Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2026-01-07 @ 12:20 AM
Study NCT ID:
NCT00673933
Status:
COMPLETED
Last Update Posted:
2013-07-12
First Post:
2008-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Patients With Skin Type V or IV With Acne Vulgaris
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C475457', 'term': 'methyl 5-aminolevulinate'}, {'id': 'C008848', 'term': '1-phenyl-3,3-dimethyltriazene'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'acbhatia@gmail.com', 'phone': '630-942-5040', 'title': 'Dr Ashish Bhatia', 'organization': 'Dermatology Institute'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Visonac Cream With PDT', 'description': 'PDT using MAL cream\n\nMethyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light', 'otherNumAtRisk': 20, 'otherNumAffected': 12, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vehicle Cream With PDT', 'description': 'PDT using Placebo cream\n\nMethyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light', 'otherNumAtRisk': 20, 'otherNumAffected': 12, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Pain of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Pruritus nos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Skin burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Skin warm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Hematoma Nos', 'notes': 'Non treatment site, included under both Visonac and vehicle arm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Visonac Cream With PDT', 'description': 'PDT using MAL cream\n\nMethyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light'}, {'id': 'OG001', 'title': 'Vehicle Cream With PDT', 'description': 'PDT using Placebo cream\n\nMethyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks after last treatment, 6 weeks after baseline', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Erythema Score (Mild and Moderate)Immediately After First PDT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Visonac Cream With PDT', 'description': 'PDT using MAL cream\n\nMethyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light'}, {'id': 'OG001', 'title': 'Vehicle Cream With PDT', 'description': 'PDT using Placebo cream\n\nMethyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately after treatment at baseline', 'description': 'Patients with mild or moderate erythema after first treatment at baseline.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change in Inflammatory Lesion Counts From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Visonac Cream With PDT', 'description': 'PDT using MAL cream\n\nMethyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light'}, {'id': 'OG001', 'title': 'Vehicle Cream With PDT', 'description': 'PDT using Placebo cream\n\nMethyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.70', 'spread': '2.43', 'groupId': 'OG000'}, {'value': '-3.90', 'spread': '2.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks after last treatment, 6 weeks after baseline', 'unitOfMeasure': 'lesion count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change in Noninflammatory Lesion Counts From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Visonac Cream With PDT', 'description': 'PDT using MAL cream\n\nMethyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light'}, {'id': 'OG001', 'title': 'Vehicle Cream With PDT', 'description': 'PDT using Placebo cream\n\nMethyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.95', 'spread': '4.84', 'groupId': 'OG000'}, {'value': '-2.50', 'spread': '2.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks after last treatment, 6 weeks after baseline', 'unitOfMeasure': 'lesion count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Erythema Score (Mild and Moderate)Immediately After Second Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Visonac Cream With PDT', 'description': 'PDT using MAL cream\n\nMethyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light'}, {'id': 'OG001', 'title': 'Vehicle Cream With PDT', 'description': 'PDT using Placebo cream\n\nMethyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light'}], 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately after second treatment, 2 weeks after baseline', 'description': 'Patients with mild or moderate erythema after second treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Erythema Score (Mild and Moderate)1 Day After First Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Visonac Cream With PDT', 'description': 'PDT using MAL cream\n\nMethyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light'}, {'id': 'OG001', 'title': 'Vehicle Cream With PDT', 'description': 'PDT using Placebo cream\n\nMethyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day after 1st treatment and baseline', 'description': 'Patients with mild or moderate erythema 1 day after first treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Visonac Cream With PDT and Vehicle and PDT', 'description': 'Two areas on the back per patient was treated, one area with Visonac and one with vehicle. Methyl aminolevulinate (MAL) PDT : Cream application followed by illumination with red light'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Two areas on the back per patient was treated, one area with Visonac and one with vehicle'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Visonac and Vehicle Cream With PDT', 'description': 'Two areas on the back per patient was treated, one area with Visonac (Methyl aminolevulinate) and one with vehicle followed by red light illumination.