Viewing Study NCT02120456

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Ignite Creation Date: 2025-12-24 @ 11:35 PM
Ignite Modification Date: 2026-01-26 @ 8:39 AM
Study NCT ID: NCT02120456
Status: COMPLETED
Last Update Posted: 2025-03-06
First Post: 2014-04-18
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': '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': 'C000612882', 'term': 'LEO 43204'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'disclosure@leo-pharma.com', 'title': 'Clinical Trial Disclosure Specialist', 'organization': 'LEO Pharma A/S'}, 'certainAgreement': {'otherDetails': 'LEO acknowledges the investigators right to publish the entire results of the study, irrespective of outcome. LEO retains the right to have any publication submitted to LEO for review. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: LEO 43204 Gel 0.018%', 'description': 'Once daily treatment for two consecutive days with LEO 43204 gel 0.018%', 'otherNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part 1: LEO 43204 Gel 0.025%', 'description': 'Once daily treatment for two consecutive days with LEO 43204 gel 0.025%', 'otherNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part 1: LEO 43204 Gel 0.037%', 'description': 'Once daily treatment for two consecutive days with LEO 43204 gel 0.037%', 'otherNumAtRisk': 12, 'otherNumAffected': 5, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part 1: LEO 43204 Gel 0.05%', 'description': 'Once daily treatment for two consecutive days with LEO 43204 gel 0.05%', 'otherNumAtRisk': 12, 'otherNumAffected': 9, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part 1: LEO 43204 Gel 0.075%', 'description': 'Once daily treatment for two consecutive days with LEO 43204 gel 0.075%', 'otherNumAtRisk': 12, 'otherNumAffected': 10, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part 1: LEO 43204 Gel 0.1%', 'description': 'Once daily treatment for two consecutive days with LEO 43204 gel 0.1%', 'otherNumAtRisk': 9, 'otherNumAffected': 7, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part 2: LEO 43204 Vehicle Gel', 'description': 'Once daily treatment for two consecutive days LEO 43204 vehicle gel', 'otherNumAtRisk': 32, 'otherNumAffected': 6, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Part 2: LEO 43204 Gel 0.075%', 'description': 'Once daily treatment for two consecutive days LEO 43204 gel 0.075%', 'otherNumAtRisk': 60, 'otherNumAffected': 36, 'seriousNumAtRisk': 60, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'Part 2: LEO 43204 Gel 0.1%', 'description': 'Once daily treatment for two consecutive days LEO 43204 gel 0.1%', 'otherNumAtRisk': 63, 'otherNumAffected': 39, 'seriousNumAtRisk': 63, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 23}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 15}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Application site paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Application site vesicles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Foreign body reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Administration site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Application site discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Application site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Helicobacter gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Viral pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Nerve compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Restless legs syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, 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'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Prostatomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'seriousEvents': [{'term': 'Keratoacanthoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1: Participants Experiencing Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: LEO 43204 Gel 0.018%', 'description': 'Once daily treatment for two consecutive days with LEO 43204 gel 0.018%'}, {'id': 'OG001', 'title': 'Part 1: LEO 43204 Gel 0.025%', 'description': 'Once daily treatment for two consecutive days with LEO 43204 gel 0.025%'}, {'id': 'OG002', 'title': 'Part 1: LEO 43204 Gel 0.037%', 'description': 'Once daily treatment for two consecutive days with LEO 43204 gel 0.037%'}, {'id': 'OG003', 'title': 'Part 1: LEO 43204 Gel 0.05%', 'description': 'Once daily treatment for two consecutive days with LEO 43204 gel 0.05%'}, {'id': 'OG004', 'title': 'Part 1: LEO 43204 Gel 0.075%', 'description': 'Once daily treatment for two consecutive days with LEO 43204 gel 0.075%'}, {'id': 'OG005', 'title': 'Part 1: LEO 43204 Gel 0.1%', 'description': 'Once daily treatment for two consecutive days with LEO 43204 gel 0.1%'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'No', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 up to and including Day 8', 'description': 'The number participants experiencing a DLT was used to identify the maximum tolerated dose(MTD) levels of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level at which less than 4 out of 12 participants experienced a DLT.