Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-03-11 @ 11:39 AM
Study NCT ID:
NCT02799069
Status:
COMPLETED
Last Update Posted:
2017-04-28
First Post:
2016-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Safety and Efficacy of BF-200 ALA for the Treatment of Actinic Keratosis With Photodynamic Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055623', 'term': 'Keratosis, Actinic'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570703', 'term': 'BF-200 ALA'}, {'id': 'D000622', 'term': 'Aminolevulinic Acid'}, {'id': 'C475457', 'term': 'methyl 5-aminolevulinate'}], 'ancestors': [{'id': 'D007982', 'term': 'Levulinic Acids'}, {'id': 'D007651', 'term': 'Keto Acids'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'b.schmitz@biofrontera.com', 'phone': '+49 214 876 32', 'title': 'Dr. Beate Schmitz', 'phoneExt': '41', 'organization': 'Biofrontera Bioscience GmbH'}, 'certainAgreement': {'otherDetails': "The publication of study results requires Biofrontera's acceptance. Investigators can claim an authorship if they have completely treated and documented at least 35 patients. Planned publications and presentations of investigations which are within the scope of the clinical study should be previously presented to Biofrontera for a statement.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Until 12 weeks after the last treatment', 'eventGroups': [{'id': 'EG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.', 'otherNumAtRisk': 76, 'otherNumAffected': 55, 'seriousNumAtRisk': 76, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Application site edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 61}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 175}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 179}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 60}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 60}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Application site exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 44}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Application site scab', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Application site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Application site vesicles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Application site paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Vascular graft occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Sarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Chronic lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': "Non-Hodgkin's lymphoma stage II", 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Arterial stenosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Temporal arteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 248, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), ITT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.1', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '27.5'}, {'value': '78.2', 'groupId': 'OG001', 'lowerLimit': '72.6', 'upperLimit': '83.2'}, {'value': '64.2', 'groupId': 'OG002', 'lowerLimit': '57.9', 'upperLimit': '70.2'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference to BF-200 ALA', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '14.0', 'ciLowerLimit': '5.9', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The sample size of 210 subjects per treatment arm (per protocol set) has a power of at least 90% to establish non-inferiority of BF-200 ALA to Metvix using a non-inferiority margin of -15% and assuming response rates of 70% for both BF-200 ALA and Metvix. The power calculation was based on a one-sided Z-test with continuity correction (unpooled) with a significance level of 0.025.The establishment of non-inferiority was performed for the PP set and verified for robustness on the ITT.'}, {'pValue': '0.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference to BF-200 ALA', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '61.1', 'ciLowerLimit': '51.2', 'ciUpperLimit': '71.0', 'groupDescription': 'Superiority of BF-200 ALA compared to placebo:\n\nA sample size of 264: 88 patients (BF-200 ALA: placebo) will have a power of more than 90% to establish superiority of BF-200 ALA over placebo, even if very conservative response rates of 65% for the BF-200 ALA group and 40% for placebo are assumed using a chi-square test with continuity correction and a two-sided significance level of 0.05.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the last PDT, up to 24 weeks after the first treatment', 'description': 'An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT.\n\nThe outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT)', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT)'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), PP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}, {'value': '236', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '31.8'}, {'value': '79.4', 'groupId': 'OG001', 'lowerLimit': '73.7', 'upperLimit': '84.4'}, {'value': '65.3', 'groupId': 'OG002', 'lowerLimit': '58.8', 'upperLimit': '71.3'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference to BF-200 ALA', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '14.2', 'ciLowerLimit': '6.0', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The sample size of 210 subjects per treatment arm (per protocol set) has a power of at least 90% to establish non-inferiority of BF-200 ALA to Metvix using a non-inferiority margin of -15% and assuming response rates of 70% for both BF-200 ALA and Metvix. The power calculation was based on a one-sided Z-test with continuity correction (unpooled) with a significance level of 0.025.The establishment of non-inferiority was performed for the PP set and verified for robustness on the ITT.'}, {'pValue': '0.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference to BF-200 ALA', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '59.4', 'ciLowerLimit': '48.4', 'ciUpperLimit': '70.4', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the last PDT, up to 24 weeks after the first treatment', 'description': 'An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT.\n\nThe outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT)', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol set (PP)'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT) Illuminated With Narrow Spectrum Devices Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '27.4'}, {'value': '84.8', 'groupId': 'OG001', 'lowerLimit': '77.3', 'upperLimit': '90.6'}, {'value': '67.5', 'groupId': 'OG002', 'lowerLimit': '58.5', 'upperLimit': '75.5'}]}]}], 'analyses': [{'pValue': '0.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference to BF-200 ALA', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '72.0', 'ciLowerLimit': '59.7', 'ciUpperLimit': '84.2', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference to BF-200 ALA', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '17.3', 'ciLowerLimit': '6.6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the last PDT, up to 24 weeks after the first treatment', 'description': 'Subgroup analysis of patients treated with a narrow spectrum device for PDT Illumination (\\~630 nm).\n\nAn overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT.\n\nThe outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT)', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Complete Response 3-4 Weeks After First Photodynamic Therapy (PDT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '9.2'}, {'value': '34.7', 'groupId': 'OG001', 'lowerLimit': '28.8', 'upperLimit': '41.0'}, {'value': '24.8', 'groupId': 'OG002', 'lowerLimit': '19.5', 'upperLimit': '30.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3-4 weeks after the first PDT', 'description': 'A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 3-4 weeks after the first PDT.