Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-01-08 @ 1:48 AM
Study NCT ID:
NCT01820260
Status:
COMPLETED
Last Update Posted:
2025-03-13
First Post:
2013-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Ingenol Mebutate Once Daily for 2 or 3 Consecutive Days in Subjects With Actinic Keratosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055623', 'term': 'Keratosis, Actinic'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ctr.disclosure@leo-pharma.com', 'phone': '+45 4494 5888', 'title': 'Clinical Trial Disclosure Manager', 'organization': 'LEO Pharma A/S'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Part 1A: Ingenol Mebutate Gel 0.005%', 'description': 'Administration on full face, once daily 3 days', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part 1A: Ingenol Mebutate Gel 0.008%', 'description': 'Administration on full face, once daily 3 days', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 7, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part 1A: Ingenol Mebutate Gel 0.012%', 'description': 'Administration on full face, once daily 3 days', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 9, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part 1A: Ingenol Mebutate Gel 0.018%', 'description': 'Administration on full face, once daily 3 days', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 10, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part 1A: Ingenol Mebutate Gel 0.027%', 'description': 'Administration on full face, once daily 3 days', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part 1A: Ingenol Mebutate Gel 0.04%', 'description': 'Administration on full face, once daily 3 days', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part 1B: Ingenol Mebutate Gel 0.04%', 'description': 'Administration on full face, once daily 2 days', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Part 1B: Ingenol Mebutate Gel 0.06%', 'description': 'Administration on full face, once daily 3 days', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 10, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Part 2: Ingenol 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Parosmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Scoliosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nasal septum deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'upper airway cough syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1: To Identify the Maximum Tolerated Dose (MTD) Levels After Once Daily Treatment for 2 or 3 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1A: Ingenol Mebutate Gel 0.005%', 'description': 'Administration on full face, once daily for 3 consecutive days'}, {'id': 'OG001', 'title': 'Part 1A: Ingenol Mebutate Gel 0.008%', 'description': 'Administration on full face, once daily for 3 consecutive days'}, {'id': 'OG002', 'title': 'Part 1A: Ingenol Mebutate Gel 0.012%', 'description': 'Administration on full face, once daily for 3 consecutive days'}, {'id': 'OG003', 'title': 'Part 1A: Ingenol Mebutate Gel 0.018%', 'description': 'Administration on full face, once daily for 3 consecutive days'}, {'id': 'OG004', 'title': 'Part 1A: Ingenol Mebutate Gel 0.027%', 'description': 'Administration on full face, once daily for 3 consecutive days'}, {'id': 'OG005', 'title': 'Part 1A: Ingenol Mebutate Gel 0.04%', 'description': 'Administration on full face, once daily for 3 consecutive days'}, {'id': 'OG006', 'title': 'Part 1B: Ingenol Mebutate Gel 0.04%', 'description': 'Administration on full face, once daily for 2 consecutive days'}, {'id': 'OG007', 'title': 'Part 1B: Ingenol Mebutate Gel 0.06%', 'description': 'Administration on full face, once daily for 2 consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 days after initial treatment', 'description': 'Dose tolerability was measures looking at the composite score of Local Skin Responses (LSR). The MTD was defined as the highest dose level with less than 4 subjects out of 12 experiencing dose limiting toxicity (DLT).\n\nDLT was defined as one or more of the following three local skin LSRs:\n\n* Crusting Grade 4\n* Erosion/Ulceration Grade 4\n* Vesiculation/Pustulation Grade 4 or two or more of the following five LSRs:\n* Erythema Grade 4\n* Crusting Grade 3\n* Swelling Grade 4\n* Erosion/Ulceration Grade 3\n* Vesiculation/Pustulation Grade 3\n\nThe grading is a scale of 1 to 4 (highest grade).