Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT00437320
Status:
COMPLETED
Last Update Posted:
2024-05-31
First Post:
2007-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparison of Metvix Photodynamic Therapy (PDT) With Its Vehicle in the Treatment of Photoaged Skin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C475457', 'term': 'methyl 5-aminolevulinate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Studies@galderma.com', 'phone': '817 961 5000', 'title': 'Clinical Operations', 'phoneExt': '1', 'organization': 'Galderma'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of administration up to Week 20', 'description': 'Safety population included all enrolled and randomized participants. As per planned analysis safety data was analyzed and collected for Metvix Cream 160 mg/g+Metvix Vehicle Cream (1 Hour Group), Metvix Cream 160 mg/g+Metvix Vehicle Cream (2 Hour Group) and Metvix Cream 160 mg/g+Metvix Vehicle Cream (3 Hour Group).', 'eventGroups': [{'id': 'EG000', 'title': 'Metvix 160 mg/g Cream+Metvix Vehicle Cream (1 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Metvix 160 mg/g Cream+Metvix Vehicle Cream (2 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 3, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Metvix 160 mg/g Cream+Metvix Vehicle Cream (3 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 8, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Photosensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Face Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Rash Pustular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Skin Exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'seriousEvents': [{'term': 'Glioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Severity of Photodamage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Metvix Cream 160 mg/g (1 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG001', 'title': 'Metvix Vehicle Cream (1 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG002', 'title': 'Metvix Cream 160 mg/g (2 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG003', 'title': 'Metvix Vehicle Cream (2 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG004', 'title': 'Metvix Cream 160 mg/g (3 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG005', 'title': 'Metvix Vehicle Cream (3 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}], 'classes': [{'categories': [{'title': 'No - Mild damage', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'Mild damage', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'Mild - Moderate damage', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}, {'title': 'Moderate damage', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}, {'title': 'Moderate - Moderate/ severe damage', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': 'Moderate/ severe damage', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}, {'title': 'Moderate/ severe - Severe damage', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'Severe damage', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 20', 'description': 'Severity of cutaneous photodamage in participants were assessed using Griffiths photo numeric scale. The severity scores of photodamage on the scale ranged from 0 (minimum) to 8 (maximum), that is, no damage (0), mild damage (1-3), moderate damage (4-6), and severe damage (7-8) where the highest score indicated worst outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled and randomized participants. "Here, \'Overall number of participants analyzed\' signifies participants who were evaluable for this outcome measure. As per planned analysis data was separately analyzed and collected for both Metvix cream and Metvix vehicle cream based on 1, 2 and 3 hours group."'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Severity of Mottled Hyper-Pigmentation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Metvix Cream 160 mg/g (1 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG001', 'title': 'Metvix Vehicle Cream (1 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG002', 'title': 'Metvix Cream 160 mg/g (2 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG003', 'title': 'Metvix Vehicle Cream (2 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG004', 'title': 'Metvix Cream 160 mg/g (3 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG005', 'title': 'Metvix Vehicle Cream (3 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}], 'classes': [{'categories': [{'title': 'None', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'Minimal', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}, {'title': 'Mild', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'Moderate', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 20', 'description': 'The evaluation of the severity of facial mottled hyperpigmentation were done using five-point scale. The score on the five-point scale ranged from 0 (minimum) to 4 (maximum), that is, 0 = none (no areas of mottled, irregular pigmentation), 1 = minimal (few, small lightly pigmented, discrete macules), 2 = mild (multiple, small lightly pigmented macules), 3 = moderate (widespread areas of mottled, moderately dark macules), 4 = severe (Widespread, multiple areas of dark macules/hyperpigmentation with uneven skin tone). The higher score indicated the worse outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled and randomized participants. "Here, \'Overall number of participants analyzed\' signifies participants who were evaluable for this outcome measure. As per planned analysis data was separately analyzed and collected for both Metvix cream and Metvix vehicle cream based on 1, 2 and 3 hours group."'