Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-29 @ 10:27 PM
Study NCT ID:
NCT01922050
Status:
COMPLETED
Last Update Posted:
2025-03-06
First Post:
2013-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Increasing Strengths, Safety and Efficacy of Two Formulas of LEO 43204 on the Face or the Chest in Patients 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'disclosure@leo-pharma.com', 'title': 'Clinical Trial Disclosure Specialist', 'organization': 'LEO Pharma A/S'}, 'certainAgreement': {'otherDetails': "LEO acknowledges the investigator's 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': 'From Day 1 to Week 8', 'description': 'The safety analysis was based on the Safety Analysis Set, which was defined as all randomized participants who received at least 1 application of investigational product and had safety information available post treatment. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and this was excluded from the safety analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: LEO 43204 Gel 0.0015', 'description': 'Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part 1: LEO 43204 Gel 0.003', 'description': 'Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment', 'otherNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part 1: LEO 43204 Gel 0.006', 'description': 'Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment', 'otherNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Part 1: LEO 43204 Gel 0.012', 'description': 'Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment', 'otherNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part 1: LEO 43204 Gel 0.018', 'description': 'Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment', 'otherNumAtRisk': 17, 'otherNumAffected': 10, 'seriousNumAtRisk': 17, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Part 1: LEO 43204 Gel 0.025', 'description': 'Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment', 'otherNumAtRisk': 18, 'otherNumAffected': 11, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part 1: LEO 43204 Cream 0.0015', 'description': 'Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment', 'otherNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Part 1: LEO 43204 Cream 0.003', 'description': 'Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment', 'otherNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Part 1: LEO 43204 Cream 0.006', 'description': 'Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment', 'otherNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Part 1: LEO 43204 Cream 0.012', 'description': 'Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment', 'otherNumAtRisk': 12, 'otherNumAffected': 8, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'Part 2: LEO 43204 Gel Vehicle', 'description': 'Part 2: Double-Blind, Once-Daily, 2-Day Treatment', 'otherNumAtRisk': 58, 'otherNumAffected': 11, 'seriousNumAtRisk': 58, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'Part 2: LEO 43204 Gel 0.006', 'description': 'Part 2: Double-Blind, Once-Daily, 2-Day Treatment', 'otherNumAtRisk': 62, 'otherNumAffected': 38, 'seriousNumAtRisk': 62, 'seriousNumAffected': 5}, {'id': 'EG012', 'title': 'Part 2: LEO 43204 Gel 0.012', 'description': 'Part 2: Double-Blind, Once-Daily, 2-Day Treatment', 'otherNumAtRisk': 60, 'otherNumAffected': 40, 'seriousNumAtRisk': 60, 'seriousNumAffected': 2}, {'id': 'EG013', 'title': 'Part 2: LEO 43204 Gel 0.018', 'description': 'Part 2: Double-Blind, Once-Daily, 2-Day Treatment', 'otherNumAtRisk': 62, 'otherNumAffected': 47, 'seriousNumAtRisk': 62, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 5}, {'groupId': 'EG010', 'numAtRisk': 58, 'numAffected': 5}, {'groupId': 'EG011', 'numAtRisk': 62, 'numAffected': 25}, {'groupId': 'EG012', 'numAtRisk': 60, 'numAffected': 33}, {'groupId': 'EG013', 'numAtRisk': 62, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 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'EG010', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Application site discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 58, 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'EG011', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG012', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 62, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Application site exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 62, 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'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Periorbital oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG013', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 