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The composite (sum) score was obtained by summing the 6 individual LSRs'}, {'type': 'PRIMARY', 'title': 'Part 2: Number of Subjects With Complete Clearance of AKs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Ingenol Mebutate Gel 0.018% for 3 Days', 'description': 'Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days\n\nIngenol mebutate gel 0.018%'}, {'id': 'OG001', 'title': 'Ingenol Mebutate Gel 0.018% for 2 Days', 'description': 'Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days\n\nIngenol mebutate gel 0.018%'}, {'id': 'OG002', 'title': 'Ingenol Mebutate Gel 0.027% for 3 Days', 'description': 'Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days\n\nIngenol mebutate gel 0.027%'}, {'id': 'OG003', 'title': 'Ingenol Mebutate Gel 0.027% for 2 Days', 'description': 'Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days\n\nIngenol mebutate gel 0.027%'}, {'id': 'OG004', 'title': 'Vehicle Gel (Placebo) for 3 Days', 'description': 'Vehicle gel administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days\n\nVehicle gel (placebo)'}, {'id': 'OG005', 'title': 'Vehicle Gel (Placebo) for 2 Days', 'description': 'Vehicle gel administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days\n\nVehicle gel (placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG001', 'OG005'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'To account for multiple testing, the 4 pairwise tests with corresponding vehicle group were performed using Bonferroni method testing at a 1.25% significance level, securing that the overall significance level did not exceed 5%', 'groupDescription': "Complete clearance of AKs at Week 8 was to be analysed by log binomial regression with factors treatment group, anatomical location (face/chest or scalp) and analysis site. Due to the low numbers of subjects obtaining complete clearance in the vehicle groups,the proposed model did not converge and Fisher's exact test was used instead to compare active treatments with the respective vehicle arm.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0037', 'groupIds': ['OG003', 'OG005'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'see comments in analysis 1', 'groupDescription': 'See comment in analysis 1', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0171', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'See comments in analysis 1', 'groupDescription': 'See comments in analysis 1', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0001', 'groupIds': ['OG002', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Number of subjects with complete clearance of Actinic Keratosis lesions (AKs) at week 8 after 2 or 3 consecutive days of treatment with ingenol mebutate gel on the full face, full balding scalp or approximately 250 cm² on the chest', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Part 2: Reduction in AK Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Ingenol Mebutate Gel 0.018% for 3 Days Treatment', 'description': 'Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days\n\nIngenol mebutate gel 0.018%'}, {'id': 'OG001', 'title': 'Ingenol Mebutate Gel 0.018% for 2 Days Treatment', 'description': 'Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days\n\nIngenol mebutate gel 0.018%'}, {'id': 'OG002', 'title': 'Ingenol Mebutate Gel 0.027% for 3 Days Treatment', 'description': 'Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days\n\nIngenol mebutate gel 0.027%'}, {'id': 'OG003', 'title': 'Ingenol Mebutate Gel 0.027% for 2 Days Treatment', 'description': 'Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days\n\nIngenol mebutate gel 0.027%'}, {'id': 'OG004', 'title': 'Vehicle Gel (Placebo) for 3 Days Treatment', 'description': 'Vehicle gel administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days\n\nVehicle gel (placebo)'}, {'id': 'OG005', 'title': 'Vehicle Gel (Placebo)for 2 Days Treatment', 'description': 'Vehicle gel administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days\n\nVehicle gel (placebo)'}], 'classes': [{'categories': [{'measurements': [{'value': '73.5', 'groupId': 'OG000', 'lowerLimit': '66.4', 'upperLimit': '79.1'}, {'value': '70.5', 'groupId': 'OG001', 'lowerLimit': '62.8', 'upperLimit': '76.6'}, {'value': '82.9', 'groupId': 'OG002', 'lowerLimit': '77.6', 