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Complete Response 12 Weeks After First Photodynamic Therapy (PDT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '11.1'}, {'value': '48.4', 'groupId': 'OG001', 'lowerLimit': '42.0', 'upperLimit': '54.8'}, {'value': '37.0', 'groupId': 'OG002', 'lowerLimit': '30.9', 'upperLimit': '43.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the first PDT', 'description': 'A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 12 weeks after the first PDT.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Complete Response 3-4 Weeks After the Second Photodynamic Therapy (PDT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '23.8'}, {'value': '48.4', 'groupId': 'OG001', 'lowerLimit': '39.5', 'upperLimit': '57.4'}, {'value': '43.9', 'groupId': 'OG002', 'lowerLimit': '35.9', 'upperLimit': '52.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3-4 weeks after the second PDT, 15-16 weeks after first treatment', 'description': 'A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 3-4 weeks after the second PDT. A second PDT was applied in case partial- or non-responding lesions remained 12 weeks after the first PDT.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Complete Response 12 Weeks After Second Photodynamic Therapy (PDT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '23.8'}, {'value': '57.8', 'groupId': 'OG001', 'lowerLimit': '48.8', 'upperLimit': '66.5'}, {'value': '43.2', 'groupId': 'OG002', 'lowerLimit': '35.3', 'upperLimit': '51.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the second PDT, 24 weeks after first treatment', 'description': 'A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 12 weeks after the second PDT. A second PDT was applied in case partial- or non-responding lesions remained 12 weeks after the first PDT.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Complete Response 3-4 Weeks After Last Photodynamic Therapy (PDT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '24.4'}, {'value': '54.0', 'groupId': 'OG001', 'lowerLimit': '47.6', 'upperLimit': '60.4'}, {'value': '43.9', 'groupId': 'OG002', 'lowerLimit': '37.6', 'upperLimit': '50.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3-4 weeks after the last PDT, up to 16 weeks after the first treatment', 'description': 'A complete responder at week 3-4 after treatment was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission). This outcome measure considered patients who were completely cleared at 3-4 weeks after the last PDT which included complete responders 3-4 weeks after the first and complete responders 3-4 weeks after the second PDT ( a second PDT was applied in case of remaining lesions 12 weeks after the first PDT).', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Partial Response at 3-4 Weeks After First Photodynamic Therapy (PDT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '9.2'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '43.6', 'upperLimit': '56.4'}, {'value': '45.9', 'groupId': 'OG002', 'lowerLimit': '39.6', 'upperLimit': '52.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3-4 weeks after the first PDT', 'description': 'A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 3-4 weeks after the first PDT.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Partial Response at 12 Weeks After the First Photodynamic Therapy (PDT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000', 'lowerLimit': '6.5', 'upperLimit': '22.9'}, {'value': '58.9', 'groupId': 'OG001', 'lowerLimit': '52.5', 'upperLimit': '65.1'}, {'value': '53.3', 'groupId': 'OG002', 'lowerLimit': '46.8', 'upperLimit': '59.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the first PDT', 'description': 'A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 12 weeks after the first PDT.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Partial Response at 3-4 Weeks After the Second Photodynamic Therapy (PDT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '31.6'}, {'value': '68.0', 'groupId': 'OG001', 'lowerLimit': '59.1', 'upperLimit': '75.9'}, {'value': '62.6', 'groupId': 'OG002', 'lowerLimit': '54.5', 'upperLimit': '70.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3-4 weeks after the second PDT, 15-16 weeks after first treatment', 'description': 'A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 3-4 weeks after the second PDT.\n\nA second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Partial Response at 12 Weeks After the Second Photodynamic Therapy (PDT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.3', 'groupId': 'OG000', 'lowerLimit': '14.2', 'upperLimit': '34.6'}, {'value': '73.4', 'groupId': 'OG001', 'lowerLimit': '64.9', 'upperLimit': '80.9'}, {'value': '65.2', 'groupId': 'OG002', 'lowerLimit': '57.1', 'upperLimit': '72.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the second PDT, 24 weeks after first treatment', 'description': 'A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 12 weeks after the second PDT.\n\nA second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Partial Response at 3-4 Weeks After Last Photodynamic Therapy (PDT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000', 'lowerLimit': '12.5', 'upperLimit': '31.9'}, {'value': '70.6', 'groupId': 'OG001', 'lowerLimit': '64.5', 'upperLimit': '76.2'}, {'value': '64.6', 'groupId': 'OG002', 'lowerLimit': '58.3', 'upperLimit': '70.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3-4 weeks after the last PDT, up to 16 weeks after the first treatment', 'description': 'A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 3-4 weeks after last PDT.\n\nThe outcome measure combined partial responders with at least 75% of lesions cleared at 3-4 weeks after the first PDT or after the second PDT (a second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT).', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Partial Response at 12 Weeks After Last Photodynamic Therapy (PDT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.3', 'groupId': 'OG000', 'lowerLimit': '16.9', 'upperLimit': '37.7'}, {'value': '87.1', 'groupId': 'OG001', 'lowerLimit': '82.3', 'upperLimit': '91.0'}, {'value': '78.0', 'groupId': 'OG002', 'lowerLimit': '72.3', 'upperLimit': '83.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the last PDT, up to 24 weeks after first treatment', 'description': 'A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 12 weeks after last PDT.\n\nThe outcome measure combined partial responders with at least 75% of lesions cleared at 12 weeks after the first PDT and after the second PDT (a second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT) .', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Complete Lesion Response Rate 3-4 Weeks After First Photodynamic Therapy (PDT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}]}, {'units': 'number of individual lesions', 'counts': [{'value': '490', 'groupId': 'OG000'}, {'value': '1504', 'groupId': 'OG001'}, {'value': '1557', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000', 'lowerLimit': '9.8', 'upperLimit': '15.9'}, {'value': '63.9', 'groupId': 'OG001', 'lowerLimit': '61.4', 'upperLimit': '66.3'}, {'value': '58.8', 'groupId': 'OG002', 'lowerLimit': '56.3', 'upperLimit': '61.