Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-25 @ 3:52 AM
Study NCT ID:
NCT02654769
Status:
COMPLETED
Last Update Posted:
2020-05-12
First Post:
2016-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055623', 'term': 'Keratosis, Actinic'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C486592', 'term': '3-ingenyl angelate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'USMedinfo@tevapharm.com', 'phone': '1-888-483-8279', 'title': 'Senior Director, Clinical R&D', 'organization': 'Teva Pharmaceuticals Inc., USA'}, 'certainAgreement': {'otherDetails': 'The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the start of the study until Week 8 (end of study).', 'eventGroups': [{'id': 'EG000', 'title': 'Generic Ingenol Mebutate', 'description': 'Generic ingenol mebutate gel, 0.05% \\[Test\\]\n\nGeneric Ingenol Mebutate: Generic formulated to have the same therapeutic effect of the brand', 'otherNumAtRisk': 149, 'deathsNumAtRisk': 149, 'otherNumAffected': 18, 'seriousNumAtRisk': 149, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Active Comparator Picato®', 'description': 'Picato® (ingenol mebutate) gel, 0.05% (Leo Pharma Inc.) \\[Reference Listed Drug (RLD)\\]\n\nIngenol Mebutate (Picato®): Brand product', 'otherNumAtRisk': 149, 'deathsNumAtRisk': 149, 'otherNumAffected': 29, 'seriousNumAtRisk': 149, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Vehicle Foam', 'description': 'Vehicle gel of the test product\n\nVehicle Foam: It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.', 'otherNumAtRisk': 143, 'deathsNumAtRisk': 143, 'otherNumAffected': 17, 'seriousNumAtRisk': 143, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctival irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema of eyelid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal wall thickening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Application site erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Application site hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Application site scab', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Application site vesicles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Application site abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Application site cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Genital herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Staphyloccocall skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperlipidaemis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Benign neoplasm of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemangioma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Occipital neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Photodermatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Spider vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Efficacy Outcome Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator Picato®', 'description': 'Picato® (ingenol mebutate) gel, 0.05% (Leo Pharma Inc.) \\[Reference Listed Drug (RLD)\\]\n\nIngenol Mebutate (Picato®): Brand product'}, {'id': 'OG001', 'title': 'Generic Ingenol Mebutate', 'description': 'Generic ingenol mebutate gel, 0.05% \\[Test\\]\n\nGeneric Ingenol Mebutate: Generic formulated to have the same therapeutic effect of the brand'}, {'id': 'OG002', 'title': 'Vehicle Foam', 'description': 'Vehicle gel of the test product\n\nVehicle Foam: It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': "90% Wald's confidence interval", 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.87', 'ciLowerLimit': '-12.37', 'ciUpperLimit': '8.63', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Difference (Generic- Picato)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'Percentage of subjects in the PP population in each treatment group with complete clearance of AK lesions. Complete clearance was defined as having no (zero) clinically visible AK lesions in the Treatment Area at the Week 8 visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Population'}, {'type': 'SECONDARY', 'title': 'The Percentage of Subjects in the PP Population in Each Treatment Group With Partial Clearance (as Having at Least 75% Reduction in the Number of Clinically Visible AK Lesions) in theTreatment Area at the Week 8 Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Comparator Picato®', 'description': 'Picato® (ingenol mebutate) gel, 0.05% (Leo Pharma Inc.) \\[Reference Listed Drug (RLD)\\]\n\nIngenol Mebutate (Picato®): Brand product'}, {'id': 'OG001', 'title': 'Generic Ingenol Mebutate', 'description': 'Generic ingenol mebutate gel, 0.05% \\[Test\\]\n\nGeneric Ingenol Mebutate: Generic formulated to have the same therapeutic effect of the brand'}, {'id': 'OG002', 'title': 'Vehicle Foam', 'description': 'Vehicle gel of the test product\n\nVehicle Foam: It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.'