000'}, {'value': '15.6', 'groupId': 'OG001'}]}]}, {'title': 'No Improvement', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the FAS who took part in this evaluation.'}, {'type': 'SECONDARY', 'title': 'Patient Opinion of Cosmetic Acceptability at End of Study (Week 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)', 'description': 'Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Metronidazole (Metrogel) Plus Doxycycline (Oracea)', 'description': 'Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks'}], 'classes': [{'title': 'Very Good', 'categories': [{'measurements': [{'value': '52.0', 'groupId': 'OG000'}, {'value': '56.3', 'groupId': 'OG001'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '34.3', 'groupId': 'OG000'}, {'value': '26.0', 'groupId': 'OG001'}]}]}, {'title': 'Satisfactory', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'No Opinion', 'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the FAS who took part in this evaluation.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient Opinion of Local Tolerability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)', 'description': 'Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks'}, {'id': 'OG001', 'title': 'Metronidazole (Metrogel) Plus Doxycycline (Oracea)', 'description': 'Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks'}], 'classes': [{'title': 'Excellent', 'categories': [{'measurements': [{'value': '53.9', 'groupId': 'OG000'}, {'value': '72.9', 'groupId': 'OG001'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '34.3', 'groupId': 'OG000'}, {'value': '15.6', 'groupId': 'OG001'}]}]}, {'title': 'Acceptable despite minor irritation', 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000'}, {'value': '11.5', 'groupId': 'OG001'}]}]}, {'title': 'Less acceptable due to continuous irritation', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'No opinion', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the FAS who took part in this evaluation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)', 'description': 'Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks'}, {'id': 'FG001', 'title': 'Metronidazole (Metrogel) Plus Doxycycline (Oracea)', 'description': 'Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '94'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'patient moved out of state', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'patient left country', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)', 'description': 'Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks'}, {'id': 'BG001', 'title': 'Metronidazole (Metrogel) Plus Doxycycline (Oracea)', 'description': 'Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.4', 'spread': '12.7', 'groupId': 'BG000'}, {'value': '48.4', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '49.4', 'spread': '12.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "Investigator's Global Assessment (IGA) score at Baseline", 'classes': [{'title': 'IGA Score 4 - Moderate', 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}]}, {'title': 'IGA Score 5 - Moderate to Severe', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': 'IGA Score 6- Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).', 'unitOfMeasure': 'Participants'}, {'title': 'Number of lesions at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '20.6', 'spread': '11.01', 'groupId': 'BG000'}, {'value': '21.9', 'spread': '10.50', 'groupId': 'BG001'}, {'value': '21.3', 'spread': '10.76', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Lesions', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Previous duration of rosacea', 'classes': [{'categories': [{'measurements': [{'value': '130.8', 'spread': '126.1', 'groupId': 'BG000'}, {'value': '134.9', 'spread': '107.2', 'groupId': 'BG001'}, {'value': '132.8', 'spread': '117.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 207}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-30', 'studyFirstSubmitDate': '2009-03-03', 'resultsFirstSubmitDate': '2012-07-25', 'studyFirstSubmitQcDate': '2009-03-03', 'lastUpdatePostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-07-25', 'studyFirstPostDateStruct': {'date': '2009-03-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient Opinion of Local Tolerability', 'timeFrame': 'Week 12'}], 'primaryOutcomes': [{'measure': 'Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward)', 'timeFrame': 'Baseline and Week 2', 'description': 'NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)'}], 'secondaryOutcomes': [{'measure': 'Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)', 'timeFrame': 'Week 2, 4, 6, 8 and 12'}, {'measure': 'Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF)', 'timeFrame': 'Baseline and Week 4, 6, 8 and 12', 'description': 'NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)'}, {'measure': 'Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF)', 'timeFrame': 'Baseline and Week 2, 4, 6, 8 and 12', 'description': 'NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions)'}, {'measure': 'Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)', 'timeFrame': 'Baseline and Weeks 2, 4, 6, 8 and 12'}, {'measure': "Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF)", 'timeFrame': 'Weeks 2, 4, 6, 8 and 12', 'description': 'IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Therapeutic success is defined as an IGA score of clear or minimal (0 or 1).'}, {'measure': 'Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF)', 'timeFrame': 'Weeks 2, 4, 6, 8 and 12', 'description': 'IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Patient response is defined as an IGA score of clear, minimal, or mild (0, 1, or 2)'}, {'measure': 'Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2', 'timeFrame': 'At Week 2', 'description': 'IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).'}, {'measure': 'Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4', 'timeFrame': 'At Week 4', 'description': 'IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).'}, {'measure': 'Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6', 'timeFrame': 'At Week 6', 'description': 'IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).'