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62, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Renal failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'seriousEvents': [{'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1: Number of Participants Experiencing a Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Cohort 1: LEO 43204 Gel 0.0015', 'description': 'Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment'}, {'id': 'OG001', 'title': 'Part 1: Cohort 2: LEO 43204 Gel 0.003', 'description': 'Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment'}, {'id': 'OG002', 'title': 'Part 1: Cohort 3: LEO 43204 Gel 0.006', 'description': 'Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment'}, {'id': 'OG003', 'title': 'Part 1: Cohort 4: LEO 43204 Gel 0.012', 'description': 'Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment'}, {'id': 'OG004', 'title': 'Part 1: Cohort 5: LEO 43204 Gel 0.018', 'description': 'Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment'}, {'id': 'OG005', 'title': 'Part 1: Cohort 6: LEO 43204 Gel 0.025', 'description': 'Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment'}, {'id': 'OG006', 'title': 'Part 1: Cohort 1: LEO 43204 Cream 0.0015', 'description': 'Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment'}, {'id': 'OG007', 'title': 'Part 1: Cohort 2: LEO 43204 Cream 0.003', 'description': 'Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment'}, {'id': 'OG008', 'title': 'Part 1: Cohort 3: LEO 43204 Cream 0.006', 'description': 'Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment'}, {'id': 'OG009', 'title': 'Part 1: Cohort 4: LEO 43204 Cream 0.012', 'description': 'Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment'}], 'classes': [{'categories': [{'title': 'No', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '9', 'groupId': 'OG009'}]}, {'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Day 1 up to and including Day 8', 'description': 'The number of participants experiencing DLTs are tabulated by treatment group. This was used to identify the maximum tolerated dose (MTD) of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level with less than 4 out of 12 participants(cohorts 1 to 4) or less than 6 out of 18 participants(cohorts 5 and 6) experiencing a DLT\n\nDLT was defined as one or more of the following 3 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* Erythema Grade 4\n* Crusting Grade 3\n* Swelling Grade 4\n* Erosion/Ulceration Grade 3\n* Vesiculation/Pustulation Grade 3\n\nThe Local Skin Responses consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category are given a numeric grade of severity from 0-4. Grade 0 being no presence and 4 being the highest grade of severity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Counts (Multiple Imputation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: LEO 43204 Gel Vehicle', 'description': 'Part 2: Double-Blind, Once-Daily, 2-Day Treatment'}, {'id': 'OG001', 'title': 'Part 2: LEO 43204 Gel 0.006', 'description': 'Part 2: Double-Blind, Once-Daily, 2-Day Treatment'}, {'id': 'OG002', 'title': 'Part 2: LEO 43204 Gel 0.012', 'description': 'Part 2: Double-Blind, Once-Daily, 2-Day Treatment'}, {'id': 'OG003', 'title': 'Part 2: LEO 43204 Gel 0.018', 'description': 'Part 2: Double-Blind, Once-Daily, 2-Day Treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '42.3', 'groupId': 'OG000', 'lowerLimit': '30.5', 'upperLimit': '52.1'}, {'value': '69.7', 'groupId': 'OG001', 'lowerLimit': '63.1', 'upperLimit': '75.1'}, {'value': '73.4', 'groupId': 'OG002', 'lowerLimit': '67.1', 'upperLimit': '78.5'}, {'value': '79.0', 'groupId': 'OG003', 'lowerLimit': '74.0', 'upperLimit': '83.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.53', 'ciLowerLimit': '0.40', 'ciUpperLimit': '0.69', 'statisticalMethod': 'Negative binominal regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.46', 'ciLowerLimit': '0.35', 'ciUpperLimit': '0.61', 'statisticalMethod': 'Negative binominal regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.36', 'ciLowerLimit': '0.28', 'ciUpperLimit': '0.48', 'statisticalMethod': 'Negative binominal regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.'}, {'pValue': '0.38', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.17', 'statisticalMethod': 'Negative binominal regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.'}, {'pValue': '0.013', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.52', 'ciUpperLimit': '0.93', 'statisticalMethod': 'Negative binominal regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.'