'upperLimit': '86.9'}, {'value': '67.7', 'groupId': 'OG003', 'lowerLimit': '59.1', 'upperLimit': '74.5'}, {'value': '4.3', 'groupId': 'OG004', 'lowerLimit': '-28.1', 'upperLimit': '28.5'}, {'value': '15.7', 'groupId': 'OG005', 'lowerLimit': '-12.9', 'upperLimit': '37.1'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'To account for multiple testing among the secondary endpoints, a hierarchical order of testing was determined, where the following evaluation was done separately for each of the four active groups: Provided the primary endpoint was significant at a 1.25% level, the comparison to vehicle in terms of reduction in AK count from baseline to week 8 was tested at a 1.25% level. Provided this test was significant, the second secondary endpoint,partial clearance, was tested(vs. vehicle) at a 1.25% level', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG005'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'See comment in analysis 1', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'See comment analysis 1', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '< 0.001', 'groupIds': ['OG003', 'OG005'], 'groupDescription': 'See comment in analysis 1', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to Week 8', 'description': 'Reduction in actinic keratosis lesion count from baseline to week 8 (percentage, adjusted for anatomical location and pooled site)', 'unitOfMeasure': 'Percentage reduction', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Part 2: Number of Subjects With Partial Clearance of AKs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Ingenol Mebutate Gel 0.018% for 3 Days Treatment', 'description': 'Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days\n\nIngenol mebutate gel 0.018%'}, {'id': 'OG001', 'title': 'Ingenol Mebutate Gel 0.018% for 2 Days Treatment', 'description': 'Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days\n\nIngenol mebutate gel 0.018%'}, {'id': 'OG002', 'title': 'Ingenol Mebutate Gel 0.027% for 3 Days Treatment', 'description': 'Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days\n\nIngenol mebutate gel 0.027%'}, {'id': 'OG003', 'title': 'Ingenol Mebutate Gel 0.027% for 2 Days Treatment', 'description': 'Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days\n\nIngenol mebutate gel 0.027%'}, {'id': 'OG004', 'title': 'Vehicle Gel (Placebo) for 3 Days Treatment', 'description': 'Vehicle gel administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days\n\nVehicle gel (placebo)'}, {'id': 'OG005', 'title': 'Vehicle Gel (Placebo)for 2 Days Treatment', 'description': 'Vehicle gel administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days\n\nVehicle gel (placebo)'}], 'classes': [{'categories': [{'measurements': [{'value': '54.8', 'groupId': 'OG000'}, {'value': '57.8', 'groupId': 'OG001'}, {'value': '76.6', 'groupId': 'OG002'}, {'value': '52.5', 'groupId': 'OG003'}, {'value': '6.5', 'groupId': 'OG004'}, {'value': '12.9', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'groupDescription': "Analysis of partial clearance of AK's at Week 8 was done in the same way as for the primary outcome (endpoint)", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG005'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '< 0.001', 'groupIds': ['OG003', 'OG005'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'description': 'Partial clearance of AKs at Week 8, defined as at least 75% reduction from baseline in the number of clinically visible AKs', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1A: Ingenol Mebutate Gel 0.005%', 'description': 'Administration on full face, once daily for 3 consecutive days'}, {'id': 'FG001', 'title': 'Part 1A: Ingenol Mebutate Gel 0.008%', 'description': 'Administration on full face, once daily for 3 consecutive days'}, {'id': 'FG002', 'title': 'Part 1A: Ingenol Mebutate Gel 0.012%', 'description': 'Administration on full face, once daily for 3 consecutive days'}, {'id': 'FG003', 'title': 'Part 1A: Ingenol Mebutate Gel 0.018%', 'description': 'Administration on full face, once daily for 3 consecutive days'}, {'id': 'FG004', 'title': 'Part 1A: Ingenol Mebutate Gel 0.027%', 'description': 'Administration on full face, once daily for 3 consecutive days'}, {'id': 'FG005', 'title': 'Part 1A: Ingenol Mebutate Gel 0.04%', 'description': 'Administration on full face, once daily for 3 consecutive days'}, {'id': 