Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-04-09 @ 2:28 AM
Study NCT ID:
NCT05079256
Status:
COMPLETED
Last Update Posted:
2025-01-22
First Post:
2021-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laser Induced Changes to Innervation and Vascularisation of Psoriatic Skin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D054025', 'term': 'Lasers, Dye'}], 'ancestors': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'tissue samples are described using random pre-assigned codes.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'single blinded intra-patient comparison'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-10-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-21', 'studyFirstSubmitDate': '2021-09-20', 'studyFirstSubmitQcDate': '2021-10-14', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recovery ration', 'timeFrame': '6 months.', 'description': 'Relative change in the ratio of the linear nerve density and linear blood vessel density.'}], 'secondaryOutcomes': [{'measure': 'Recovery ratio vs lymphocyte infiltration', 'timeFrame': '6 months', 'description': 'Correlation between change in the ratio of the linear nerve density and linear blood vessel density versus change in number of infiltrating lymphocytes'}, {'measure': 'Clinical improvement', 'timeFrame': '6 months', 'description': 'Change in severity determined using a visual-analogue scale.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Psoriasis Vulgaris']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://zbcmulticare.nl/lasering-psoriasis-away/', 'label': 'This investigation is part of a larger research collaboration, more information on which can be found at the website mentioned above.'}]}, 'descriptionModule': {'briefSummary': 'The researchers investigate the effect of a treatment with selective photothermolysis using a 595 nm pulsed dye laser on the blood vessel density and the nerve fibre density of a psoriatic lesion. By comparing tissue samples collected before and after two treatments, the researchers determine the relative effect of laser therapy on the (hyper)innervation of psoriatic skin.', 'detailedDescription': "Vascular laser therapy for psoriasis seems to achieve a remarkably long treatment-free duration of remission. But why would sub-second heating of the blood vessels of the skin result in a year-long resolution of an infamously stubborn condition?\n\nUnraveling the mechanism of action of laser therapy would not only allow for the improvement of existing laser therapy protocols but also, could open the door to a whole new range of interventions offering quasi-permanent solutions for patients. There is a high need for such enduring therapies: Psoriasis is both, a common and a costly skin condition. It affects between 1% and 9% of the population and has a very severe impact on the quality of life of the patient. It's chronic character implies lifelong treatment, and the associated risks and effort\n\nThis project aims to assess the effect of laser therapy on the blood vessels and (peripheral) innervation of psoriasis plaques. The primary objective is to quantify the regression and recovery of nerves compared to blood vessels. The researchers hypothesize that the recovery of nerves after Selective Photo Thermolysis (SPT) is decreased compared to the recovery of blood vessels."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 - 69 years of age\n* Psoriasis vulgaris\n* Skin type I - III\n* Minimal surface of lesion of 3 cm2\n* Contralateral psoriasis vulgaris lesions located on chest, back, or upper legs\n\nExclusion criteria\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study if:\n\n* The participant uses other treatments (than laser therapy) during the study or two weeks before the start of the study that are known to affect psoriasis\n* The participant suffers from any known neurological, vascular, or immunological condition other than psoriasis.\n* The participant is allergic to lidocaine'}, 'identificationModule': {'nctId': 'NCT05079256', 'acronym': 'LPA-01', 'briefTitle': 'Laser Induced Changes to Innervation and Vascularisation of Psoriatic Skin', 'organization': {'class': 'OTHER', 'fullName': 'ZBC MultiCare'}, 'officialTitle': 'A Preliminary Study on the Effect of Photothermal Laser Therapy on the Vascularization and Innervation of Psoriatic Lesions', 'orgStudyIdInfo': {'id': 'LPA-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laser therapy', 'description': '595 nm Pulsed dye laser (PDL) therapy for psoriasis', 'interventionNames': ['Device: 595 nm Pulsed dye laser (Candela V-beam perfecta)']}], 'interventions': [{'name': '595 nm Pulsed dye laser (Candela V-beam perfecta)', 'type': 'DEVICE', 'description': '595 nm pulsed dye laser therapy. 2 treatments Fluence \\~ 6 - 9 J/cm\\^2 Pulse duration \\~ 0.45 - 3.0 ms 33% overlap.', 'armGroupLabels': ['Laser therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1217AB', 'city': 'Hilversum', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'ZBC MultiCare', 'geoPoint': {'lat': 52.22333, 'lon': 5.17639}}], 'overallOfficials': [{'name': 'Nick van der Beek, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ZBC MultiCare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data acquired during the investigation will be made available upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nick van der Beek', 'class': 'OTHER'}, 'collaborators': [{'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Managing director', 'investigatorFullName': 'Nick van der Beek', 'investigatorAffiliation': 'ZBC MultiCare'}}}}