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3-4 weeks after the first PDT', 'description': 'Completely cleared individual lesions as defined at 3-4 weeks after first photodynamic therapy (PDT)', 'unitOfMeasure': 'percentage of lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'number of individual lesions', 'denomUnitsSelected': 'number of individual lesions', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Complete Lesion Response Rate 12 Weeks After First Photodynamic Therapy (PDT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}]}, {'units': 'number of individual lesions', 'counts': [{'value': '490', 'groupId': 'OG000'}, {'value': '1504', 'groupId': 'OG001'}, {'value': '1557', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.7', 'groupId': 'OG000', 'lowerLimit': '20.9', 'upperLimit': '28.8'}, {'value': '73.8', 'groupId': 'OG001', 'lowerLimit': '71.5', 'upperLimit': '76.0'}, {'value': '66.5', 'groupId': 'OG002', 'lowerLimit': '64.1', 'upperLimit': '68.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the first PDT', 'description': 'Completely cleared individual lesions as defined at 12 weeks after the first photodynamic therapy (PDT).', 'unitOfMeasure': 'percentage of lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'number of individual lesions', 'denomUnitsSelected': 'number of individual lesions', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Complete Lesion Response Rate 3-4 Weeks After the Second Photodynamic Therapy (PDT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}]}, {'units': 'number of individiual lesions', 'counts': [{'value': '369', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}, {'value': '522', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.3', 'groupId': 'OG000', 'lowerLimit': '12.6', 'upperLimit': '20.4'}, {'value': '60.4', 'groupId': 'OG001', 'lowerLimit': '55.4', 'upperLimit': '65.3'}, {'value': '54.8', 'groupId': 'OG002', 'lowerLimit': '50.4', 'upperLimit': '59.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3-4 weeks after the second PDT, 15-16 weeks after first treatment', 'description': 'Completely cleared individual lesions as defined at 3-4 weeks after the second PDT. A second PDT was applied in case the individual lesion showed no or partial response12 weeks after first PDT.', 'unitOfMeasure': 'percentage of lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'number of individiual lesions', 'denomUnitsSelected': 'number of individiual lesions', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Complete Lesion Response Rate 12 Weeks After Second PDT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}]}, {'units': 'number of individual lesions', 'counts': [{'value': '369', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}, {'value': '522', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000', 'lowerLimit': '17.8', 'upperLimit': '26.5'}, {'value': '69.3', 'groupId': 'OG001', 'lowerLimit': '64.5', 'upperLimit': '73.8'}, {'value': '58.0', 'groupId': 'OG002', 'lowerLimit': '53.7', 'upperLimit': '62.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the second PDT, 24 weeks after first treatment', 'description': 'Completely cleared individual lesions as defined at 12 weeks after second PDT. A second PDT was applied in case the individual lesion showed no or partial response 12 weeks after first PDT.', 'unitOfMeasure': 'percentage of lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'number of individual lesions', 'denomUnitsSelected': 'number of individual lesions', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Complete Lesion Response Rate 3-4 Weeks After Last Photodynamic Therapy (PDT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}]}, {'units': 'number of individual lesions', 'counts': [{'value': '490', 'groupId': 'OG000'}, {'value': '1504', 'groupId': 'OG001'}, {'value': '1557', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.4', 'groupId': 'OG000', 'lowerLimit': '27.3', 'upperLimit': '35.7'}, {'value': '79.0', 'groupId': 'OG001', 'lowerLimit': '76.8', 'upperLimit': '81.0'}, {'value': '73.5', 'groupId': 'OG002', 'lowerLimit': '71.2', 'upperLimit': '75.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3-4 weeks after the last PDT, up to 16 weeks after first treatment', 'description': 'Completely cleared individual lesions defined at 3-4 weeks after the last PDT comprising of completely cleared individual lesions 3-4 weeks after the first and after the second PDT (a second PDT was applied in case lesions show no or partial response 12 weeks after the first PDT).', 'unitOfMeasure': 'percentage of lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'number of individual lesions', 'denomUnitsSelected': 'number of individual lesions', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Complete Lesion Response Rate 12 Weeks After Last Photodynamic Therapy (PDT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}]}, {'units': 'num,ber of individual lesions', 'counts': [{'value': '490', 'groupId': 'OG000'}, {'value': '1504', 'groupId': 'OG001'}, {'value': '1557', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.1', 'groupId': 'OG000', 'lowerLimit': '32.9', 'upperLimit': '41.6'}, {'value': '90.4', 'groupId': 'OG001', 'lowerLimit': '88.8', 'upperLimit': '91.8'}, {'value': '83.2', 'groupId': 'OG002', 'lowerLimit': '81.2', 'upperLimit': '85.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the last PDT, up to 24 weeks after first treatment', 'description': 'Completely cleared individual lesions 12 weeks after last PDT comprising of completely cleared individual lesions 12 weeks after the first or second PDT (a second PDT was applied in case individual lesions show no or partial response 12 weeks after first PDT).', 'unitOfMeasure': 'percentage of lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'num,ber of individual lesions', 'denomUnitsSelected': 'num,ber of individual lesions', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Complete Lesion Response Rates 12 Weeks After Last Photodynamic Therapy (PDT) Illuminated With Narrow Spectrum Devices Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}, {'units': 'lesions treated with narrow spectrum', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '831', 'groupId': 'OG001'}, {'value': '847', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.5', 'groupId': 'OG000', 'lowerLimit': '26.9', 'upperLimit': '38.4'}, {'value': '93.6', 'groupId': 'OG001', 'lowerLimit': '91.7', 'upperLimit': '95.2'}, {'value': '89.3', 'groupId': 'OG002', 'lowerLimit': '87.0', 'upperLimit': '91.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 12 weeks after the last PDT, up to 24 weeks after first treatment', 'description': 'Completely cleared individual lesions 12 weeks after last PDT comprising of individual cleared lesions 12 weeks after the first or second PDT. A second PDT was applied in case individual lesion showed no or partial response 12 weeks after the first PDT.\n\nLesions were illuminated during photodynamic therapy with narrow spectrum devices only (\\~630 nm).', 'unitOfMeasure': 'percentage of lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions treated with narrow spectrum', 'denomUnitsSelected': 'lesions treated with narrow spectrum', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Lesion Area 3-4 Weeks After the First Photodynamic Therapy (PDT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.9', 'spread': '32.74', 'groupId': 'OG000'}, {'value': '-78.9', 'spread': '27.71', 'groupId': 'OG001'}, {'value': '-75.7', 'spread': '27.76', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-4 weeks after the first PDT', 'description': 'Percentage of change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed at 3-4 weeks after the first PDT.', 'unitOfMeasure': 'percentage of change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Lesion Area 12 Weeks After the First Photodynamic Therapy (PDT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '-37.0', 'spread': '39.86', 'groupId': 'OG000'}, {'value': '-85.4', 'spread': '22.81', 'groupId': 'OG001'}, {'value': '-80.9', 'spread': '27.65', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks after the first PDT', 'description': 'the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed 12 weeks