}, {'measure': 'Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8', 'timeFrame': 'At Week 8', 'description': 'IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).'}, {'measure': 'Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12', 'timeFrame': 'At Week 12', 'description': 'IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information).'}, {'measure': 'Investigator Rating of Overall Improvement at End of Study (Week 12)', 'timeFrame': 'Week 12'}, {'measure': 'Patient Rating of Overall Improvement at End of Study (Week 12)', 'timeFrame': 'Week 12'}, {'measure': 'Patient Opinion of Cosmetic Acceptability at End of Study (Week 12)', 'timeFrame': 'Week 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rosacea'], 'conditions': ['Papulopustular Rosacea']}, 'referencesModule': {'references': [{'pmid': '20645521', 'type': 'RESULT', 'citation': 'Del Rosso JQ, Bruce S, Jarratt M, Menter A, Staedtler G. Efficacy of topical azelaic acid (AzA) gel 15% plus oral doxycycline 40 mg versus metronidazole gel 1% plus oral doxycycline 40 mg in mild-to-moderate papulopustular rosacea. J Drugs Dermatol. 2010 Jun;9(6):607-13.'}]}, 'descriptionModule': {'briefSummary': 'Subjects with moderate papulopustular rosacea will be treated either with azelaic acid 15% gel topically plus an anti-inflammatory dose of doxycyline (40mg) daily or with metronidazole 1% gel topically once daily plus an anti-inflammatory dose of doxycycline (40mg) over at total of twelve weeks to determine the rapidity of improvement, and the length of time to reach 25%, 50% and 75% clearing compared to baseline.', 'detailedDescription': "The change in inflammatory lesion count will be assessed at each post-baseline visit by an analysis of variance model (ANOVA) with factors treatment and center, but not including treatment-by-center interaction.\n\nInvestigator's Global Assessment (IGA) of papulopustular rosacea (static score): 0 - Clear (Virtually no rosacea ie, no papules and/or pustules; no or residual erythema; no or mild to moderate degree of telangiectasia may be present); 1 - Minimal (Rare papules and/or pustules; residual to mild erythema; mild to moderate degree of telangiectasia may be present); 2 - Mild (Few papules and/or pustules; mild erythema; mild to moderate degree of telangiectasia may be present); 3 - Mild to moderate (Distinct number of papules and/or pustules; mild to moderate erythema; mild to moderate degree of telangiectasia may be present); 4 - Moderate (Pronounced number of papules and/or pustules; moderate erythema; mild to moderate degree of telangiectasia may be present); 5 - Moderate to severe (Many papules and/or pustules, occasionally with large inflamed lesions; moderate erythema; moderate degree of telangiectasia may be present); 6 - Severe (Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate or severe erythema; moderate or severe degree of telangiectasia may be present)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Moderate papulopustular rosacea (IGA\\>4) with a minimum of 10 and no more than 50 inflammatory lesions and persistent erythema with or without telangiectasia\n\nExclusion Criteria:\n\n* Sensitivity to any of the treatments used\n* Co-existing conditions that would unfavorably influence the course of the disease\n* Pregnant or lactating women\n* Severe rosacea'}, 'identificationModule': {'nctId': 'NCT00855595', 'briefTitle': 'Efficacy of Topical Azelaic Acid 15% Gel Plus Anti-inflammatory Dose Doxycycline or Metronidazole Gel 1% Plus Anti-inflammatory Dose Doxycycline in Moderate Papulopustular Rosacea', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'officialTitle': 'An Exploratory, Multicenter, Investigator-blinded, Active-controlled Study to Investigate the Efficacy of Topical Azelaic Acid (AzA)15% Gel Twice Daily or Metronidazole Topical Gel 1% Once Daily, Plus Anti-inflammatory Dose Doxycycline (40mg) Once Daily in Subjects With Moderate Papulopustular Rosacea', 'orgStudyIdInfo': {'id': '14366'}, 'secondaryIdInfos': [{'id': '1402604', 'type': 'OTHER', 'domain': 'Intendis GmbH'}, {'id': '256-0024', 'type': 'OTHER', 'domain': 'Intendis GmbH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Azelaic acid (Finacea, BAY39-6251) plus Doxycycline (Oracea)', 'description': 'Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks', 'interventionNames': ['Drug: Azelaic acid (Finacea, BAY39-6251)', 'Drug: Doxycycline (Oracea)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metronidazole (Metrogel) plus Doxycycline (Oracea)', 'description': 'Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks', 'interventionNames': ['Drug: Metronidazole (Metrogel)', 'Drug: Doxycycline (Oracea)']}], 'interventions': [{'name': 'Azelaic acid (Finacea, BAY39-6251)', 'type': 'DRUG', 'description': 'Participants received topical azelaic acid gel 15% twice daily for 12 weeks', 'armGroupLabels': ['Azelaic acid (Finacea, BAY39-6251) plus Doxycycline (Oracea)']}, {'name': 'Metronidazole (Metrogel)', 'type': 'DRUG', 'description': 'Participants received topical metronidazole 1% gel once daily for 12 weeks', 'armGroupLabels': ['Metronidazole (Metrogel) plus Doxycycline (Oracea)']}, {'name': 'Doxycycline (Oracea)', 'type': 'DRUG', 'description': 'Participants received systemic doxycycline 40 mg once daily for 12 week', 'armGroupLabels': ['Azelaic acid (Finacea, BAY39-6251) plus Doxycycline (Oracea)', 'Metronidazole (Metrogel) plus Doxycycline (Oracea)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '80209', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '02114-2517', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48088', 'city': 'Warren', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.49044, 'lon': -83.01304}}, {'zip': '55432', 'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'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': '11790', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '45040', 'city': 'Mason', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.36006, 'lon': -84.30994}}, {'zip': '97223', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77056', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'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'}}}}