Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-31 @ 11:48 PM
Study NCT ID:
NCT01497951
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2011-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Photodynamic Therapy for Oral Precursor Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007971', 'term': 'Leukoplakia'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C428044', 'term': '5-aminolaevulinic acid-n-pentylester'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-16', 'studyFirstSubmitDate': '2011-12-09', 'studyFirstSubmitQcDate': '2011-12-22', 'lastUpdatePostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in percent (%) of the initial area in mm2 assessed on recall appointment and by a blinded examiner on photographs with a caliper.', 'timeFrame': 'each treatment average once a week, recall after 4 weeks'}], 'secondaryOutcomes': [{'measure': 'pain due to treatment, assessed by visual analogue scale (VAS)', 'timeFrame': 'each treatment, average once a week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Leukoplakia', 'Lichen']}, 'descriptionModule': {'briefSummary': 'Pre-malignant lesions are difficult to treat. Even after surgical removal they tend to re-appear. Often the lesions are to large and are apparent on many sites, therefore surgical removal is not always possible. The photodynamic therapy uses a special substance, which is absorbed in cells, and thereafter activated by a defined light. The aim of this study is to compare the photodynamic therapy in potentially malignant lesions to a placebo. The investigators assume a significant better result in photodynamic therapy then treatment with a placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Existing Leukoplakia simplex SIN III (diagnostics by Biopsie)\n* Leukoplakia verrucosa without indications of malignant changes (diagnostics by Biopsie)\n* Oral Lichen planus SIN III (diagnostics by Biopsie)\n* Good mouth hygiene status (tartar, surface)\n* Correct seat of the prosthesis and/or the denture\n* Located erosions in the oral cavity\n* Minimum age:18 years\n* Women at the age capable of child-bearing with an appropriate contraception\n\nExclusion Criteria:\n\n* Malignant changes of the mucous membrane, heavy Dysplasie SIN III, Carcinoma in situ - heavy vitamin deficiency\n* Pregnancy\n* less than 18\n* Satisfying women\n* No tobacco abuse\n* satisfying therapy with local immunmodulators in lichen ruber\n* surgical therapy of leukoplakia indicated'}, 'identificationModule': {'nctId': 'NCT01497951', 'acronym': 'PDT', 'briefTitle': 'Photodynamic Therapy for Oral Precursor Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'A Randomized Controlled Trial: Photodynamic Treatment for the Therapy of Premalignant Mucosal Oral Lesions.', 'orgStudyIdInfo': {'id': '2010_MuSH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aminolaevulinic acid', 'interventionNames': ['Other: Aminolaevulinic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Methylcellulose Placebo']}], 'interventions': [{'name': 'Aminolaevulinic acid', 'type': 'OTHER', 'description': 'Photodynamic therapy', 'armGroupLabels': ['Aminolaevulinic acid']}, {'name': 'Methylcellulose Placebo', 'type': 'OTHER', 'description': 'Methylcellulose', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Bernhard Gottlieb University Clinic of Dentistry', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Gabriella Dvorak, PD, DMD, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical University Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Univ.Ass.DDr., senior staff at department of oral surgery', 'investigatorFullName': 'Dvorak Gabriella', 'investigatorAffiliation': 'Medical University of Vienna'}}}}