Role of Interleukin-13 Pathways on Pain and Itch Sensitivity
ConditionItch
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAalborg University
About this trial
Atopic dermatitis (AD) is as chronic, inflammatory skin disorder affecting 20% of the world's population. Intense itch and skin pain are the main symptoms. Research has shown that the proteins interleukins are involved in inflammation and itch in atopic dermatitis. The medicinal product called Lebrikizumab, used for treatment of AD, has shown to block the interleukin called IL-13. The purpose of this experiment is to evaluate the role of IL-13 in itch in both healthy subjects and people with atopic dermatitis.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy men and women
18-60 years
Disqualifiers
Pregnancy or lactation
Drug addiction defined as any use of cannabis, opioids, or other drugs
Previous or current history of neurological, dermatological (e.g., AD, psoriasis, etc.), immunological, musculoskeletal, cardiac disorder, or psychiatric diagnoses that may affect the results (e.g., neuropathy, muscular pain in the upper extremities, anxiety, depression, schizophrenia, etc.)
Moles, wounds, scars, or tattoos in the area to be treated or tested
Trial design
Design model
Single group
Treatments tested in this trial
Histamine
Other interventionA small drop of histamine dihydrochloride (1%, in saline) will be applied to a previously determined area on the volar forearm followed by a prick through the drop.
Cowhage
Other interventionApproximately 30-35 cowhage spicules will be manually inserted into the subject's skin.
bovine adrenal medulla (BAM8-22)
Other interventionA small drop of BAM8-22 solution will be applied to a previously determined area on the volar forearm followed by a prick through the drop.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: LebrikizumabExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Measuring itch by computerized Visual Analog Scale Scoring
The subjects will be asked to rate the sensation of itch on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no itch" and 100 indicates "worst itch imaginable".
Time frame
1 minute after every itch induction2
Measuring pain by computerized Visual Analog Scale Scoring
The subjects will be asked to rate the sensation of pain on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no pain" and 100 indicates "worst pain imaginable".
Time frame
1 minute after every itch induction3
Superficial blood perfusion
Superficial blood perfusion (SBP) is measured by a Speckle contrast imager
Time frame
Baseline4
Superficial blood perfusion
Superficial blood perfusion (SBP) is measured by a Speckle contrast imager
Time frame
10 minute after every itch inductionSecondary outcomes
1
Mechanical Pain Thresholds (MPT)
This test is conducted using a pinprick set. The set consists of 7 needles each with a diameter of 0.6 mm and different force applications: 8, 16, 32, 64, 128, 256, and 512 mN.
Time frame
Baseline2
Mechanical Pain Sensitivity (MPS)
This test is conducted with the same pinprick set used to test the MPT.
Time frame
Baseline3
Pressure Pain Thresholds (PPT)
Pressure will be applied by a handheld electronic pressure algometer (Somedic AB, Stockholm, Sweden) on to the supinator muscle on the left forearm.
Time frame
Baseline4
Cold Detection Thresholds (CDT)
The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device
Time frame
BaselieneSponsors and contacts
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Source ClinicalTrials.gov