'FG006', 'title': 'Part 1B: Ingenol Mebutate Gel 0.06%', 'description': 'Administration on full face, once daily for 2 consecutive days'}, {'id': 'FG007', 'title': 'Part 1B: Ingenol Mebutate Gel 0.04%', 'description': 'Administration on full face, once daily for 2 consecutive days'}, {'id': 'FG008', 'title': 'Part 2: Ingenol Mebutate Gel 0.018% for 2 Days', 'description': 'Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days'}, {'id': 'FG009', 'title': 'Part 2: Ingenol Mebutate Gel 0.018% for 3 Days', 'description': 'Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days'}, {'id': 'FG010', 'title': 'Part 2: Ingenol Mebutate Gel 0.027% for 2 Days', 'description': 'Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days'}, {'id': 'FG011', 'title': 'Part 2: Ingenol Mebutate Gel 0.027% for 3 Days', 'description': 'Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days'}, {'id': 'FG012', 'title': 'Part 2: Vehicle Gel (Placebo) for 2 Days', 'description': 'Vehicle gel administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days'}, {'id': 'FG013', 'title': 'Part 2: Vehicle Gel (Placebo) for 3 Days', 'description': 'Vehicle gel administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days'}], 'periods': [{'title': 'Phase 1 (Part 1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '12'}, {'groupId': 'FG007', 'numSubjects': '11'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'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': '12'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '11'}, {'groupId': 'FG007', 'numSubjects': '11'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'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': '1'}, {'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'}]}], 'dropWithdraws': [{'type': 'Subject withdrew after randomization before treatment assignment', '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'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}]}, {'title': 'Phase 2 (Part 2)', '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': '64'}, {'groupId': 'FG009', 'numSubjects': '62'}, {'groupId': 'FG010', 'numSubjects': '61'}, {'groupId': 'FG011', 'numSubjects': '64'}, {'groupId': 'FG012', 'numSubjects': '31'}, {'groupId': 'FG013', 'numSubjects': '31'}]}, {'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': '64'}, {'groupId': 'FG009', 'numSubjects': '61'}, {'groupId': 'FG010', 'numSubjects': '61'}, {'groupId': 'FG011', 'numSubjects': '64'}, {'groupId': 'FG012', 'numSubjects': '31'}, {'groupId': 'FG013', 'numSubjects': '31'}]}, {'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': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', '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': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Part 1: There was 1 of the 82 subjects who withdrew before receiving any treatment but after collection of baseline characteristics. 81 subjects received treatment and all completed the trial.\n\nPart 2: There were 2 of the 315 randomized subjects who withdrew consent prior to any baseline characteristics being recorded (therefore they received no treatment) and are excluded from the total number of participants, full analysis set and safety analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '62', 'groupId': 'BG008'}, {'value': '64', 'groupId': 'BG009'}, {'value': '64', 'groupId': 'BG010'}, {'value': '61', 'groupId': 'BG011'}, {'value': '31', 'groupId': 'BG012'}, {'value': '31', 'groupId': 'BG013'}, {'value': '395', 'groupId': 'BG014'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1A: Ingenol Mebutate Gel 0.005%', 'description': 'Administration on full face, once daily for 3 days'}, {'id': 'BG001', 'title': 'Part 1A: Ingenol Mebutate Gel 0.008%', 'description': 'Administration on full face, once daily for 3 days'}, {'id': 'BG002', 'title': 'Part 1A: Ingenol Mebutate Gel 0.012%', 'description': 'Administration on full face, once daily for 3 days'}, {'id': 'BG003', 'title': 'Part 1A: Ingenol Mebutate Gel 0.018%', 'description': 'Administration on full face, once daily for 3 days'}, {'id': 'BG004', 'title': 'Part 1A: Ingenol Mebutate Gel 0.027%', 'description': 'Administration on full face, once daily for 3 days'}, {'id': 'BG005', 'title': 'Part 1A: Ingenol Mebutate Gel 0.04%', 'description': 'Administration on full face, once daily for 3 days'}, {'id': 'BG006', 'title': 