This pilot study compares three photosensitisers, hexylaminolevulinate (HAL) and aminolevulinic acid nano emulsion (BF-200 ALA) to methylaminolevulinate (MAL) in photodynamic therapy of superficially growing basal cell carcinomas. Study is conducted using randomised prospective double blinded comparing design. Fluorescence is measured in A.U. (Arbitrary Unit) with standardised set-up before and after the exposure. Efficacy is assessed clinically, histologically and by hyperspectral imaging system at 3 months, 12 months and 5 years.
Study recruits volunteering patients, who are referred to the department of dermatology and allergology, Päijät-Häme Central Hospital, Lahti, with 99 clinically assessed superficial basal cell carcinoma on the body area, not face and scalp. Diagnoses is confirmed histologically by punch biopsies and hyperspectral images are taken before the biopsies. The lesions are randomised in three groups: interventions HAL and BF-200 ALA and comparator MAL. Photodynamic therapy is given by the standard procedure. Fluorescence is measured in A.U. (Arbitrary Unit) with standardised set-up, with Wood's light, digital camera and a yellow lens, before and after the exposure. Pain is measured in VAS-scale before, during and after the exposure. Efficacy is assessed clinically, histologically and by hyperspectral imaging system at 3 months, 12 months and 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
117
The cream is mixed up by the Pharmacy Yliopiston Apteekki for the study and every set is analysed by mass spectrometry.
In the study we use Ameluz.
In the study we use Metvix.
Joint Authority for Päijät-Häme Social and Health Care
Lahti, Finland
Histological lesion clearance
Time frame: 3 months
Histological lesion clearance
Time frame: 12 months
Histological lesion clearance
Time frame: 5 years
Detection of subclinical lesion with hyperspectral imaging system
Time frame: 3 months
Detection of subclinical lesion with hyperspectral imaging system
Time frame: 12 months
Detection of subclinical lesion with hyperspectral imaging system
Time frame: 5 years
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