Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-02-20 @ 6:20 PM
Study NCT ID:
NCT04085367
Status:
COMPLETED
Last Update Posted:
2022-04-01
First Post:
2019-09-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream for Actinic Keratosis of the Face
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055623', 'term': 'Keratosis, Actinic'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Studies@galderma.com', 'phone': '817 961 5000', 'title': 'Clinical Operations', 'phoneExt': '+1', 'organization': 'Galderma'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to Week 14', 'description': 'Safety population consisted of all randomized participants who received at least 1 application of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'MAL 16.8% Cream', 'description': 'Participants received two treatment session at least 2 weeks apart. Investigator was to apply a thin layer of methyl aminolevulinate (MAL) hydrochloride 16.8% cream to each lesion during treatment. At 30 minutes after cream application, participants were to go outside in daylight for 2 hours. After this time, the cream was to be removed by investigative site personnel by washing the skin with gentle skin cleanser.', 'otherNumAtRisk': 364, 'deathsNumAtRisk': 364, 'otherNumAffected': 89, 'seriousNumAtRisk': 364, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'MAL Vehicle Cream', 'description': 'Participants received two treatment session at least 2 weeks apart. Investigator was to apply a thin layer of vehicle cream to each lesion during treatment. At 30 minutes after cream application, participants were to go outside in daylight for 2 hours. After this time, the cream was to be removed by investigative site personnel by washing the skin with gentle skin cleanser.', 'otherNumAtRisk': 193, 'deathsNumAtRisk': 193, 'otherNumAffected': 41, 'seriousNumAtRisk': 193, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Actinic keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 30}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Application site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Application site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Application site dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Application site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}], 'seriousEvents': [{'term': 'Back injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Streptococcal endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}, {'term': 'Pancreatic carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 364, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 193, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (22.0)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Complete Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MAL 16.8% Cream', 'description': 'Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of methyl aminolevulinate (MAL) hydrochloride 16.8% cream to each lesion. At 30 minutes after cream application, participants went outside in daylight for 2 hours (Daylight photodynamic therapy \\[DL-PDT\\]). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser.'}, {'id': 'OG001', 'title': 'MAL Vehicle Cream', 'description': 'Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of vehicle cream to each lesion. At 30 minutes after cream application, participants went outside in daylight for 2 hours (DL-PDT). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.3', 'groupId': 'OG000'}, {'value': '23.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Complete response was defined as clearance of all AK lesion treated, at week 12 after the last Daylight photodynamic therapy (DL-PDT).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis population included all participants randomized in the study.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Lesion Complete Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MAL 16.8% Cream', 'description': 'Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of methyl aminolevulinate (MAL) hydrochloride 16.8% cream to each lesion. At 30 minutes after cream application, participants went outside in daylight for 2 hours (Daylight photodynamic therapy \\[DL-PDT\\]). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser.'}, {'id': 'OG001', 'title': 'MAL Vehicle Cream', 'description': 'Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of vehicle cream to each lesion. At 30 minutes after cream application, participants went outside in daylight for 2 hours (DL-PDT). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser.'}], 'classes': [{'categories': [{'measurements': [{'value': '-61.1', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '-49.4', 'spread': '2.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Lesion complete response was defined as percent reduction from baseline in the number of cleared treated lesions, at 12 weeks after the last DL-PDT treatment. This outcome measure was analyzed as an intra-individual comparison between MAL cream and Vehicle cream.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis population included all participants randomized in the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Partial Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MAL 16.8% Cream', 'description': 'Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of methyl aminolevulinate (MAL) hydrochloride 16.8% cream to each lesion. At 30 minutes after cream application, participants went outside in daylight for 2 hours (Daylight photodynamic therapy \\[DL-PDT\\]). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser.'}, {'id': 'OG001', 'title': 'MAL Vehicle Cream', 'description': 'Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of vehicle cream to each lesion. At 30 minutes after cream application, participants went outside in daylight for 2 hours (DL-PDT). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.2', 'groupId': 'OG000'}, {'value': '35.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Participants achieving partial response was defined as participants with 75% or greater reduction from baseline in the number of cleared treated lesions, at 12 weeks after the last DL-PDT treatment, comparing MAL cream with vehicle cream.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis population included all participants randomized in the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MAL 16.8% Cream', 'description': 'Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of methyl aminolevulinate (MAL) hydrochloride 16.8% cream to each lesion during treatment. At 30 minutes after cream application, participants went outside in daylight for 2 hours (Daylight photodynamic therapy \\[DL-PDT\\]). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser.'}, {'id': 'FG001', 'title': 'MAL Vehicle Cream', 'description': 'Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of vehicle cream to each lesion during treatment. At 30 minutes after cream application, participants went outside in daylight for 2 hours (DL-PDT). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '364'}, {'groupId': 'FG001', 'numSubjects': '193'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '344'}, {'groupId': 'FG001', 'numSubjects': '185'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other unspecified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Status Unknown', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 557 participants were randomized in 2:1 ratio in two treatment group, MAL 16.8% cream and vehicle cream in study centers in the United States with diverse latitude, altitude, and climate characteristics.