'Part 1B: Ingenol Mebutate Gel 0.04%', 'description': 'Administration on full face, once daily for 2 days'}, {'id': 'BG007', 'title': 'Part 1B: Ingenol Mebutate Gel 0.06%', 'description': 'Administration on full face, once daily for 2 days'}, {'id': 'BG008', 'title': 'Part 2: Ingenol Mebutate Gel 0.018% for 3 Days Treatment', 'description': 'Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days\n\nIngenol mebutate gel 0.018%'}, {'id': 'BG009', 'title': 'Part 2: Ingenol Mebutate Gel 0.027% for 3 Days Treatment', 'description': 'Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days\n\nIngenol mebutate gel 0.027%'}, {'id': 'BG010', 'title': 'Part 2: Ingenol Mebutate Gel 0.018% for 2 Days Treatment', 'description': 'Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days\n\nIngenol mebutate gel 0.018%'}, {'id': 'BG011', 'title': 'Part 2: Ingenol Mebutate Gel 0.027% for 2 Days Treatment', 'description': 'Administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days\n\nIngenol mebutate gel 0.027%'}, {'id': 'BG012', 'title': 'Part 2: Vehicle Gel (Placebo)for 2 Days Treatment', 'description': 'Vehicle gel administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 2 consecutive days\n\nVehicle gel (placebo)'}, {'id': 'BG013', 'title': 'Part 2: Vehicle Gel (Placebo) for 3 Days Treatment', 'description': 'Vehicle gel administration on full face, full balding scalp, or approximately 250 cm² on the chest, once daily for 3 consecutive days\n\nVehicle gel (placebo)'}, {'id': 'BG014', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.3', 'groupId': 'BG000', 'lowerLimit': '72', 'upperLimit': '78'}, {'value': '69.6', 'groupId': 'BG001', 'lowerLimit': '51', 'upperLimit': '85'}, {'value': '68.7', 'groupId': 'BG002', 'lowerLimit': '48', 'upperLimit': '81'}, {'value': '67.4', 'groupId': 'BG003', 'lowerLimit': '41', 'upperLimit': '83'}, {'value': '69.7', 'groupId': 'BG004', 'lowerLimit': '56', 'upperLimit': '84'}, {'value': '68.0', 'groupId': 'BG005', 'lowerLimit': '47', 'upperLimit': '85'}, {'value': '67.5', 'groupId': 'BG006', 'lowerLimit': '57', 'upperLimit': '83'}, {'value': '71.7', 'groupId': 'BG007', 'lowerLimit': '52', 'upperLimit': '92'}, {'value': '68.0', 'groupId': 'BG008', 'lowerLimit': '46', 'upperLimit': '88'}, {'value': '66.3', 'groupId': 'BG009', 'lowerLimit': '49', 'upperLimit': '88'}, {'value': '66.9', 'groupId': 'BG010', 'lowerLimit': '47', 'upperLimit': '91'}, {'value': '66.1', 'groupId': 'BG011', 'lowerLimit': '50', 'upperLimit': '84'}, {'value': '68.4', 'groupId': 'BG012', 'lowerLimit': '48', 'upperLimit': '83'}, {'value': '69.0', 'groupId': 'BG013', 'lowerLimit': '43', 'upperLimit': '87'}, {'value': '68.0', 'groupId': 'BG014', 'lowerLimit': '41', 'upperLimit': '92'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '20', 'groupId': 'BG008'}, {'value': '15', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}, {'value': '15', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}, {'value': '5', 'groupId': 'BG013'}, {'value': '79', 'groupId': 'BG014'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '42', 'groupId': 'BG008'}, {'value': '49', 'groupId': 'BG009'}, {'value': '56', 'groupId': 'BG010'}, {'value': '46', 'groupId': 'BG011'}, {'value': '28', 'groupId': 'BG012'}, {'value': '26', 'groupId': 'BG013'}, {'value': '316', 'groupId': 'BG014'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '62', 'groupId': 'BG008'}, {'value': '64', 'groupId': 'BG009'}, {'value': '64', 'groupId': 'BG010'}, {'value': '61', 'groupId': 'BG011'}, {'value': '31', 'groupId': 'BG012'}, {'value': '31', 'groupId': 'BG013'}, {'value': '395', 'groupId': 'BG014'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'For the Safety Analysis set for Part 1 the was 1 subject out of 12 not included in the Part 1B Ingenol Mebute Gel 0.06%. This subject discontinued before receiving any trial medication. Therefore, there are only 11 subjects.