after the first PDT.', 'unitOfMeasure': 'percentage of change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Lesion Area 3-4 Weeks After the Second Photodynamic Therapy (PDT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '-46.2', 'spread': '43.16', 'groupId': 'OG000'}, {'value': '-91.4', 'spread': '15.83', 'groupId': 'OG001'}, {'value': '-87.5', 'spread': '22.93', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-4 weeks after the second PDT, 15-16 weeks after first treatment', 'description': 'the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed 3-4 weeks after the second PDT. A second PDT was applied in case of non or partially responding lesions 12 weeks after first PDT.', 'unitOfMeasure': 'percentage of change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Lesion Area 12 Weeks After Second Photodynamic Therapy (PDT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '-50.1', 'spread': '43.89', 'groupId': 'OG000'}, {'value': '-92.3', 'spread': '17.15', 'groupId': 'OG001'}, {'value': '-88.9', 'spread': '19.03', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks after the second PDT, 24 after first treatment', 'description': 'the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed 12 weeks after the second PDT. A second PDT was applied in case of non- or partially responding lesions 12 weeks after first PDT.', 'unitOfMeasure': 'percentage of change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Lesion Area 3-4 Weeks After Last Photodynamic Therapy (PDT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '-43.8', 'spread': '43.40', 'groupId': 'OG000'}, {'value': '-89.4', 'spread': '20.13', 'groupId': 'OG001'}, {'value': '-86.6', 'spread': '22.57', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-4 weeks after the last PDT, up to 16 weeks after the first treatment', 'description': 'the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed at 3-4 weeks after last PDT, combining the changes from baseline in total lesion area of subjects 3-4 weeks after first PDT and second PDT (a second PDT was applied for subjects who showed non- or partially responding lesions 12 weeks after the first PDT).', 'unitOfMeasure': 'percentage of change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Lesion Area 12 Weeks After Last Photodynamic Therapy (PDT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '-48.5', 'spread': '44.83', 'groupId': 'OG000'}, {'value': '-95.0', 'spread': '15.66', 'groupId': 'OG001'}, {'value': '-92.0', 'spread': '17.74', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks after the last PDT, up to 24 weeks after the first treatment', 'description': 'the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed at 12 weeks after last PDT, combining the changes from baseline in total lesion area at 12 weeks after the first PDT and at 12 weeks after the second PDT (a second PDT was applied to subjects with non- or partially responding lesions 12 weeks after the first PDT).', 'unitOfMeasure': 'percentage of change from baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Overall Cosmetic Outcome of the Treated Skin 12 Weeks After Last Photodynamic Therapy (PDT) Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}, {'value': '240', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'title': 'very good or good', 'categories': [{'measurements': [{'value': '29.4', 'groupId': 'OG000', 'lowerLimit': '19.0', 'upperLimit': '41.7'}, {'value': '36.0', 'groupId': 'OG001', 'lowerLimit': '29.9', 'upperLimit': '42.3'}, {'value': '37.1', 'groupId': 'OG002', 'lowerLimit': '31.0', 'upperLimit': '43.5'}]}]}, {'title': 'very good', 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000', 'lowerLimit': '7.3', 'upperLimit': '25.4'}, {'value': '16.5', 'groupId': 'OG001', 'lowerLimit': '12.1', 'upperLimit': '21.8'}, {'value': '19.2', 'groupId': 'OG002', 'lowerLimit': '14.4', 'upperLimit': '24.7'}]}]}, {'title': 'good', 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000', 'lowerLimit': '7.3', 'upperLimit': '25.4'}, {'value': '19.4', 'groupId': 'OG001', 'lowerLimit': '14.6', 'upperLimit': '25.0'}, {'value': '17.9', 'groupId': 'OG002', 'lowerLimit': '13.3', 'upperLimit': '23.4'}]}]}, {'title': 'Satisfactory', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '37.6', 'upperLimit': '62.4'}, {'value': '55.8', 'groupId': 'OG001', 'lowerLimit': '49.3', 'upperLimit': '62.1'}, {'value': '53.3', 'groupId': 'OG002', 'lowerLimit': '46.8', 'upperLimit': '59.8'}]}]}, {'title': 'Unsatisfactory', 'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000', 'lowerLimit': '8.4', 'upperLimit': '27.1'}, {'value': '6.6', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '10.5'}, {'value': '5.8', 'groupId': 'OG002', 'lowerLimit': '3.2', 'upperLimit': '9.6'}]}]}, {'title': 'Impaired', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '12.4'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '4.2'}, {'value': '3.8', 'groupId': 'OG002', 'lowerLimit': '1.7', 'upperLimit': '7.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the last PDT, up to 24 weeks after first treatment', 'description': 'The cosmetic outcome 12 weeks after the last PDT (12 weeks after 1st PDT for subjects who are completely cleared at this time point, 12 weeks after 2nd PDT for subjects retreated due to remaining lesions 12 weeks after 1st PDT) will be calculated on the basis of the skin quality assessment (skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring, and atrophy) upon visual examination (scale: 0= none, 1= mild, 2= moderate, 3=severe). The cosmetic outcome is rated as very good if the sum score of the previously mentioned ratings (all ratings for each sign added up) has improved by at least 2 points as compared to baseline; as good if the sum score has improved by at least 1 point as compared to baseline; as satisfactory if the sum score is identical to the one at baseline; as unsatisfactory if the sum score has worsened by 1 point compared to baseline and as impaired if the sum score has worsened by at least 2 points compared to baseline.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Local Skin Reactions During First Photodynamic Therapy (PDT-1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'title': 'Erythema', 'categories': [{'measurements': [{'value': '32.9', 'groupId': 'OG000'}, {'value': '72.6', 'groupId': 'OG001'}, {'value': '71.1', 'groupId': 'OG002'}]}]}, {'title': 'Edema', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '22.2', 'groupId': 'OG001'}, {'value': '23.6', 'groupId': 'OG002'}]}]}, {'title': 'Induration', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '9.3', 'groupId': 'OG001'}, {'value': '8.5', 'groupId': 'OG002'}]}]}, {'title': 'Vesicles', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}, {'value': '6.1', 'groupId': 'OG002'}]}]}, {'title': 'Erosion', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}, {'value': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'Ulceration', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Scaling/Flaking', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Scabbing/Crusting', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Weeping/Exudate', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}, {'value': '1.