Intradermal and intramuscular injection of levcromacalim and placebo (sterile saline) on the forehead and forearm of healthy subjects and the following will be investigated: 1. Prevalence and intensity of pain 2. Prevalence and intensity of itching 3. Occurrence and intensity of local redness and swelling 4. Occurrence and intensity of local changes in skin temperature and blood flow
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
20
To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.
To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.
Danish headache center
Glostrup Municipality, Copenhagen, Denmark
Occurrence and change of pain from baseline
Occurrence and intensity of pain after levcromakalim injektion compared to placebo. To measure pain numerical rating scale (NRS) 0-10 will be used. The outcome measure is pain and the unit that will be used to measure the pain is NRS.
Time frame: Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection
Occurrence and change of Itching from baseline
Occurrence and intensity of Itching after levcromakalim injektion compared to placebo. To measure itching numerical rating scale (NRS) 0-10 will be used. The outcome measure is itching and the unit that will be used to measure the itching is NRS.
Time frame: Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection
Occurrence and change of redness from baseline
Occurrence and change of redness after levcromakalim injektion compared to placebo. The areal of the redness will be measured. The outcome measure is redness and the unit that will be used to measure the redness is areal cm\^2.
Time frame: Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection.
Occurrence and change of swelling from baseline
Occurrence and change of swelling after levcromakalim injektion compared to placebo. The areal of the swelling will be measured. The outcome measure is swelling and the unit that will be used to measure the swelling is areal cm\^2.
Time frame: Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection.
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Change of blood flow from baseline
Change of blodflow after levcromakalim injektion compared to placebo. The intensity of the blodd flow will be measured by laser speckle The outcome measure is change of blood flow and the laser speckle will be used to measure the blood flow.
Time frame: Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection.
Change of skin temperature from baseline
Change of skin temperature after levcromakalim injektion compared to placebo. The temperature will be measured by thermovision camera. The outcome measure is the change of skin temperature and the thermovision camera will be used to measure skin temperature.
Time frame: Before and after injection of levcromakalim compared with before and after injection of saline. Time of measurements is baseline, 5 min, 10 min, 15 min, 20 min, 25 min, 30 min, 35 min, 40 min and 45 min after the injection.