Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-02-06 @ 2:35 PM
Study NCT ID:
NCT02005666
Status:
COMPLETED
Last Update Posted:
2020-10-14
First Post:
2013-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
To Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel of CHL Versus DUAC® Gel
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C007084', 'term': 'clindamycin phosphate'}, {'id': 'D001585', 'term': 'Benzoyl Peroxide'}, {'id': 'D005782', 'term': 'Gels'}], 'ancestors': [{'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Anuj.Saini@zyduscadila.com', 'phone': '02717623666', 'title': 'Mr Anuj K Saini', 'phoneExt': '314', 'organization': 'Cadila Healthcare Limited'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 to Day 78', 'eventGroups': [{'id': 'EG000', 'title': 'Test-Cadila Healthcare Limited', 'description': '1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days Other Name: 1.2% Clindamycin Phosphate/ 5%', 'otherNumAtRisk': 338, 'deathsNumAtRisk': 338, 'otherNumAffected': 59, 'seriousNumAtRisk': 338, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Reference-DUAC® Gel', 'description': 'DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days', 'otherNumAtRisk': 343, 'deathsNumAtRisk': 343, 'otherNumAffected': 61, 'seriousNumAtRisk': 343, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days', 'otherNumAtRisk': 169, 'deathsNumAtRisk': 169, 'otherNumAffected': 29, 'seriousNumAtRisk': 169, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Application site dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Application site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Application site oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Facial pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastrointestinal viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Chapped lips', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hyperchlorhydria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pain in Jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Mechanical urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Heat stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Breast tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Scleral cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Eosinophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ear deformity acquired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Percent Change From Baseline to Week 11 (Study Day 77) for Inflammatory (Papules and Pustules) Lesions.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test-Cadila Healthcare Limited', 'description': '1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days'}, {'id': 'OG001', 'title': 'Reference-DUAC® Gel', 'description': 'DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '-67.6', 'spread': '28.39', 'groupId': 'OG000'}, {'value': '-71.3', 'spread': '25.98', 'groupId': 'OG001'}, {'value': '-51.9', 'spread': '33.99', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 11', 'description': 'Mean percent change from baseline to week 11 (study Day 77) for inflammatory (papules and pustules) lesions in PP populations. The primary endpoint of the study is mean percent change from baseline to week 11 (study Day 77) in the inflammatory (papules and pustules) lesion count.\n\nPapule was Inflammatory lesion; small (\\< 5mm in diameter), solid palpable lesion, usually with inflamed elevation of the skin that does not contain pus. Pustule was Inflammatory lesion; small (\\< 5mm in diameter), inflamed skin swelling that is filled with pus. The test product was judged therapeutically equivalent to the reference product in the reduction of inflammatory lesions if the 90% confidence interval was contained within the interval (0.80, 1.25)', 'unitOfMeasure': 'percentage of mean change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Percent Change From Baseline to Week 11 in the Non-inflammatory Lesion Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test-Cadila Healthcare Limited', 'description': '1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days'}, {'id': 'OG001', 'title': 'Reference-DUAC® Gel', 'description': 'DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '-61.7', 'spread': '29.50', 'groupId': 'OG000'}, {'value': '-61.3', 'spread': '28.46', 'groupId': 'OG001'}, {'value': '-42.0', 'spread': '34.99', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 11', 'description': 'Mean percent change from baseline to week 11 in the non-inflammatory lesion count. The mean percent change from baseline to week 11 in the non-inflammatory (open and closed comedones) lesion count in per protocol population . The analysis was same as the analysis performed for the mean percent reduction from baseline to Day 77 in the number of inflammatory lesion count.