}], 'classes': [{'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': "90% Wald's confidence interval", 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-2.64', 'ciLowerLimit': '-13.14', 'ciUpperLimit': '7.86', 'groupDescription': 'Partial Clearance at Week 8', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Difference (Generic - Picato)'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Comparator Picato®', 'description': 'Picato® (ingenol mebutate) gel, 0.05% (Leo Pharma Inc.) \\[Reference Listed Drug (RLD)\\]\n\nIngenol Mebutate (Picato®): Brand product'}, {'id': 'FG001', 'title': 'Generic Ingenol Mebutate', 'description': 'Generic ingenol mebutate gel, 0.05% \\[Test\\]\n\nGeneric Ingenol Mebutate: Generic formulated to have the same therapeutic effect of the brand'}, {'id': 'FG002', 'title': 'Vehicle Foam', 'description': 'Vehicle gel of the test product\n\nVehicle Foam: It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '149'}, {'groupId': 'FG001', 'numSubjects': '149'}, {'groupId': 'FG002', 'numSubjects': '143'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '145'}, {'groupId': 'FG001', 'numSubjects': '148'}, {'groupId': 'FG002', 'numSubjects': '142'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}, {'value': '439', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Comparator Picato®', 'description': 'Picato® (ingenol mebutate) gel, 0.05% (Leo Pharma Inc.) \\[Reference Listed Drug (RLD)\\]\n\nIngenol Mebutate (Picato®): Brand product'}, {'id': 'BG001', 'title': 'Generic Ingenol Mebutate', 'description': 'Generic ingenol mebutate gel, 0.05% \\[Test\\]\n\nGeneric Ingenol Mebutate: Generic formulated to have the same therapeutic effect of the brand'}, {'id': 'BG002', 'title': 'Vehicle Foam', 'description': 'Vehicle gel of the test product\n\nVehicle Foam: It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.4', 'spread': '9.49', 'groupId': 'BG000'}, {'value': '66.6', 'spread': '11.11', 'groupId': 'BG001'}, {'value': '66.2', 'spread': '9.07', 'groupId': 'BG002'}, {'value': '66.7', 'spread': '9.93', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '200', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '239', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}, {'value': '399', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}, {'value': '438', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Fitzpatrick Skin Type I', 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Typical features: Pale white skin, blue/hazel eyes, blond/red hair. Tanning ability: Always burns, does not tan.', 'unitOfMeasure': 'Participants'}, {'title': 'Fitzpatrick Skin Type II', 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '186', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Typical features: fair skin, blue eyes. Tanning ability: burns easily, tans poorly.', 'unitOfMeasure': 'Participants'}, {'title': 'Fitzpatrick Skin Type III', 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Typical features: darker white skin. Tanning ability: tans after initial burn.', 'unitOfMeasure': 'Participants'}, {'title': 'Fitzpatrick Skin Type IV', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Typical features: light brown skin. Tanning ability: burns minimally, tans easily.', 'unitOfMeasure': 'Participants'}, {'title': 'Fitzpatrick Skin Type V', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Typical features: brown skin. Tanning ability: rarely burns, tans darkly easily.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Subjects in Modified Intent-to-Treat Population'}}, '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': 441}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-30', 'studyFirstSubmitDate': '2016-01-12', 'resultsFirstSubmitDate': '2020-04-14', 'studyFirstSubmitQcDate': '2016-01-12', 'lastUpdatePostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-30', 'studyFirstPostDateStruct': {'date': '2016-01-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Efficacy Outcome Measure', 'timeFrame': '8 weeks', 'description': 'Percentage of subjects in the PP population in each treatment group with complete clearance of AK lesions. Complete clearance was defined as having no (zero) clinically visible AK lesions in the Treatment Area at the Week 8 visit.'