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'during PDT treatment [3 h - 4 h ]', 'description': 'Local skin reactions in the treatment area as assessed by the investigator during the first PDT (PDT-1)', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Local Skin Reactions During Second Photodynamic Therapy (PDT-2) for Retreated Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'title': 'Erythema', 'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000'}, {'value': '61.8', 'groupId': 'OG001'}, {'value': '70.0', 'groupId': 'OG002'}]}]}, {'title': 'Edema', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '10.6', 'groupId': 'OG001'}, {'value': '11.3', 'groupId': 'OG002'}]}]}, {'title': 'Induration', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '4.1', 'groupId': 'OG001'}, {'value': '3.3', 'groupId': 'OG002'}]}]}, {'title': 'Vesicles', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Erosion', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Ulceration', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Scaling/Flaking', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Scabbing/Crusting', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Weeping/Exudate', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'during PDT treatment [3 h - 4 h ]', 'description': 'Local skin reactions in the treatment area as assessed by the investigator during PDT-2; only applicable for subjects who were retreated with a second PDT due to remaining lesions 12 weeks after the first PDT (subjects with data).', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - retreated subjects only'}, {'type': 'SECONDARY', 'title': 'Local Discomfort During First Photodynamic Therapy (PDT-1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'title': 'Itching during PDT-1', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '9.7', 'groupId': 'OG001'}, {'value': '14.6', 'groupId': 'OG002'}]}]}, {'title': 'Burning during PDT-1', 'categories': [{'measurements': [{'value': '28.9', 'groupId': 'OG000'}, {'value': '81.9', 'groupId': 'OG001'}, {'value': '85.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'during PDT treatment [3 h - 4 h ]', 'description': 'Local discomfort reported by the patients during Illumination of first PDT (PDT1)', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Local Discomfort During Second Photodynamic Therapy (PDT-2) for Retreated Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'title': 'Itching during PDT-2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '7.3', 'groupId': 'OG001'}, {'value': '8.7', 'groupId': 'OG002'}]}]}, {'title': 'Burning during PDT-2', 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000'}, {'value': '69.9', 'groupId': 'OG001'}, {'value': '74.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'during PDT treatment [3 h - 4 h ]', 'description': 'Local discomfort reported by the patients during Illumination phase of retreatment (PDT-2); only applicable for subjects who received a retreatment (PDT-2) due to remaining lesions 12 weeks after the first treatment (PDT-1) (subjects with data)', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - retreated subjects only'}, {'type': 'SECONDARY', 'title': 'Local Discomfort - Pain During First Photodynamic Therapy (PDT-1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '3.50', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '3.52', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during PDT treatment [3 h - 4 h ]', 'description': "Pain (11-point numeric rating scale) by PDT Session; Overall (If both areas have been treated, maximum intensity over both areas is used for analysis.) Patients assessed the pain experienced during PDT using an 11-point numeric rating pain scale (NRPS) ranging from 0 (no pain at all) to 10 (worst possible pain). This score reflects the patient's maximum pain during PDT. This outcome measure shows pain score after the first PDT.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Local Discomfort - Pain During Second Photodynamic Therapy (PDT-2) for Retreated Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '3.26', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '3.22', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during PDT treatment [3 h - 4 h ]', 'description': "Pain (11-point numeric rating scale) by PDT Session; Overall (If both areas have been treated, maximum intensity over both areas is used for analysis.) Patients assessed the pain experienced during PDT using an 11-point numeric rating pain scale (NRPS) ranging from 0 (no pain at all) to 10 (worst possible pain). This score reflects the patient's maximum pain during PDT.\n\nOnly applicable for subjects who received a retreatment (PDT-2) due to remaining lesions 12 weeks after the first treatment (PDT-1) (subjects with data)", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Adverse Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'OG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'classes': [{'title': 'Application site irritation', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '222', 'groupId': 'OG002'}]}]}, {'title': 'Application site erythema', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}]}, {'title': 'Application site pain', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}]}]}, {'title': 'Application site edema', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}]}, {'title': 'Application site pruritus', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}]}, {'title': 'Application site exfoliation', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}]}, {'title': 'Application site scab', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': 'Application site induration', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'Application site vesicles', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Application site paraesthesia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Skin exfoliation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 12 weeks after the last PDT, up to 24 weeks after first treatment', 'description': 'Adverse reactions are Treatment-Emergent Adverse Events considered at least possibly related to the treatment with the randomized investigational medicinal products; Adverse reactions are shown with a frequency cut off of \\>=5%.\n\nTEAEs are considered from subjects who received only one PDT or subjects who received 2 PDTs (initial Treatment (PDT-1) and retreatment (PDT-2) due to remaining lesions 12 weeks after first photodynamic therapy.\n\nThe safety set consists of all patients treated at least once with investigational product. Treatment with investigational product consists of application of study drug followed by illumination. This excludes one patient from the safety set; for this patient the investigational product was applied on the skin but it was not illuminated. Patients are treated according to actual treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'safety population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'FG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'FG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '248'}, {'groupId': 'FG002', 'numSubjects': '247'}]}, {'type': 'ITT/Safety', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '248'}, {'comment': '1 subject received medication without Illumination and thus was excluded from ITT/safety population', 'groupId': 'FG002', 'numSubjects': '246'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '241'}, {'groupId': 'FG002', 'numSubjects': '240'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Multinational / 26 centers sites: Germany (23), Austria (2) and Switzerland (1); 08 Apr 2008: First subject signed informed consent; 21 Aug 2009: Last subject completed clinical part of study', 'preAssignmentDetails': '616 patients with actinic keratosis (AK) were planned to be randomized in a 3:3:1 ratio allowing for 20% of non-evaluable patients excluded from the per-protocol set. Due to the low drop out rates, recruiting was stopped after 600 patients were screened. Of those, 571 patients were randomized and 29 patients were screening failures.