Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-03 @ 6:42 PM
Study NCT ID:
NCT05456334
Status:
UNKNOWN
Last Update Posted:
2023-11-21
First Post:
2022-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Treatments for Actinic Keratoses of the Scalp
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055623', 'term': 'Keratosis, Actinic'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'half-side comparative randomized controlled study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-19', 'studyFirstSubmitDate': '2022-07-04', 'studyFirstSubmitQcDate': '2022-07-08', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient complete (%, P) or partial clearance (%, P)', 'timeFrame': '2 year', 'description': 'All actinic keratoses on the particular treatment area cleared, or 75% of lesions on treatment area cleared'}, {'measure': 'Lesion-specific clearance (%, P)', 'timeFrame': '2 year', 'description': 'Proportion of lesions that completely healed, partially healed or not healed in the particular treatment'}], 'secondaryOutcomes': [{'measure': 'Patient reported pain', 'timeFrame': '1 day', 'description': 'Maximal pain during treatment on the Numerical Rating Scale (0-10)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Photodamaged Skin', 'Actinic Keratoses']}, 'descriptionModule': {'briefSummary': 'This blinded controlled 2-year study on 120 patients with 2 or more actinic keratoses, compare the efficacy and tolerability of pulsed dye-laser- mediated photodynamic therapy compared to conventional photodynamic therapy and fractional-laser assisted daylight photodynamic therapy compared to daylight photodynamic therapy.', 'detailedDescription': 'Actinic keratoses are premalign skin lesions with increasing prevalence, causing a rising burden on the health care system. In this blinded controlled study we assess the efficacy of pulsed dye-laser- mediated photodynamic therapy compared to conventional photodynamic therapy and fractional-laser assisted daylight photodynamic therapy to daylight photodynamic therapy. It is a prospective, randomized and blinded split-head comparative study during the years 2016- 2024. 120 patients are recruited based on referral or from patients attending the clinic, with 2 or more actinic keratoses on the head, 60 to the pulsed dye-laser study and 60 to the fractional laser study. Follow-up appointments are 6 months, 1 year and 2 years post treatment. Patient reported maximal pain during treatment is documented.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 2 AKs located on both sides of the head (either the scalp, forehead, temples, or cheeks)\n\nExclusion Criteria:\n\n* pigmented AKs, in situ-carcinomas, skin cancers, psoriasis or eczema on the treatment area'}, 'identificationModule': {'nctId': 'NCT05456334', 'briefTitle': 'New Treatments for Actinic Keratoses of the Scalp', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'New Treatments for Actinic Keratoses of the Scalp', 'orgStudyIdInfo': {'id': '2016-001268-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pulsed dye laser-mediated photodynamic therapy', 'description': 'After curretage light-sensitizer (methyl aminolaevulinate cream) was applied on the lesions and covered with an occlusive plastic foil for 2-3-h incubation. Then a local lidocaine anaesthetic spray was applied. The lesions were illuminated with 30% overlapping pulsed laser double-stacked pulses (, energy 7 J/cm2, spot size 7 mm, pulse duration 10 ms, wavelength 595 nm and dynamic cooling 2/3).', 'interventionNames': ['Device: Pulsed-dye laser', 'Drug: Metvix cream']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional photodynamic therapy', 'description': 'After curretage a light-sensitizer (methyl aminolaevulinate cream) was applied on the lesions and covered with an occlusive plastic foil for 2-3-h incubation. Then a local lidocaine anaesthetic spray was applied. The lesions were illuminated with a red LED light for 7-8 min (exposure 75 J/cm2, wavelength 630 nm).', 'interventionNames': ['Drug: Metvix cream']}, {'type': 'EXPERIMENTAL', 'label': 'Ablative fractional laser- mediated daylight photodynamic therapy', 'description': 'After curretage lidocaine anaesthetic spray was applied on the whole treatment area. Lesions were treated with an ablative fractional CO2-laser (19 W, Dot mode, spacing 1000 µm, stack 3, scanning dwell time 1800 µs, repeat 0.5 s). A thin layer of light sensitizer (methyl aminolaevulinate cream) was applied on the treatment area. The patients were asked to move outdoors (temperature \\>10C, no rain, June-August) or to our adPDT-room (IndoorLux®, wavelength 350-750 nm, 15-25 000 lux) within 30 minutes, for the 2h-illumination.', 'interventionNames': ['Device: Fractional CO2-laser', 'Drug: Metvix cream']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Daylight photodynamic therapy', 'description': 'After curretage lidocaine anaesthetic spray was applied on the whole treatment area. A thin layer of light sensitizer (methyl aminolaevulinate cream) was applied on the treatment area. The patients were asked to move outdoors (temperature \\>10C, no rain, June-August) or to our adPDT-room (IndoorLux®, wavelength 350-750 nm, 15-25 000 lux) within 30 minutes, for the 2h-illumination.', 'interventionNames': ['Drug: Metvix cream']}], 'interventions': [{'name': 'Pulsed-dye laser', 'type': 'DEVICE', 'description': 'Comparance of pulsed-dye laser-mediated and conventional photodynamic therapy in a split-head design', 'armGroupLabels': ['Pulsed dye laser-mediated photodynamic therapy']}, {'name': 'Fractional CO2-laser', 'type': 'DEVICE', 'description': 'Comparance of fractional CO2-laser-mediated or plain daylight photodynamic therapy in a split-head design', 'armGroupLabels': ['Ablative fractional laser- mediated daylight photodynamic therapy']}, {'name': 'Metvix cream', 'type': 'DRUG', 'description': 'Metvix-cream was used for photodynamic therapy in all experimental arms', 'armGroupLabels': ['Ablative fractional laser- mediated daylight photodynamic therapy', 'Conventional photodynamic therapy', 'Daylight photodynamic therapy', 'Pulsed dye laser-mediated photodynamic therapy']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Kirsi Isoherranen', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}