}], 'secondaryOutcomes': [{'measure': 'The Percentage of Subjects in the PP Population in Each Treatment Group With Partial Clearance (as Having at Least 75% Reduction in the Number of Clinically Visible AK Lesions) in theTreatment Area at the Week 8 Visit.', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Actinic Keratosis']}, 'descriptionModule': {'briefSummary': 'The objective of this study was to evaluate the safety and therapeutic equivalence of generic ingenol mebutate gel, 0.05% to Picato gel, 0.05% and to establish the superiority of the efficacy of these two products over the vehicle gel in the treatment of Actinic Keratosis (AK) on the trunk or extremities.', 'detailedDescription': 'Picato® (ingenol mebutate) gel is the first and only ingenol mebutate product approved by the FDA in 2012 for the topical treatment of AK(s) on the face and scalp (0.015% formulation) and on the trunk and extremities (0.05% formulation). A generic ingenol mebutate gel, 0.05% has been developed for the topical treatment of clinically typical, visible, and discrete non-hyperkeratotic, non-hypertrophic AK lesions of the trunk or extremities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject was a male or non-pregnant female 18 years of age or older\n* Subject provided written informed consent.\n* Subject was willing and able to apply the test article as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.\n* Subject had a clinical diagnosis of AK at Baseline with at least four (4), but no more than eight (8), visible and discrete non-hyperkeratotic, non-hypertrophic AK lesions, each at least 4 mm in diameter, within a contiguous 25 cm2 treatment area ("the Treatment Area") on the trunk or extremities.\n* Subject was in good general health and free of any disease state or physical condition that might have impaired evaluation of AK lesions or which, in the investigator\'s opinion, exposed the subject to an unacceptable risk by study participation.\n* Females must have been post-menopausal , surgically sterile , or have used an effective method of birth control , with a negative urine pregnancy test (UPT) at the Baseline Visit.\n\nExclusion Criteria:\n\n* Subject was pregnant, lactating, or was planning to become pregnant during the study.\n* Subject was currently enrolled in an investigational drug or device study.\n* Subject used an investigational drug or investigational device treatment within 30 days prior to the Baseline Visit.\n* Subject had hyperkeratotic, hypertrophic, or large mat-like AKs (e.g., AK \\>1 cm2 in size) within the contiguous 25 cm2 Treatment Area.\n* Subject had more than eight (8) AKs, independent of size, within the contiguous 25 cm2 Treatment Area.\n* Subject had the need or planned to be exposed to artificial tanning devices or excessive sunlight during the trial.\n* Subject was immunosuppressed (e.g., HIV, systemic malignancy, graft host disease, etc.)\n* Subject had experienced an unsuccessful outcome from previous ingenol mebutate therapy (an unsuccessful outcome was defined as after a reasonable therapeutic trial with no compliance issues and the topical drug did not work).\n* Subject had a history of sensitivity to any of the ingredients in the test articles (see Section 9.4.2).\n* Subject used topical creams, lotions, or gels of any kind within the selected Treatment Area within one (1) day prior to entry into the study.\n* Subject used topical medications; corticosteroids, alpha hydroxy acids (e.g., glycolic acid, lactic acid etc. \\>5%), beta hydroxy acid (salicylic acid \\>2%), urea \\>5%, 5-fluorouracil, diclofenac, imiquimod, ingenol mebutate, or prescription retinoids (e.g., tazarotene, adapalene, tretinoin) within the selected Treatment Area (trunk or extremities) within one (1) month prior to the Baseline Visit.\n* Subject had cryodestruction, curettage, photodynamic therapy, surgical excision, or other treatments for AK within the selected Treatment Area (trunk or extremities) within one (1) month prior to the Baseline Visit.\n* Subject used oral corticosteroid therapy, interferon, cytotoxic drugs, immunomodulators, immunosuppressive therapies, or retinoids within one (1) month prior to the Baseline Visit.\n* Subject had dermatologic procedures or surgeries such as laser resurfacing, Psoralen + ultraviolet A (PUVA) therapy, ultraviolet B (UVB) therapy, chemical peels, or dermabrasion on the selected Treatment area (trunk or extremities) within six (6) months prior to the Baseline Visit.\n* Subject had lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the selected Treatment Area (trunk or extremities).\n* Subject had any skin pathology or condition that, in the investigator\'s opinion, could interfere with the evaluation of the test article or required the use of interfering topical, systemic, or surgical therapy.\n* Subject had any condition which, in the investigator\'s opinion, would have made it unsafe or precluded the subject\'s ability to fully participate in this research study.\n* Subject was unable to communicate or cooperate with the investigator due to language problems, poor mental development, impaired cerebral function, or physical limitations.