The purpose of this study is to find out whether injecting ALA into the skin with a jet-injection device and activating the drug with light is a safe treatment that causes few or mild side effects in people with basal cell carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
The Basal Cell Carcinoma/BCC tumor and a 5 mm margin will be injected with a grid of 80 microliters of 20% ALA at 5-8.5 mm between each injection (30-50% overlap).
In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted).
For patients 5-16,after 3h incubation (+/- 30 min), the tumor will be illuminated with red light corresponding to a dose of 75 J/cm2 570- 670 nm or equivalent dose of narrowband red light. The intervention will be repeated at after 14 days in patient 5-16. If the wound is not healed at two weeks, the treatment may be postponed to allow healing (patient 5-16).
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Clinical evaluation of local skin responses on Day 0
Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 0 (PDT treatment #1)
Time frame: Day 1
Clinical evaluation of local skin responses on Day 3
Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 3
Time frame: Day 3
Clinical evaluation of local skin responses on Day 14
Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 14 (PDT treatment #2)
Time frame: Day 14
Clinical evaluation of local skin responses on Day 17
Clinical evaluation of local skin responses on a 0-4 point scale will be performed at Day 17
Time frame: Day 17
Clinical evaluation of local skin responses 3 months post treatment
Clinical evaluation of local skin responses on a 0-4 point scale will be performed 3 months post treatment
Time frame: 3 months after treatment
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After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).