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '248', 'groupId': 'BG001'}, {'value': '246', 'groupId': 'BG002'}, {'value': '570', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Vehicle', 'description': 'Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'BG001', 'title': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nBF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'BG002', 'title': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.\n\nMAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.'}, {'id': 'BG003', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}, {'value': '476', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.5', 'spread': '6.68', 'groupId': 'BG000'}, {'value': '70.2', 'spread': '7.18', 'groupId': 'BG001'}, {'value': '71.0', 'spread': '6.93', 'groupId': 'BG002'}, {'value': '70.7', 'spread': '7.01', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}, {'value': '479', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Europe', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '248', 'groupId': 'BG001'}, {'value': '246', 'groupId': 'BG002'}, {'value': '570', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of individual lesions', 'classes': [{'categories': [{'measurements': [{'value': '490', 'groupId': 'BG000'}, {'value': '1504', 'groupId': 'BG001'}, {'value': '1557', 'groupId': 'BG002'}, {'value': '3551', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'individual lesions'}], 'populationDescription': 'Intended-to-treat (ITT)'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 571}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-28', 'studyFirstSubmitDate': '2016-05-26', 'resultsFirstSubmitDate': '2016-09-07', 'studyFirstSubmitQcDate': '2016-06-09', 'lastUpdatePostDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-02', 'studyFirstPostDateStruct': {'date': '2016-06-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), ITT', 'timeFrame': '12 weeks after the last PDT, up to 24 weeks after the first treatment', 'description': 'An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT.\n\nThe outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT)'}, {'measure': 'Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), PP', 'timeFrame': '12 weeks after the last PDT, up to 24 weeks after the first treatment', 'description': 'An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT.\n\nThe outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT)'}, {'measure': 'Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT) Illuminated With Narrow Spectrum Devices Only', 'timeFrame': '12 weeks after the last PDT, up to 24 weeks after the first treatment', 'description': 'Subgroup analysis of patients treated with a narrow spectrum device for PDT Illumination (\\~630 nm).\n\nAn overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT.\n\nThe outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT)'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Complete Response 3-4 Weeks After First Photodynamic Therapy (PDT)', 'timeFrame': '3-4 weeks after the first PDT', 'description': 'A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 3-4 weeks after the first PDT.'}, {'measure': 'Percentage of Participants With Complete Response 12 Weeks After First Photodynamic Therapy (PDT)', 'timeFrame': '12 weeks after the first PDT', 'description': 'A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 12 weeks after the first PDT.'}, {'measure': 'Percentage of Participants With Complete Response 3-4 Weeks After the Second Photodynamic Therapy (PDT)', 'timeFrame': '3-4 weeks after the second PDT, 15-16 weeks after first treatment', 'description': 'A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 3-4 weeks after the second PDT. A second PDT was applied in case partial- or non-responding lesions remained 12 weeks after the first PDT.'}, {'measure': 'Percentage of Participants With Complete Response 12 Weeks After Second Photodynamic Therapy (PDT)', 'timeFrame': '12 weeks after the second PDT, 24 weeks after first treatment', 'description': 'A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 12 weeks after the second PDT. A second PDT was applied in case partial- or non-responding lesions remained 12 weeks after the first PDT.'}, {'measure': 'Percentage of Participants With Complete Response 3-4 Weeks After Last Photodynamic Therapy (PDT)', 'timeFrame': '3-4 weeks after the last PDT, up to 16 weeks after the first treatment', 'description': 'A complete responder at week 3-4 after treatment was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission). This outcome measure considered patients who were completely cleared at 3-4 weeks after the last PDT which included complete responders 3-4 weeks after the first and complete responders 3-4 weeks after the second PDT ( a second PDT was applied in case of remaining lesions 12 weeks after the first PDT).'}, {'measure': 'Percentage of Participants With Partial Response at 3-4 Weeks After First Photodynamic Therapy (PDT)', 'timeFrame': '3-4 weeks after the first PDT', 'description': 'A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 3-4 weeks after the first PDT.'}, {'measure': 'Percentage of Participants With Partial Response at 12 Weeks After the First Photodynamic Therapy (PDT)', 'timeFrame': '12 weeks after the first PDT', 'description': 'A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 12 weeks after the first PDT.'}, {'measure': 'Percentage of Participants With Partial Response at 3-4 Weeks After the Second Photodynamic Therapy (PDT)', 'timeFrame': '3-4 weeks after the second PDT, 15-16 weeks after first treatment', 'description': 'A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 3-4 weeks after the second PDT.\n\nA second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT.'}, {'measure': 'Percentage of Participants With Partial Response at 12 Weeks After the Second Photodynamic Therapy (PDT)', 'timeFrame': '12 weeks after the second PDT, 24 weeks after first treatment', 'description': 'A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 12 weeks after the second PDT.\n\nA second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT.'}, {'measure': 'Percentage of Participants With Partial Response at 3-4 Weeks After Last Photodynamic Therapy (PDT)', 'timeFrame': '3-4 weeks after the last PDT, up to 16 weeks after the first treatment', 'description': 'A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 3-4 weeks after last PDT.\n\nThe outcome measure combined partial responders with at least 75% of lesions cleared at 3-4 weeks after the first PDT or after the second PDT (a second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT).'}, {'measure': 'Percentage of Participants With Partial Response at 12 Weeks After Last Photodynamic Therapy (PDT)', 'timeFrame': '12 weeks after the last PDT, up to 24 weeks after first treatment', 'description': 'A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 12 weeks after last PDT.\n\nThe outcome measure combined partial responders with at least 75% of lesions cleared at 12 weeks after the first PDT and after the second PDT (a second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT) .'}, {'measure': 'Complete Lesion Response Rate 3-4 Weeks After First Photodynamic Therapy (PDT)', 'timeFrame': '3-4 weeks after the first PDT', 'description': 'Completely cleared individual lesions as defined at 3-4 weeks after first photodynamic therapy (PDT)'}, {'measure': 'Complete Lesion Response Rate 12 Weeks After First Photodynamic Therapy (PDT)', 'timeFrame': '12 weeks after the first PDT', 'description': 'Completely cleared individual lesions as defined at 12 weeks after the first photodynamic therapy (PDT).'}, {'measure': 'Complete Lesion Response Rate 3-4 Weeks After the Second Photodynamic Therapy (PDT)', 'timeFrame': '3-4 weeks after the second PDT, 15-16 weeks after first treatment', 'description': 'Completely cleared individual lesions as defined at 3-4 weeks after the second PDT. A second PDT was applied in case the individual lesion showed no or partial response12 weeks after first PDT.'