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Skin type', 'classes': [{'title': 'Skin type V', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'Skin type VI', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Skin type according to the Fitzpatrick Classification Scale. Skin type V: Brown, dark brown.Very rarely burns, tans very easily Skin type VI: Black, very dark brown to black. Never burns, tans very easily, deeply pigmented', 'unitOfMeasure': 'participants'}, {'title': 'Inflammatory lesions', 'classes': [{'title': 'Visonac treated area', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'BG000', 'lowerLimit': '5', 'upperLimit': '11'}]}]}, {'title': 'vehicle treated area', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'BG000', 'lowerLimit': '5', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'lesion', 'dispersionType': 'FULL_RANGE'}, {'title': 'Non inflammatory lesions', 'classes': [{'title': 'Visonac treated area', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '21'}]}]}, {'title': 'vehicle treated area', 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '17'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Lesion', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-11', 'studyFirstSubmitDate': '2008-05-05', 'resultsFirstSubmitDate': '2013-02-14', 'studyFirstSubmitQcDate': '2008-05-05', 'lastUpdatePostDateStruct': {'date': '2013-07-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-07-11', 'studyFirstPostDateStruct': {'date': '2008-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment', 'timeFrame': '4 weeks after last treatment, 6 weeks after baseline'}], 'secondaryOutcomes': [{'measure': 'Erythema Score (Mild and Moderate)Immediately After First PDT', 'timeFrame': 'Immediately after treatment at baseline', 'description': 'Patients with mild or moderate erythema after first treatment at baseline.'}, {'measure': 'Change in Inflammatory Lesion Counts From Baseline', 'timeFrame': '4 weeks after last treatment, 6 weeks after baseline'}, {'measure': 'Change in Noninflammatory Lesion Counts From Baseline', 'timeFrame': '4 weeks after last treatment, 6 weeks after baseline'}, {'measure': 'Erythema Score (Mild and Moderate)Immediately After Second Treatment', 'timeFrame': 'Immediately after second treatment, 2 weeks after baseline', 'description': 'Patients with mild or moderate erythema after second treatment.'}, {'measure': 'Erythema Score (Mild and Moderate)1 Day After First Treatment', 'timeFrame': '1 day after 1st treatment and baseline', 'description': 'Patients with mild or moderate erythema 1 day after first treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acne Vulgaris']}, 'descriptionModule': {'briefSummary': 'In this multicenter study, patients with dark skin and acne vulgaris will be included. The patients will receive treatment with MAL PDT and placebo PDT.', 'detailedDescription': 'The treatment period started within 2 weeks of the study screen. Patients received two treatments (MAL PDT and vehicle PDT) to each of the treatment areas, 2 weeks apart, and were followed-up 4 weeks after last treatment. The total duration of the study was 6-8 weeks.\n\nMethyl aminolevulinate 80 mg/g cream (MAL cream 8%)and vehicle was applied for 1.5 hours before illumination (Aktilite® CL128), total light dose 37 J/cm2'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Female and male patients, age 15 to 40 years with acne vulgaris.\n2. Patients with skin type V or VI (Fitzpatrick).\n3. Patients with two areas of each 8x8 cm2 on the back that include at least 5 inflammatory lesions (papules, pustules, and nodules) each. The minimum distance between the two areas should be at least 4 cm.\n4. Patients with no more than 2 nodular lesions in any of the two areas of each 8x8 cm2 on the back.\n5. Patients who are surgically sterile, postmenopausal, abstinent, or willing to use an adequate means of contraception including birth control pills, or barrier methods and spermicide for at least 14 days prior to Day 0. Patients using birth control pills must have used the same product and dose for at least 3 months and must agree to stay with the same product and dose for an additional 3 months.\n6. Patients must be willing and capable of following study instructions to the extent and degree required by the protocol.\n7. Patients must sign the approved informed consent form prior to any study procedures.\n8. Patients must be willing to be photographed. Patients must be willing to sign a photography consent form.\n\nExclusion Criteria:\n\n1. Known allergy to MAL, to a similar PDT compound, or to excipients of the cream.\n2. Participation in other clinical studies either concurrently or within the last 30 days.\n3. Patients who have a condition or who are in a situation, which, in the investigator's opinion, may put the patient at risk, may confound the study results, or may interfere with the patient's participation in the study.\n4. Clinically significant sensitivity to visible light, or has porphyria or porphyrin sensitivity.\n5. Exposure to ultraviolet radiation (UVB phototherapy) within the last 30 days.\n6. Patients with a washout period for topical treatments for their acne in the two treatment areas of less than 14 days. Any topical treatment on the face or other areas outside the two treatment areas will be allowed.\n7. Patients with a washout period for oral antibiotics for treatment of their acne of less than 1 month.\n8. Patients with a washout period for oral isotretinoin of less than 6 months."}, 'identificationModule': {'nctId': 'NCT00673933', 'briefTitle': 'Photodynamic Therapy (PDT) With Methyl Aminolevulinate (MAL) Cream in Patients With Skin Type V or IV With Acne Vulgaris', 'organization': {'class': 'INDUSTRY', 'fullName': 'Photocure'}, 'officialTitle': 'A Blinded, Randomized, Intra-individual, Vehicle-controlled and Multi-centre Study of Photodynamic Therapy With MAL Cream in Patients With Skin Type V or VI With Acne Vulgaris', 'orgStudyIdInfo': {'id': 'PC TA203/08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'PDT using MAL crem', 'interventionNames': ['Drug: Methyl aminolevulinate (MAL) PDT']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'PDT using Placebo cream', 'interventionNames': ['Drug: Methyl aminolevulinate (MAL) PDT']}], 'interventions': [{'name': 'Methyl aminolevulinate (MAL) PDT', 'type': 'DRUG', 'description': 'Cream application followed by illumination with red light', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60563', 'city': 'Naperville', 'state': 'Illinois', 'country': 'United States', 'facility': 'DuPage Medical Group', 'geoPoint': {'lat': 41.78586, 'lon': -88.14729}}, {'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Academic Dermatology Associates', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Ashish C Bhatia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dermatology Institute of DuPage Medical Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Photocure', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}