NCT06503510

Role of Interleukin-13 Pathways on Pain and Itch Sensitivity

The Role of the Interleukin-13 Pathways on Pain and Itch Sensitivity in Patients With Atopic Dermatitis and Healthy Volunteers

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Aalborg University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

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 interleukin-13 is involved in inflammation and itch in atopic dermatitis by increasing the neuronal sensitivity to pruritogens. However, the physiological mechanisms by which IL-13 increases the itch sensitivity are unclear. The aim of this project is to use, for the first time in humans, the monoclonal antibody Lebrikizumab that inhibits IL-13 with high affinity as a novel experimental tool to modulate the IL-13 pathway and evaluate its role in the transmission and processing of itch and pain.

Conditions

• Itch

Interventions

Type	Name	Description
OTHER	Histamine	A 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.
OTHER	Cowhage	Approximately 30-35 cowhage spicules will be manually inserted into the subject's skin.
OTHER	bovine adrenal medulla (BAM8-22)	A 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.

Timeline

• Start date: 2025-01-06
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2024-07-16
• Last updated: 2025-06-04

Locations

3 sites across 1 country: Denmark