}, {'measure': 'Complete Lesion Response Rate 12 Weeks After Second PDT', 'timeFrame': '12 weeks after the second PDT, 24 weeks after first treatment', 'description': 'Completely cleared individual lesions as defined at 12 weeks after second PDT. A second PDT was applied in case the individual lesion showed no or partial response 12 weeks after first PDT.'}, {'measure': 'Complete Lesion Response Rate 3-4 Weeks After Last Photodynamic Therapy (PDT)', 'timeFrame': '3-4 weeks after the last PDT, up to 16 weeks after first treatment', 'description': 'Completely cleared individual lesions defined at 3-4 weeks after the last PDT comprising of completely cleared individual lesions 3-4 weeks after the first and after the second PDT (a second PDT was applied in case lesions show no or partial response 12 weeks after the first PDT).'}, {'measure': 'Complete Lesion Response Rate 12 Weeks After Last Photodynamic Therapy (PDT)', 'timeFrame': '12 weeks after the last PDT, up to 24 weeks after first treatment', 'description': 'Completely cleared individual lesions 12 weeks after last PDT comprising of completely cleared individual lesions 12 weeks after the first or second PDT (a second PDT was applied in case individual lesions show no or partial response 12 weeks after first PDT).'}, {'measure': 'Complete Lesion Response Rates 12 Weeks After Last Photodynamic Therapy (PDT) Illuminated With Narrow Spectrum Devices Only', 'timeFrame': 'up to 12 weeks after the last PDT, up to 24 weeks after first treatment', 'description': 'Completely cleared individual lesions 12 weeks after last PDT comprising of individual cleared lesions 12 weeks after the first or second PDT. A second PDT was applied in case individual lesion showed no or partial response 12 weeks after the first PDT.\n\nLesions were illuminated during photodynamic therapy with narrow spectrum devices only (\\~630 nm).'}, {'measure': 'Change From Baseline in Total Lesion Area 3-4 Weeks After the First Photodynamic Therapy (PDT)', 'timeFrame': '3-4 weeks after the first PDT', 'description': 'Percentage of change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed at 3-4 weeks after the first PDT.'}, {'measure': 'Change From Baseline in Total Lesion Area 12 Weeks After the First Photodynamic Therapy (PDT)', 'timeFrame': '12 weeks after the first PDT', 'description': 'the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed 12 weeks after the first PDT.'}, {'measure': 'Change From Baseline in Total Lesion Area 3-4 Weeks After the Second Photodynamic Therapy (PDT)', 'timeFrame': '3-4 weeks after the second PDT, 15-16 weeks after first treatment', 'description': 'the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed 3-4 weeks after the second PDT. A second PDT was applied in case of non or partially responding lesions 12 weeks after first PDT.'}, {'measure': 'Change From Baseline in Total Lesion Area 12 Weeks After Second Photodynamic Therapy (PDT)', 'timeFrame': '12 weeks after the second PDT, 24 after first treatment', 'description': 'the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed 12 weeks after the second PDT. A second PDT was applied in case of non- or partially responding lesions 12 weeks after first PDT.'}, {'measure': 'Change From Baseline in Total Lesion Area 3-4 Weeks After Last Photodynamic Therapy (PDT)', 'timeFrame': '3-4 weeks after the last PDT, up to 16 weeks after the first treatment', 'description': 'the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed at 3-4 weeks after last PDT, combining the changes from baseline in total lesion area of subjects 3-4 weeks after first PDT and second PDT (a second PDT was applied for subjects who showed non- or partially responding lesions 12 weeks after the first PDT).'}, {'measure': 'Change From Baseline in Total Lesion Area 12 Weeks After Last Photodynamic Therapy (PDT)', 'timeFrame': '12 weeks after the last PDT, up to 24 weeks after the first treatment', 'description': 'the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed at 12 weeks after last PDT, combining the changes from baseline in total lesion area at 12 weeks after the first PDT and at 12 weeks after the second PDT (a second PDT was applied to subjects with non- or partially responding lesions 12 weeks after the first PDT).'}, {'measure': 'Overall Cosmetic Outcome of the Treated Skin 12 Weeks After Last Photodynamic Therapy (PDT) Compared to Baseline', 'timeFrame': '12 weeks after the last PDT, up to 24 weeks after first treatment', 'description': 'The cosmetic outcome 12 weeks after the last PDT (12 weeks after 1st PDT for subjects who are completely cleared at this time point, 12 weeks after 2nd PDT for subjects retreated due to remaining lesions 12 weeks after 1st PDT) will be calculated on the basis of the skin quality assessment (skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring, and atrophy) upon visual examination (scale: 0= none, 1= mild, 2= moderate, 3=severe). The cosmetic outcome is rated as very good if the sum score of the previously mentioned ratings (all ratings for each sign added up) has improved by at least 2 points as compared to baseline; as good if the sum score has improved by at least 1 point as compared to baseline; as satisfactory if the sum score is identical to the one at baseline; as unsatisfactory if the sum score has worsened by 1 point compared to baseline and as impaired if the sum score has worsened by at least 2 points compared to baseline.'}, {'measure': 'Local Skin Reactions During First Photodynamic Therapy (PDT-1)', 'timeFrame': 'during PDT treatment [3 h - 4 h ]', 'description': 'Local skin reactions in the treatment area as assessed by the investigator during the first PDT (PDT-1)'}, {'measure': 'Local Skin Reactions During Second Photodynamic Therapy (PDT-2) for Retreated Subjects', 'timeFrame': 'during PDT treatment [3 h - 4 h ]', 'description': 'Local skin reactions in the treatment area as assessed by the investigator during PDT-2; only applicable for subjects who were retreated with a second PDT due to remaining lesions 12 weeks after the first PDT (subjects with data).'}, {'measure': 'Local Discomfort During First Photodynamic Therapy (PDT-1)', 'timeFrame': 'during PDT treatment [3 h - 4 h ]', 'description': 'Local discomfort reported by the patients during Illumination of first PDT (PDT1)'}, {'measure': 'Local Discomfort During Second Photodynamic Therapy (PDT-2) for Retreated Subjects', 'timeFrame': 'during PDT treatment [3 h - 4 h ]', 'description': 'Local discomfort reported by the patients during Illumination phase of retreatment (PDT-2); only applicable for subjects who received a retreatment (PDT-2) due to remaining lesions 12 weeks after the first treatment (PDT-1) (subjects with data)'}, {'measure': 'Local Discomfort - Pain During First Photodynamic Therapy (PDT-1)', 'timeFrame': 'during PDT treatment [3 h - 4 h ]', 'description': "Pain (11-point numeric rating scale) by PDT Session; Overall (If both areas have been treated, maximum intensity over both areas is used for analysis.) Patients assessed the pain experienced during PDT using an 11-point numeric rating pain scale (NRPS) ranging from 0 (no pain at all) to 10 (worst possible pain). This score reflects the patient's maximum pain during PDT. This outcome measure shows pain score after the first PDT."}, {'measure': 'Local Discomfort - Pain During Second Photodynamic Therapy (PDT-2) for Retreated Subjects', 'timeFrame': 'during PDT treatment [3 h - 4 h ]', 'description': "Pain (11-point numeric rating scale) by PDT Session; Overall (If both areas have been treated, maximum intensity over both areas is used for analysis.) Patients assessed the pain experienced during PDT using an 11-point numeric rating pain scale (NRPS) ranging from 0 (no pain at all) to 10 (worst possible pain). This score reflects the patient's maximum pain during PDT.