\n\nClosed Comedone was Non-inflammatory lesion; whitehead, skin-colored or slightly inflamed "bump" in the skin. Open Comedone was Non-inflammatory lesion; blackhead, surface of the plugged sebaceous follicle has a blackish appearance. The test product was judged therapeutically equivalent to the reference product in the reduction of Non inflammatory lesions if the 90% confidence interval was contained within the interval (0.80, 1.25)', 'unitOfMeasure': 'percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Total randomized subjects 850,in 2:2:1 ratio(Test:338,Reference:343,Placebo:169).80 subjects withdrawn,770 subjects completed study.Efficacy analysis done in Per Protocol (PP)Population, total 253 subjects were excluded from total randomized subjects.For efficacy analysis,597 subjects considered in PP population (Test:236,Reference:233,Placebo:128)'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With a Clinical Response of "Success" at Week 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test-Cadila Healthcare Limited', 'description': '1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days'}, {'id': 'OG001', 'title': 'Reference-DUAC® Gel', 'description': 'DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days'}], 'classes': [{'categories': [{'title': 'Success Rate', 'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}, {'title': 'Failure Rate', 'measurements': [{'value': '196', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 11', 'description': 'Success was defined as an Investigator Global Assessment (IGA) score that is at least 2 grades less than the baseline assessment.\n\nPercentage of subjects with at least 2 grades improvement in IGA scoring from baseline to week 11 for test, reference and placebo in Per protocol population.\n\nIGA is evaluated in the range of 0 to 4. Grade 0=Clear skin with no inflammatory or non-inflammatory lesions;Grade 1=Almost clear;rare non-inflammatory lesions with no more than one small inflammatory lesion; Grade 2 = Mild severity; greater than grade 1;some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions);Grade 3 = Moderate severity; greater than Grade 2; up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion;Grade 4= Severe; greater than Grade 3;up to many non-inflammatory lesions and may have some inflammatory lesions,but no more than a few nodular lesions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Test-Cadila Healthcare Limited', 'description': '1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days'}, {'id': 'FG001', 'title': 'Reference-DUAC® Gel', 'description': 'DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '338'}, {'groupId': 'FG001', 'numSubjects': '343'}, {'groupId': 'FG002', 'numSubjects': '169'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '311'}, {'groupId': 'FG001', 'numSubjects': '299'}, {'groupId': 'FG002', 'numSubjects': '160'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'BG000'}, {'value': '343', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}, {'value': '850', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Test-Cadila Healthcare Limited', 'description': '1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days'}, {'id': 'BG001', 'title': 'Reference-DUAC® Gel', 'description': 'DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<18', 'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '220', 'groupId': 'BG003'}]}]}, {'title': '18 - 40', 'categories': [{'measurements': [{'value': '252', 'groupId': 'BG000'}, {'value': '256', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}, {'value': '630', 'groupId': 'BG003'}]}]}, {'title': '41 - 65', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': '>65', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '481', 'groupId': 'BG003'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '369', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '240', 'groupId': 'BG000'}, {'value': '245', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}, {'value': '606', 'groupId': 'BG003'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or other pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '216', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic/Latino', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}]}]}, {'title': 'Non Hispanic/Latino', 'categories': [{'measurements': [{'value': '294', 'groupId': 'BG000'}, {'value': '293', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}, {'value': '733', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 850}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-18', 'studyFirstSubmitDate': '2013-11-28', 'resultsFirstSubmitDate': '2020-08-21', 'studyFirstSubmitQcDate': '2013-12-06', 'lastUpdatePostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-21', 'studyFirstPostDateStruct': {'date': '2013-12-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Percent Change From Baseline to Week 11 (Study Day 77) for Inflammatory (Papules and Pustules) Lesions.', 'timeFrame': 'week 11', 'description': 'Mean percent change from baseline to week 11 (study Day 77) for inflammatory (papules and pustules) lesions in PP populations. The primary endpoint of the study is mean percent change from baseline to week 11 (study Day 77) in the inflammatory (papules and pustules) lesion count.