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Severity of Fine Lines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Metvix Cream 160 mg/g (1 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG001', 'title': 'Metvix Vehicle Cream (1 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG002', 'title': 'Metvix Cream 160 mg/g (2 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG003', 'title': 'Metvix Vehicle Cream (2 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG004', 'title': 'Metvix Cream 160 mg/g (3 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG005', 'title': 'Metvix Vehicle Cream (3 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}], 'classes': [{'categories': [{'title': 'Moderate', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': 'Severe', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}, {'title': 'Mild', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}, {'title': 'Minimal', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}, {'title': 'None', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 20', 'description': 'The evaluation of the severity of facial fine lines were done using the five-point scale ranging from 0 to 4, that is, 0 = none- (lines disappear with stretching), 1 = minimal (few lines which do not completely disappear with stretching), 2 = mild (few lines which only diminish with stretching), 3 = moderate (widespread areas of lines which change minimally with stretching), 4 = severe- (widespread areas of lines which do not change at all with stretching), where the higher score indicated the worse outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled and randomized participants. "Here, \'Overall number of participants analyzed\' signifies participants who were evaluable for this outcome measure. As per planned analysis data was separately analyzed and collected for both Metvix cream and Metvix vehicle cream based on 1, 2 and 3 hours group."'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Severity of Telangiectasia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Metvix Cream 160 mg/g (1 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG001', 'title': 'Metvix Vehicle Cream (1 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG002', 'title': 'Metvix Cream 160 mg/g (2 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG003', 'title': 'Metvix Vehicle Cream (2 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG004', 'title': 'Metvix Cream 160 mg/g (3 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG005', 'title': 'Metvix Vehicle Cream (3 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}], 'classes': [{'categories': [{'title': 'Absent', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'Mild', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}, {'title': 'Moderate', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 20', 'description': 'The severity of telangiectasia by using the scale ranging from 0 (minimum) to 3 (maximum), that is, 0 = absent (no telangiectasia), 1 = mild (slight telangiectasia characterized by appearance of a few fine, small red vessels \\[0.2 millimeters \\[mm\\] or less in diameter); telangiectasia covers less than 10 percent (%) of the target area, 2 = moderate (pronounced telangiectasia characterized by appearance of several fine vessels and/or few large vessels \\[0.2 mm or greater in diameter\\]; telangiectasia covers between 10 to 30% of the target area), 3 = severe (severe telangiectasia characterized by the appearance of many fine vessels and/or large vessels; telangiectasia covers greater than 30% of the target area), where the higher score indicated the worse outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled and randomized participants. "Here, \'Overall number of participants analyzed\' signifies participants who were evaluable for this outcome measure. As per planned analysis data was separately analyzed and collected for both Metvix cream and Metvix vehicle cream based on 1, 2 and 3 hours group."'