}, {'pValue': '0.13', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.58', 'ciUpperLimit': '1.07', 'statisticalMethod': 'Negative binominal regression', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Negative binominal regression with log baseline count as offset variable and treatment group and analysis site as factors.'}], 'paramType': 'MEAN', 'timeFrame': 'At Week 8', 'unitOfMeasure': 'percentage of reduction', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the Full Analysis Set, which was defined as all randomized participants who applied investigation product. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and thus was excluded from the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Part 2: Percentage of Participants With Complete Clearance of Actinic Keratosis Lesions (AKs) (Multiple Imputation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: LEO 43204 Gel Vehicle', 'description': 'Part 2: Double-Blind, Once-Daily, 2-Day Treatment'}, {'id': 'OG001', 'title': 'Part 2: LEO 43204 Gel 0.006', 'description': 'Part 2: Double-Blind, Once-Daily, 2-Day Treatment'}, {'id': 'OG002', 'title': 'Part 2: LEO 43204 Gel 0.012', 'description': 'Part 2: Double-Blind, Once-Daily, 2-Day Treatment'}, {'id': 'OG003', 'title': 'Part 2: LEO 43204 Gel 0.018', 'description': 'Part 2: Double-Blind, Once-Daily, 2-Day Treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '20.7'}, {'value': '9.9', 'groupId': 'OG001', 'lowerLimit': '2.4', 'upperLimit': '17.3'}, {'value': '18.8', 'groupId': 'OG002', 'lowerLimit': '8.8', 'upperLimit': '28.8'}, {'value': '24.2', 'groupId': 'OG003', 'lowerLimit': '13.5', 'upperLimit': '34.9'}]}]}], 'analyses': [{'pValue': '0.57', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of clearance rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.27', 'ciUpperLimit': '2.04', 'groupDescription': 'Log binomial regression with treatment group as factor and baseline AK count included as covariate.', 'statisticalMethod': 'Log binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.51', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of clearance rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.33', 'ciLowerLimit': '0.56', 'ciUpperLimit': '3.13', 'groupDescription': 'Log binomial regression with treatment group as factor and baseline AK count included as covariate.', 'statisticalMethod': 'Log binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.11', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of clearance rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.90', 'ciLowerLimit': '0.86', 'ciUpperLimit': '4.21', 'groupDescription': 'Log binomial regression with treatment group as factor and baseline AK count included as covariate.', 'statisticalMethod': 'Log binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.21', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of clearance rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.79', 'ciLowerLimit': '0.72', 'ciUpperLimit': '4.43', 'groupDescription': 'Log binomial regression with treatment group as factor and baseline AK count included as covariate.', 'statisticalMethod': 'Log binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.031', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of clearance rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.55', 'ciLowerLimit': '1.09', 'ciUpperLimit': '5.98', 'groupDescription': 'Log binomial regression with treatment group as factor and baseline AK count included as covariate.', 'statisticalMethod': 'Log binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.29', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of clearance rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.43', 'ciLowerLimit': '0.74', 'ciUpperLimit': '2.75', 'groupDescription': 'Log binomial regression with treatment group as factor and baseline AK count included as covariate.', 'statisticalMethod': 'Log binomial regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 8', 'description': 'Complete clearance was defined as a 100% reduction from baseline in AK count. For treatment groups Vehicle, 0.006 and 0.012 the table shows the percentage of mean number of participants across imputations with complete clearance. For treatment group 0.018 the table shows the percentage of mean number of participants with complete clearance in observed cases.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the Full Analysis Set, which was defined as all randomized participants who applied investigation product. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and thus was excluded from the efficacy analysis.'