Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2026-01-04 @ 3:28 AM
Study NCT ID:
NCT01893203
Status:
COMPLETED
Last Update Posted:
2016-07-11
First Post:
2013-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Daylight-PDT for AKs: Comparing Two Photosensitizers (BF-200 ALA and MAL)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000622', 'term': 'Aminolevulinic Acid'}, {'id': 'C475457', 'term': 'methyl 5-aminolevulinate'}], 'ancestors': [{'id': 'D007982', 'term': 'Levulinic Acids'}, {'id': 'D007651', 'term': 'Keto Acids'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'noora.neittaanmaki@fimnet.fi', 'phone': '+358407190362', 'title': 'Noora Neittaanmäki-Perttu', 'organization': 'Helsinki university hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'BF200 ALA vs MAL', 'description': 'BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized slipt face design on symmetrical treatment areas.', 'otherNumAtRisk': 13, 'otherNumAffected': 13, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Adverse reactions: erythema, crusting, scaling', 'notes': 'Erythema, crusting and scaling were assessed all together as one score of mild, moderate or severe', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'notes': 'Pain in VAS scale 1-10', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Histological Lesion Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BF200 ALA vs MAL', 'description': 'BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.'}], 'classes': [{'title': 'BF-200 ALA', 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000'}]}]}, {'title': 'MAL', 'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.375', 'groupIds': ['OG000'], 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '0 (baseline) and 3 months', 'description': 'Punch biopsies were taken symmetrically on both treatment fields from equally graded \\>6 mm AKs prior to treatment and again at 3 months, blinded observer (pathologist). HE- and p53-stainings. Samples not fulfilling the criteria of an AK were defined as healthy or completely cleared. The p53 reactivity expressed as average percentage of positive nuclei in three consecutive high power fields from the region of highest reactivity (\\<10 % normal)', 'unitOfMeasure': 'percentage of complete clearance', 'reportingStatus': 'POSTED', 'populationDescription': 'Punch biopsies bilaterally on treatment fields'}, {'type': 'SECONDARY', 'title': 'Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BF200 ALA vs MAL', 'description': 'BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.'}], 'classes': [{'title': 'BF-200 ALA treatment sides', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '8.6'}]}]}, {'title': 'MAL treatment sides', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '8.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 hours', 'description': 'Pain using visual analog scale (VAS 0-10, where 0 is no pain and 10 is the worst pain imaginable) on both treatment sides is assessed in every 30 minutes during 2-hour sun-exposure and afterwards once in two hours until 9 p.m.\n\n(treatment day). Of these values, the mean maximal pain is assessed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients'}, {'type': 'SECONDARY', 'title': 'Clinical Lesion Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}, {'units': 'AKs total', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BF200 ALA vs MAL', 'description': 'BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.'}], 'classes': [{'title': 'BF-200 ALA treated lesions', 'categories': [{'measurements': [{'value': '84.5', 'groupId': 'OG000', 'lowerLimit': '75.2', 'upperLimit': '90.9'}]}]}, {'title': 'MAL treated lesions', 'categories': [{'measurements': [{'value': '74.2', 'groupId': 'OG000', 'lowerLimit': '64.4', 'upperLimit': '82.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Clinical lesion clearance is observed by a blinded observer', 'unitOfMeasure': 'percentage of complete clearance', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'AKs total', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Adverse Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BF200 ALA vs MAL', 'description': 'BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.'}], 'classes': [{'title': 'BF-200 ALA treated areas', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'MAL treated areas', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'No difference between the sides', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week', 'description': 'Adverse reactions are evaluated by blinded observer at one week after treatment. A dermatologist will assess which side of the face or scalp presents a stronger reaction.