\n\nA DLT was defined as one or more of the following three LSRs:\n\n* Crusting Grade 4\n* Erosion/Ulceration Grade 4\n* Vesiculation/Pustulation Grade 4\n\nor two or more of the following five LSRs:\n\n* Crusting Grade 3\n* Swelling Grade 4\n* Erosion/Ulceration Grade 3\n* Vesiculation/Pustulation Grade 3\n\nor other clinically relevant signs or symptoms observed, which the Investigator judged to be counted as a DLT.\n\nThe LSRs consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category was given a numeric grade of severity from 0-4. Grade 0 being no presence and Grade 4 being the highest grade of severity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: LEO 43204 Vehicle Gel', 'description': 'Once daily treatment for two consecutive days LEO 43204 vehicle gel'}, {'id': 'OG001', 'title': 'Part 2: LEO 43204 Gel 0.075%', 'description': 'Once daily treatment for two consecutive days LEO 43204 gel 0.075%'}, {'id': 'OG002', 'title': 'Part 2: LEO 43204 Gel 0.1%', 'description': 'Once daily treatment for two consecutive days LEO 43204 gel 0.1%'}], 'classes': [{'categories': [{'measurements': [{'value': '32.7', 'groupId': 'OG000', 'lowerLimit': '17.9', 'upperLimit': '44.8'}, {'value': '70.0', 'groupId': 'OG001', 'lowerLimit': '64.1', 'upperLimit': '74.9'}, {'value': '62.2', 'groupId': 'OG002', 'lowerLimit': '55.5', 'upperLimit': '67.8'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.45', 'ciLowerLimit': '0.34', 'ciUpperLimit': '0.58', 'groupDescription': 'Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.', 'statisticalMethod': 'Negative binominal regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.56', 'ciLowerLimit': '0.44', 'ciUpperLimit': '0.73', 'groupDescription': 'Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.', 'statisticalMethod': 'Negative binominal regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.058', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.26', 'ciLowerLimit': '0.99', 'ciUpperLimit': '1.60', 'statisticalMethod': 'Negative binominal regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Week 8', 'description': 'Percent reduction from baseline in clinically visible actinic keratosis lesions (AKs) identified in the treatment area.', 'unitOfMeasure': 'percentage of reduction', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Part 2: Participants With Complete Clearance of AKs (Last Observation Carried Forward [LOCF])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: LEO 43204 Vehicle Gel', 'description': 'Once daily treatment for two consecutive days LEO 43204 vehicle gel'}, {'id': 'OG001', 'title': 'Part 2: LEO 43204 Gel 0.075%', 'description': 'Once daily treatment for two consecutive days LEO 43204 gel 0.075%'}, {'id': 'OG002', 'title': 'Part 2: LEO 43204 Gel 0.1%', 'description': 'Once daily treatment for two consecutive days LEO 43204 gel 0.1%'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.94', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of clearance rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.30', 'ciUpperLimit': '4.73', 'groupDescription': 'Log binomial regression with factors treatment group and baseline AK count as a covariate.', 'statisticalMethod': 'Log binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.00', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of clearance rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.28', 'ciUpperLimit': '4.51', 'groupDescription': 'Log binomial regression with factors treatment group and baseline AK count as a covariate.', 'statisticalMethod': 'Log binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.93', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of clearance rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.31', 'ciUpperLimit': '2.89', 'groupDescription': 'Log binomial regression with factors treatment group and baseline AK count as a covariate.', 'statisticalMethod': 'Log binomial regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to Week 8', 'description': 'Complete clearance was defined as a 100% reduction from baseline in AK count.