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Severity of Skin Roughness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Metvix Cream 160 mg/g (1 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG001', 'title': 'Metvix Vehicle Cream (1 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG002', 'title': 'Metvix Cream 160 mg/g (2 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG003', 'title': 'Metvix Vehicle Cream (2 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG004', 'title': 'Metvix Cream 160 mg/g (3 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG005', 'title': 'Metvix Vehicle Cream (3 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}], 'classes': [{'categories': [{'title': 'None', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}, {'title': 'Minimal', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'Mild', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 20', 'description': 'The evaluation of the severity of skin roughness were done by using the five-point scale ranging from 0 to 4,that is, 0 = none ( very smooth, no patches of roughness), 1 = minimal (smooth with only a few patches of roughness), 2 = mild (mostly smooth with scattered patches of roughness), 3 = moderate (slightly rough with diffuse patches of roughness), 4 = severe (rough with diffuse areas of roughness, some scales may be visible), where the higher score indicated the worse outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled and randomized participants. "Here, \'Overall number of participants analyzed\' signifies participants who were evaluable for this outcome measure. As per planned analysis data was separately analyzed and collected for both Metvix cream and Metvix vehicle cream based on 1, 2 and 3 hours group."'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Severity of Skin Laxity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Metvix Cream 160 mg/g (1 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG001', 'title': 'Metvix Vehicle Cream (1 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG002', 'title': 'Metvix Cream 160 mg/g (2 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG003', 'title': 'Metvix Vehicle Cream (2 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG004', 'title': 'Metvix Cream 160 mg/g (3 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG005', 'title': 'Metvix Vehicle Cream (3 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix vehicle cream on the other half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}], 'classes': [{'categories': [{'title': 'None', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'Mild', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}, {'title': 'Moderate', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}, {'title': 'Severe', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 20', 'description': 'The evaluation of the severity of skin laxity were done by using the scale ranging from 0 to 3 that is, 0 = none (no skin laxity), 1 = mild (mild skin sagging), 2 = moderate (moderate skin sagging), 3 = severe (severe skin sagging), where the higher score indicated the worse outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled and randomized participants. "Here, \'Overall number of participants analyzed\' signifies participants who were evaluable for this outcome measure. As per planned analysis data was separately analyzed and collected for both Metvix cream and Metvix vehicle cream based on 1, 2 and 3 hours group."'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Tolerability Assessment of Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Metvix Cream 160 mg/g (1 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG001', 'title': 'Metvix Vehicle Cream (1 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG002', 'title': 'Metvix Cream 160 mg/g (2 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG003', 'title': 'Metvix Vehicle Cream (2 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG004', 'title': 'Metvix Cream 160 mg/g (3 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG005', 'title': 'Metvix Vehicle Cream (3 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}], 'classes': [{'categories': [{'title': 'None', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}, {'title': 'Mild', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}, {'title': 'Moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 20', 'description': 'Erythema was defined as an abnormal redness of the skin and was measured on the scale score ranging from 0 (minimum) to 3 (maximum) that is, 0 = none (no erythema),1 = mild (slight pinkness present), 2 = moderate (definite redness, easily recognized), and 3 = severe (intense redness), where the higher score indicated the worse outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all enrolled and randomized participants. "Here, \'Overall number of participants analyzed\' signifies participants who were evaluable for this outcome measure. As per planned analysis data was separately analyzed and collected for both Metvix cream and Metvix vehicle cream based on 1, 2 and 3 hours."'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Tolerability Assessment of Edema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Metvix Cream 160 mg/g (1 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG001', 'title': 'Metvix Vehicle Cream (1 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG002', 'title': 'Metvix Cream 160 mg/g (2 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG003', 'title': 'Metvix Vehicle Cream (2 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 2 hours at Baseline, Week 20. The target area was then exposed to Aktilite 128 lamp for 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG004', 'title': 'Metvix Cream 160 mg/g (3 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG005', 'title': 'Metvix Vehicle Cream (3 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}], 'classes': [{'categories': [{'title': 'None', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}, {'title': 'Mild', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}, {'title': 'Severe', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 20', 'description': 'Abnormal tenseness of the skin was measured on a scale ranging from 0 to 3. 