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Masking only for Part 2'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Part 1 was an open-label, dose escalation. Part 2 was a randomised, double-blind, parallel group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 395}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'dispFirstSubmitDate': '2015-07-02', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2013-03-25', 'dispFirstSubmitQcDate': '2015-07-02', 'resultsFirstSubmitDate': '2018-10-30', 'studyFirstSubmitQcDate': '2013-03-27', 'dispFirstPostDateStruct': {'date': '2015-07-27', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-03', 'studyFirstPostDateStruct': {'date': '2013-03-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: To Identify the Maximum Tolerated Dose (MTD) Levels After Once Daily Treatment for 2 or 3 Days', 'timeFrame': '8 days after initial treatment', 'description': 'Dose tolerability was measures looking at the composite score of Local Skin Responses (LSR). The MTD was defined as the highest dose level with less than 4 subjects out of 12 experiencing dose limiting toxicity (DLT).\n\nDLT was defined as one or more of the following three local skin LSRs:\n\n* Crusting Grade 4\n* Erosion/Ulceration Grade 4\n* Vesiculation/Pustulation Grade 4 or two or more of the following five LSRs:\n* Erythema Grade 4\n* Crusting Grade 3\n* Swelling Grade 4\n* Erosion/Ulceration Grade 3\n* Vesiculation/Pustulation Grade 3\n\nThe grading is a scale of 1 to 4 (highest grade).'}, {'measure': 'Part 2: Number of Subjects With Complete Clearance of AKs', 'timeFrame': '8 weeks', 'description': 'Number of subjects with complete clearance of Actinic Keratosis lesions (AKs) at week 8 after 2 or 3 consecutive days of treatment with ingenol mebutate gel on the full face, full balding scalp or approximately 250 cm² on the chest'}], 'secondaryOutcomes': [{'measure': 'Part 2: Reduction in AK Count', 'timeFrame': 'From baseline to Week 8', 'description': 'Reduction in actinic keratosis lesion count from baseline to week 8 (percentage, adjusted for anatomical location and pooled site)'}, {'measure': 'Part 2: Number of Subjects With Partial Clearance of AKs', 'timeFrame': 'Week 8', 'description': 'Partial clearance of AKs at Week 8, defined as at least 75% reduction from baseline in the number of clinically visible AKs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Actinic Keratosis']}, 'descriptionModule': {'briefSummary': 'To identify the Maximum Tolerated Dose levels of ingenol mebutate gel after once daily treatment for 2 or 3 consecutive days and to evaluate efficacy of ingenol mebutate gel in different doses after once daily treatment for 2 or 3 consecutive days compared to vehicle gel'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects must be competent to understand the nature of the trial and provide informed consent\n* Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the face Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on either the face, the balding scalp (the balding part of the scalp should be at least 25 cm2) or a contiguous area of approximately 250 cm2 on the chest\n* Subject at least 18 years of age\n* Female subjects must be of either:\n\n 1. Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,\n 2. Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to trial treatment, to rule out pregnancy\n* Female subjects of childbearing potential1 must be willing to use effective contraception at trial entry and until completion\n\nExclusion Criteria:\n\n* Location of the treatment area (full face, full balding scalp or chest)\n\n * within 5 cm of an incompletely healed wound,\n * within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC\n* Prior treatment with ingenol mebutate gel within 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\n* 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)\n* Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the treatment areas.\n* Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety and efficacy during the course of the trial, as determined by the investigator's clinical judgment\n* Any abnormal laboratory tests that are medically significant and would impact the safety of the subjects or the interpretation of the trial results, as determined by the investigator's judgment\n* 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\n* Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel\n* Presence of acute sunburn within the treatment areas\n* Current enrolment or participation in an investigational clinical trial within 30 days of entry into this trial.\n* Subjects previously assigned to treatment in Part 1 or rand\n* Female subjects who are breastfeeding.