\n\nPapule was Inflammatory lesion; small (\\< 5mm in diameter), solid palpable lesion, usually with inflamed elevation of the skin that does not contain pus. Pustule was Inflammatory lesion; small (\\< 5mm in diameter), inflamed skin swelling that is filled with pus. The test product was judged therapeutically equivalent to the reference product in the reduction of inflammatory lesions if the 90% confidence interval was contained within the interval (0.80, 1.25)'}], 'secondaryOutcomes': [{'measure': 'Mean Percent Change From Baseline to Week 11 in the Non-inflammatory Lesion Count', 'timeFrame': 'week 11', 'description': 'Mean percent change from baseline to week 11 in the non-inflammatory lesion count. The mean percent change from baseline to week 11 in the non-inflammatory (open and closed comedones) lesion count in per protocol population . The analysis was same as the analysis performed for the mean percent reduction from baseline to Day 77 in the number of inflammatory lesion count.\n\nClosed Comedone was Non-inflammatory lesion; whitehead, skin-colored or slightly inflamed "bump" in the skin. Open Comedone was Non-inflammatory lesion; blackhead, surface of the plugged sebaceous follicle has a blackish appearance. The test product was judged therapeutically equivalent to the reference product in the reduction of Non inflammatory lesions if the 90% confidence interval was contained within the interval (0.80, 1.25)'}, {'measure': 'Proportion of Subjects With a Clinical Response of "Success" at Week 11', 'timeFrame': 'Week 11', 'description': 'Success was defined as an Investigator Global Assessment (IGA) score that is at least 2 grades less than the baseline assessment.\n\nPercentage of subjects with at least 2 grades improvement in IGA scoring from baseline to week 11 for test, reference and placebo in Per protocol population.\n\nIGA is evaluated in the range of 0 to 4. Grade 0=Clear skin with no inflammatory or non-inflammatory lesions;Grade 1=Almost clear;rare non-inflammatory lesions with no more than one small inflammatory lesion; Grade 2 = Mild severity; greater than grade 1;some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions);Grade 3 = Moderate severity; greater than Grade 2; up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion;Grade 4= Severe; greater than Grade 3;up to many non-inflammatory lesions and may have some inflammatory lesions,but no more than a few nodular lesions'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acne Vulgaris', 'DUAC', 'CADILA', 'CLIANTHA'], 'conditions': ['Acne Vulgaris']}, 'referencesModule': {'references': [{'pmid': '2804254', 'type': 'BACKGROUND', 'citation': 'Eller MG, Smith RB, Phillips JP. Absorption kinetics of topical clindamycin preparations. Biopharm Drug Dispos. 1989 Sep-Oct;10(5):505-12. doi: 10.1002/bdd.2510100508.'}, {'pmid': '19911678', 'type': 'BACKGROUND', 'citation': 'Zouboulis CC, Fischer TC, Wohlrab J, Barnard J, Alio AB. Study of the efficacy, tolerability, and safety of 2 fixed-dose combination gels in the management of acne vulgaris. Cutis. 2009 Oct;84(4):223-9.'}], 'seeAlsoLinks': [{'url': 'http://www.aafp.org/afp/2004/0501/p2123.html', 'label': '1\\. Feldman S, Careccia RE, Barham KL, et al. Diagnosis and treatment of acne. Am Fam Physician'}, {'url': 'http://www.bioline.org.br/pdf?dv09082', 'label': '2\\. NilFroushzadeh MA, Siadat AH, Baradaran EH, Moradi S. Clindamycin lotion alone versus combination lotion of clindamycin phosphate plus Tretinoin versus combination lotion of clindamycin phosphate plus salicylic acid in the topical treatment of mild to'}, {'url': 'http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=16509', 'label': 'Cleocin T® Prescribing Information'}, {'url': 'http://www.ncbi.nlm.nih.gov/pmc/articles/PMC172501', 'label': 'Plaisnce KI, Drusano GL, Forrest A, Townsend RJ, Standiford HC. Pharmacokinetic evaluation of two dosage regimens of clindamycin phosphate. Antimicrob Agents Chemother'}, {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050741s019lbl.pdf', 'label': 'DUAC® Gel Prescribing Information'}, {'url': 'http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071292.pdf', 'label': 'U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Draft Guidance for Industry: Acne Vulgaris: Developing Drugs for Treatment.'}]}, 'descriptionModule': {'briefSummary': 'This is an Randomized, Double-blind, Multicentric, Parallel-group, Active and Placebo Controlled, Three Arm Clinical Study.\n\nThe main objective is to evaluate bioequivalence of Test formulation (Clindamycin Phosphate 1.2%/Benzoyl peroxide 5% gel) of Cadila Healthcare with Reference formulation (DUAC® Gel of Stiefel Laboratories)in the ratio of 2:2:1 of Test drug, Reference drug and Placebo respectively.\n\nTotal study duration will be for a period of 78 days which includes treatment duration of 77 days.\n\n850 subjects will be enrolled (randomized)as per the inclusion and exclusion criteria mentioned in the protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of Acne vulgaris\n2. On the face, ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤ 2 nodulocystic lesions (i.e., nodules and cysts).\n3. Investigator's Global Assessment (IGA) of acne severity grade 2, 3 OR 4\n4. Willing to refrain from use of all other topical acne medications or antibiotics during the 11 week treatment period.\n5. If female of childbearing potential, willing to use an acceptable form of birth control during the study.\n6. Have used the same brand of make-up for a minimum period of 2 weeks prior to randomization, for subjects who use make-up, and agree to not change make-up brands or types during the study.