0 (none) no edema, 1 (mild) slight tenseness of skin without firmness, 2 (moderate) moderate tenseness of the skin with slight firmness, 3 (severe) severe tenseness of the skin with resistance to distortion. The higher score means the worse outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all enrolled and randomized participants. "Here, \'Overall number of participants analyzed\' signifies participants who were evaluable for this outcome measure. As per planned analysis data was separately analyzed and collected for both Metvix cream and Metvix vehicle cream based on 1, 2 and 3 hours group."'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Tolerability Assessment of Oozing/Crusting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Metvix Cream 160 mg/g (1 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG001', 'title': 'Metvix Vehicle Cream (1 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG002', 'title': 'Metvix Cream 160 mg/g (2 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG003', 'title': 'Metvix Vehicle Cream (2 Hour Group)', 'description': 'Participants were topically treated Metvix vehicle cream on the other half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG004', 'title': 'Metvix Cream160 mg/g (3 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG005', 'title': 'Metvix Vehicle Cream (3 Hour Group)', 'description': 'Participants were topically treated Metvix vehicle cream on the other half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}], 'classes': [{'categories': [{'title': 'None', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}, {'title': 'Mild', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 20', 'description': 'Oozing/crusting was a continuing process of exudation of fluid from the lesions/formation of scab-like material on the surface of lesions resulting from dried serum. Oozing/crusting was assessed on a scale ranging from 0-3. 0 (none) no oozing/crusting, 1 (mild) faint sign of oozing and/or weeping; slight crusting on a few of the lesions, 2 (moderate) definite oozing, but not extensive (a few lesions/areas); definite crusting on several of the lesions, 3 (severe) marked oozing/weeping; heavy crusting on the majority of the lesions. The higher score indicated the worse outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all enrolled and randomized participants. "Here, \'Overall number of participants analyzed\' signifies participants who were evaluable for this outcome measure. As per planned analysis data was separately analyzed and collected for both Metvix cream and Metvix vehicle cream based on 1, 2 and 3 hours group."'}, {'type': 'PRIMARY', 'title': "Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Metvix Cream 160 mg/g (1 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG001', 'title': 'Metvix Vehicle Cream (1 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG002', 'title': 'Metvix Cream 160 mg/g (2 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG003', 'title': 'Metvix Vehicle Cream (2 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG004', 'title': 'Metvix Cream 160 mg/g (3 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG005', 'title': 'Metvix Vehicle Cream (3 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '2.9', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '0.7', 'groupId': 'OG003'}, {'value': '6.3', 'spread': '2.9', 'groupId': 'OG004'}, {'value': '0.3', 'spread': '0.4', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 4', 'description': 'Participant skin discomfort was evaluated on a scale of 0 to 10. 0 ("no skin discomfort") to 10 ("worst possible skin discomfort") evaluation of skin discomfort (including pain and itching) on each half-face was analyzed using a VAS. The higher score indicated the worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all enrolled and randomized participants. "Here, \'Overall number of participants analyzed\' signifies participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable for this OM at given timepoint. As per planned analysis data was separately analyzed and collected for both Metvix cream and Metvix vehicle cream based on 1, 2 and 3 hours group."'}, {'type': 'PRIMARY', 'title': "Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Metvix Cream 160 mg/g (1 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG001', 'title': 'Metvix Vehicle Cream (1 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG002', 'title': 'Metvix Cream 160 mg/g (2 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG003', 'title': 'Metvix Vehicle Cream (2 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG004', 'title': 'Metvix Cream 160 mg/g (3 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG005', 'title': 'Metvix Vehicle Cream (3 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '4.9', 'spread': '2.6', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG003'}, {'value': '6.4', 'spread': '2.3', 'groupId': 'OG004'}, {'value': '0.2', 'spread': '0.5', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 8', 'description': 'Participant skin discomfort was evaluated on a scale of 0 to 10. 