Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-01-09 @ 6:49 PM
Study NCT ID:
NCT02547233
Status:
COMPLETED
Last Update Posted:
2025-03-10
First Post:
2015-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up
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 investigators right to publish the entire results of the study, irrespective of outcome. LEO retains the right to have any publication submitted to LEO for review. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14)', 'description': 'Adverse events presented in the table are investigator-reported terms. Adverse events of special interest within system organ class (SOC) Neoplasm benign, malignant and unspecified (incl cysts and polyps), were adjudicated by an Independent Adjudication Committee based on central biopsy review.\n\nFor further details on the adjudication outcomes, see link to the full report in section "More information"\n\nAdverse events are reported with a \\>=2% frequency threshold for the active treatment group.', 'eventGroups': [{'id': 'EG000', 'title': 'LEO 43204 0.018% Gel - Treatment Period Including Follow-up', 'description': 'Treatment once daily for 3 consecutive days with LEO 43204 0.018% gel', 'otherNumAtRisk': 205, 'otherNumAffected': 134, 'seriousNumAtRisk': 205, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Vehicle Gel - Treatment Period Including Follow-up', 'description': 'Treatment once daily for 3 consecutive days with LEO 43204 vehicle gel', 'otherNumAtRisk': 100, 'otherNumAffected': 3, 'seriousNumAtRisk': 100, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'LEO 43204 0.018% Gel - Extended Follow-up', 'description': 'Treatment once daily for 3 consecutive days with LEO 43204 0.018% gel', 'otherNumAtRisk': 199, 'otherNumAffected': 23, 'seriousNumAtRisk': 199, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Vehicle Gel - Extended Follow-up', 'description': 'Treatment once daily for 3 consecutive days with LEO 43204 vehicle gel', 'otherNumAtRisk': 84, 'otherNumAffected': 3, 'seriousNumAtRisk': 84, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Periorbital oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Application site discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 120}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Application site paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Scar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 84, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'seriousEvents': [{'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 199, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 84, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Complete Clearance of Actinic Keratosis (AK)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 43204 0.018% Gel', 'description': 'Treatment once daily for 3 consecutive days with LEO 43204 0.018% gel'}, {'id': 'OG001', 'title': 'Vehicle Gel', 'description': 'Treatment once daily for 3 consecutive days with LEO 43204 vehicle gel'}], 'classes': [{'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000', 'lowerLimit': '24.9', 'upperLimit': '37.6'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '3.1'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of clearance rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.55', 'ciLowerLimit': '4.28', 'ciUpperLimit': '218.0', 'estimateComment': 'Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 8', 'description': 'Complete clearance was defined as an AK count of zero, i.e. no clinically visible AKs (actinic keratosis lesions) in the treatment area.\n\nThe table shows the percentage of mean number of subjects across imputations with complete clearance.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Partial Clearance (Multiple Imputation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 43204 0.018% Gel', 'description': 'Treatment once daily for 3 consecutive days with LEO 43204 0.018% gel'}, {'id': 'OG001', 'title': 'Vehicle Gel', 'description': 'Treatment once daily for 3 consecutive days with LEO 43204 vehicle gel'}], 'classes': [{'categories': [{'measurements': [{'value': '55.8', 'groupId': 'OG000', 'lowerLimit': '49.0', 'upperLimit': '62.7'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '8.9'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of clearance rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.26', 'ciLowerLimit': '4.73', 'ciUpperLimit': '31.78', 'estimateComment': 'Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.', 'groupDescription': 'The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 8', 'description': 'Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.\n\nThe table shows the percentage of mean number of participants across imputations with partial clearance.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Partial Clearance (Multiple Imputation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 43204 0.018% Gel', 'description': 'Treatment once daily for 3 consecutive days with LEO 43204 0.018% gel'}, {'id': 'OG001', 'title': 'Vehicle Gel', 'description': 'Treatment once daily for 3 consecutive days with LEO 43204 vehicle gel'}], 'classes': [{'categories': [{'measurements': [{'value': '56.6', 'groupId': 'OG000', 'lowerLimit': '49.7', 'upperLimit': '63.4'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '10.2'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of clearance rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.31', 'ciLowerLimit': '4.43', 'ciUpperLimit': '23.97', 'estimateComment': 'Mantel-Haenszel estimate (0.018% relative to vehicle), adjusted for pooled sites.', 'groupDescription': 'The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 4', 'description': 'Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.\n\nThe table shows the percentage of mean number of participants across imputations with partial clearance.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Reduction in AK Count in the Treatment Area Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LEO 43204 0.018% Gel', 'description': 'Treatment once daily for 3 consecutive days with LEO 43204 0.018% gel'}, {'id': 'OG001', 'title': 'Vehicle Gel', 'description': 'Treatment once daily for 3 consecutive days with LEO 43204 vehicle gel'}], 'classes': [{'categories': [{'measurements': [{'value': '72.1', 'groupId': 'OG000', 'lowerLimit': '68.3', 'upperLimit': '75.5'}, {'value': '7.3', 'groupId': 'OG001', 'lowerLimit': '-7.8', 'upperLimit': '20.3'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Week 8 AK count ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.30', 'ciLowerLimit': '0.25', 'ciUpperLimit': '0.37', 'pValueComment': 'Negative binominal regression with treatment group and pooled site as factors and log baseline count as offset variable.', 'estimateComment': '0.018% relative to vehicle.', 'groupDescription': 'The p-values for secondary endpoints have been corrected by the Holm-Bonferroni method to account for multiplicity. The prespecified multiplicity adjustment by the Holm-Bonferroni method requires the ordering of the p-values for the secondary endpoints by size.