Role of Interleukin-13 Pathways on Pain and Itch Sensitivity

NCT06503510 | Recruiting DMC

• 1 other identifier: N-20240029
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

Itch

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (8)

• Mechanical Pain Thresholds (MPT)

  Baseline

• Mechanical Pain Sensitivity (MPS)

  Baseline

• Pressure Pain Thresholds (PPT)

  Baseline

• Cold Detection Thresholds (CDT)

  Baseliene

• Warm Detection Thresholds (WDT)

  Baseline

Study Arms (1)

Lebrikizumab

EXPERIMENTAL

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.

Other: Histamine; Other: Cowhage; Other: bovine adrenal medulla (BAM8-22)

Interventions

Histamine 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.

Lebrikizumab

Cowhage OTHER

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

Lebrikizumab

bovine adrenal medulla (BAM8-22) 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.

Lebrikizumab

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men and women
• years

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (3)

Aalborg University

Gistrup, Aalborg, 9260, Denmark

RECRUITING

CNAP

Gistrup, Aalborg, 9260, Denmark

ACTIVE NOT RECRUITING

Aalborg University

Aalborg, Denmark, 9260, Denmark

NOT YET RECRUITING

MeSH Terms

Conditions

Pruritus

Interventions

Histamine; bovine adrenal medulla 8-22

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Ethylamines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Autacoids; Inflammation Mediators; Biological Factors

Central Study Contacts

Silvia Lo Vecchio

CONTACT

21397785; slv@hst.aau.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Each participant will be treated with Lebrikizumab and will receive 3 pruritogens: Histamine, cowhage and BAM8-22.

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 16, 2024
• Study Start: January 6, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-01

Locations

DK (3)