0 ("no skin discomfort") to 10 ("worst possible skin discomfort") evaluation of skin discomfort (including pain and itching) on each half-face was analyzed using a VAS. The higher score indicated the worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all enrolled and randomized participants. "Here, \'Overall number of participants analyzed\' signifies participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable for this OM at given timepoint. As per planned analysis data was separately analyzed and collected for both Metvix cream and Metvix vehicle cream based on 1, 2 and 3 hours group."'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Tolerability Assessment of Scaling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Metvix Cream 160 mg/g (1 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG001', 'title': 'Metvix Vehicle Cream (1 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG002', 'title': 'Metvix Cream 160 mg/g (2 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG003', 'title': 'Metvix Vehicle Cream (2 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG004', 'title': 'Metvix Cream 160 mg/g (3 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG005', 'title': 'Metvix Vehicle Cream (3 Hour Group)', 'description': 'Participants were topically treated with Metvix vehicle cream on the other half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}], 'classes': [{'categories': [{'title': 'None', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}, {'title': 'Mild', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}, {'title': 'Moderate', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 20', 'description': 'Abnormal shedding of the stratum corneum is measured on a scale 0 to 3. 0 (none) no scaling, 1 (mild) barely perceptible shedding, noticeable only on light scratching or rubbing, 2 (moderate) obvious but not profuse shedding, 3 (severe) heavy scale production. The higher score indicated the worse outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all enrolled and randomized participants. "Here, \'Overall number of participants analyzed\' signifies participants who were evaluable for this outcome measure. As per planned efficacy data was separately analyzed and collected for both Metvix cream and Metvix vehicle cream based on 1, 2 and 3 hours group."'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Metvix Cream 160 mg/g+Metvix Vehicle Cream (1 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light LED light source: Aktilite 128 lamp\\] during 7 to 10 minutes to deliver a total dose of 37 Joules per centimeter square J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG001', 'title': 'Metvix Cream 160 mg/g+Metvix Vehicle Cream (2 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light LED light source: Aktilite 128 lamp\\] during 7 to 10 minutes to deliver a total dose of 37 Joules per centimeter square J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'OG002', 'title': 'Metvix Cream 160 mg/g+Metvix Vehicle Cream (3 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 20', 'description': 'AE was defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the study drug. Abnormalities presented at Baseline were considered AEs if they reoccurred after resolution or worsen during the AE collection period. Number of participants with AEs were reported.', 'unitOfMeasure': 'count of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all enrolled and randomized participants. "Here, \'Overall number of participants analyzed\' signifies participants who were evaluable for this outcome measure. As per planned analysis safety data was analyzed and collected for Metvix Cream 160 mg/g+Metvix Vehicle Cream (1 Hour Group), Metvix Cream 160 mg/g+Metvix Vehicle Cream (2 Hour Group) and Metvix Cream 160 mg/g+Metvix Vehicle Cream (3 Hour Group).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Metvix Cream 160 mg/g+Metvix Vehicle Cream (1 Hour Group)', 'description': 'Participants were topically treated with 160 milligrams per gram (mg/g) Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light \\[using a large-field light emitting diode (LED) light source: Aktilite 128 lamp\\] during 7 to 10 minutes to deliver a total dose of 37 Joules per centimeter square J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'FG001', 'title': 'Metvix Cream 160 mg/g+Metvix Vehicle Cream (2 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'FG002', 'title': 'Metvix Cream 160 mg/g+Metvix Vehicle Cream (3 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '11', 'numSubjects': '11'}, {'groupId': 'FG001', 'numUnits': '9', 'numSubjects': '9'}, {'groupId': 'FG002', 'numUnits': '12', 'numSubjects': '12'}]}, {'type': 'Metvix Cream (1 Hour)', 