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'At Week 8', 'description': 'The percent reduction at Week 8 from baseline was analysed using a negative binomial regression for the AK count at Week 8 with treatment group and pooled sites as factors and baseline count as offset variable (using multiple imputations to account for missing values). The table presents adjusted mean percent reduction at Week 8 from baseline.', 'unitOfMeasure': 'percentage of reduction', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LEO 43204 0.018% Gel', 'description': 'Treatment with LEO 43204 0.018% gel once daily for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest.'}, {'id': 'FG001', 'title': 'Vehicle Gel', 'description': 'Treatment with vehicle gel once daily for 3 consecutive days applied on full face or within a contiguous area of approximately 250 cm2 on the chest.'}], 'periods': [{'title': '3-day Treatment and 8-week Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '205'}, {'groupId': 'FG001', 'numSubjects': '102'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '205'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '203'}, {'groupId': 'FG001', 'numSubjects': '92'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Unacceptable Local Skin Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': '12-month Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '199'}, {'groupId': 'FG001', 'numSubjects': '84'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '185'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 437 participants were enrolled across 4 countries: United States, United Kingdom, France, and Spain. 130 were screening failures, and 307 participants were randomized to 1 of the 2 treatment groups'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '305', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LEO 43204 0.018% Gel', 'description': 'Treatment once daily for 3 consecutive days with LEO 43204 0.018% gel'}, {'id': 'BG001', 'title': 'Vehicle Gel', 'description': 'Treatment once daily for 3 consecutive days with LEO 43204 vehicle gel'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.2', 'spread': '8.9', 'groupId': 'BG000'}, {'value': '67.4', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '67.9', 'spread': '9.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age group', 'categories': [{'title': '18-64 years', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': '65-84 years', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}, {'title': '>=85 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 437}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'dispFirstSubmitDate': '2017-12-20', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2015-09-09', 'dispFirstSubmitQcDate': '2017-12-20', 'resultsFirstSubmitDate': '2018-10-05', 'studyFirstSubmitQcDate': '2015-09-10', 'dispFirstPostDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-04', 'studyFirstPostDateStruct': {'date': '2015-09-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Complete Clearance of Actinic Keratosis (AK)', 'timeFrame': 'At Week 8', 'description': 'Complete clearance was defined as an AK count of zero, i.e. no clinically visible AKs (actinic keratosis lesions) in the treatment area.\n\nThe table shows the percentage of mean number of subjects across imputations with complete clearance.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Partial Clearance (Multiple Imputation)', 'timeFrame': 'At Week 8', 'description': 'Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.\n\nThe table shows the percentage of mean number of participants across imputations with partial clearance.'}, {'measure': 'Percentage of Participants With Partial Clearance (Multiple Imputation)', 'timeFrame': 'At Week 4', 'description': 'Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.\n\nThe table shows the percentage of mean number of participants across imputations with partial clearance.'}, {'measure': 'Percent Reduction in AK Count in the Treatment Area Compared to Baseline', 'timeFrame': 'At Week 8', 'description': 'The percent reduction at Week 8 from baseline was analysed using a negative binomial regression for the AK count at Week 8 with treatment group and pooled sites as factors and baseline count as offset variable (using multiple imputations to account for missing values). The table presents adjusted mean percent reduction at Week 8 from baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Actinic Keratosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.leopharmatrials.com/en', 'label': 'Clinical Trials at LEO Pharma'}]}, 'descriptionModule': {'briefSummary': 'The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on face or chest when applied topically once daily for 3 consecutive days as field treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on either the full face or a contiguous area of approximately 250 cm2 (40 in2) on the chest\n* Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking area of 50 cm2 (8 in2). The tracking area must be within the treatment area\n\nExclusion Criteria:\n\n* Location of the treatment area (full face or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected BCC or SCC\n* Treatment with ingenol mebutate gel in the treatment area within the last 12 months\n* Lesions in the treatment area that have: atypical clinical appearance (e.g. hyperthrophic, hyperkeratotic or cutaneous horns) and /or, 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)'}, 'identificationModule': {'nctId': 'NCT02547233', 'briefTitle': 'Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'officialTitle': 'Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up', 'orgStudyIdInfo': {'id': 'LP0084-1193'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LEO 43204 gel', 'description': 'Treatment once daily for 3 days', 'interventionNames': ['Drug: LEO 43204 gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle gel', 'description': 'Treatment once daily for 3 days', 'interventionNames': ['Drug: Vehicle gel']}], 'interventions': [{'name': 'LEO 43204 gel', 'type': 'DRUG', 'armGroupLabels': ['LEO 43204 gel']}, {'name': 'Vehicle gel', 'type': 'DRUG', 'armGroupLabels': ['Vehicle gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60005', 'city': 'Arlington Heights', 'state': 'Illinois', 'country': 'United States', 'facility': 'Altman Dermatology Associates', 'geoPoint': {'lat': 42.08836, 'lon': -87.98063}}], 'overallOfficials': [{'name': 'Michael Bukhalo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Altman Dermatology Associates'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LEO Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}