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Part 2: Participants With Partial Clearance of AKs (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: LEO 43204 Vehicle Gel', 'description': 'Once daily treatment for two consecutive days LEO 43204 vehicle gel'}, {'id': 'OG001', 'title': 'Part 2: LEO 43204 Gel 0.075%', 'description': 'Once daily treatment for two consecutive days LEO 43204 gel 0.075%'}, {'id': 'OG002', 'title': 'Part 2: LEO 43204 Gel 0.1%', 'description': 'Once daily treatment for two consecutive days LEO 43204 gel 0.1%'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of clearance rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.88', 'ciLowerLimit': '1.36', 'ciUpperLimit': '7.85', 'groupDescription': 'Log binomial regression with factors treatment group and baseline AK count as a covariate.', 'statisticalMethod': 'Log binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of clearance rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.84', 'ciLowerLimit': '1.35', 'ciUpperLimit': '7.74', 'groupDescription': 'Log binomial regression with factors treatment group and baseline AK count as a covariate.', 'statisticalMethod': 'Log binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.95', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of clearance rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.47', 'groupDescription': 'Log binomial regression with factors treatment group and baseline AK count as a covariate.', 'statisticalMethod': 'Log binomial regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to Week 8', 'description': 'Partial clearance was defined as at least 75% reduction from baseline in AK count.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1: LEO 43204 Gel 0.018%', 'description': 'Once daily treatment for two consecutive days with LEO 43204 gel 0.018% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.'}, {'id': 'FG001', 'title': 'Part 1: LEO 43204 Gel 0.025%', 'description': 'Once daily treatment for two consecutive days with LEO 43204 gel 0.025% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.'}, {'id': 'FG002', 'title': 'Part 1: LEO 43204 Gel 0.037%', 'description': 'Once daily treatment for two consecutive days with LEO 43204 gel 0.037% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.'}, {'id': 'FG003', 'title': 'Part 1: LEO 43204 Gel 0.05%', 'description': 'Once daily treatment for two consecutive days with LEO 43204 gel 0.05% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.'}, {'id': 'FG004', 'title': 'Part 1: LEO 43204 Gel 0.075%', 'description': 'Once daily treatment for two consecutive days with LEO 43204 gel 0.075% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.'}, {'id': 'FG005', 'title': 'Part 1: LEO 43204 Gel 0.1%', 'description': 'Once daily treatment for two consecutive days with LEO 43204 gel 0.1% on sun exposed area of 250 cm2 on the arm between wrist and shoulder.'}, {'id': 'FG006', 'title': 'Part 2: LEO 43204 Vehicle Gel', 'description': 'Once daily treatment for two consecutive days with LEO 43204 vehicle gel on sun exposed area of 250 cm2 on the extremities or trunk (except chest).'}, {'id': 'FG007', 'title': 'Part 2: LEO 43204 Gel 0.075%', 'description': 'Once daily treatment for two consecutive days with LEO 43204 gel 0.075% on sun exposed area of 250 cm2 on the extremities or trunk (except chest).'}, {'id': 'FG008', 'title': 'Part 2: LEO 43204 Gel 0.1%', 'description': 'Once daily treatment for two consecutive days with LEO 43204 gel 0.1% on sun exposed area of 250 cm2 on the extremities or trunk (except chest).'}], 'periods': [{'title': 'Part 1 Open-label, Dose-escalation Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}, {'title': 'Part 2 Double-blind Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '32'}, {'groupId': 'FG007', 'numSubjects': '60'}, {'groupId': 'FG008', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '30'}, {'groupId': 'FG007', 'numSubjects': '60'}, {'groupId': 'FG008', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Withdrawal of consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Unable to attend visit due to work', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}, {'value': '60', 'groupId': 'BG007'}, {'value': '63', 'groupId': 'BG008'}, {'value': '224', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: LEO 43204 Gel 0.018%', 'description': 'Once daily treatment for two consecutive days with LEO 43204 gel 0.018%'}, {'id': 'BG001', 'title': 'Part 1: LEO 43204 Gel 0.025%', 'description': 'Once daily treatment for two consecutive days with LEO 43204 gel 0.025%'}, {'id': 