Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-26 @ 11:10 AM
Study NCT ID:
NCT04991012
Status:
COMPLETED
Last Update Posted:
2021-08-05
First Post:
2021-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Effectiveness of Photodynamic Therapy in the Treatment of Lesions of the Lichen Planus Type in the Oral Mucosa and Its Diagnostics With the Use of Autofluorescence, in Various Wavelength Ranges, in Combination With the Use of Texture Analysis and Fractal Dimension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017676', 'term': 'Lichen Planus, Oral'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D008010', 'term': 'Lichen Planus'}, {'id': 'D017512', 'term': 'Lichenoid Eruptions'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010778', 'term': 'Photochemotherapy'}, {'id': 'D014221', 'term': 'Triamcinolone'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D010789', 'term': 'Phototherapy'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'full contralateral split-mouth'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-26', 'studyFirstSubmitDate': '2021-06-17', 'studyFirstSubmitQcDate': '2021-07-26', 'lastUpdatePostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'length of oral lichen planus', 'timeFrame': '12 weeks', 'description': 'The measurement was made with a periodontal probe PCP UNC 15 in millimeters\n\nwe measured the length of the lesions'}, {'measure': 'height of oral lichen planus', 'timeFrame': '12 weeks', 'description': 'The measurement was made with a periodontal probe PCP UNC 15 in millimeters\n\nwe measured the height'}], 'secondaryOutcomes': [{'measure': 'computer analysis of autofluorescence of lesions', 'timeFrame': '12 weeks', 'description': 'Based on photos taken in various light spectrum and fractal analysis of changes\n\nIn this study, we used two wavelengths: 405, 450 and 405+450 nm together for the autofluorescence of lesions\n\nAll fractal analysis was performed in ImageJ version 1.53e (Image Processing and Analysis in Java)\n\nApplied the intensity difference fractal dimension counting method.\n\nWe measured the size of oral lichen planus on photos taken with different light wave using computer program as mentioned above'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['photodynamic therapy'], 'conditions': ['Oral Lichen Planus']}, 'descriptionModule': {'briefSummary': 'Lesions of the lichen planus type within the oral mucosa are now considered a potentially cancerous condition. One of the minimally invasive methods of treating these lesions is photodynamic therapy, and the gold standard in therapy is topical steroid administration', 'detailedDescription': 'Lichen planus shows an irregular shape, which is quite difficult to measure objectively, which is important in assessing the effectiveness of treatment.\n\nPatients will be treated in protocol split mouth with the treatment of lesions on one cheek with a steroid (on an adhesive plaster) and on the other - photodynamic therapy with a foot sensitizer in the form of a methylene blue also on an adhesive plaster The treatment evaluation procedure will consist of taking a series of intraoral photographs. These photos will be taken at each visit. This procedure will involve taking pictures traditionally in "white" light and in the spectrum of 405 nm, 460 nm and 405 + 460 nm (using the unique feature of the prototype laser - emission of two wavelengths simultaneously) in order to induce autofluorescence of the mucosa and treated lesions to better visualize them\n\nA prospective, randomized, single-blind 12-week clinical trial of full contralateral split-mouth in patients with bilateral erythematous or erosive lichen planus in the mouth.On one side, the OLP lesion eligible for treatment was subjected to photodynamic therapy using methylene blue in four sessions every 2 days.\n\nolp on the other side was treated with the administration of the steroid triamcinolone for 8 days\n\nThe clinical evaluation of the evolution of OLP eruptions was performed within 12 weeks of qualifying for treatment: at baseline, at the end of both treatments (day 8) and after the next 11 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histological diagnosis of OLP\n* non smoker\n* no diabetes melitus\n* no hepatitis\n\nExclusion Criteria:\n\n* diabetes melitus\n* hepatitis\n* occurrence dysplasia in the histopathological specimen;\n* use of lichenoid reaction inducing medication and presence of amalgam fillings nearby the lesions;\n* interventions for OLP in the previous 12 weeks;\n* pregnant or breastfeeding women;\n* proved or suspected hypersensitivity to any of the chemicals used in the treatment'}, 'identificationModule': {'nctId': 'NCT04991012', 'briefTitle': 'Evaluation of the Effectiveness of Photodynamic Therapy in the Treatment of Lesions of the Lichen Planus Type in the Oral Mucosa and Its Diagnostics With the Use of Autofluorescence, in Various Wavelength Ranges, in Combination With the Use of Texture Analysis and Fractal Dimension', 'organization': {'class': 'OTHER', 'fullName': 'Wroclaw Medical University'}, 'officialTitle': 'Evaluation of the Effectiveness of Photodynamic Therapy in the Treatment of Lesions of the Lichen Planus Type in the Oral Mucosa and Its Diagnostics With the Use of Autofluorescence, in Various Wavelength Ranges, in Combination With the Use of Texture Analysis and Fractal Dimension', 'orgStudyIdInfo': {'id': 'kb845/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'photodynamic therapy side', 'description': 'On one side, the OLP lesion eligible for treatment was subjected to photodynamic therapy in four sessions every 2 days.Using as photosensitizer Methylen blue for 10min the lesion was irradiated with a 650 nm semiconductor laser at a dose of 120 J / cm2', 'interventionNames': ['Device: PDT Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Triamcinolone (Substance) therapy side', 'description': 'on the other side The OLP on the other side was treated by daily sticking a cut-to-size carrier with 0.05% triamcinolone acetonide for 8 days', 'interventionNames': ['Drug: Triamcinolone (Substance) therapy side']}], 'interventions': [{'name': 'PDT Therapy', 'type': 'DEVICE', 'otherNames': ['Photodynamic Therapy'], 'description': 'the olp was photosensitized with methylen blue and was irradiated with a semiconductor laser with a wavelength of 650 nm, using a dose of 120 J / cm2 and power density', 'armGroupLabels': ['photodynamic therapy side']}, {'name': 'Triamcinolone (Substance) therapy side', 'type': 'DRUG', 'otherNames': ['Steroid therapy'], 'description': 'th The OLP on the other side was treated by daily sticking a cut-to-size carrier with 0.05% triamcinolone acetonide for 8 days', 'armGroupLabels': ['Triamcinolone (Substance) therapy side']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50-425', 'city': 'Wroclaw', 'state': 'Lower Silesian Voivodeship', 'country': 'Poland', 'facility': 'Wroclaw Medical University', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'overallOfficials': [{'name': 'kamil jurczyszyn, prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wroclaw Medical University'}, {'name': 'tomasz konopka, prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Wroclaw Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wroclaw Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}