}, {'type': 'SECONDARY', 'title': 'Part 2: Percentage of Participants With Partial Clearance of AKs (Multiple Imputation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: LEO 43204 Gel Vehicle', 'description': 'Part 2: Double-Blind, Once-Daily, 2-Day Treatment'}, {'id': 'OG001', 'title': 'Part 2: LEO 43204 Gel 0.006', 'description': 'Part 2: Double-Blind, Once-Daily, 2-Day Treatment'}, {'id': 'OG002', 'title': 'Part 2: LEO 43204 Gel 0.012', 'description': 'Part 2: Double-Blind, Once-Daily, 2-Day Treatment'}, {'id': 'OG003', 'title': 'Part 2: LEO 43204 Gel 0.018', 'description': 'Part 2: Double-Blind, Once-Daily, 2-Day Treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '29.9', 'groupId': 'OG000', 'lowerLimit': '18.0', 'upperLimit': '41.9'}, {'value': '52.4', 'groupId': 'OG001', 'lowerLimit': '39.9', 'upperLimit': '64.9'}, {'value': '54.5', 'groupId': 'OG002', 'lowerLimit': '41.8', 'upperLimit': '67.2'}, {'value': '62.9', 'groupId': 'OG003', 'lowerLimit': '50.9', 'upperLimit': '74.9'}]}]}], 'analyses': [{'pValue': '0.026', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of clearance rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.69', 'ciLowerLimit': '1.06', 'ciUpperLimit': '2.69', 'groupDescription': 'Log binomial regression with treatment group as factor and baseline AK count included as covariate.', 'statisticalMethod': 'Log binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.013', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of clearance rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.79', 'ciLowerLimit': '1.13', 'ciUpperLimit': '2.84', 'groupDescription': 'Log binomial regression with treatment group as factor and baseline AK count included as covariate.', 'statisticalMethod': 'Log binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of clearance rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.10', 'ciLowerLimit': '1.35', 'ciUpperLimit': '3.25', 'statisticalMethod': 'Log binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.73', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Ratio of clearance rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.47', 'statisticalMethod': 'Log binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.16', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Ratio of clearance rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.24', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.67', 'statisticalMethod': 'Log binomial regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.30', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Ratio of clearance rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.57', 'groupDescription': 'Log binomial regression with treatment group as factor and baseline AK count included as covariate.', 'statisticalMethod': 'Log binomial regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 8', 'description': 'Partial clearance was defined as at least 75% reduction from baseline in AK count.\n\nFor treatment groups Vehicle, 0.006 and 0.012 the table shows the percentage of mean number of participants across imputations with partial clearance. For treatment group 0.018 the table shows the percentage of mean number of participants with partial clearance in observed cases.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the Full Analysis Set, which was defined as all randomized participants who applied investigation product. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and thus was excluded from the efficacy analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1: LEO 43204 Gel 0.0015', 'description': 'Part 1: Dose-Escalation\n\nLEO 43204 gel 0.0015% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest.'}, {'id': 'FG001', 'title': 'Part 1: LEO 43204 Gel 0.003', 'description': 'Part 1: Dose-Escalation\n\nLEO 43204 gel 0.003% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest.'}, {'id': 'FG002', 'title': 'Part 1: LEO 43204 Gel 0.006', 'description': 'Part 1: Dose-Escalation\n\nLEO 43204 gel 0.006% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest.'}, {'id': 'FG003', 'title': 'Part 1: LEO 43204 Gel 0.012', 'description': 'Part 1: Dose-Escalation\n\nLEO 43204 gel 0.012% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest.'}, {'id': 'FG004', 'title': 'Part 1: LEO 43204 Gel 0.018', 'description': 'Part 1: Dose-Escalation\n\nLEO 43204 gel 0.018% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest.'}, {'id': 'FG005', 'title': 'Part 1: LEO 43204 Gel 0.025', 'description': 'Part 1: Dose-Escalation\n\nLEO 43204 gel 0.025% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest.'}, {'id': 'FG006', 'title': 'Part 1: LEO 43204 Cream 0.0015', 'description': 'Part 1: Dose-Escalation\n\nLEO 43204 cream 0.0015% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest.'