'achievements': [{'groupId': 'FG000', 'numUnits': '11', 'numSubjects': '11'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'Metvix Vehicle Cream (1 Hour)', 'achievements': [{'groupId': 'FG000', 'numUnits': '11', 'numSubjects': '11'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'Metvix Cream (2 Hour)', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '9', 'numSubjects': '9'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'Metvix Vehicle Cream (2 Hour)', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '9', 'numSubjects': '9'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'Metvix Cream (3 Hour)', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '12', 'numSubjects': '12'}]}, {'type': 'Metvix Vehicle Cream (3 Hour)', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '12', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '9', 'numSubjects': '9'}, {'groupId': 'FG001', 'numUnits': '8', 'numSubjects': '8'}, {'groupId': 'FG002', 'numUnits': '8', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '2'}, {'groupId': 'FG001', 'numUnits': '1', 'numSubjects': '1'}, {'groupId': 'FG002', 'numUnits': '4', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Participant request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'typeUnitsAnalyzed': 'Half face', 'recruitmentDetails': 'The study was conducted at 3 centers in the United Kingdom and Spain from 18 April 2007 to 1 September 2008.', 'preAssignmentDetails': 'A total of 32 participants were enrolled in the study and randomized in three different groups (1 hour group, 2 hour group, and 3 hour group).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Metvix Cream 160 mg/g+Metvix Vehicle Cream (1 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'BG001', 'title': 'Metvix Cream 160 mg/g+Metvix Vehicle Cream (2 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'BG002', 'title': 'Metvix Cream 160 mg/g+Metvix Vehicle Cream (3 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.0', 'spread': '7.3', 'groupId': 'BG000'}, {'value': '57.0', 'spread': '10.4', 'groupId': 'BG001'}, {'value': '58.4', 'spread': '9.3', 'groupId': 'BG002'}, {'value': '59.9', 'spread': '9.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Phototype', 'classes': [{'categories': [{'title': 'Phototype I', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Phototype II', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Phototype III', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Skin phototype was used to describe a person's skin type. It ranges from skin phototype I to III. Where, skin phototype I = pale white skin, always burns easily, never tans; skin phototype II = fair skin, always burns easily, tans minimally and with difficulty; skin phototype III = darker white skin, burns minimally, tans gradually and uniformly.", 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) population included all enrolled and randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2008-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-08', 'studyFirstSubmitDate': '2007-02-19', 'resultsFirstSubmitDate': '2022-10-10', 'studyFirstSubmitQcDate': '2007-02-19', 'lastUpdatePostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-08', 'studyFirstPostDateStruct': {'date': '2007-02-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Severity of Photodamage', 'timeFrame': 'At Week 20', 'description': 'Severity of cutaneous photodamage in participants were assessed using Griffiths photo numeric scale. The severity scores of photodamage on the scale ranged from 0 (minimum) to 8 (maximum), that is, no damage (0), mild damage (1-3), moderate damage (4-6), and severe damage (7-8) where the highest score indicated worst outcome.'}, {'measure': 'Number of Participants With Severity of Mottled Hyper-Pigmentation', 'timeFrame': 'At Week 20', 'description': 'The evaluation of the severity of facial mottled hyperpigmentation were done using five-point scale. The score on the five-point scale ranged from 0 (minimum) to 4 (maximum), that is, 0 = none (no areas of mottled, irregular pigmentation), 1 = minimal (few, small lightly pigmented, discrete macules), 2 = mild (multiple, small lightly pigmented macules), 3 = moderate (widespread areas of mottled, moderately dark macules), 4 = severe (Widespread, multiple areas of dark macules/hyperpigmentation with uneven skin tone). The higher score indicated the worse outcome.'}, {'measure': 'Number of Participants With Severity of Fine Lines', 'timeFrame': 'At Week 20', 'description': 'The evaluation of the severity of facial fine lines were done using the five-point scale ranging from 0 to 4, that is, 0 = none- (lines disappear with stretching), 1 = minimal (few lines which do not completely disappear with stretching), 2 = mild (few lines which only diminish with stretching), 3 = moderate (widespread areas of lines which change minimally with stretching), 4 = severe- (widespread areas of lines which do not change at all with stretching), where the higher score indicated the worse outcome.'