'BG002', 'title': 'Part 1: LEO 43204 Gel 0.037%', 'description': 'Once daily treatment for two consecutive days with LEO 43204 gel 0.037%'}, {'id': 'BG003', 'title': 'Part 1: LEO 43204 Gel 0.05%', 'description': 'Once daily treatment for two consecutive days with LEO 43204 gel 0.05%'}, {'id': 'BG004', 'title': 'Part 1: LEO 43204 Gel 0.075%', 'description': 'Once daily treatment for two consecutive days with LEO 43204 gel 0.075%'}, {'id': 'BG005', 'title': 'Part 1: LEO 43204 Gel 0.1%', 'description': 'Once daily treatment for two consecutive days with LEO 43204 gel 0.1%'}, {'id': 'BG006', 'title': 'Part 2: LEO 43204 Vehicle Gel', 'description': 'Once daily treatment for two consecutive days LEO 43204 vehicle gel'}, {'id': 'BG007', 'title': 'Part 2: LEO 43204 Gel 0.075%', 'description': 'Once daily treatment for two consecutive days LEO 43204 gel 0.075%'}, {'id': 'BG008', 'title': 'Part 2: LEO 43204 Gel 0.1%', 'description': 'Once daily treatment for two consecutive days LEO 43204 gel 0.1%'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '22', 'groupId': 'BG007'}, {'value': '23', 'groupId': 'BG008'}, {'value': '82', 'groupId': 'BG009'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '21', 'groupId': 'BG006'}, {'value': '38', 'groupId': 'BG007'}, {'value': '40', 'groupId': 'BG008'}, {'value': '142', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}, {'value': '24', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}, {'value': '96', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '36', 'groupId': 'BG007'}, {'value': '37', 'groupId': 'BG008'}, {'value': '128', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '20', 'groupId': 'BG007'}, {'value': '21', 'groupId': 'BG008'}, {'value': '52', 'groupId': 'BG009'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '21', 'groupId': 'BG006'}, {'value': '40', 'groupId': 'BG007'}, {'value': '42', 'groupId': 'BG008'}, {'value': '172', 'groupId': 'BG009'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'dispFirstSubmitDate': '2016-04-18', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2014-04-18', 'dispFirstSubmitQcDate': '2016-04-18', 'resultsFirstSubmitDate': '2018-11-14', 'studyFirstSubmitQcDate': '2014-04-21', 'dispFirstPostDateStruct': {'date': '2016-05-17', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-28', 'studyFirstPostDateStruct': {'date': '2014-04-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Participants Experiencing Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs)', 'timeFrame': 'From Day 1 up to and including Day 8', 'description': 'The number participants experiencing a DLT was used to identify the maximum tolerated dose(MTD) levels of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level at which less than 4 out of 12 participants experienced a DLT.\n\nA DLT was defined as one or more of the following three LSRs:\n\n* Crusting Grade 4\n* Erosion/Ulceration Grade 4\n* Vesiculation/Pustulation Grade 4\n\nor two or more of the following five LSRs:\n\n* Crusting Grade 3\n* Swelling Grade 4\n* Erosion/Ulceration Grade 3\n* Vesiculation/Pustulation Grade 3\n\nor other clinically relevant signs or symptoms observed, which the Investigator judged to be counted as a DLT.\n\nThe LSRs consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category was given a numeric grade of severity from 0-4. Grade 0 being no presence and Grade 4 being the highest grade of severity.'}, {'measure': 'Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Count', 'timeFrame': 'From baseline to Week 8', 'description': 'Percent reduction from baseline in clinically visible actinic keratosis lesions (AKs) identified in the treatment area.'}], 'secondaryOutcomes': [{'measure': 'Part 2: Participants With Complete Clearance of AKs (Last Observation Carried Forward [LOCF])', 'timeFrame': 'From baseline to Week 8', 'description': 'Complete clearance was defined as a 100% reduction from baseline in AK count.'}, {'measure': 'Part 2: Participants With Partial Clearance of AKs (LOCF)', 'timeFrame': 'From baseline to Week 8', 'description': 'Partial clearance was defined as at least 75% reduction from baseline in AK count.