}, {'id': 'FG007', 'title': 'Part 1: LEO 43204 Cream 0.003', 'description': 'Part 1: Dose-Escalation\n\nLEO 43204 cream 0.003% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest.'}, {'id': 'FG008', 'title': 'Part 1: LEO 43204 Cream 0.006', 'description': 'Part 1: Dose-Escalation\n\nLEO 43204 cream 0.006% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest.'}, {'id': 'FG009', 'title': 'Part 1: LEO 43204 Cream 0.012', 'description': 'Part 1: Dose-Escalation\n\nLEO 43204 cream 0.0012% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest.'}, {'id': 'FG010', 'title': 'Part 2: LEO 43204 Gel 0.006', 'description': 'Part 2: Double-Blind phase\n\nLEO 43204 gel 0.006% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest. The first treatment was to be applied on Day 1 by the participant at the site under supervision of the study staff. The second treatment was applied by the participant on Day 2 at home.'}, {'id': 'FG011', 'title': 'Part 2: LEO 43204 Gel 0.012', 'description': 'Part 2: Double-Blind phase LEO 43204 gel 0.012% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest. The first treatment was to be applied on Day 1 by the participant at the site under supervision of the study staff. The second treatment was applied by the participant on Day 2 at home.'}, {'id': 'FG012', 'title': 'Part 2: LEO 43204 Gel 0.018', 'description': 'Part 2: Double-Blind phase LEO 43204 gel 0.018% applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest. The first treatment was to be applied on Day 1 by the participant at the site under supervision of the study staff. The second treatment was applied by the participant on Day 2 at home.'}, {'id': 'FG013', 'title': 'Part 2: LEO 43204 Gel Vehicle', 'description': 'Part 2: Double-Blind phase LEO 43204 gel vehicle applied once daily for 2 consecutive days to full face or approximately 250 cm2 on the chest. The first treatment was to be applied on Day 1 by the participant at the site under supervision of the study staff. The second treatment was applied by the participant on Day 2 at home.'}], 'periods': [{'title': 'Part 1 Open-label, Dose-escalation Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '18'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '12'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '18'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '12'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', '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'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', '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': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '62'}, {'groupId': 'FG011', 'numSubjects': '60'}, {'groupId': 'FG012', 'numSubjects': '62'}, {'groupId': 'FG013', 'numSubjects': '59'}]}, {'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': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '61'}, {'groupId': 'FG011', 'numSubjects': '58'}, {'groupId': 'FG012', 'numSubjects': '62'}, {'groupId': 'FG013', 'numSubjects': '56'}]}, {'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'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '12', 'groupId': 'BG009'}, {'value': '59', 'groupId': 'BG010'}, {'value': '62', 'groupId': 'BG011'}, {'value': '60', 'groupId': 'BG012'}, {'value': '62', 'groupId': 'BG013'}, {'value': '320', 'groupId': 'BG014'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: LEO 43204 Gel 0.0015', 'description': 'Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment'}, {'id': 'BG001', 'title': 'Part 1: LEO 43204 Gel 0.003', 'description': 'Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment'}, {'id': 'BG002', 'title': 'Part 1: LEO 43204 Gel 0.006', 'description': 'Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment'}, {'id': 'BG003', 'title': 'Part 1: LEO 43204 Gel 0.012', 'description': 'Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment'}, {'id': 'BG004', 'title': 'Part 1: LEO 43204 Gel 0.018', 'description': 'Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment'}, {'id': 'BG005', 'title': 'Part 1: LEO 43204 Gel 0.025', 'description': 'Part 1: Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment'}, {'id': 'BG006', 'title': 'Part 1: LEO 43204 Cream 0.0015', 'description': 'Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment'}, {'id': 'BG007', 'title': 'Part 1: LEO 43204 Cream 0.003', 'description': 'Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment'}, {'id': 'BG008', 'title': 'Part 1: LEO 43204 Cream 0.006', 'description': 'Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment'}, {'id': 'BG009', 'title': 'Part 1: LEO 43204 Cream 0.012', 'description': 'Part 1: Open-Label phase, Dose-Escalation, Once-Daily, 2-Day Treatment'}, {'id': 'BG010', 'title': 'Part 