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Clinical trial

New Treatments for Actinic Keratoses of the Scalp

ID
Name
2016-001268-12
Description
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.
Trial arms
Trial start
2016-03-24
Estimated PCD
2023-12-31
Trial end
2024-12-31
Status
Active (not recruiting)
Treatment
Pulsed-dye laser
Comparance of pulsed-dye laser-mediated and conventional photodynamic therapy in a split-head design
Arms:
Pulsed dye laser-mediated photodynamic therapy
Fractional CO2-laser
Comparance of fractional CO2-laser-mediated or plain daylight photodynamic therapy in a split-head design
Arms:
Ablative fractional laser- mediated daylight photodynamic therapy
Metvix cream
Metvix-cream was used for photodynamic therapy in all experimental arms
Arms:
Ablative fractional laser- mediated daylight photodynamic therapy, Conventional photodynamic therapy, Daylight photodynamic therapy, Pulsed dye laser-mediated photodynamic therapy
Size
120
Primary endpoint
Patient complete (%, P) or partial clearance (%, P)
2 year
Lesion-specific clearance (%, P)
2 year
Eligibility criteria
Inclusion Criteria: * at least 2 AKs located on both sides of the head (either the scalp, forehead, temples, or cheeks) Exclusion Criteria: * pigmented AKs, in situ-carcinomas, skin cancers, psoriasis or eczema on the treatment area
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'half-side comparative randomized controlled study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}
Updated at
2023-11-21

1 organization

1 product

2 indications

Organization
Helsinki University Central Hospital
Product
Metvix
Indication
Photodamaged Skin
Indication
Actinic Keratosis