}, {'measure': 'Number of Participants With Severity of Telangiectasia', 'timeFrame': 'At Week 20', 'description': 'The severity of telangiectasia by using the scale ranging from 0 (minimum) to 3 (maximum), that is, 0 = absent (no telangiectasia), 1 = mild (slight telangiectasia characterized by appearance of a few fine, small red vessels \\[0.2 millimeters \\[mm\\] or less in diameter); telangiectasia covers less than 10 percent (%) of the target area, 2 = moderate (pronounced telangiectasia characterized by appearance of several fine vessels and/or few large vessels \\[0.2 mm or greater in diameter\\]; telangiectasia covers between 10 to 30% of the target area), 3 = severe (severe telangiectasia characterized by the appearance of many fine vessels and/or large vessels; telangiectasia covers greater than 30% of the target area), where the higher score indicated the worse outcome.'}, {'measure': 'Number of Participants With Severity of Skin Roughness', 'timeFrame': 'At Week 20', 'description': 'The evaluation of the severity of skin roughness were done by using the five-point scale ranging from 0 to 4,that is, 0 = none ( very smooth, no patches of roughness), 1 = minimal (smooth with only a few patches of roughness), 2 = mild (mostly smooth with scattered patches of roughness), 3 = moderate (slightly rough with diffuse patches of roughness), 4 = severe (rough with diffuse areas of roughness, some scales may be visible), where the higher score indicated the worse outcome.'}, {'measure': 'Number of Participants With Severity of Skin Laxity', 'timeFrame': 'At Week 20', 'description': 'The evaluation of the severity of skin laxity were done by using the scale ranging from 0 to 3 that is, 0 = none (no skin laxity), 1 = mild (mild skin sagging), 2 = moderate (moderate skin sagging), 3 = severe (severe skin sagging), where the higher score indicated the worse outcome.'}, {'measure': 'Number of Participants With Tolerability Assessment of Erythema', 'timeFrame': 'At Week 20', 'description': 'Erythema was defined as an abnormal redness of the skin and was measured on the scale score ranging from 0 (minimum) to 3 (maximum) that is, 0 = none (no erythema),1 = mild (slight pinkness present), 2 = moderate (definite redness, easily recognized), and 3 = severe (intense redness), where the higher score indicated the worse outcome.'}, {'measure': 'Number of Participants With Tolerability Assessment of Edema', 'timeFrame': 'At Week 20', 'description': 'Abnormal tenseness of the skin was measured on a scale ranging from 0 to 3. 0 (none) no edema, 1 (mild) slight tenseness of skin without firmness, 2 (moderate) moderate tenseness of the skin with slight firmness, 3 (severe) severe tenseness of the skin with resistance to distortion. The higher score means the worse outcome.'}, {'measure': 'Number of Participants With Tolerability Assessment of Oozing/Crusting', 'timeFrame': 'At Week 20', 'description': 'Oozing/crusting was a continuing process of exudation of fluid from the lesions/formation of scab-like material on the surface of lesions resulting from dried serum. Oozing/crusting was assessed on a scale ranging from 0-3. 0 (none) no oozing/crusting, 1 (mild) faint sign of oozing and/or weeping; slight crusting on a few of the lesions, 2 (moderate) definite oozing, but not extensive (a few lesions/areas); definite crusting on several of the lesions, 3 (severe) marked oozing/weeping; heavy crusting on the majority of the lesions. The higher score indicated the worse outcome.'}, {'measure': "Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS)", 'timeFrame': 'At Week 4', 'description': 'Participant skin discomfort was evaluated on a scale of 0 to 10. 0 ("no skin discomfort") to 10 ("worst possible skin discomfort") evaluation of skin discomfort (including pain and itching) on each half-face was analyzed using a VAS. The higher score indicated the worse outcome.'}, {'measure': "Participant's Skin Discomfort Score Using Visual Analogue Scale (VAS)", 'timeFrame': 'At Week 8', 'description': 'Participant skin discomfort was evaluated on a scale of 0 to 10. 0 ("no skin discomfort") to 10 ("worst possible skin discomfort") evaluation of skin discomfort (including pain and itching) on each half-face was analyzed using a VAS. The higher score indicated the worse outcome.'}, {'measure': 'Number of Participants With Tolerability Assessment of Scaling', 'timeFrame': 'At Week 20', 'description': 'Abnormal shedding of the stratum corneum is measured on a scale 0 to 3. 0 (none) no scaling, 1 (mild) barely perceptible shedding, noticeable only on light scratching or rubbing, 2 (moderate) obvious but not profuse shedding, 3 (severe) heavy scale production. The higher score indicated the worse outcome.'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to Week 20', 'description': 'AE was defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the study drug. Abnormalities presented at Baseline were considered AEs if they reoccurred after resolution or worsen during the AE collection period. Number of participants with AEs were reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PDT', 'Photoaging', 'Galderma'], 'conditions': ['Photoaged Skin']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.metvix.com/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Skin photoaging or skin photodamage were terms used to describe the change in the structure, function and appearance of skin caused by prolonged and repeated exposure to sunlight or other ultraviolet light sources.