2: LEO 43204 Gel Vehicle', 'description': 'Part 2: Double-Blind, Once-Daily, 2-Day Treatment'}, {'id': 'BG011', 'title': 'Part 2: LEO 43204 Gel 0.006', 'description': 'Part 2: Double-Blind, Once-Daily, 2-Day Treatment'}, {'id': 'BG012', 'title': 'Part 2: LEO 43204 Gel 0.012', 'description': 'Part 2: Double-Blind, Once-Daily, 2-Day Treatment'}, {'id': 'BG013', 'title': 'Part 2: LEO 43204 Gel 0.018', 'description': 'Part 2: Double-Blind, Once-Daily, 2-Day Treatment'}, {'id': 'BG014', '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'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '18', 'groupId': 'BG010'}, {'value': '17', 'groupId': 'BG011'}, {'value': '21', 'groupId': 'BG012'}, {'value': '21', 'groupId': 'BG013'}, {'value': '110', 'groupId': 'BG014'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '41', 'groupId': 'BG010'}, {'value': '45', 'groupId': 'BG011'}, {'value': '39', 'groupId': 'BG012'}, {'value': '41', 'groupId': 'BG013'}, {'value': '210', 'groupId': 'BG014'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '17', 'groupId': 'BG010'}, {'value': '20', 'groupId': 'BG011'}, {'value': '19', 'groupId': 'BG012'}, {'value': '21', 'groupId': 'BG013'}, {'value': '103', 'groupId': 'BG014'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '42', 'groupId': 'BG010'}, {'value': '42', 'groupId': 'BG011'}, {'value': '41', 'groupId': 'BG012'}, {'value': '41', 'groupId': 'BG013'}, {'value': '217', 'groupId': 'BG014'}]}]}], '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': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '32', 'groupId': 'BG010'}, {'value': '31', 'groupId': 'BG011'}, {'value': '31', 'groupId': 'BG012'}, {'value': '32', 'groupId': 'BG013'}, {'value': '126', 'groupId': 'BG014'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '12', 'groupId': 'BG009'}, {'value': '27', 'groupId': 'BG010'}, {'value': '31', 'groupId': 'BG011'}, {'value': '29', 'groupId': 'BG012'}, {'value': '30', 'groupId': 'BG013'}, {'value': '194', 'groupId': 'BG014'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline characteristics are provided for all randomized participants'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'dispFirstSubmitDate': '2015-10-20', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2013-08-12', 'dispFirstSubmitQcDate': '2015-10-20', 'resultsFirstSubmitDate': '2018-11-14', 'studyFirstSubmitQcDate': '2013-08-12', 'dispFirstPostDateStruct': {'date': '2015-11-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-06', 'studyFirstPostDateStruct': {'date': '2013-08-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Number of Participants Experiencing a Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs)', 'timeFrame': 'From Day 1 up to and including Day 8', 'description': 'The number of participants experiencing DLTs are tabulated by treatment group. This was used to identify the maximum tolerated dose (MTD) of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level with less than 4 out of 12 participants(cohorts 1 to 4) or less than 6 out of 18 participants(cohorts 5 and 6) experiencing a DLT\n\nDLT was defined as one or more of the following 3 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* Erythema Grade 4\n* Crusting Grade 3\n* Swelling Grade 4\n* Erosion/Ulceration Grade 3\n* Vesiculation/Pustulation Grade 3\n\nThe Local Skin Responses consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category are given a numeric grade of severity from 0-4. Grade 0 being no presence and 4 being the highest grade of severity.'}, {'measure': 'Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Counts (Multiple Imputation)', 'timeFrame': 'At Week 8'}], 'secondaryOutcomes': [{'measure': 'Part 2: Percentage of Participants With Complete Clearance of Actinic Keratosis Lesions (AKs) (Multiple Imputation)', 'timeFrame': 'At Week 8', 'description': 'Complete clearance was defined as a 100% reduction from baseline in AK count. For treatment groups Vehicle, 0.006 and 0.012 the table shows the percentage of mean number of participants across imputations with complete clearance. For treatment group 0.018 the table shows the percentage of mean number of participants with complete clearance in observed cases.'}, {'measure': 'Part 2: Percentage of Participants With Partial Clearance of AKs (Multiple Imputation)', 'timeFrame': 'At Week 8', 'description': 'Partial clearance was defined as at least 75% reduction from baseline in AK count.\n\nFor treatment groups Vehicle, 0.006 and 0.012 the table shows the percentage of mean number of participants across imputations with partial clearance. For treatment group 0.018 the table shows the percentage of mean number of participants with partial clearance in observed cases.