Role of Interleukin-13 Pathways on Pain and Itch Sensitivity

NCT ID: NCT06503510

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-06
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lebrikizumab

The initial doses will be subcutaneous Lebrikizumab 500 mg (two 250 mg injections) at both week 0 (baseline) and week 2, followed by 250 mg administered subcutaneously at week 4.

Group Type: EXPERIMENTAL

Histamine

Intervention Type: OTHER

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.

Cowhage

Intervention Type: OTHER

Approximately 30-35 cowhage spicules will be manually inserted into the subject's skin.

bovine adrenal medulla (BAM8-22)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Cowhage

Approximately 30-35 cowhage spicules will be manually inserted into the subject's skin.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy men and women
• 18-60 years

Exclusion Criteria

• 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
• Current use of medications that may affect the trial such as antihistamines and pain killers (use of antihistamines should be discontinued 72 hours before the experiment and all topical agents and emollients should be discontinued 24 hours before the experiment).
• Use of systemic and topical corticosteroids
• Consumption of alcohol or painkillers 24 hours before the study days and between these
• Acute or chronic pain
• Participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials)
• Lack of ability to cooperate

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aalborg University

OTHER

Sponsor Role: lead

Responsible Party

Silvia Lo Vecchio

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aalborg University

Gistrup, Aalborg, Denmark

Site Status: RECRUITING

CNAP

Gistrup, Aalborg, Denmark

Site Status: ACTIVE_NOT_RECRUITING

Aalborg University

Aalborg, Denmark, Denmark

Site Status: NOT_YET_RECRUITING

Countries

Denmark

Central Contacts

Silvia Lo Vecchio

Role: CONTACT

slv@hst.aau.dk

21397785

Facility Contacts

Silvia Lo Vecchio, PhD

Role: primary

slv@hst.aau.dk

21397785

Botilla Markussen

Role: backup

bam@hst.aau.dk

20567502

Silvia Lo Vecchio

Role: primary

Other Identifiers

N-20240029

Identifier Type: -

Identifier Source: org_study_id