\n7. Willing to provide written informed consent or assent (HIPAA consent/authorization, as applicable)\n\nExclusion Criteria:\n\n1. Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).\n2. Patients who have acne conglobata, acne fulminans and secondary acne (e.g.: chloracne and drug induced acne).\n3. Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris. Well trimmed moustaches are allowed.\n4. History of hypersensitivity or allergy to benzoyl peroxide or clindamycin and/or any of the study medication ingredients.\n5. Patients who have a severe or intense irritation on the Face.\n6. Use within 6 months prior to baseline (Randomization) of oral retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).\n7. Use for less than 3 months prior to baseline (Randomization) of estrogens or oral contraceptives; use of such therapy is allowed if it will remain constant throughout the study.\n8. Use on the face within 1 month prior to baseline (Randomization) or during the study of: 1) cryodestruction or chemodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy.\n9. Use within 1 month prior to baseline (Randomization) of: 1) spironolactone, 2) systemic steroids, 3) systemic antibiotics, 4) systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout), or 5) systemic anti-inflammatory agents.\n10. Use within 2 weeks prior to baseline (Randomization) of: 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, 5) medicated cleansers or 6) topical antibiotics.\n11. Patients who have had general anesthesia for any reason and patients who have received neuromuscular blocking agents within 14 days prior to study entry (Randomization).\n12. Concomitant use of facial product containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non mild cleansers or moisturizers containing retinol, salicylic or α- or β-hydroxy acids.\n13. Concomitant use of mega-doses of certain vitamins (such as vitamin D and vitamin B12), haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.\n14. Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 2 weeks or during the study.\n15. Concomitant use of tanning booths or sunbathing.\n16. A significant medical history of or are currently immunocompromised\n17. Have any systemic or dermatologic disease that may affect the evaluation of study results.\n18. Have a history of regional enteritis, ulcerative colitis, pseudomembranous colitis or antibiotic-associated colitis.\n19. Subjects with clinically significant unstable medical disorders, life-threatening disease, or current malignancies.\n20. Subjects who engage in activities that involve excessive or prolonged exposure to sunlight.\n21. Subjects with History of Alcohol abuse or other drugs of abuse within 2 years prior to Randomization.\n22. Female subjects who are breast-feeding or planning to become pregnant.\n23. Subjects who have been treated with an investigational drug or investigational device within a period of 30 days prior to study enrollment."}, 'identificationModule': {'nctId': 'NCT02005666', 'briefTitle': 'To Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel of CHL Versus DUAC® Gel', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zydus Lifesciences Limited'}, 'officialTitle': 'A Randomized, Double-blind, Multicentric, Parallel-group, Active and Placebo Controlled, Three Arm Clinical Study to Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel (of Cadila Healthcare Limited, India) Versus DUAC® Gel (of Stiefel Laboratories, USA) Versus Placebo (Vehicle Gel) in the Ratio of 2:2:1 Respectively, in Patients With Acne Vulgaris', 'orgStudyIdInfo': {'id': 'CRL/CT/09/11-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test-Cadila healthcare limited', 'description': 'Drug:-Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days', 'interventionNames': ['Drug: Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference', 'description': 'Drug:-DUAC® Gel (of Stiefel Laboratories, USA) Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days', 'interventionNames': ['Drug: DUAC® Gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Drug:-Placebo (Vehicle Gel) Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel', 'type': 'DRUG', 'otherNames': ['1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of CHL'], 'description': 'Drug:-1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days', 'armGroupLabels': ['Test-Cadila healthcare limited']}, {'name': 'DUAC® Gel', 'type': 'DRUG', 'otherNames': ['DUAC® Gel (of Stiefel Laboratories'], 'description': 'Drug:-DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days', 'armGroupLabels': ['Reference']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo (Vehicle Gel)'], 'description': 'Drug:-Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93618', 'city': 'Dinuba', 'state': 'California', 'country': 'United States', 'facility': 'Universal BioPharma Research', 'geoPoint': {'lat': 36.54328, 'lon': -119.38707}}, {'zip': '92705', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Research Across America', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '33472', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Visions Clinical Research', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Dermatology Research Instititue', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'International Dermatology Research, Inc.