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Actinic Keratosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.leopharmatrials.com/en', 'label': 'Clinical Trials at LEO Pharma'}]}, 'descriptionModule': {'briefSummary': 'Part 1: To identify Maximum Tolerated Dose (MTD) levels of LEO 43204 after once daily treatment for two consecutive days\n\nPart 2: To evaluate the efficacy of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the arm\n* Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the extremities or trunk\n\nExclusion Criteria:\n\n* Location of the treatment area\n\n * within 5 cm of an incompletely healed wound\n * within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)\n* Prior treatment with ingenol mebutate gel on the treatment area\n* Lesions in the treatment areas that have:\n\n * atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or\n * recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions)'}, 'identificationModule': {'nctId': 'NCT02120456', 'briefTitle': 'Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'officialTitle': 'Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis', 'orgStudyIdInfo': {'id': 'LP0084-1015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LEO 43204', 'description': 'Open-label, dose-escalation, 2-day treatment', 'interventionNames': ['Drug: LEO 43204']}, {'type': 'EXPERIMENTAL', 'label': 'LEO 43204 Dose 0.1%', 'description': 'LEO 43204 dose 0.1% once daily for two consecutive days', 'interventionNames': ['Drug: LEO 43204']}, {'type': 'EXPERIMENTAL', 'label': 'LEO 43204 Dose 0.075%', 'description': 'LEO 43204 dose 0.075% once daily for two days', 'interventionNames': ['Drug: LEO 43204']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo once daily for two days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LEO 43204', 'type': 'DRUG', 'armGroupLabels': ['LEO 43204', 'LEO 43204 Dose 0.075%', 'LEO 43204 Dose 0.1%']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Omni Dermatology', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90717', 'city': 'Lomita', 'state': 'California', 'country': 'United States', 'facility': 'Torrance Clinical Research Institute Inc.', 'geoPoint': {'lat': 33.79224, 'lon': -118.31507}}, {'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Dermatology Associates and Research', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Leavitt Medical Associates of Florida', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'zip': '47713', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Deaconess Clinic, Inc.', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '47714', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Hudson Dermatology, LLC', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '46168', 'city': 'Plainfield', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Clinical Trials Center', 'geoPoint': {'lat': 39.70421, 'lon': -86.39944}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'DermAssociates, PC', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '48706', 'city': 'Bay City', 'state': 'Michigan', 'country': 'United States', 'facility': 'Great Lakes Research Group, Inc.', 'geoPoint': {'lat': 43.59447, 'lon': -83.88886}}, {'zip': '07044', 'city': 'Verona', 'state': 'New Jersey', 'country': 'United States', 'facility': 'The Dermatology Group, P.C.', 'geoPoint': {'lat': 40.82982, 'lon': -74.24015}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '78660', 'city': 'Pflugerville', 'state': 'Texas', 'country': 'United States', 'facility': 'Pflugerville Dermatology Clinical Research Center, Inc.', 'geoPoint': {'lat': 30.43937, 'lon': -97.62}}, {'zip': 'T2G 1B1', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Kirk Barber Research', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V3R 6A7', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Enverus Medical', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'V5Z 4E8', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Skin Care Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'R3C 0N2', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Winnipeg Clinic Dermatology Research', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'L4M 6L2', 'city': 'Barrie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'UltraNova Skincare', 'geoPoint': {'lat': 44.40011, 'lon': -79.66634}}, {'zip': 'L8N 1V6', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dermatrials Research Incorporated', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A 3H7', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Guenther Dermatology Research Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'K9J 1Z2', 'city': 'Peterborough', 'state': 'Ontario', 'country': 'Canada', 'facility': 'SKiN Centre for Dermatology', 'geoPoint': {'lat': 44.30012, 'lon': -78.31623}}], 'overallOfficials': [{'name': 'Gary Goldenberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mount Sinai School of Medicine, Dermatology Faculty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LEO Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}