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One week after the first photodynamic therapy (PDT), seven patients had more severe reactions (erythema, crusting) at the site treated with BF-200 ALA, five patients had more severe reactions at the MAL site and one patient showed no difference between sites.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BF200 ALA vs MAL', 'description': '5-aminulevulinic acid nanoemulsion (BF-200 ALA, Ameluz, Biofrontera) and methylaminolevulinic acid (MAL, Metvix, Galderma) in randomized split face design on symmetrical treatment areas.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'BF-200 ALA vs MAL', 'description': 'BF-200 ALA cream and MAL (Metvix, Galderma) used in a randomized split-face design'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '79.8', 'groupId': 'BG000', 'lowerLimit': '66', 'upperLimit': '88'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of AKs', 'classes': [{'categories': [{'measurements': [{'value': '177', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Number of actinic keratoses (AKs)'}], 'populationDescription': '14 patients were recruited. One withdrew because of conditions not related to the study. This patient was not included in the analysis.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-29', 'studyFirstSubmitDate': '2013-07-02', 'resultsFirstSubmitDate': '2015-12-23', 'studyFirstSubmitQcDate': '2013-07-02', 'lastUpdatePostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-05-29', 'studyFirstPostDateStruct': {'date': '2013-07-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse Reactions', 'timeFrame': '1 week', 'description': 'Adverse reactions are evaluated by blinded observer at one week after treatment. A dermatologist will assess which side of the face or scalp presents a stronger reaction.'}], 'primaryOutcomes': [{'measure': 'Histological Lesion Clearance', 'timeFrame': '0 (baseline) and 3 months', 'description': 'Punch biopsies were taken symmetrically on both treatment fields from equally graded \\>6 mm AKs prior to treatment and again at 3 months, blinded observer (pathologist). HE- and p53-stainings. Samples not fulfilling the criteria of an AK were defined as healthy or completely cleared. The p53 reactivity expressed as average percentage of positive nuclei in three consecutive high power fields from the region of highest reactivity (\\<10 % normal)'}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': '12 hours', 'description': 'Pain using visual analog scale (VAS 0-10, where 0 is no pain and 10 is the worst pain imaginable) on both treatment sides is assessed in every 30 minutes during 2-hour sun-exposure and afterwards once in two hours until 9 p.m.\n\n(treatment day). Of these values, the mean maximal pain is assessed.'}, {'measure': 'Clinical Lesion Clearance', 'timeFrame': '3 months', 'description': 'Clinical lesion clearance is observed by a blinded observer'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Multiple Actinic Keratoses']}, 'referencesModule': {'availIpds': [{'id': '25109244', 'url': 'http://www.ncbi.nlm.nih.gov/pubmed/', 'type': 'Clinical Study Report'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the efficacy of two photosensitizers, methyl-aminolaevulinate (MAL) and 5-aminolaevulinic nanoemulsion (BF-200 ALA) in the treatment of facial actinic keratosis. We use randomized, double-blinded prospective study design. The efficacy will be assessed clinically, histopathologically and immunohistochemically.', 'detailedDescription': "Actinic keratoses (AKs) are superficial premalignant skin lesions that can progress into an invasive or metastatic squamous cell carcinoma. AKs can be treated with photodynamic therapy (PDT), of which cure rate compares to cryo surgery with an excellent cosmesis. In PDT the AK lesions are first curettaged, then a photosensitizer is applied on the skin and let to absorb for 3 hours. The skin is illuminated using a blue or red light source light source depending on the photosensitizer, which induces activation of protoporphyrin IX (PpIX) and phototoxic reaction destroying the cancer cells.\n\nThe approved photosensitizers in Europe are methyl-aminolevulinic acid cream, (MAL, Metvix™, Galderma), a patch containing 5-aminolevulinic acid (5-ALA, Alacare®, Spirig AG) and 5-aminolevulinic acid gel (BF-200 ALA, Ameluz®, Biofrontera AG) to be used with a red LED light (630-635 nm). In North America a 5-aminolevulinic acid stick (5-ALA, Levulan® Kerastick) can also be used with a blue light source (417 nm).