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '46168', 'city': 'Plainfield', 'state': 'Indiana', 'country': 'United States', 'facility': 'The Indiana Clinical Trials Center', 'geoPoint': {'lat': 39.70421, 'lon': -86.39944}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Dermatology Specialists', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '55432', 'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Clinical Study Center', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'zip': '68144', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Skin Specialists, PC', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Academic Dermatology Associates', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '19067', 'city': 'Yardley', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Yardley Dermatology Associates', 'geoPoint': {'lat': 40.24566, 'lon': -74.846}}, {'zip': '77802', 'city': 'Bryan', 'state': 'Texas', 'country': 'United States', 'facility': 'Discover Research', 'geoPoint': {'lat': 30.67436, 'lon': -96.36996}}, {'zip': '500012', 'city': 'Hyderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Osmania General Hospital'}, {'zip': '500048', 'city': 'Hyderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Gandhi Hospital,'}, {'zip': '530002', 'city': 'Visakhapatnam', 'state': 'Andrapradesh', 'country': 'India', 'facility': 'King George Hospital', 'geoPoint': {'lat': 17.68009, 'lon': 83.20161}}, {'zip': '380006', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'NHL Medical College and VS Hospital', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '380008', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'AMC-MET Medical College, Sheth LG General Hospital,', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '380015', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Sanjeevani Hospital,', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '380016', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Dept of Dermatology, Leprosy and STI, Civil Hospital and BJ Medical College,', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '400 008', 'city': 'Mumbai', 'state': 'Gujarat', 'country': 'India', 'facility': 'Dept of Dermatology, BYL Nair Hospital and TN medical college, Dr ALNair Road, Mumbai Central,'}, {'zip': '395001', 'city': 'Surat', 'state': 'Gujarat', 'country': 'India', 'facility': 'Department of Dermatology, New Civil Hospital and Government Medical College', 'geoPoint': {'lat': 21.19594, 'lon': 72.83023}}, {'zip': '390001', 'city': 'Vadodara', 'state': 'Gujarat', 'country': 'India', 'facility': 'Baroda Medical College', 'geoPoint': {'lat': 22.29941, 'lon': 73.20812}}, {'zip': '560 052', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Dept of Dermatology, Bhagawan Mahaveer Jain Hospital Millers Road,Vasanthnagar -', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560004', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Dept of Dermatology, Kempegowda Institute of Medical Sciences', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '560073', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Sapthagiri Hospital,', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '570004', 'city': 'Mysore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Dept of Skin & STD, JSS Hospital Ramanuja Road, -', 'geoPoint': {'lat': 12.29791, 'lon': 76.63925}}, {'zip': '440003', 'city': 'Nagpur', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Government Medical Collge', 'geoPoint': {'lat': 21.14631, 'lon': 79.08491}}, {'zip': '440019', 'city': 'Nagpur', 'state': 'Maharashtra', 'country': 'India', 'facility': 'NKP Salve Institute of Medical Siences and Lata Mangeshkar Hospital,', 'geoPoint': {'lat': 21.14631, 'lon': 79.08491}}, {'zip': '400706', 'city': 'Navi Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Dr. D Y Patil Hospital and Research Center', 'geoPoint': {'lat': 19.03681, 'lon': 73.01582}}, {'zip': '411001', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Jehangir Clinical Development Center', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '411007.', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Medipoint Hosp', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '110002', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Maulana Azad Medical College', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '160012', 'city': 'Chandigarh', 'state': 'Punjab', 'country': 'India', 'facility': 'Postgraduate Institute of Medical Education & Research (PGIMER)'}, {'zip': '226003', 'city': 'Lucknow', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'M.V. Hospital and research Center', 'geoPoint': {'lat': 26.83928, 'lon': 80.92313}}, {'zip': '700020', 'city': 'Kolkata', 'state': 'West Bengal', 'country': 'India', 'facility': 'Institute of Post graduate medical and Research', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'zip': '110 060', 'city': 'Delhi', 'country': 'India', 'facility': 'Ganga Ram Hospital,', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}], 'overallOfficials': [{'name': 'Dr Dharmesh Domadia, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cliantha Research Limited'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zydus Lifesciences Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}