\n\nOnly applicable for subjects who received a retreatment (PDT-2) due to remaining lesions 12 weeks after the first treatment (PDT-1) (subjects with data)"}, {'measure': 'Adverse Reactions', 'timeFrame': 'up to 12 weeks after the last PDT, up to 24 weeks after first treatment', 'description': 'Adverse reactions are Treatment-Emergent Adverse Events considered at least possibly related to the treatment with the randomized investigational medicinal products; Adverse reactions are shown with a frequency cut off of \\>=5%.\n\nTEAEs are considered from subjects who received only one PDT or subjects who received 2 PDTs (initial Treatment (PDT-1) and retreatment (PDT-2) due to remaining lesions 12 weeks after first photodynamic therapy.\n\nThe safety set consists of all patients treated at least once with investigational product. Treatment with investigational product consists of application of study drug followed by illumination. This excludes one patient from the safety set; for this patient the investigational product was applied on the skin but it was not illuminated. Patients are treated according to actual treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Actinic Keratosis']}, 'referencesModule': {'references': [{'pmid': '21910711', 'type': 'BACKGROUND', 'citation': 'Dirschka T, Radny P, Dominicus R, Mensing H, Bruning H, Jenne L, Karl L, Sebastian M, Oster-Schmidt C, Klovekorn W, Reinhold U, Tanner M, Grone D, Deichmann M, Simon M, Hubinger F, Hofbauer G, Krahn-Senftleben G, Borrosch F, Reich K, Berking C, Wolf P, Lehmann P, Moers-Carpi M, Honigsmann H, Wernicke-Panten K, Helwig C, Foguet M, Schmitz B, Lubbert H, Szeimies RM; AK-CT002 Study Group. Photodynamic therapy with BF-200 ALA for the treatment of actinic keratosis: results of a multicentre, randomized, observer-blind phase III study in comparison with a registered methyl-5-aminolaevulinate cream and placebo. Br J Dermatol. 2012 Jan;166(1):137-46. doi: 10.1111/j.1365-2133.2011.10613.x. Epub 2011 Dec 21.'}, {'pmid': '23252768', 'type': 'BACKGROUND', 'citation': 'Dirschka T, Radny P, Dominicus R, Mensing H, Bruning H, Jenne L, Karl L, Sebastian M, Oster-Schmidt C, Klovekorn W, Reinhold U, Tanner M, Grone D, Deichmann M, Simon M, Hubinger F, Hofbauer G, Krahn-Senftleben G, Borrosch F, Reich K, Berking C, Wolf P, Lehmann P, Moers-Carpi M, Honigsmann H, Wernicke-Panten K, Hahn S, Pabst G, Voss D, Foguet M, Schmitz B, Lubbert H, Szeimies RM; AK-CT002 Study Group; AK-CT003 Study Group. Long-term (6 and 12 months) follow-up of two prospective, randomized, controlled phase III trials of photodynamic therapy with BF-200 ALA and methyl aminolaevulinate for the treatment of actinic keratosis. Br J Dermatol. 2013 Apr;168(4):825-36. doi: 10.1111/bjd.12158.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the non-inferiority of BF-200 ALA (Ameluz) in the treatment of actinic keratosis (AK) with photodynamic therapy (PDT) compared to Metvix.', 'detailedDescription': 'This was a randomized, observer-blind, multinational, comparator and placebo-controlled parallel group, (3:3:1 ratio) study to compare the efficacy and safety of BF-200 ALA with the comparator Metvix® (methyl-\\[5-amino-4-oxopentanoate\\]) and placebo, for the treatment of AK with PDT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Written informed consent.\n* Men and women between 18 and 85 years of age.\n* 4-8 AK lesions of 0.5 to 1.5 cm diameter of mild to moderate intensity (Olsen grade 1 and 2) in the face and/or on the bald scalp. Lesions on the eyes, nostrils, ears and mouth were not considered for treatment during the planned study.\n* Target AK lesions were to be discrete and quantifiable; adjacent AK lesions were to show a minimum distance of 1.0 cm from one another.\n* Confirmation of AK by biopsy taken at screening.\n* Free of significant physical abnormalities (e.g., tattoos, dermatoses) in the potential treatment region that could have caused difficulty with examination or final evaluation.\n* Willingness to stop the use of moisturizers and any other topical treatments within the treatment region.\n* Good general health condition.\n* Healthy subjects and subjects with clinically stable medical conditions including, but not limited to the following diseases (controlled hypertension, diabetes mellitus type II, hypercholesterolemia, osteoarthritis) were permitted to be included in the study if the medication taken for the treatment of the disease did not match an exclusion criterion or was not specified as prohibited concomitant medication.\n* No extensive sunbathing or solarium use during the trial.\n* Negative pregnancy test at screening.\n\nMain exclusion criteria:\n\n* Known hypersensitivity to BF-200 ALA, MAL (methyl-aminolevulinic acid) and/or any of the ingredients of the formulations\n* Clinically significant medical conditions (tumor disease etc.) making implementation of the protocol or interpretation of the study results difficult\n* Presence of photodermatoses\n* Presence of other tumors in the treatment areas within the last 4 weeks\n* Start of treatment with phototoxic or photoallergic drugs within 8 weeks prior to screening\n* Current treatment with immunosuppression therapy\n* Hypersensitivity to porphyrins\n* Presence of porphyria\n* Presence of inherited or acquired coagulation defect\n* Any topical treatment within the treatment area within 12 weeks before PDT1 (first PDT Treatment)\n* Topical treatment with ALA or MAL outside the treatment area during participation in the study\n* None of the specified systemic treatments within the designated period before PDT1'}, 'identificationModule': {'nctId': 'NCT02799069', 'briefTitle': 'Evaluation of Safety and Efficacy of BF-200 ALA for the Treatment of Actinic Keratosis With Photodynamic Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biofrontera Bioscience GmbH'}, 'officialTitle': 'A Randomized, Observer Blind, Multinational Phase III Study to Evaluate the Safety and Efficacy of a Nanoemulsion Gel Formulation BF-200 ALA, in Comparison With Metvix® and Placebo, for the Treatment of Actinic Keratosis With PDT', 'orgStudyIdInfo': {'id': 'ALA-AK-CT002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BF-200 ALA', 'description': 'Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.', 'interventionNames': ['Drug: BF-200 ALA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MAL Cream', 'description': 'Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.', 'interventionNames': ['Drug: MAL Cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'Topical application of matched Placebo to BF-200 ALA gel (without containing active ingredient) ). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.', 'interventionNames': ['Drug: Vehicle']}], 'interventions': [{'name': 'BF-200 ALA', 'type': 'DRUG', 'otherNames': ['Ameluz'], 'description': 'topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.', 'armGroupLabels': ['BF-200 ALA']}, {'name': 'MAL Cream', 'type': 'DRUG', 'otherNames': ['Metvix', 'Metvixia'], 'description': 'topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.', 'armGroupLabels': ['MAL Cream']}, {'name': 'Vehicle', 'type': 'DRUG', 'otherNames': ['matched placebo to BF-200 ALA gel'], 'description': 'topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Thomas Dirschka, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Akademische Lehrpraxis der Universität Witten-Herdecke Heinz-Fangman-Straße 57 42287 Wuppertal'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biofrontera Bioscience GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Accovion GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}