\n* Subject was known to be noncompliant or was unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.\n* Subject had been previously enrolled in the same study.'}, 'identificationModule': {'nctId': 'NCT02654769', 'briefTitle': 'A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Actavis Inc.'}, 'officialTitle': 'Multicenter Randomized Double-Blind Vehicle-Controlled Parallel Group Study to Determine the Therapeutic Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato® Gel 0.05% in Subjects With Actinic Keratosis on the Trunk or Extremities', 'orgStudyIdInfo': {'id': '094-8151-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator Picato®', 'description': 'Picato® (ingenol mebutate) gel, 0.05% (Leo Pharma Inc.) \\[Reference Listed Drug (RLD)\\]', 'interventionNames': ['Drug: Ingenol Mebutate (Picato®)']}, {'type': 'EXPERIMENTAL', 'label': 'Generic Ingenol Mebutate', 'description': 'Generic ingenol mebutate gel, 0.05% \\[Test\\]', 'interventionNames': ['Drug: Generic Ingenol Mebutate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle Foam', 'description': 'Vehicle gel of the test product', 'interventionNames': ['Drug: Vehicle Foam']}], 'interventions': [{'name': 'Ingenol Mebutate (Picato®)', 'type': 'DRUG', 'otherNames': ['Picato'], 'description': 'Brand product', 'armGroupLabels': ['Active Comparator Picato®']}, {'name': 'Generic Ingenol Mebutate', 'type': 'DRUG', 'description': 'Generic formulated to have the same therapeutic effect of the brand', 'armGroupLabels': ['Generic Ingenol Mebutate']}, {'name': 'Vehicle Foam', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.', 'armGroupLabels': ['Vehicle Foam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Center for Dermatology Clinical Research, Inc', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'SD Sports Medicine & Family Health Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'The Center for Clinical and Cosmetic Research', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Savin Medical Group Research Center', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '33162', 'city': 'North Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Tory P. Sullivan, M.D., P.A.', 'geoPoint': {'lat': 25.93315, 'lon': -80.16255}}, {'zip': '33609', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moore Clinical Research, Inc.', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '83704', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Northwest Clinical Trials, Inc.', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '60005', 'city': 'Arlington Heights', 'state': 'Illinois', 'country': 'United States', 'facility': 'Altman Dermatology Associates', 'geoPoint': {'lat': 42.08836, 'lon': -87.98063}}, {'zip': '61820', 'city': 'Champaign', 'state': 'Illinois', 'country': 'United States', 'facility': 'Christie Clinic, LLC', 'geoPoint': {'lat': 40.11642, 'lon': -88.24338}}, {'zip': '46032', 'city': 'Carmel', 'state': 'Indiana', 'country': 'United States', 'facility': 'Shideler Clinical Research Center', 'geoPoint': {'lat': 39.97837, 'lon': -86.11804}}, {'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Dawes Fretzin Clinical Research Group, LLC', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46168', 'city': 'Plainfield', 'state': 'Indiana', 'country': 'United States', 'facility': 'The Indiana Clinical Trials Center', 'geoPoint': {'lat': 39.70421, 'lon': -86.39944}}, {'zip': '89074', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'Bettencourt Skin Center', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Union Square Dermatology', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Dermatology Consulting Services', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Winston-Salem, LLC', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '02886', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Omega Medical Research, 400 Bald Hill Road, Warwick, RI 02886', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '29607', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Greenville Dermatology, LLC', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '37917', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Dermatology Associates of Knoxville, PC', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'DermResearch, Inc.Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77056', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The Center for Skin Research', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Clinical Research', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Oleg Khatsenko, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Actavis Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Actavis Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}