\n* 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': 'NCT01820260', 'briefTitle': 'Safety and Efficacy of Ingenol Mebutate Once Daily for 2 or 3 Consecutive Days in Subjects With Actinic Keratosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'officialTitle': 'Safety and Efficacy of Escalating Doses of Ingenol Mebutate Once Daily for Two or Three Consecutive Days When Used on Full Face, Full Balding Scalp or Approximately 250 cm2 on the Chest in Subjects With Actinic Keratosis', 'orgStudyIdInfo': {'id': 'LP0105-1012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1A: Ingenol mebutate gel 0.005%', 'description': 'Open-label, dose escalation, 3 days treatment', 'interventionNames': ['Drug: Ingenol mebutate gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part 2: Ingenol mebutate gel 0.018% for 3 days treatment', 'description': 'Randomized, 3 days treatment', 'interventionNames': ['Drug: Ingenol mebutate gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part 2: Ingenol mebutate gel 0.018% for 2 days treatment', 'description': 'Randomized 2 days treatment', 'interventionNames': ['Drug: Ingenol mebutate gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part 2: Ingenol mebutate gel 0.027% for 3 days treatment', 'description': 'Randomized 3 days treatment', 'interventionNames': ['Drug: Ingenol mebutate gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part 2: Ingenol mebutate gel 0.027% for 2 days treatment', 'description': 'Randomized 2 days treatment', 'interventionNames': ['Drug: Ingenol mebutate gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 2: Placebo for 3 days treatment', 'description': 'Randomized 3 days treatment', 'interventionNames': ['Drug: placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 2: Placebo for 2 days treatment', 'description': 'Randomized 2 days treatment', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1A: Ingenol mebutate gel 0.008%', 'description': 'Open-label, dose escalation, 3 days treatment', 'interventionNames': ['Drug: Ingenol mebutate gel']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1A: Ingenol mebutate gel 0.012%', 'description': 'Open-label, dose escalation, 3 days treatment', 'interventionNames': ['Drug: Ingenol mebutate gel']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1A: Ingenol mebutate gel 0.027%', 'description': 'Open-label, dose escalation, 3 days treatment', 'interventionNames': ['Drug: Ingenol mebutate gel']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1A: Ingenol mebutate gel 0.04%', 'description': 'Open-label, dose escalation, 3 days treatment', 'interventionNames': ['Drug: Ingenol mebutate gel']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1B: Ingenol mebutate gel 0.06%', 'description': 'Open-label, dose escalation, 2 days treatment', 'interventionNames': ['Drug: Ingenol mebutate gel']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1A: Ingenol mebutate gel 0.018%', 'description': 'Open-label, dose escalation, 3 days treatment', 'interventionNames': ['Drug: Ingenol mebutate gel']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1B: Ingenol mebutate gel 0.04%', 'description': 'Open-label, dose escalation, 2 days treatment', 'interventionNames': ['Drug: Ingenol mebutate gel']}], 'interventions': [{'name': 'Ingenol mebutate gel', 'type': 'DRUG', 'armGroupLabels': ['Part 1A: Ingenol mebutate gel 0.005%', 'Part 1A: Ingenol mebutate gel 0.008%', 'Part 1A: Ingenol mebutate gel 0.012%', 'Part 1A: Ingenol mebutate gel 0.018%', 'Part 1A: Ingenol mebutate gel 0.027%', 'Part 1A: Ingenol mebutate gel 0.04%', 'Part 1B: Ingenol mebutate gel 0.04%', 'Part 1B: Ingenol mebutate gel 0.06%', 'Part 2: Ingenol mebutate gel 0.018% for 2 days treatment', 'Part 2: Ingenol mebutate gel 0.018% for 3 days treatment', 'Part 2: Ingenol mebutate gel 0.027% for 2 days treatment', 'Part 2: Ingenol mebutate gel 0.027% for 3 days treatment']}, {'name': 'placebo', 'type': 'DRUG', 'armGroupLabels': ['Part 2: Placebo for 2 days treatment', 'Part 2: Placebo for 3 days treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46032', 'city': 'Carmel', 'state': 'Indiana', 'country': 'United States', 'facility': 'Laser & Skin Surgery Center of Inidana', 'geoPoint': {'lat': 39.97837, 'lon': -86.11804}}], 'overallOfficials': [{'name': 'C. William Hanke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laser & Skin Surgery Center of Indiana'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LEO Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}