Role of Interleukin-13 Pathways on Pain and Itch Sensitivity
NCT Number: NCT06503510
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Itch
Interventions: OTHER: Histamine|OTHER: Cowhage|OTHER: bovine adrenal medulla (BAM8-22)
Sponsor: Aalborg University
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2026-12-31
Locations: Aalborg University, Aalborg, 9260, Denmark

Summary:
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.

Primary Outcome Measures: 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"., 1 minute after every itch induction|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"., 1 minute after every itch induction|Superficial blood perfusion, Superficial blood perfusion (SBP) is measured by a Speckle contrast imager, Baseline|Superficial blood perfusion, Superficial blood perfusion (SBP) is measured by a Speckle contrast imager, 10 minute after every itch induction|Wheal reaction, Wheal reaction measurement will be conducted immediately after the removal of pruritogens by measuring the longest diameter with a ruler., 10 minute after every itch induction|Average pruritis and pain numerical rating scale (NRS), The subject will be asked to retrospectively rate the average and worst itch/pain on an 11-point scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)experience they had during the last 7 days., Baseline|Skin peak pain numerical rating scale (SPP-NRS), According to the SPP-NRS, the subject will be asked about "worst skin pain" they felt in the past 24 hours on an 11-point scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain), Baseline|Peak pruritus numerical rating scale (PP-NRS), The subject will be asked about the "worst itch" they felt in the past 24 hours on an 11-point scale ranging from 0 to 10 (0 = no itch and 10 = worst imaginable itch), Baseline|Mechanically evoked itch (MEI), MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force)., Baseline|Mechanically evoked itch (MEI), MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force)., 10 minutes after every itch induction
Secondary Outcome Measures: 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., Baseline|Mechanical Pain Sensitivity (MPS), This test is conducted with the same pinprick set used to test the MPT., Baseline|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., Baseline|Cold Detection Thresholds (CDT), The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device, Baseliene|Warm Detection Thresholds (WDT), The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testingdevice, Baseline|Cold Pain Thresholds (CPT), The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device, Baseline|Heat Pain Thresholds (HPT), The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device, Baseline|Pain to Supra-threshold Heat Stimuli (STHS), The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device, Baseline