\n\nPpIX absorption peaks are within the visual spectrum of light, which allows PpIX daylight activation. During natural daylight PDT (NDL-PDT) protocol, PpIX is continuously activated during its development, whereas in conventional PDT (LED-PDT) using red LED lamps, large amounts of accumulated PpIX are momentarily activated.\n\nSince skin field cancerization refers to presence of different degrees of visible and invisible dysplastic changes, the whole area should be treated to prevent the development of non-melanoma skin cancers (NMSCs). NDL-PDT enables treatment of field cancerization in one sitting whereas LED-PDT may need repeated illuminations to cover the whole area. NDL-PDT results in enhanced cost-efficacy due to reduced staff expenses, since there's no need for sensitizer absorption and illumination.\n\nAt the moment two photosensitizers have marketing authorization in Finland, ALA (Ameluz®) and MAL (Metvix™). We are piloting a study comparing the efficacy of these two light sensitizers in NDL-PDT. The efficacy of the treatments will be assessed clinically, histopathologically and immunohistochemically."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* actinic keratoses symmetrically on face or scalp\n* age over 18 years\n* there must be at minumum one ak sized 6mm2 symmetrically on both sides\n* patients must be able to make the decision to attend independently\n\nExclusion Criteria:\n\n* pregnancy\n* lactation\n* lack of compliance'}, 'identificationModule': {'nctId': 'NCT01893203', 'acronym': '2013-002108-15', 'briefTitle': 'Daylight-PDT for AKs: Comparing Two Photosensitizers (BF-200 ALA and MAL)', 'organization': {'class': 'OTHER', 'fullName': 'Joint Authority for Päijät-Häme Social and Health Care'}, 'officialTitle': 'Treatment of AKs With Daylight-PDT: Comparing Two Photosensitizers (BF-200 ALA and MAL)', 'orgStudyIdInfo': {'id': 'R13073 / Q257'}, 'secondaryIdInfos': [{'id': '2013-002108-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'BF-200 ALA vs MAL', 'description': 'BF-200 ALA cream and MAL (Metvix, Galderma) used in a randomized split-face design', 'interventionNames': ['Drug: BF-200 ALA cream', 'Drug: MAL cream']}], 'interventions': [{'name': 'BF-200 ALA cream', 'type': 'DRUG', 'otherNames': ['5-aminolaevulenic acid nanoemulsion', 'Ameluz'], 'description': 'The symmetrical treatment areas will be randomized for treatments. First the treatment area will be wiped ethanol. Then sun protection factor (SPF) 20 cream will be applied on all sun-exposed areas of the skin. Then a 0,25mm layer application of Ameluz cream on the area. After appropriate absorption time of 30 minutes, the patients will be taken to the hospital balcony for 2 hour illumination with daylight to accomplish the phototoxic reaction. Maximum dosage will be 2 grams. The treatment will be repeated after 2 weeks for thicker gr II-III lesions with the same protocol.', 'armGroupLabels': ['BF-200 ALA vs MAL']}, {'name': 'MAL cream', 'type': 'DRUG', 'otherNames': ['methylaminolevulinic acid', 'Metvix'], 'description': 'The symmetrical treatment areas will be randomized for treatments. First the treatment area will be wiped ethanol. Then SPF20 sun protection cream will be applied on all sun-exposed areas of the skin. Then a 0,25mm layer application of Metvix cream on the area. After appropriate absorption time of 30 minutes, the patientswill be taken to the hospital balcony for 2 hour illumination with daylight to accomplish the phototoxic reaction. Maximum dosage will be 2 grams. The treatment will be repeated after 2 weeks for thicker gr II-III lesions with the same protocol.', 'armGroupLabels': ['BF-200 ALA vs MAL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15850', 'city': 'Lahti', 'country': 'Finland', 'facility': 'Päijät-Häme Central Hospital', 'geoPoint': {'lat': 60.98267, 'lon': 25.66151}}], 'overallOfficials': [{'name': 'Noora E Neittaanmäki-Perttu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital'}, {'name': 'Toni T Karppinen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Päijät Häme Central Hospital'}, {'name': 'Taneli Tani, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Päijät Häme Central Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joint Authority for Päijät-Häme Social and Health Care', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}