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Actinic Keratosis']}, 'referencesModule': {'references': [{'pmid': '28264612', 'type': 'DERIVED', 'citation': 'Bourcier M, Stein Gold L, Guenther L, Andreassen CM, Selmer J, Goldenberg G. A dose-finding trial with a novel ingenol derivative (ingenol disoxate: LEO 43204) for field treatment of actinic keratosis on full face or 250 cm2 on the chest. J Dermatolog Treat. 2017 Nov;28(7):652-658. doi: 10.1080/09546634.2017.1303568. Epub 2017 Apr 4.'}]}, 'descriptionModule': {'briefSummary': 'Part 1:\n\nTo identify Maximum Tolerated Dose (MTD) levels of two formulations of LEO 43204 after once daily treatment for two consecutive days\n\nPart 2:\n\nTo evaluate efficacy of two formulations of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle formulations'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Following verbal and written information about the trial, subject must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial-related procedures.\n2. Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the face\n3. Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on either the face or within a contiguous area of approximately 250 cm2 (40 in2) on the chest\n4. Subject at least 18 years of age.\n5. Female subjects must be of either:\n\n 1. Non-childbearing potential, i.e., have a confirmed clinical history of sterility (e.g., the subject is without a uterus or have tubal ligation), or,\n 2. Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to trial treatment.\n6. Female subjects of childbearing potential must use effective contraception throughout the study.\n\nExclusion Criteria:\n\n1. Location of the treatment area within 5 cm (2 inches) of:\n\n 1. an incompletely healed wound,\n 2. a suspected basal or squamous cell carcinoma.\n2. Prior treatment with ingenol mebutate gel on the treatment area.\n3. Lesions in the treatment areas that have:\n\n 1. atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or\n 2. recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).\n4. History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g., eczema, unstable psoriasis, xeroderma pigmentosum, Rosacea), at the investigator's discretion.\n5. Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the treatment areas.\n6. Any other disease or medical condition such as history or presence of cancer, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, or neurological disease or disorder, that, in the opinion of the investigator, makes the subject unsuitable to participate in the trial.\n7. Any abnormal laboratory or ECG findings that are clinically significant and would impact the safety of the subjects or the interpretation of the study results, as determined by the investigator.\n8. Anticipated need for hospitalisation or out-patient surgery during the first 15 days after the first trial medication application. Note that cosmetic/therapeutic procedures are not excluded if they fall outside of the criteria detailed in Prohibited Therapies or Medications.\n9. Known sensitivity or allergy to any of the ingredients in the LEO 43204.\n10. Presence of acute sunburn within the treatment areas.\n11. Current enrolment or participation in an investigational clinical trial within 30 days of entry into this trial.\n12. Subjects previously randomised in the trial (Part 1 or 2).\n13. Female subjects who are breastfeeding.\n14. In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state)."}, 'identificationModule': {'nctId': 'NCT01922050', 'briefTitle': 'A Study of Increasing Strengths, Safety and Efficacy of Two Formulas of LEO 43204 on the Face or the Chest in Patients With Actinic Keratosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'officialTitle': 'Safety and Efficacy of Escalating Doses of Two LEO 43204 Formulations Applied Once Daily for Two Consecutive Days on Full Face or Approximately 250 cm2 (40 in2) on the Chest in Subjects With Actinic Keratosis', 'orgStudyIdInfo': {'id': 'LP0084-1013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: LEO 43204 Formulation 1', 'description': 'Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment', 'interventionNames': ['Drug: LEO 43204 Formulation 1']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: LEO 43204 Formulation 2', 'description': 'Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment', 'interventionNames': ['Drug: LEO 43204 Formulation 2']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: LEO 43204 Formulation 1 Dose X', 'description': 'Double-Blind, Once-Daily, 2-Day Treatment', 'interventionNames': ['Drug: LEO 43204 Formulation 1 Dose