\n\nThe visible effects of skin photodamage were fine lines, skin sagging, skin roughness, liver spots and also the appearance of red patches made up of thin red vessels (called telangiectasia).\n\nMore and more people were presenting to doctors with concerns about skin photodamage and the demand for corrective procedures was increasing.\n\nMetvix photodynamic therapy (Metvix PDT) is a procedure currently marketed in several countries in Europe (including the United Kingdom \\[UK\\] and Spain) and in Australia, for the treatment of benign forms of skin cancer (example, actinic keratosis).\n\nThe aim of the study was to assess whether Metvix PDT would be effective in correcting the effects related to photodamage and whether it would be well tolerated.', 'detailedDescription': 'Different application times of the study treatment were being investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female participants older than 30 years of age.\n* Participants with a photodamage grade of at least 4 on the Griffiths photonumeric scale (symmetrical photodamage on the two target areas)\n* Participants with mottled hyper-pigmentation on the face\n* Participants willing and capable of cooperating to the extent and degree required by the protocol\n* Participants must read the Patient Information Sheet and read and sign the Informed Consent form prior to any study related procedures.\n\nExclusion Criteria:\n\n* Participants who were at risk in terms of precautions, warnings, and contra-indication in the package insert for Metvix\n* Participants with suspected porphyria\n* Participants with specific wash-out period for interfering treatments\n* Participants requiring concurrent treatment that would interfere with study objectives and/or evaluations'}, 'identificationModule': {'nctId': 'NCT00437320', 'briefTitle': 'Comparison of Metvix Photodynamic Therapy (PDT) With Its Vehicle in the Treatment of Photoaged Skin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'Comparison of Metvix PDT With Its Vehicle in the Treatment of Photoaged Skin', 'orgStudyIdInfo': {'id': 'RD.03.SPR.29057'}, 'secondaryIdInfos': [{'id': '2006-004237-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metvix Cream 160 mg/g +Metvix Vehicle Cream (1 Hour Group)', 'description': 'Participants were topically treated with 160 milligrams per gram (mg/g) Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light \\[using a large-field light emitting diode (LED) light source: Aktilite 128 lamp\\] during 7 to 10 minutes to deliver a total dose of 37 Joules per centimeter square J/cm\\^2. The total study duration was 20 weeks.', 'interventionNames': ['Drug: Metvix Cream 160 mg/g', 'Drug: Metvix Vehicle Group']}, {'type': 'EXPERIMENTAL', 'label': 'Metvix Cream 160 mg/g +Metvix Vehicle Cream (2 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.', 'interventionNames': ['Drug: Metvix Cream 160 mg/g', 'Drug: Metvix Vehicle Group']}, {'type': 'EXPERIMENTAL', 'label': 'Metvix Cream 160 mg/g +Metvix Vehicle Cream (3 Hour Group)', 'description': 'Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\\^2. The total study duration was 20 weeks.', 'interventionNames': ['Drug: Metvix Cream 160 mg/g', 'Drug: Metvix Vehicle Group']}], 'interventions': [{'name': 'Metvix Cream 160 mg/g', 'type': 'DRUG', 'otherNames': ['methyl aminolevulinate'], 'description': 'Participants were treated with topical administration of Metvix cream.', 'armGroupLabels': ['Metvix Cream 160 mg/g +Metvix Vehicle Cream (1 Hour Group)', 'Metvix Cream 160 mg/g +Metvix Vehicle Cream (2 Hour Group)', 'Metvix Cream 160 mg/g +Metvix Vehicle Cream (3 Hour Group)']}, {'name': 'Metvix Vehicle Group', 'type': 'DRUG', 'description': 'Participants were treated with topical administration of Metvix Vehicle cream.', 'armGroupLabels': ['Metvix Cream 160 mg/g +Metvix Vehicle Cream (1 Hour Group)', 'Metvix Cream 160 mg/g +Metvix Vehicle Cream (2 Hour Group)', 'Metvix Cream 160 mg/g +Metvix Vehicle Cream (3 Hour Group)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Madrid', 'country': 'Spain', 'facility': 'Policlinico Ruber', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Whittington Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'University of Manchester-Hope Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'CEM Griffiths', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The study protocol was submitted to and approved by the local Ethics Committees prior to study initiation, and by the regulatory authorities. The study was followed-up closely by the Sponsor or representatives according to the Declaration of Helsinki (1964) and its Tokyo 9(175), Venice (1983), Hong-Kong (1989), Somerset West (1996), and Edinburgh (2000) amendments, the ICH Good Clinical Practice (GCP) principles, Standard Operating Procedures (SOPs) and local regulatory requirements.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Galderma R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}