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '364', 'groupId': 'BG000'}, {'value': '193', 'groupId': 'BG001'}, {'value': '557', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MAL 16.8% Cream', 'description': 'Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of methyl aminolevulinate (MAL) hydrochloride 16.8% cream to each lesion during treatment. At 30 minutes after cream application, participants went outside in daylight for 2 hours (Daylight photodynamic therapy \\[DL-PDT\\]). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser.'}, {'id': 'BG001', 'title': 'MAL Vehicle Cream', 'description': 'Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of vehicle cream to each lesion during treatment. At 30 minutes after cream application, participants went outside in daylight for 2 hours (DL-PDT). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.2', 'spread': '8.75', 'groupId': 'BG000'}, {'value': '68.9', 'spread': '9.00', 'groupId': 'BG001'}, {'value': '69.1', 'spread': '8.83', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '266', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '398', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '327', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '504', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '359', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '551', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) analysis population included all participants randomized in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-12', 'size': 7251669, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-03-01T00:52', 'hasProtocol': True}, {'date': '2021-04-06', 'size': 7283400, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-03-01T00:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 557}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-04-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-07', 'studyFirstSubmitDate': '2019-09-09', 'resultsFirstSubmitDate': '2022-03-01', 'studyFirstSubmitQcDate': '2019-09-09', 'lastUpdatePostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-07', 'studyFirstPostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Complete Response at Week 12', 'timeFrame': 'Week 12', 'description': 'Complete response was defined as clearance of all AK lesion treated, at week 12 after the last Daylight photodynamic therapy (DL-PDT).'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Lesion Complete Response at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Lesion complete response was defined as percent reduction from baseline in the number of cleared treated lesions, at 12 weeks after the last DL-PDT treatment. This outcome measure was analyzed as an intra-individual comparison between MAL cream and Vehicle cream.'}, {'measure': 'Percentage of Participants With Partial Response at Week 12', 'timeFrame': 'Week 12', 'description': 'Participants achieving partial response was defined as participants with 75% or greater reduction from baseline in the number of cleared treated lesions, at 12 weeks after the last DL-PDT treatment, comparing MAL cream with vehicle cream.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Actinic Keratoses']}, 'descriptionModule': {'briefSummary': 'A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Assess the Efficacy and Safety of Methyl aminolevulinate hydrochloride (MAL) 16.8% cream (CD06809-41) versus vehicle cream in the treatment of thin and moderately thick, non-hyperkeratotic, non-pigmented actinic keratosis of the face and scalp when using daylight photodynamic therapy (DL-PDT).', 'detailedDescription': 'This was a randomized, double-blind, vehicle-controlled, multicenter, parallel-group study in adult participants with clinically-confirmed mild to moderate AKs on the face and the balding scalp, to be conducted at approximately 60 clinical sites in the United States. Sites were selected to ensure that diverse daylight conditions represented in the study to understand the effects of latitude, elevation, and climate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants aged ≥ 18 years at the Screening visit.\n* Participants had at least 4, but no more than 12, clinically-confirmed thin or moderately thick, non-hyperkeratotic, non-pigmented AKs located on the face (e.g., forehead, cheek, chin), and balding scalp.\n* Female Participants of non-childbearing potential.\n* Participants fully understood and signed an ICF before any investigational procedure(s) are performed.\n\nExclusion Criteria:\n\n* Participants with pigmented AK in the treatment areas.\n* Female participants who were pregnant, nursing, or planning a pregnancy during the study.\n* Participants with a clinical diagnosis of a skin disease other than AK.\n* Immunocompromised participants.\n* Participants with any condition that may be associated with a risk of poor protocol compliance.'}, 'identificationModule': {'nctId': 'NCT04085367', 'briefTitle': 'Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream for Actinic Keratosis of the Face', 'organization': {'class': 'INDUSTRY', 'fullName': 'Galderma R&D'}, 'officialTitle': 'A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream in the Treatment of Thin and Moderately Thick, Non-hyperkeratotic, Non-pigmented Actinic Keratosis (AK) of the Face and Scalp When Using Daylight Photodynamic Therapy (DL-PDT)', 'orgStudyIdInfo': {'id': 'RD.06.SPR.112199'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MAL 16.8% Cream', 'description': 'Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of methyl aminolevulinate (MAL) hydrochloride 16.8% cream to each lesion during treatment. At 30 minutes after cream application, participants went outside in daylight for 2 hours (Daylight photodynamic therapy \\[DL-PDT\\]). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser.', 'interventionNames': ['Drug: MAL 16.8% cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'MAL Vehicle Cream', 'description': 'Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of vehicle cream to each lesion during treatment. At 30 minutes after cream application, participants went outside in daylight for 2 hours (DL-PDT). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser.', 'interventionNames': ['Drug: MAL Vehicle Cream']}], 'interventions': [{'name': 'MAL 16.8% cream', 'type': 'DRUG', 'otherNames': ['CD06809-41'], 'description': 'Day light photodynamic therapy with MAL 16.8% cream', 'armGroupLabels': ['MAL 16.8% Cream']}, {'name': 'MAL Vehicle Cream', 'type': 'DRUG', 'description': 'Day light photodynamic therapy with MAL vehicle cream', 'armGroupLabels': ['MAL Vehicle Cream']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85718', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Galderma Investigational Site (Site 8768)', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72916-6103', 'city': 'Fort Smith', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Galderma Investigational Site (Site 8447)', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'zip': '92024', 'city': 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