X']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: LEO 43204 Formulation 1 Dose Y', 'description': 'Double-Blind, Once-Daily, 2-Day Treatment', 'interventionNames': ['Drug: LEO 43204 Formulation 1 Dose Y']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: LEO 43204 Formulation 2 Dose XX', 'description': 'Double-Blind, Once-Daily, 2-Day Treatment', 'interventionNames': ['Drug: LEO 43204 Formulation 2 Dose XX']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: LEO 43204 Formulation 2 Dose YY', 'description': 'Double-Blind, Once-Daily, 2-Day Treatment', 'interventionNames': ['Drug: LEO 43204 Formulation 2 Dose YY']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 2: Placebo Formulation 1', 'description': 'Double-Blind, Once-Daily, 2-Day Treatment', 'interventionNames': ['Drug: Placebo Formulation 1']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 2: Placebo Formulation 2', 'description': 'Double-Blind, Once-Daily, 2-Day Treatment', 'interventionNames': ['Drug: Placebo Formulation 2']}], 'interventions': [{'name': 'LEO 43204 Formulation 1', 'type': 'DRUG', 'armGroupLabels': ['Part 1: LEO 43204 Formulation 1']}, {'name': 'LEO 43204 Formulation 2', 'type': 'DRUG', 'armGroupLabels': ['Part 1: LEO 43204 Formulation 2']}, {'name': 'LEO 43204 Formulation 1 Dose X', 'type': 'DRUG', 'armGroupLabels': ['Part 2: LEO 43204 Formulation 1 Dose X']}, {'name': 'LEO 43204 Formulation 1 Dose Y', 'type': 'DRUG', 'armGroupLabels': ['Part 2: LEO 43204 Formulation 1 Dose Y']}, {'name': 'LEO 43204 Formulation 2 Dose XX', 'type': 'DRUG', 'armGroupLabels': ['Part 2: LEO 43204 Formulation 2 Dose XX']}, {'name': 'LEO 43204 Formulation 2 Dose YY', 'type': 'DRUG', 'armGroupLabels': ['Part 2: LEO 43204 Formulation 2 Dose YY']}, {'name': 'Placebo Formulation 1', 'type': 'DRUG', 'armGroupLabels': ['Part 2: Placebo Formulation 1']}, {'name': 'Placebo Formulation 2', 'type': 'DRUG', 'armGroupLabels': ['Part 2: Placebo Formulation 2']}]}, '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': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Leavitt Medical Associates of Florida', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Center, Morsani Center for Advanced Healthcare', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '47713', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Research Institute of Deaconess Clinic', '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': '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': '48322', 'city': 'West Bloomfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Medical Center, Dept. of Dermatology', 'geoPoint': {'lat': 42.56891, 'lon': -83.38356}}, {'zip': '07044', 'city': 'Verona', 'state': 'New Jersey', 'country': 'United States', 'facility': 'The Dermatology Group, P.C.', 'geoPoint': {'lat': 40.82982, 'lon': -74.24015}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Clinical Trials of Texas, Inc.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': 'T5K 1X3', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Stratica Medical Inc.', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V3R 6A7', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Guildford Dermatology Specialists', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'E1C 8X3', 'city': 'Moncton', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Durondel C.P. Inc./Dermatology Clinic', 'geoPoint': {'lat': 46.09454, 'lon': -64.7965}}, {'zip': 'L4M 6L2', 'city': 'Barrie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ultranova Skincare', 'geoPoint': {'lat': 44.40011, 'lon': -79.66634}}, {'zip': 'L1E 3C3', 'city': 'Courtice', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Co-Medica Research Network Inc.', 'geoPoint': {'lat': 43.91682, 'lon': -78.76626}}, {'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': 'L3P 1A8', 'city': 'Markham', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Lynderm Research Inc.', 'geoPoint': {'lat': 43.86682, 'lon': -79.2663}}, {'zip': 'K9J 1Z2', 'city': 'Peterborough', 'state': 'Ontario', 'country': 'Canada', 'facility': 'SKiN Centre for Dermatology', 'geoPoint': {'lat': 44.30012, 'lon': -78.31623}}, {'zip': 'N2J 1C4', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'K. Papp Clinical Research', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}, {'zip': 'N8W 1E6', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'XLR8 Medical Research', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': 'G1V 4X7', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre de Recherche Dermatologique du Quebec Metropolitain', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], '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'}}}}